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Background: Domestic violence during pregnancy is especially concerning due to its significant detrimental impact on a woman's health and that of her unborn child. The study aims to evaluate the effects of a behavioural intervention package (BIP) delivered during pregnancy on the quality of life (QOL), domestic violence (DV), and reproductive and child health (RCH) of women experiencing DV. Methods: A randomised controlled trial was conducted on 211 pregnant women recruited between 18 and 20 weeks of pregnancy and randomly assigned to one of two groups: intervention (n = 105) or control (n = 106). The intervention group received BIP and standard care, while the control group received only standard care for 28 weeks. Study tools included socio-demographic variables, a short-form health survey, an abuse assessment screening tool, and an RCH checklist. The tools were completed once before the intervention and again at 6 weeks postnatal. The tools and their subscales were compared pre- and post-intervention using a paired t-test, or Wilcoxon signed test as appropriate to estimate the effect size at baseline and post-intervention. Results: Post-intervention, the QOL scores were found to be significant, with a positive effect favouring the intervention as compared to the control group. The BIP intervention, which was found to be significantly effective (P ≤ 0.001) in reducing DV for pregnant women experiencing DV, was higher in the intervention group than in the control group. Conclusion: The BIP may be an appropriate method for treating pregnant women experiencing DV from low socioeconomic strata who attend public hospitals in India to improve their QOL. The approach may offer an intervention that healthcare institutions or other organizations in contact with women at risk of violence can implement. Trial registration: Indian Registry of Clinical Trials CTRI/2019/01/017009. Registered on 09/01/2019. [ABSTRACT FROM AUTHOR]

Abstract Background Domestic violence during pregnancy is especially concerning due to its significant detrimental impact on a woman’s health and that of her unborn child. The study aims to evaluate the effects of a behavioural intervention package (BIP) delivered during pregnancy on the quality of life (QOL), domestic violence (DV), and reproductive and child health (RCH) of women experiencing DV. Methods A randomised controlled trial was conducted on 211 pregnant women recruited between 18 and 20 weeks of pregnancy and randomly assigned to one of two groups: intervention (n = 105) or control (n = 106). The intervention group received BIP and standard care, while the control group received only standard care for 28 weeks. Study tools included socio-demographic variables, a short-form health survey, an abuse assessment screening tool, and an RCH checklist. The tools were completed once before the intervention and again at 6 weeks postnatal. The tools and their subscales were compared pre- and post-intervention using a paired t-test, or Wilcoxon signed test as appropriate to estimate the effect size at baseline and post-intervention. Results Post-intervention, the QOL scores were found to be significant, with a positive effect favouring the intervention as compared to the control group. The BIP intervention, which was found to be significantly effective (P ≤ 0.001) in reducing DV for pregnant women experiencing DV, was higher in the intervention group than in the control group. Conclusion The BIP may be an appropriate method for treating pregnant women experiencing DV from low socioeconomic strata who attend public hospitals in India to improve their QOL. The approach may offer an intervention that healthcare institutions or other organizations in contact with women at risk of violence can implement. Trial registration Indian Registry of Clinical Trials CTRI/2019/01/017009. Registered on 09/01/2019.

Abstract Background Concerns about mental and cognitive health are common among university students. Engaging in regular physical exercise has been shown to enhance both mental health and cognitive performance, yet most students are not participating in the level of exercise required to obtain these benefits. The Behaviour Change Wheel (BCW) provides a framework for developing behavioural interventions that are informed by theory, evidence, and stakeholder perspectives. The current study aimed to apply the BCW to develop the PEAK Mood, Mind, and Marks program (i.e., PEAK), a behaviour change intervention designed to increase university students’ exercise engagement for the benefit of their mental and cognitive health. Methods PEAK was developed across three stages of the BCW: (1) understand the target behaviour, (2) identify intervention options, and (3) identify intervention content and delivery mode. Development was informed by triangulated data from a systematic literature review, co-design consultations with key stakeholders, and knowledge of relevant experts. Consultations with stakeholders involved focus groups with 25 university students and individual interviews with 10 university leaders and staff to identify barriers and facilitators to students’ exercise engagement and the adoption and implementation of PEAK by universities. Template analysis was used to code transcripts to the capability, opportunity, and motivation (COM-B) model of behaviour. The BCW was applied to identify the most appropriate intervention types and behaviour change techniques (BCTs). Results Thirty-one barriers and facilitators were identified and mapped to seven intervention types (Education; Modelling; Persuasion; Environmental Restructuring; Incentivisation; Training; and Enablement) and 26 BCTs, which were delivered across digital channels and in-person. The final intervention consisted of multiple components targeting students’ capability (e.g., increasing knowledge about the mental and cognitive health benefits of exercise), opportunity (e.g., providing a flexible range of accessible exercise options and social support), and motivation (e.g., increasing the perceived importance of exercise) to exercise. Conclusions University students and staff describe a need and appetite for more empowering, scalable solutions to support students’ mental and cognitive health. Exercise-based approaches that are informed by behaviour change frameworks, evidence, and stakeholder perspectives, such as PEAK, have the potential to address this need. Current findings will inform a pilot of PEAK to evaluate its efficacy and implementation.

Abstract Background Sleep problems are common among infants and can have a serious impact on the health and wellbeing of both child and parents. To sustainably promote infant sleep on a population level, it is necessary to develop evidence-based programs that can be implemented on a large scale. The Youth Health Care setting, with its focus on prevention, child health promotion and services widely available for parents, can be a suitable setting to do so. Currently however, sleep health promotion in this setting seems to be suboptimal. To promote healthy infant sleep on a population level, programs need to be accessible and comprehensible for all parents, including parents with limited (health) literacy. Therefore, this study aims to develop, implement and evaluate a program called ‘Sleep on number 1’, that is tailored to Dutch Youth Health Care, to sustainably promote healthy sleep in 0-2-year-old infants. Methods The program was developed based on co-creation with parents and Youth Health Care professionals, evidence-based behaviour change theories and sleep health promotion methods. Program effectiveness is investigated with a quasi-experimental study design comparing the program group with the care as usual control group. Participants consist of parents of 0-2-year-old children. Primary outcome is infant sleep quality at the age of 10 weeks and 6, 9, 14 and 24 months, measured with a sleep diary. The primary data analysis focuses on night awakenings at 9 months. Secondary outcomes focus on parental behaviour regarding infant sleep, related behavioural determinants and parental satisfaction with Youth Health Care sleep advice. Program effectiveness is analysed using a linear mixed-model in case of data clustering, and an independent samples T-test or linear regression in case no substantial clustering effects are found. A mixed methods process evaluation is performed with parents and Youth Health Care professionals, assessing program reach, adoption, implementation, maintenance and working mechanisms. Discussion The ‘Sleep on number 1’ program is an evidence-based sleep health program for 0-2-year-old children, tailored to Dutch Youth Health Care. If effective, this program has the potential to improve infant sleep on a population level. Trial registration ISRCTN, ISRCTN27246394, registered on 10/03/2023. https://www.isrctn.com/ISRCTN27246394 .

Background: Sleep problems are common among infants and can have a serious impact on the health and wellbeing of both child and parents. To sustainably promote infant sleep on a population level, it is necessary to develop evidence-based programs that can be implemented on a large scale. The Youth Health Care setting, with its focus on prevention, child health promotion and services widely available for parents, can be a suitable setting to do so. Currently however, sleep health promotion in this setting seems to be suboptimal. To promote healthy infant sleep on a population level, programs need to be accessible and comprehensible for all parents, including parents with limited (health) literacy. Therefore, this study aims to develop, implement and evaluate a program called 'Sleep on number 1', that is tailored to Dutch Youth Health Care, to sustainably promote healthy sleep in 0-2-year-old infants. Methods: The program was developed based on co-creation with parents and Youth Health Care professionals, evidence-based behaviour change theories and sleep health promotion methods. Program effectiveness is investigated with a quasi-experimental study design comparing the program group with the care as usual control group. Participants consist of parents of 0-2-year-old children. Primary outcome is infant sleep quality at the age of 10 weeks and 6, 9, 14 and 24 months, measured with a sleep diary. The primary data analysis focuses on night awakenings at 9 months. Secondary outcomes focus on parental behaviour regarding infant sleep, related behavioural determinants and parental satisfaction with Youth Health Care sleep advice. Program effectiveness is analysed using a linear mixed-model in case of data clustering, and an independent samples T-test or linear regression in case no substantial clustering effects are found. A mixed methods process evaluation is performed with parents and Youth Health Care professionals, assessing program reach, adoption, implementation, maintenance and working mechanisms. Discussion: The 'Sleep on number 1' program is an evidence-based sleep health program for 0-2-year-old children, tailored to Dutch Youth Health Care. If effective, this program has the potential to improve infant sleep on a population level. Trial registration: ISRCTN, ISRCTN27246394, registered on 10/03/2023. https://www.isrctn.com/ISRCTN27246394. [ABSTRACT FROM AUTHOR]

Simple Summary: This study investigates how the Prostate Cancer Patient Empowerment Program (PC-PEP) helps men with prostate cancer by promoting patient empowerment and activation. This program encourages patients to engage actively in their care, fostering healthy living habits daily, over six months. Involving 128 patients, this research found that those participating in the PC-PEP experienced significant improvements in self-efficacy and emotional responses, leading to reduced psychological distress compared to those receiving standard care. These findings underscore the importance of integrating the PC-PEP into clinical practice to enhance mental health and patient care strategies. Understanding how interventions reduce psychological distress in patients with prostate cancer is crucial for improving patient care. This study examined the roles of self-efficacy, illness perceptions, and heart rhythm coherence in mediating the effects of the Prostate Cancer Patient Empowerment Program (PC-PEP) on psychological distress compared to standard care. In a randomized controlled trial, 128 patients were assigned to either the PC-PEP intervention or standard care. The PC-PEP, a six-month program emphasizing daily healthy living habits, included relaxation and stress management, diet, exercise, pelvic floor muscle exercises, and strategies to improve relationships and intimacy, with daily activities supported by online resources and live sessions. Participants in the intervention group showed significant improvements in self-efficacy and specific illness perceptions, such as personal control and emotional response, compared to the control group. These factors mediated the relationship between the intervention and its psychological benefits, with self-efficacy accounting for 52% of the reduction in psychological distress. No significant differences in heart rhythm coherence were observed. This study highlights the critical role of self-efficacy and illness perceptions in enhancing psychological health in prostate cancer patients through the PC-PEP. The results underscore this program's effectiveness and the key mechanisms through which it operates. Given the high rates of distress among men undergoing prostate cancer treatments, these findings emphasize the importance of integrating the PC-PEP into clinical practice. The implementation of the PC-PEP in clinical settings can provide a structured approach to reducing psychological distress and improving overall patient well-being. [ABSTRACT FROM AUTHOR]

Introduction: Regular exercise has the potential to enhance university students' mental and cognitive health. The PEAK Mood, Mind and Marks program (i.e., PEAK) is a neuroscience-informed intervention developed using the Behaviour Change Wheel to support students to exercise three or more times per week to benefit their mental and cognitive health. This pilot study assessed the impact of PEAK on exercise, mental and cognitive health, and implementation outcomes. Methods: PEAK was delivered to 115 undergraduate university students throughout a 12-week university semester. The primary outcome was weekly exercise frequency. Secondary outcomes were: time spent engaged in moderate-vigorous exercise, sedentary behaviour and perceived mental health and cognitive health. All were measured via online self-report questionnaires. Qualitative interviews with 15 students investigated influences on engagement, the acceptability and appropriateness of PEAK, and its mechanisms of behaviour change. Paired t-tests, Wilcoxon Signed-Rank tests and template analysis were used to analyse quantitative and qualitative data, respectively. Results: On average, 48.4% of students engaged in the recommended frequency of three or more exercise sessions per week. This proportion decreased towards the end of PEAK. Sedentary behaviour significantly decreased from baseline to end-point, and moderate-vigorous exercise significantly increased among students' who were non-exercisers. Mental wellbeing, stress, loneliness, and sense of belonging to the university significantly improved. There were no significant changes in psychological distress. Concentration, memory, and productivity significantly improved. Sixty-eight percent of students remained engaged in one or more components of PEAK at end-point. Qualitative data indicated students found PEAK to be acceptable and appropriate, and that it improved aspects of their capability, opportunity, and motivation to exercise. Conclusions: Students are receptive to an exercise-based program to support their mental and cognitive health. Students exercise frequency decreased; however, these figures are likely a conservative estimate of students exercise engagement. Students valued the neuroscience-informed approach to motivational and educational content and that the program's goals aligned with their academic goals. Students identified numerous areas PEAK's content and implementation can be optimised, including use of a single digital delivery platform, more opportunities to connect with peers and to expand the content's cultural inclusivity. [ABSTRACT FROM AUTHOR]

Coronary artery disease (CAD) poses a significant health risk to the global population and behavioural change theory intervention on lifestyle and physical activities are needed to improve patient's quality of life. Our main objective is to examine the application of behaviour change intervention program on the on the lifestyle and quality of life of patients after coronary intervention. The randomised controlled trial was carried at Fuawi Hospital consisting of 156 participants divided into control and intervention groups. The primary outcomes showed significant changes and increase in levels of physical activity between intervention and controls with the intervention group showing higher frequency, duration and intensity in both moderate physical activity and walking. Secondary outcomes showed significant reductions in the blood pressure, BMI, and improved healthcare-related quality of life. Alsos, significant lifestyle changes were observed with cessation of smoking, increased intake of healthy diets, stress and sleep management. Thus, the behavioural intervention change program was significant in improving the outcomes of CAD patients through increased levels of physical activity, increased quality of life and lifestyle changes. [ABSTRACT FROM AUTHOR]

Mild cognitive impairment (MCI) confers a higher risk of developing dementia. While largely preserved, instrumental activities of daily living (IADLs) may be affected to varying degrees by MCI. The Memory Support System (MSS) is a curriculum and calendar/note-taking system that has proven effective in sustaining independence in IADLs for individuals with MCI and in protecting mood among care partners. Until recently, the MSS has only been utilized among English- and Spanish-speaking samples. This study investigated the use of a translated and culturally adapted MSS in four Frenchspeaking, community-dwelling participants with MCI and their support partners. Measures of treatment adherence, daily function, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden were assessed at baseline, treatment end, and eight-week follow-up. By treatment end and follow-up, participants with MCI showed improvement in adherence to the MSS calendar, IADLs, everyday abilities requiring memory and planning, self-efficacy, depression and anxiety symptoms, and quality of life. Care partners showed improvement in quality of life and depressive symptoms, while their caregiver burden and anxiety symptoms generally remained unchanged. Findings suggest that, with appropriate training, Francophones with MCI can and will use the MSS, and that MSS training may contribute to daily functioning and aspects of participant and care partner well-being. [ABSTRACT FROM AUTHOR]

A reduction in meat consumption is urgently needed to address multiple harms related to the environment, animal welfare, and human health. Social norm interventions have been found to be feasible and effective at shifting consumer behaviour, however, evidence related to meat reduction behaviour is limited - especially in naturalistic settings. Two social norm interventions were conducted at university food outlets in Aotearoa New Zealand and in the UK, to assess the effect of social norm messages on meat and meatless food purchases. Both interventions consisted of a week-long intervention phase during which descriptive dynamic social norm messages referring to reduced meat intake were displayed in the food outlets (study one and two) and via social media (study two). Meat and meatless food purchases during the interventions were compared to pre- and post-intervention weeks. Surveys were also conducted with a sub-group of customers to assess demographics, dietary habits, and awareness of the social norm message. In both studies, there was no significant effect of the social norm interventions on meat or meatless food purchases, and awareness of the norms message across both studies was low. These findings indicate that social norm interventions alone may be ineffective in encouraging meat reduction. Implications for interventions to reduce meat intake to support pro-environmental food choices are discussed. [ABSTRACT FROM AUTHOR]

Background: The Prostate Cancer—Patient Empowerment Program (PC-PEP) is a six-month daily home-based program shown to improve mental health and urinary function. This secondary analysis explores weight loss in male PC-PEP participants. Methods: In a randomized clinical trial with 128 men undergoing curative prostate cancer (PC) treatment, 66 received 'early' PC-PEP, while 62 were assigned to the 'late' waitlist-control group, receiving 6 months of standard-of-care treatment followed by 6 months of PC-PEP. PC-PEP comprised 182 daily emails with video-based exercise and dietary (predominantly plant-based) education, live online events, and 30 min strength training routines (using body weight and elastic bands). Weight and height data were collected via online surveys (baseline, 6 months, and 12 months) including medical chart reviews. Adherence was tracked weekly. Results: No attrition or adverse events were reported. At 6 months, the early PC-PEP group experienced significant weight loss, averaging 2.7 kg (p < 0.001) compared to the waitlist-control group. Weight loss was noted in the late intervention group of PC-PEP, albeit less pronounced than in the early group. Early PC-PEP surgery patients lost on average 1.4 kg (SE = 0.65) from the trial's start to surgery day. High adherence to exercise and dietary recommendations was noted. Conclusions: PC-PEP led to significant weight loss in men undergoing curative prostate cancer treatment compared to standard-of-care. [ABSTRACT FROM AUTHOR]

Simple Summary: In this research, we explore the effectiveness of a unique home-based 6-month comprehensive program designed to empower prostate cancer patients during their treatment. The Prostate Cancer-Patient Empowerment Program (PC-PEP) aims to enhance the quality of life for men undergoing curative treatment for prostate cancer, focusing on improving urologic function. Through a blend of physical activities, dietary education and recommendations, stress management, and social support, PC-PEP offers an innovative approach to patient care. This study rigorously assesses the impact of PC-PEP through a detailed 6-month comparison with standard care, evaluating its potential to significantly improve patient-reported outcomes. Our findings hold the promise of reshaping patient care strategies, presenting a potentially valuable addition to clinical practices for men battling prostate cancer, with the hope of improving not just their physical well-being but also their overall quality of life. Purpose: This is a secondary analysis examining a six-month home-based Prostate Cancer-Patient Empowerment Program (PC-PEP) on patient-reported urinary, bowel, sexual, and hormonal function in men with curative prostate cancer (PC) against standard of care. Methods: In a crossover clinical trial, 128 men scheduled for PC surgery (n = 62) or radiotherapy with/without hormones (n = 66) were randomized to PC-PEP (n = 66) or waitlist-control and received the standard of care for 6 months, and then PC-PEP to the end of the year. PC-PEP included daily emails with video instructions, aerobic and strength training, dietary guidance, stress management, and social support, with an initial PFMT nurse consultation. Over 6 months, participants in the PC-PEP received optional text alerts (up to three times daily) reminding them to follow the PFMT video program, encompassing relaxation, quick-twitch, and endurance exercises; compliance was assessed weekly. Participants completed baseline, 6, and 12-month International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (EPIC) questionnaires. Results: At 6 months, men in the PC-PEP reported improved urinary bother (IPSS, p = 0.004), continence (EPIC, p < 0.001), and irritation/obstruction function (p = 0.008) compared to controls, with sustained urinary continence benefits at 12 months (p = 0.002). Surgery patients in the waitlist-control group had 3.5 (95% CI: 1.2, 10, p = 0.024) times and 2.3 (95% CI: 0.82, 6.7, p = 0.11) times higher odds of moderate to severe urinary problems compared to PC-PEP at 6 and 12 months, respectively. Conclusions: PC-PEP significantly improves lower urinary tract symptoms, affirming its suitability for clinical integration alongside established mental health benefits in men with curative prostate cancer. [ABSTRACT FROM AUTHOR]

IntroductionRegular exercise has the potential to enhance university students’ mental and cognitive health. The PEAK Mood, Mind and Marks program (i.e., PEAK) is a neuroscience-informed intervention developed using the Behaviour Change Wheel to support students to exercise three or more times per week to benefit their mental and cognitive health. This pilot study assessed the impact of PEAK on exercise, mental and cognitive health, and implementation outcomes.MethodsPEAK was delivered to 115 undergraduate university students throughout a 12-week university semester. The primary outcome was weekly exercise frequency. Secondary outcomes were: time spent engaged in moderate-vigorous exercise, sedentary behaviour and perceived mental health and cognitive health. All were measured via online self-report questionnaires. Qualitative interviews with 15 students investigated influences on engagement, the acceptability and appropriateness of PEAK, and its mechanisms of behaviour change. Paired t-tests, Wilcoxon Signed-Rank tests and template analysis were used to analyse quantitative and qualitative data, respectively.ResultsOn average, 48.4% of students engaged in the recommended frequency of three or more exercise sessions per week. This proportion decreased towards the end of PEAK. Sedentary behaviour significantly decreased from baseline to end-point, and moderate-vigorous exercise significantly increased among students’ who were non-exercisers. Mental wellbeing, stress, loneliness, and sense of belonging to the university significantly improved. There were no significant changes in psychological distress. Concentration, memory, and productivity significantly improved. Sixty-eight percent of students remained engaged in one or more components of PEAK at end-point. Qualitative data indicated students found PEAK to be acceptable and appropriate, and that it improved aspects of their capability, opportunity, and motivation to exercise.ConclusionsStudents are receptive to an exercise-based program to support their mental and cognitive health. Students exercise frequency decreased; however, these figures are likely a conservative estimate of students exercise engagement. Students valued the neuroscience-informed approach to motivational and educational content and that the program’s goals aligned with their academic goals. Students identified numerous areas PEAK’s content and implementation can be optimised, including use of a single digital delivery platform, more opportunities to connect with peers and to expand the content’s cultural inclusivity.

Background: Timely detection and management of gestational diabetes mellitus (GDM) have been identified as a high priority for policymakers in low- and middle-income countries (LMICs). The GUIDES trial will evaluate a package of three interconnected film-based interventions aimed at improving the timely detection and management of GDM. The protocol for this trial has previously been published; this publication outlines the statistical analysis plan for the trial. Methods and design: The GUIDES study is a multi-country cluster-randomised controlled trial consisting of one trial conducted in Uganda and one in India (30 clusters in each country). Mixed effects models will be used to compare the primary study outcomes of the proportion of women who are tested for GDM between 24 and 32 weeks of pregnancy and the mean fasting blood sugar of women with GDM at 34-week follow-up while accounting for clustering. Secondary analyses will compare the proportion of women with self-reported GDM diagnosis at 32 weeks of pregnancy and the proportion of women with adverse perinatal outcomes related to GDM up to 4 weeks after birth in each trial arm. Trial status and discussion: Follow-up is expected to end in March 2023 in Uganda and in May 2023 in India. Analyses will be carried out following this statistical analysis plan in the month following trial completion. Trial registration: ClinicalTrials.gov NCT03937050. Registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605. Registered on 26 February 2020. [ABSTRACT FROM AUTHOR]

A reduction in meat consumption is urgently needed to address multiple harms related to the environment, animal welfare, and human health. Social norm interventions have been found to be feasible and effective at shifting consumer behaviour, however, evidence related to meat reduction behaviour is limited – especially in naturalistic settings. Two social norm interventions were conducted at university food outlets in Aotearoa New Zealand and in the UK, to assess the effect of social norm messages on meat and meatless food purchases. Both interventions consisted of a week-long intervention phase during which descriptive dynamic social norm messages referring to reduced meat intake were displayed in the food outlets (study one and two) and via social media (study two). Meat and meatless food purchases during the interventions were compared to pre- and post-intervention weeks. Surveys were also conducted with a sub-group of customers to assess demographics, dietary habits, and awareness of the social norm message. In both studies, there was no significant effect of the social norm interventions on meat or meatless food purchases, and awareness of the norms message across both studies was low. These findings indicate that social norm interventions alone may be ineffective in encouraging meat reduction. Implications for interventions to reduce meat intake to support pro-environmental food choices are discussed.

Abstract Background Timely detection and management of gestational diabetes mellitus (GDM) have been identified as a high priority for policymakers in low- and middle-income countries (LMICs). The GUIDES trial will evaluate a package of three interconnected film-based interventions aimed at improving the timely detection and management of GDM. The protocol for this trial has previously been published; this publication outlines the statistical analysis plan for the trial. Methods and design The GUIDES study is a multi-country cluster-randomised controlled trial consisting of one trial conducted in Uganda and one in India (30 clusters in each country). Mixed effects models will be used to compare the primary study outcomes of the proportion of women who are tested for GDM between 24 and 32 weeks of pregnancy and the mean fasting blood sugar of women with GDM at 34-week follow-up while accounting for clustering. Secondary analyses will compare the proportion of women with self-reported GDM diagnosis at 32 weeks of pregnancy and the proportion of women with adverse perinatal outcomes related to GDM up to 4 weeks after birth in each trial arm. Trial status and discussion Follow-up is expected to end in March 2023 in Uganda and in May 2023 in India. Analyses will be carried out following this statistical analysis plan in the month following trial completion. Trial registration ClinicalTrials.gov NCT03937050. Registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605. Registered on 26 February 2020.

Abstract Background The growing burden of type 2 diabetes mellitus (T2DM) and the rising cost of healthcare worldwide make it imperative to identify interventions that can promote sustained self-management behaviour in T2DM populations while minimising costs for healthcare systems. The present FEEDBACK study (Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change) aims to evaluate the effects of a novel behaviour change intervention designed to be easily implemented and scaled across a wide range of primary care settings. Methods A cluster randomised controlled trial (RCT) with a 6-month follow-up will be conducted to evaluate the effects of the FEEDBACK intervention. FEEDBACK is a personalised, multi-component intervention intended to be delivered by general practitioners during a routine diabetes consultation. It consists of five steps aimed at enhancing doctor-patient partnership to motivate self-management behaviour: (1) communication of cardiovascular risks using a ‘heart age’ tool, (2) goal setting, (3) action planning, (4) behavioural contracting, and (5) feedback on behaviour. We aim to recruit 264 adults with T2DM and suboptimal glycaemic control from 20 primary care practices in Japan (cluster units) that will be randomly assigned to either the intervention or control group. The primary outcome measure will be the change in HbA1c levels at 6-month follow-up. Secondary outcome measures include the change in cardiovascular risk score, the probability to achieve the recommended glycaemic target (HbA1c

Public and private institutions have gained traction in developing interventions to alter people's behaviours in predictable ways without limiting the freedom of choice or significantly changing the incentive structure. A nudge is designed to facilitate actions by minimizing friction, while a sludge is an intervention that inhibits actions by increasing friction, but the underlying cognitive mechanisms behind these interventions remain largely unknown. Here, we develop a novel cognitive framework by organizing these interventions along six cognitive processes: attention, perception, memory, effort, intrinsic motivation and extrinsic motivation. In addition, we conduct a meta-analysis of field experiments (i.e. randomized controlled trials) that contained real behavioural measures (n = 184 papers, k = 184 observations, N = 2 245 373 participants) from 2008 to 2021 to examine the effect size of these interventions targeting each cognitive process. Our findings demonstrate that interventions changing effort are more effective than interventions changing intrinsic motivation, and nudge and sludge interventions had similar effect sizes. However, these results need to be interpreted with caution due to a potential publication bias. This new meta-analytic framework provides cognitive principles for organizing nudge and sludge with corresponding behavioural impacts. The insights gained from this framework help inform the design and development of future interventions based on cognitive insights.

Background: Fine particulate matter (PM2.5) is a well-known risk factor for worse outcomes of chronic obstructive pulmonary disease (COPD). However, evidence-based guidance on effective personal behavioural strategies to minimise the effects of PM2.5 is limited. This study aimed to assess the effectiveness of a behavioural intervention in reducing PM2.5 exposure and improving clinical outcomes in patients with COPD. Materials and Methods: Participants were 1:1 randomised, and the intervention group received a behavioural intervention consisting of five activities, while the control group received usual care. The participants were followed up for 9 months. The primary outcomes were differences in the score of St. George’s Respiratory Questionnaire for patients with COPD (SGRQ-C) and COPD assessment test (CAT) from baseline. Results: A total of 106 participants were enrolled and 102 completed the study. At the end of the study, the intervention group showed significant improvements in the primary outcomes compared to the control group, with a group difference of −5.9 in the reduction of total SGRQ-C (−3.4 vs. 2.5; p = 0.049) and −3.8 in the CAT score (−1.2 vs. 2.7; p = 0.001). Participants with good adherence to the intervention demonstrated a greater extent of improvement in CAT score and lower PM2.5 levels compared to those who had poor adherence or were in the control group. Regular checking of air quality forecasts was significantly associated with a reduction in CAT scores among all the intervention activities. Conclusion: Individual-level behavioural interventions can be an effective strategy for mitigating the health hazards associated with PM2.5.ClinicalTrials.gov Identifier: NCT04878367.

Background: The growing burden of type 2 diabetes mellitus (T2DM) and the rising cost of healthcare worldwide make it imperative to identify interventions that can promote sustained self-management behaviour in T2DM populations while minimising costs for healthcare systems. The present FEEDBACK study (Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change) aims to evaluate the effects of a novel behaviour change intervention designed to be easily implemented and scaled across a wide range of primary care settings. Methods: A cluster randomised controlled trial (RCT) with a 6-month follow-up will be conducted to evaluate the effects of the FEEDBACK intervention. FEEDBACK is a personalised, multi-component intervention intended to be delivered by general practitioners during a routine diabetes consultation. It consists of five steps aimed at enhancing doctor-patient partnership to motivate self-management behaviour: (1) communication of cardiovascular risks using a 'heart age' tool, (2) goal setting, (3) action planning, (4) behavioural contracting, and (5) feedback on behaviour. We aim to recruit 264 adults with T2DM and suboptimal glycaemic control from 20 primary care practices in Japan (cluster units) that will be randomly assigned to either the intervention or control group. The primary outcome measure will be the change in HbA1c levels at 6-month follow-up. Secondary outcome measures include the change in cardiovascular risk score, the probability to achieve the recommended glycaemic target (HbA1c <7.0% [53mmol/mol]) at 6-month follow-up, and a range of behavioural and psychosocial variables. The planned primary analyses will be carried out at the individual level, according to the intention-to-treat principle. Between-group comparisons for the primary outcome will be analysed using mixed-effects models. This study protocol received ethical approval from the research ethics committee of Kashima Hospital, Fukushima, Japan (reference number: 2022002). Discussion: This article describes the design of a cluster RCT that will evaluate the effects of FEEDBACK, a personalised, multicomponent intervention aimed at enhancing doctor-patient partnership to engage adults with T2DM more effectively in self-management behaviour. Trial registration: The study protocol was prospectively registered in the UMIN Clinical Trials Registry (UMIN-CTR ID UMIN000049643 assigned on 29/11/2022). On submission of this manuscript, recruitment of participants is ongoing. [ABSTRACT FROM AUTHOR]

BackgroundGiven the documented decline in levels of physical activity in early adolescence, promoting physical activity in young people is a priority for health promotion. School physical education (PE) is an important existing network in which participation in physical activity beyond school can be promoted to the captive young people. The objective of current article is to present the protocol for a PE teacher-delivered theory-based trial to promote secondary school students' participation in physical activity out-of-school contexts. The intervention will be guided by the trans-contextual model explaining the processes by which PE teachers' support for autonomous motivation in the classroom promotes students' motivation to engage in out-of-school physical activity. We hypothesize that school students receiving the teacher-delivered intervention to promote autonomous motivation toward physical activity will exhibit greater participation in physical activities outside of school, relative to students receiving a control intervention.MethodsThe trial will adopt a waitlist-control design with cluster-randomization by school. PE teachers assigned to the intervention condition will receive a two-week, 12-h training program comprising basic information on how to promote out-of-school physical activity and theory-based training on strategies to promote students' autonomous motivation toward physical activity. Teachers assigned to the waitlist control condition will receive an alternative training on how to monitor physical functional capacity in children with special needs. PE teachers (n = 29) from eleven schools will apply the intervention program to students (n = 502) in PE classes for one month. Physical activity participation, the primary outcome variable, and psychological mediators from the trans-contextual model will be measured at pre-trial, post-trial, and at one-, three- and six-months post-trial. We will also assess teachers' autonomy-supportive techniques and behaviours by observation.DiscussionThe study will make a unique contribution to the literature by testing a theory-based intervention delivered by PE teachers to promote school students' participation in out-of-school physical activity. Information will be useful for educators, community stakeholders and policy makers interested in developing programs to promote students' out-of-school physical activity.Trial registrationISRCTN39374060 . Registered 19.7.2018.

This study intervened in the problem behaviours of aggression and violence noticed in Nigerian primary schools in Abuja F.C.T using Cognitive Behavioural Intervention (CBI). The study employed a quasi-experimental research design. The study population comprises all primary school pupils in Abuja FCT, Nigeria. Two purposes, research questions and hypotheses, guided this study. The sample size consists of 44 pupils, drawn from six primary schools purposively sampled from 40 schools in FCT. The instrument used for data collection was the aggression and Violence Questionnaire (AVQ). Data were analyzed using means and analysis of covariance (ANCOVA). Findings indicate that Cognitive Behavioural Intervention (CBI) positively affects aggression and violence, leading to a change in behaviours. It is recommended that Cognitive Behavioural Intervention (CBI) should be employed in all primary schools in Nigeria and the world as an Intervention and corrective mechanism to problem behaviours in the classroom to enhance teaching and learning in schools.

Abstract Background Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist ‘Tier 3’ Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity. Methods This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted. Discussion This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients. Trial registration ISRCTN number 22088800.

Abstract Introduction Despite the importance of intervention fidelity in interpreting the outcomes of complex public health interventions, there is a lack of both reporting fidelity trial protocols and uniformity. In evaluating complex, adaptable/pragmatic interventions in resource-strapped settings with systemic issues, unique challenges to intervention adherence and monitoring are introduced, increasing the importance of a fidelity protocol. We aim to describe the intervention fidelity and monitoring protocol for the Healthy Life Trajectories Initiative (HeLTI) South Africa, a complex four-phase intervention set in urban Soweto, starting preconceptionally and continuing through to pregnancy, infancy, and early childhood to improve the health of young women and reduce the intergenerational risk of obesity. Methods The HeLTI SA fidelity protocol was based on the NIH Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. Context-specific fidelity challenges were identified. The intervention fidelity components and associated monitoring strategies were developed to align with HeLTI SA. Strategies for fidelity monitoring include, amongst others, qualitative process evaluation methods, reviewing observed and recorded intervention sessions, monitoring of activity logs, standardized training, and intervention session checklists. Possible challenges to fidelity and fidelity monitoring include high provider turnover, lack of qualification amongst providers, difficulty tracing participants for follow-up sessions, participant health literacy levels, and the need to prioritize participants’ non-health-related challenges. Solutions proposed include adapting intervention delivery methods, recruitment methods, and provider training methods. Discussion The NIH BCC Treatment Fidelity Framework provided a solid foundation for reporting intervention fidelity across settings to improve intervention validity, ability to assess intervention effectiveness, and transparency. However, context-specific challenges to fidelity (monitoring) were identified, and transparency around such challenges and possible solutions in low- and middle-income settings could help foster solutions to improve adherence, reporting, and monitoring of intervention fidelity in this setting. Trial registration Pan African Clinical Trials Registry PACTR201903750173871 . Registered on 27 March 2019

Abstract Background Between 2012 and 2015, the Uthando Lwethu (UL) study demonstrated that a theory-based behavioural couples-focused intervention significantly increased participation in couples HIV testing and counselling (CHTC) among South African couples who had never previously tested for HIV together or mutually disclosed their HIV status, 42% compared to 12% of the control group at 9 months follow-up. Although effective, we were nonetheless concerned that in this high prevalence setting the majority (58%) of intervention couples chose not to test together. In response we optimised the UL intervention and in a new study, ‘Igugu Lethu’, we are evaluating the success of the optimised intervention in promoting CHTC. Methods One hundred eighty heterosexual couples, who have been in a relationship together for at least 6 months, are being recruited and offered the optimised couples-focused intervention. In the Igugu Lethu study, we have expanded the health screening visit offered to couples to include other health conditions in addition to CHTC. Enrolled couples who choose to schedule CHTC will also have the opportunity to undertake a random blood glucose test, blood pressure and BMI measurements, and self-sample for STI testing as part of their health screening. Individual surveys are administered at baseline, 4 weeks and 4 months follow-up. The proportion of couples who decide to test together for HIV will be compared to the results of the intervention arm in the UL study (historical controls). To facilitate this comparison, we will use the same recruitment and follow-up strategies in the same community as the previous UL study. Discussion By strengthening communication and functioning within the relationship, the Igugu Lethu study, like the previous UL study, aims to transform the motivation of individual partners from a focus on their own health to shared health as a couple. The Igugu Lethu study findings will answer whether the optimised couples-focused behavioural intervention and offering CHTC as part of a broader health screening for couples can increase uptake of CHTC by 40%, an outcome that would be highly desirable in populations with high HIV prevalence. Trial registration Retrospectively registered. ISRCTN Registry ISRCTN 46162564 Registered on 26th May 2022.

Abstract Background About 85% of patients receiving opioid agonist therapy (OAT) for opioid dependence are smoking tobacco. Although smoke-related pulmonary diseases are significant contributors to morbidity and mortality, few smoking cessation interventions are evaluated within this group, and few OAT patients are offered smoking cessation as an integrated part of their addiction treatment. This study protocol describes an integrated smoking cessation intervention aimed at patients receiving OAT and smoking tobacco. Methods This is a multicentre, randomised controlled clinical trial that will recruit 266 daily tobacco smoking patients receiving OAT in OAT outpatient clinics in Bergen and Stavanger, Norway. The patients randomised for the intervention arm will be offered smoking cessation therapy consisting of weekly brief behavioural interventions and prescription-free nicotine replacement products. In the control arm, patients will receive standard care without any added interventions related to smoking cessation. The smoking cessation intervention includes psychoeducational techniques with components from motivational interviewing, and nicotine replacement products such as nicotine lozenges, patches, and chewing gum. The duration of the intervention is 16 weeks, with the option of extending it by a further 8 weeks. The main outcomes are measured at 16 weeks after initiation of the intervention, and sustained effects are evaluated 1 year after intervention initiation. The primary outcome is smoking cessation verified by carbon monoxide (CO) levels or at least a 50% reduction in the number of cigarettes smoked. Secondary outcomes are changes in psychological well-being, biochemical inflammation markers, changes in physical health, quality of life, and fatigue. Discussion Integration of other treatments to standard OAT care improves adherence and completion rates providing another rationale for integrated smoking cessation treatment. Thus, if integrated smoking cessation treatment is superior to standard care, this trial provides important information on further scale-up. Trial registration ClinicalTrials.gov NCT05290025. Registered on 22 March 2022

Abstract Background Smoking poses a serious risk of early preventable death and disease especially for women living with socio-economic disadvantage (SED). A smoking cessation programme, ‘We Can Quit’, was developed in Ireland tailored to SED women. This includes group-based support delivered by trained lay local community facilitators (CFs) and free nicotine replacement therapy (NRT). The intervention was pilot tested in a cluster randomised controlled trial, ‘We Can Quit 2’. This paper reports on the WCQ2 process evaluation which assessed feasibility and acceptability of the programme and trial processes. Methods Embedded qualitative design using the UK Medical Research Council’s process evaluation framework. Semi-structured interviews with trial participants (N = 21) and CFs (N = 8). Thematic analysis was utilised. Results Peer-modelling, a non-judgemental environment, CFs facilitation of group support were viewed as acceptable programme related factors. Some participants expressed concerns about NRT side effects. Provision of free NRT was welcomed and accepted by participants, although structural barriers made access challenging. Pharmacists took on a role that became larger than originally envisaged – and the majority provided additional support to women in their quit attempts between group meetings which augmented and supplemented the intervention sessions provided by the CFs. Participants reported good acceptance of repeated measures for data collection, but mixed acceptability of provision of saliva samples. Low literacy affected the feasibility of some women to fully engage with programme and trial-related materials. This was despite efforts made by intervention developers and the trial team to make materials (e.g., participant intervention booklet; consent forms and participant information leaflets) accessible while also meeting requirements under 2018 European General Data Protection Regulation legislation. Hypothetical scenarios of direct (e.g., researcher present during programme delivery) and indirect (e.g., audio recordings of programme sessions) observational fidelity assessments for a future definitive trial (DT) were acceptable. Conclusions Intervention and trial-related processes were generally feasible and acceptable to participants and CFs. Any future DT will need to take further steps to mitigate structural barriers to accessing free NRT; and the established problem of low literacy and low educational attainment in SED areas, while continuing to comply within the contemporary legislative research environment. Trial registration WCQ2 pilot trial ( ISRCTN74721694 ).

Abstract Background Fidelity assessment of behaviour change interventions is vital to understanding trial outcomes. This study assesses the delivery fidelity of behaviour change techniques used in the Retirement in ACTion (REACT) randomised controlled trial. REACT is a community-based physical activity (PA) and behaviour maintenance intervention to prevent decline of physical functioning in older adults (≥ 65 years) at high risk of mobility-related disability in the UK. Methods The delivery fidelity of intervention behaviour change techniques and delivery processes were assessed using multi-observer coding of purposively sampled in-vivo audio recordings (n = 25) of health behaviour maintenance sessions over 12-months. Delivery fidelity was scored using a modified Dreyfus scale (scores 0–5) to assess competence and completeness of delivery for each technique and delivery process. “Competent delivery” was defined as a score of 3 points or more for each item. Examples of competent intervention delivery were identified to inform recommendations for future programme delivery and training. Results The mean intervention fidelity score was 2.5 (SD 0.45) with delivery fidelity varying between techniques/processes and intervention groups. Person-centred delivery, Facilitating Enjoyment and Promoting Autonomy were delivered competently (scoring 3.0 or more). There was scope for improvement (score 2.0—2.9) in Monitoring Progress (Acknowledging and Reviewing), Self-Monitoring, Monitoring Progress (Eliciting Benefits of Physical Activity), Goal Setting and Action Planning, Modelling, Supporting Self-Efficacy for Physical Activity and Supporting Relatedness. Managing Setbacks and Problem Solving was delivered with low fidelity. Numerous examples of both good and sub-optimal practice were identified. Conclusions This study highlights successes and improvements needed to enhance delivery fidelity in future implementation of the behavioural maintenance programme of the REACT intervention. Future training of REACT session leaders and assessment of delivery fidelity needs to focus on the delivery of Goal setting and Action Planning, Modelling, Supporting Relatedness, Supporting Self-Efficacy for Physical Activity, and Managing Setbacks/ Problem Solving.

Abstract Background Sending a social norms feedback letter to general practitioners who are high prescribers of antibiotics has been shown to reduce antibiotic prescribing. The 2017-9 Quality Premium for primary care in England sets a target for broad-spectrum prescribing, which should be at or below 10% of total antibiotic prescribing. We tested a social norm feedback letter that targeted broad-spectrum prescribing and the addition of a chart to a text-only letter that targeted overall prescribing. Methods We conducted three 2-armed randomised controlled trials, on different groups of practices: Trial A compared a broad-spectrum message and chart to the standard-practice overall prescribing letter (practices whose percentage of broad-spectrum prescribing was above 10% and who had relatively high overall prescribing). Trial C compared a broad-spectrum message and a chart to a no-letter control (practices whose percentage of broad-spectrum prescribing was above 10% and who had relatively moderate overall prescribing). Trial B compared an overall-prescribing message with a chart to the standard practice overall letter (practices whose percentage of broad-spectrum prescribing was below 10% but who had relatively high overall prescribing). Letters were posted to general practitioners, timed to be received on 1 November 2018. The primary outcomes were practices’ percentage of broad-spectrum prescribing (trials A and C) and overall antibiotic prescribing (trial B) each month from November 2018 to April 2019 (all weighted by the number and characteristics of patients registered in the practice). Results We randomly assigned 1909 practices; 58 closed or merged during the trial, leaving 1851 practices: 385 in trial A, 674 in trial C, and 792 in trial B. AR(1) models showed that there were no statistically significant differences in our primary outcome measures: trial A β = − .199, p = .13; trial C β = .006, p = .95; trial B β = − .0021, p = .81. In all three trials, there were statistically significant time trends, showing that overall antibiotic prescribing and total broad-spectrum prescribing were decreasing. Conclusion Our broad-spectrum feedback letters had no effect on broad-spectrum prescribing; adding a bar chart to a text-only letter had no effect on overall antibiotic prescribing. Broad-spectrum and overall prescribing were both decreasing over time. Trial registration ClinicalTrials.gov NCT03862794. March 5, 2019.

Abstract Background People with disadvantaged backgrounds are less likely to visit the dentist for planned care, even though they have disproportionately poorer oral health. They are correspondingly more likely to experience dental problems and use urgent dental care, general practices and Accident and Emergency departments, which not only makes meeting their needs expensive, but, since these services often rely on prescriptions rather than addressing the clinical cause, can contribute to antimicrobial resistance. Methods The RETURN intervention has been developed with substantial community co-production, to be delivered opportunistically in urgent dental care settings. This brief intervention is delivered by dental nurses and involves material relevant to the ‘in-group’ targeted. The material includes booklets relating to barriers to planned dental visiting with corresponding short video clips featuring local people and including a modelling element. Dental nurses are trained to have supportive and non-judgemental conversations, assisting patients to set personal goals and action plans, which are reinforced in a follow-up text within a few weeks. A randomised controlled trial will be undertaken in 3 types of sites: dental practices delivering urgent care (a) within working hours, (b) out of hours, and (c) in a Dental Hospital. The trial will recruit 1180 adult urgent dental care users over 12 months, who have not visited a dentist for a planned care appointment for 2 years or more and do not have a dentist who they visit for routine care. It aims to investigate the effectiveness and cost-effectiveness of the intervention and to explore whether the intervention has different effects across the socio-economic gradient. Participants will be followed up at 6, 12 and 18 months after randomisation. Co-primary outcomes are attendance at a dental practice for planned care within 12 months and self-reported oral health-related quality of life at 12 months. Discussion This is a pragmatic trial, evaluating the effectiveness of the intervention under the usual condition in which it might be applied. Since dental practices work as independent contractors to the NHS, this brings implementation and fidelity challenges which will be explored and described in embedded qualitative work. Trial registration ISRCTN registry identifier ISRCTN84666712. Registered 12/04/2021.

Abstract Background While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)). Methods A pilot cluster randomised controlled trial will be conducted, using a mixed-methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention based on pre-defined progression criteria. A total of 16 practices will be recruited (eight in ROI; eight in NI), and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥ 10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment and 4 and 8 months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed. Discussion The findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies. Trial registration ISRCTN Registry, ISRCTN80017020 . Date of confirmation is 4/11/2019.

Abstract Background There is a need to develop cost-effective weight loss maintenance interventions to prolong the positive impact of weight loss on health outcomes. Conducting pre-trial health economic modelling is recommended to inform the design and development of behavioural interventions. We aimed to use health economic modelling to estimate the maximum cost per-person (justifiable cost) of a cost-effective behavioural weight loss maintenance intervention, given an estimated intervention effect for individuals with: i) a Body Mass Index (BMI) of 28 kg/m2 or above without diabetes and ii) a diagnosis of type 2 diabetes prescribed a single non-insulin diabetes medication. Methods The School for Public Health Research Diabetes prevention model was used to estimate the lifetime Quality-adjusted life year (QALY) gains, healthcare costs, and maximum justifiable cost associated with a weight loss maintenance intervention. Based on a meta-analysis, the estimated effect of a weight loss maintenance intervention following a 9 kg weight loss, was a regain of 1.33 kg and 4.38 kg in years one and two respectively compared to greater regain of 2.84 kg and 5.6 kg in the control group. Sensitivity analysis was conducted around the rate of regain, duration of effect and initial weight loss. Results The justifiable cost for a weight loss maintenance intervention at an ICER of £20,000 per QALY was £104.64 for an individual with a BMI of 28 or over and £88.14 for an individual with type 2 diabetes. Within sensitivity analysis, this varied from £36.42 to £203.77 for the former, and between £29.98 and £173.05 for the latter. Conclusions Researchers developing a weight loss maintenance intervention should consider these maximum justifiable cost estimates and the potential impact of the duration of effect and initial weight loss when designing intervention content and deciding target populations. Future research should consider using the methods demonstrated in this study to use health economic modelling to inform the design and budgetary decisions in the development of a behavioural interventions.

Abstract Background Attention-deficit hyperactivity disorder (ADHD) is the most common behavioral disorder. Behavioural intervention in preschool children with ADHD is considered effective. This study discussed the long-term effectiveness of behavioural intervention in the context of nondrug therapy. Methods The study was a prospective, randomised controlled trial in which 201 preschoolers diagnosed with ADHD who were not receiving any treatment were assigned to two groups from January 2018 to May 2019, 101 were assigned to the conventional group and 100 to the behavioural intervention group. The behavioural intervention group included parental training, behavioural therapy, attention training, relief therapy and game therapy, in addition to the conventional group offerings. Children were evaluated at a baseline, at the end of the 12-month intervention and six months after the intervention. The primary and secondary outcome variables included attention time, the impulse-hyperactivity and hyperactivity index from Conners parent symptom questionnaire (PSQ), full-scale attention quotient (FAQ) and full-scale response control quotient (FRCQ) from integrated visual and auditory comprehensive continuous performance tests. The attention time was observed and recorded by parents, and others were performe(PSQ)d by physicians in the clinic. All statistical analyses were conducted using SPSS V26.0 (IBM), including the descriptive statistics and mixed-effects models and so on. Results The participants’ mean age was (66.17±9.00) months in the behavioural group and (67.54±6.22) months in the conventional group .A total of 190 participants completed a follow-up six months after the intervention. The attention time, Conners parent symptom questionnaire (PSQ), full-scale attention quotient (FAQ) and full-scale response control quotient (FRCQ) increased significantly over time, and the behavioural group improvements were higher than those of conventional group. There was a significant main effect of time (pretest/posttest/follow-up) and group on all outcome measures (t =-12.549-4.069, p

Background: Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist 'Tier 3' Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity. Methods: This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted. Discussion: This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients. Trial registration: ISRCTN number 22088800. [ABSTRACT FROM AUTHOR]

Introduction: Despite the importance of intervention fidelity in interpreting the outcomes of complex public health interventions, there is a lack of both reporting fidelity trial protocols and uniformity. In evaluating complex, adaptable/pragmatic interventions in resource-strapped settings with systemic issues, unique challenges to intervention adherence and monitoring are introduced, increasing the importance of a fidelity protocol. We aim to describe the intervention fidelity and monitoring protocol for the Healthy Life Trajectories Initiative (HeLTI) South Africa, a complex four-phase intervention set in urban Soweto, starting preconceptionally and continuing through to pregnancy, infancy, and early childhood to improve the health of young women and reduce the intergenerational risk of obesity.Methods: The HeLTI SA fidelity protocol was based on the NIH Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. Context-specific fidelity challenges were identified. The intervention fidelity components and associated monitoring strategies were developed to align with HeLTI SA. Strategies for fidelity monitoring include, amongst others, qualitative process evaluation methods, reviewing observed and recorded intervention sessions, monitoring of activity logs, standardized training, and intervention session checklists. Possible challenges to fidelity and fidelity monitoring include high provider turnover, lack of qualification amongst providers, difficulty tracing participants for follow-up sessions, participant health literacy levels, and the need to prioritize participants' non-health-related challenges. Solutions proposed include adapting intervention delivery methods, recruitment methods, and provider training methods.Discussion: The NIH BCC Treatment Fidelity Framework provided a solid foundation for reporting intervention fidelity across settings to improve intervention validity, ability to assess intervention effectiveness, and transparency. However, context-specific challenges to fidelity (monitoring) were identified, and transparency around such challenges and possible solutions in low- and middle-income settings could help foster solutions to improve adherence, reporting, and monitoring of intervention fidelity in this setting.Trial Registration: Pan African Clinical Trials Registry PACTR201903750173871 . Registered on 27 March 2019. [ABSTRACT FROM AUTHOR]

Background: Between 2012 and 2015, the Uthando Lwethu (UL) study demonstrated that a theory-based behavioural couples-focused intervention significantly increased participation in couples HIV testing and counselling (CHTC) among South African couples who had never previously tested for HIV together or mutually disclosed their HIV status, 42% compared to 12% of the control group at 9 months follow-up. Although effective, we were nonetheless concerned that in this high prevalence setting the majority (58%) of intervention couples chose not to test together. In response we optimised the UL intervention and in a new study, 'Igugu Lethu', we are evaluating the success of the optimised intervention in promoting CHTC.Methods: One hundred eighty heterosexual couples, who have been in a relationship together for at least 6 months, are being recruited and offered the optimised couples-focused intervention. In the Igugu Lethu study, we have expanded the health screening visit offered to couples to include other health conditions in addition to CHTC. Enrolled couples who choose to schedule CHTC will also have the opportunity to undertake a random blood glucose test, blood pressure and BMI measurements, and self-sample for STI testing as part of their health screening. Individual surveys are administered at baseline, 4 weeks and 4 months follow-up. The proportion of couples who decide to test together for HIV will be compared to the results of the intervention arm in the UL study (historical controls). To facilitate this comparison, we will use the same recruitment and follow-up strategies in the same community as the previous UL study.Discussion: By strengthening communication and functioning within the relationship, the Igugu Lethu study, like the previous UL study, aims to transform the motivation of individual partners from a focus on their own health to shared health as a couple. The Igugu Lethu study findings will answer whether the optimised couples-focused behavioural intervention and offering CHTC as part of a broader health screening for couples can increase uptake of CHTC by 40%, an outcome that would be highly desirable in populations with high HIV prevalence.Trial Registration: Retrospectively registered. ISRCTN Registry ISRCTN 46162564 Registered on 26th May 2022. [ABSTRACT FROM AUTHOR]

Background: About 85% of patients receiving opioid agonist therapy (OAT) for opioid dependence are smoking tobacco. Although smoke-related pulmonary diseases are significant contributors to morbidity and mortality, few smoking cessation interventions are evaluated within this group, and few OAT patients are offered smoking cessation as an integrated part of their addiction treatment. This study protocol describes an integrated smoking cessation intervention aimed at patients receiving OAT and smoking tobacco.Methods: This is a multicentre, randomised controlled clinical trial that will recruit 266 daily tobacco smoking patients receiving OAT in OAT outpatient clinics in Bergen and Stavanger, Norway. The patients randomised for the intervention arm will be offered smoking cessation therapy consisting of weekly brief behavioural interventions and prescription-free nicotine replacement products. In the control arm, patients will receive standard care without any added interventions related to smoking cessation. The smoking cessation intervention includes psychoeducational techniques with components from motivational interviewing, and nicotine replacement products such as nicotine lozenges, patches, and chewing gum. The duration of the intervention is 16 weeks, with the option of extending it by a further 8 weeks. The main outcomes are measured at 16 weeks after initiation of the intervention, and sustained effects are evaluated 1 year after intervention initiation. The primary outcome is smoking cessation verified by carbon monoxide (CO) levels or at least a 50% reduction in the number of cigarettes smoked. Secondary outcomes are changes in psychological well-being, biochemical inflammation markers, changes in physical health, quality of life, and fatigue.Discussion: Integration of other treatments to standard OAT care improves adherence and completion rates providing another rationale for integrated smoking cessation treatment. Thus, if integrated smoking cessation treatment is superior to standard care, this trial provides important information on further scale-up.Trial Registration: ClinicalTrials.gov NCT05290025. Registered on 22 March 2022. [ABSTRACT FROM AUTHOR]

Background: Smoking poses a serious risk of early preventable death and disease especially for women living with socio-economic disadvantage (SED). A smoking cessation programme, 'We Can Quit', was developed in Ireland tailored to SED women. This includes group-based support delivered by trained lay local community facilitators (CFs) and free nicotine replacement therapy (NRT). The intervention was pilot tested in a cluster randomised controlled trial, 'We Can Quit 2'. This paper reports on the WCQ2 process evaluation which assessed feasibility and acceptability of the programme and trial processes.Methods: Embedded qualitative design using the UK Medical Research Council's process evaluation framework. Semi-structured interviews with trial participants (N = 21) and CFs (N = 8). Thematic analysis was utilised.Results: Peer-modelling, a non-judgemental environment, CFs facilitation of group support were viewed as acceptable programme related factors. Some participants expressed concerns about NRT side effects. Provision of free NRT was welcomed and accepted by participants, although structural barriers made access challenging. Pharmacists took on a role that became larger than originally envisaged - and the majority provided additional support to women in their quit attempts between group meetings which augmented and supplemented the intervention sessions provided by the CFs. Participants reported good acceptance of repeated measures for data collection, but mixed acceptability of provision of saliva samples. Low literacy affected the feasibility of some women to fully engage with programme and trial-related materials. This was despite efforts made by intervention developers and the trial team to make materials (e.g., participant intervention booklet; consent forms and participant information leaflets) accessible while also meeting requirements under 2018 European General Data Protection Regulation legislation. Hypothetical scenarios of direct (e.g., researcher present during programme delivery) and indirect (e.g., audio recordings of programme sessions) observational fidelity assessments for a future definitive trial (DT) were acceptable.Conclusions: Intervention and trial-related processes were generally feasible and acceptable to participants and CFs. Any future DT will need to take further steps to mitigate structural barriers to accessing free NRT; and the established problem of low literacy and low educational attainment in SED areas, while continuing to comply within the contemporary legislative research environment.Trial Registration: WCQ2 pilot trial ( ISRCTN74721694 ). [ABSTRACT FROM AUTHOR]

Background: Sending a social norms feedback letter to general practitioners who are high prescribers of antibiotics has been shown to reduce antibiotic prescribing. The 2017-9 Quality Premium for primary care in England sets a target for broad-spectrum prescribing, which should be at or below 10% of total antibiotic prescribing. We tested a social norm feedback letter that targeted broad-spectrum prescribing and the addition of a chart to a text-only letter that targeted overall prescribing.Methods: We conducted three 2-armed randomised controlled trials, on different groups of practices: Trial A compared a broad-spectrum message and chart to the standard-practice overall prescribing letter (practices whose percentage of broad-spectrum prescribing was above 10% and who had relatively high overall prescribing). Trial C compared a broad-spectrum message and a chart to a no-letter control (practices whose percentage of broad-spectrum prescribing was above 10% and who had relatively moderate overall prescribing). Trial B compared an overall-prescribing message with a chart to the standard practice overall letter (practices whose percentage of broad-spectrum prescribing was below 10% but who had relatively high overall prescribing). Letters were posted to general practitioners, timed to be received on 1 November 2018. The primary outcomes were practices' percentage of broad-spectrum prescribing (trials A and C) and overall antibiotic prescribing (trial B) each month from November 2018 to April 2019 (all weighted by the number and characteristics of patients registered in the practice).Results: We randomly assigned 1909 practices; 58 closed or merged during the trial, leaving 1851 practices: 385 in trial A, 674 in trial C, and 792 in trial B. AR(1) models showed that there were no statistically significant differences in our primary outcome measures: trial A β = - .199, p = .13; trial C β = .006, p = .95; trial B β = - .0021, p = .81. In all three trials, there were statistically significant time trends, showing that overall antibiotic prescribing and total broad-spectrum prescribing were decreasing.Conclusion: Our broad-spectrum feedback letters had no effect on broad-spectrum prescribing; adding a bar chart to a text-only letter had no effect on overall antibiotic prescribing. Broad-spectrum and overall prescribing were both decreasing over time.Trial Registration: ClinicalTrials.gov NCT03862794. March 5, 2019. [ABSTRACT FROM AUTHOR]

Background: People with disadvantaged backgrounds are less likely to visit the dentist for planned care, even though they have disproportionately poorer oral health. They are correspondingly more likely to experience dental problems and use urgent dental care, general practices and Accident and Emergency departments, which not only makes meeting their needs expensive, but, since these services often rely on prescriptions rather than addressing the clinical cause, can contribute to antimicrobial resistance.Methods: The RETURN intervention has been developed with substantial community co-production, to be delivered opportunistically in urgent dental care settings. This brief intervention is delivered by dental nurses and involves material relevant to the 'in-group' targeted. The material includes booklets relating to barriers to planned dental visiting with corresponding short video clips featuring local people and including a modelling element. Dental nurses are trained to have supportive and non-judgemental conversations, assisting patients to set personal goals and action plans, which are reinforced in a follow-up text within a few weeks. A randomised controlled trial will be undertaken in 3 types of sites: dental practices delivering urgent care (a) within working hours, (b) out of hours, and (c) in a Dental Hospital. The trial will recruit 1180 adult urgent dental care users over 12 months, who have not visited a dentist for a planned care appointment for 2 years or more and do not have a dentist who they visit for routine care. It aims to investigate the effectiveness and cost-effectiveness of the intervention and to explore whether the intervention has different effects across the socio-economic gradient. Participants will be followed up at 6, 12 and 18 months after randomisation. Co-primary outcomes are attendance at a dental practice for planned care within 12 months and self-reported oral health-related quality of life at 12 months.Discussion: This is a pragmatic trial, evaluating the effectiveness of the intervention under the usual condition in which it might be applied. Since dental practices work as independent contractors to the NHS, this brings implementation and fidelity challenges which will be explored and described in embedded qualitative work.Trial Registration: ISRCTN registry identifier ISRCTN84666712. Registered 12/04/2021. [ABSTRACT FROM AUTHOR]

Background: Fidelity assessment of behaviour change interventions is vital to understanding trial outcomes. This study assesses the delivery fidelity of behaviour change techniques used in the Retirement in ACTion (REACT) randomised controlled trial. REACT is a community-based physical activity (PA) and behaviour maintenance intervention to prevent decline of physical functioning in older adults (≥ 65 years) at high risk of mobility-related disability in the UK.Methods: The delivery fidelity of intervention behaviour change techniques and delivery processes were assessed using multi-observer coding of purposively sampled in-vivo audio recordings (n = 25) of health behaviour maintenance sessions over 12-months. Delivery fidelity was scored using a modified Dreyfus scale (scores 0-5) to assess competence and completeness of delivery for each technique and delivery process. "Competent delivery" was defined as a score of 3 points or more for each item. Examples of competent intervention delivery were identified to inform recommendations for future programme delivery and training.Results: The mean intervention fidelity score was 2.5 (SD 0.45) with delivery fidelity varying between techniques/processes and intervention groups. Person-centred delivery, Facilitating Enjoyment and Promoting Autonomy were delivered competently (scoring 3.0 or more). There was scope for improvement (score 2.0-2.9) in Monitoring Progress (Acknowledging and Reviewing), Self-Monitoring, Monitoring Progress (Eliciting Benefits of Physical Activity), Goal Setting and Action Planning, Modelling, Supporting Self-Efficacy for Physical Activity and Supporting Relatedness. Managing Setbacks and Problem Solving was delivered with low fidelity. Numerous examples of both good and sub-optimal practice were identified.Conclusions: This study highlights successes and improvements needed to enhance delivery fidelity in future implementation of the behavioural maintenance programme of the REACT intervention. Future training of REACT session leaders and assessment of delivery fidelity needs to focus on the delivery of Goal setting and Action Planning, Modelling, Supporting Relatedness, Supporting Self-Efficacy for Physical Activity, and Managing Setbacks/ Problem Solving. [ABSTRACT FROM AUTHOR]

Background: More than one million people acquire sexually transmitted infections (STIs) every day globally. It is possible that predicting an individual's future risk of HIV/STIs could contribute to behaviour change or improve testing. We developed a series of machine learning models and a subsequent risk-prediction tool for predicting the risk of HIV/STIs over the next 12 months. Methods: Our data included individuals who were re-tested at the clinic for HIV (65,043 consultations), syphilis (56,889 consultations), gonorrhoea (60,598 consultations), and chlamydia (63,529 consultations) after initial consultations at the largest public sexual health centre in Melbourne from 2 March 2015 to 31 December 2019. We used the receiver operating characteristic (AUC) curve to evaluate the model's performance. The HIV/STI risk-prediction tool was delivered via a web application. Results: Our risk-prediction tool had an acceptable performance on the testing datasets for predicting HIV (AUC = 0.72), syphilis (AUC = 0.75), gonorrhoea (AUC = 0.73), and chlamydia (AUC = 0.67) acquisition. Conclusions: Using machine learning techniques, our risk-prediction tool has acceptable reliability in predicting HIV/STI acquisition over the next 12 months. This tool may be used on clinic websites or digital health platforms to form part of an intervention tool to increase testing or reduce future HIV/STI risk. [ABSTRACT FROM AUTHOR]

Background: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)). Methods: A pilot cluster randomised controlled trial will be conducted, using a mixed-methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention based on pre-defined progression criteria. A total of 16 practices will be recruited (eight in ROI; eight in NI), and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥ 10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment and 4 and 8 months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed. Discussion: The findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies. Trial registration: ISRCTN Registry, ISRCTN80017020. Date of confirmation is 4/11/2019. [ABSTRACT FROM AUTHOR]

Background: Attention-deficit hyperactivity disorder (ADHD) is the most common behavioral disorder. Behavioural intervention in preschool children with ADHD is considered effective. This study discussed the long-term effectiveness of behavioural intervention in the context of nondrug therapy.Methods: The study was a prospective, randomised controlled trial in which 201 preschoolers diagnosed with ADHD who were not receiving any treatment were assigned to two groups from January 2018 to May 2019, 101 were assigned to the conventional group and 100 to the behavioural intervention group. The behavioural intervention group included parental training, behavioural therapy, attention training, relief therapy and game therapy, in addition to the conventional group offerings. Children were evaluated at a baseline, at the end of the 12-month intervention and six months after the intervention. The primary and secondary outcome variables included attention time, the impulse-hyperactivity and hyperactivity index from Conners parent symptom questionnaire (PSQ), full-scale attention quotient (FAQ) and full-scale response control quotient (FRCQ) from integrated visual and auditory comprehensive continuous performance tests. The attention time was observed and recorded by parents, and others were performe(PSQ)d by physicians in the clinic. All statistical analyses were conducted using SPSS V26.0 (IBM), including the descriptive statistics and mixed-effects models and so on.Results: The participants' mean age was (66.17±9.00) months in the behavioural group and (67.54±6.22) months in the conventional group .A total of 190 participants completed a follow-up six months after the intervention. The attention time, Conners parent symptom questionnaire (PSQ), full-scale attention quotient (FAQ) and full-scale response control quotient (FRCQ) increased significantly over time, and the behavioural group improvements were higher than those of conventional group. There was a significant main effect of time (pretest/posttest/follow-up) and group on all outcome measures (t =-12.549-4.069, p<0.05), and a significant interaction of time and group on attention time, impulsivity/hyperactivity, FAQ and FRCQ (t =-3.600-3.313, p<0.05).Conclusion: Behavioural intervention can effectively improve behaviour management and relieve symptoms in children with ADHD. These effects lasted at least six months. This study provides a promising approach for improving clinical efficacy with preschool children with ADHD. [ABSTRACT FROM AUTHOR]

Objective: To identify dietary self-monitoring implementation strategies in behavioural weight loss interventions.Design: We conducted a systematic review of eight databases and examined fifty-nine weight loss intervention studies targeting adults with overweight/obesity that used dietary self-monitoring.Setting: NA.Participants: NA.Results: We identified self-monitoring implementation characteristics, effectiveness of interventions in supporting weight loss and examined weight loss outcomes among higher and lower intensity dietary self-monitoring protocols. Included studies utilised diverse self-monitoring formats (paper, website, mobile app, phone) and intensity levels (recording all intake or only certain aspects of diet). We found the majority of studies using high- and low-intensity self-monitoring strategies demonstrated statistically significant weight loss in intervention groups compared with control groups.Conclusions: Based on our findings, lower and higher intensity dietary self-monitoring may support weight loss, but variability in adherence measures and limited analysis of weight loss relative to self-monitoring usage limits our understanding of how these methods compare with each other. [ABSTRACT FROM AUTHOR]

Abstract Background There is a need for effective behavioural interventions in dentistry. This paper presents an innovative behavioural intervention for young adults with dental caries, in an interdisciplinary collaboration between dental personnel and licensed psychologist in general dental care. The intervention has been evaluated in an RCT, with positive effects on oral health behaviour. Method The intervention, Acceptance and Commitment Therapy (ACT), a recent form of cognitive behaviour therapy (CBT), was adapted to young adult patients (18–25 years of age) with high dental caries activity. Results The intervention included two individual sessions, provided by a clinical psychologist at general dental clinics. The rationale for selecting ACT as the theory base is presented, together with the treatment manual and a case illustration. Conclusions ACT may be a promising alternative for behavioural interventions in dentistry for patients with oral diseases, specifically dental caries. Interprofessional collaboration between psychologists and dental personnel opens up for new possibilities to help and treat patients with various health issues in public dental care. Trial registration TRN ISRCTN15009620 www.isrctn.com , retrospectively registered 14/03/2018.

Abstract Background Behavioural weight management programmes are effective in assisting people with overweight or obesity to lose excess body weight. Yet, many still struggle to attain their weight loss goals in such programmes. Little is understood about the factors which impact success in these programmes. Synthesising this data will allow for theory to be developed on how to improve success in such programmes. The main aim of this review will be to extract and synthesise the barriers and facilitators of successful weight loss during participation of behavioural weight loss programmes in adults living with overweight and obesity. Methods A systematic search of MEDLINE, Embase, PsycINFO, The Cochrane Library and CINAHL will be performed from inception onwards. Studies will also be sought by contacting experts in the field, reference and website searching. Studies will be eligible if the participants are adults living with obesity (population) undertaking or recently completed behavioural weight loss programmes (intervention) with the primary focus of weight loss (outcome). The primary outcomes will be amount of weight lost and information on barriers and/or facilitators to success. The secondary outcomes will be reasons or factors related to attrition and adherence and behaviour change techniques used in programmes. Two reviewers will screen citations and full-text data. Reviewer 1 will screen all, and reviewer 2 will screen a random 50% of articles. Data extraction will be completed by reviewer 1, and 10% will be checked by the research team. Potential conflicts will be resolved through discussion. Data will be synthesised and described narratively to show the characteristics of each study, levels of success and barriers and facilitators during programme participation. A thematic approach will be taken, and themes will be coded against the levels of the socioecological model. Quantitative data will be extracted and categorised according to these themes and presented alongside the qualitative data. Discussion Our findings can be used to inform how weight loss programmes can be improved to facilitate success in those at risk of failure. Results will be published in a peer-reviewed journal. Systematic review registration ( PROSPERO CRD42019148158 )

Abstract Background Accessing quality mental health care poses significant challenges for persons affected by adversity, especially in low- and middle-income countries where resources are scarce. To mitigate this, the World Health Organization has developed group problem management plus (gPM+), a low-intensity psychological intervention for adults experiencing psychological distress. gPM+ is a group-based intervention consisting of five-sessions, and can be delivered by non-specialist providers. This paper outlines the study protocol for a trial of gPM+ in Jordan. Methods We will conduct a single-blind, two-arm, randomized controlled trial in a Syrian refugee camp in Jordan. We aim to enrol 480 adults into the trial. Participants will be eligible for the trial if they screen positive for levels of psychological distress. Following screening, those eligible will be randomly assigned to receive the gPM+ intervention or enhanced treatment as usual. The primary outcome is reduction in levels of psychological distress at 3-months post-treatment. Secondary outcomes include anxiety, depression, prodromal psychotic symptoms, posttraumatic stress disorder, prolonged grief, daily functioning, economic effectiveness, and change in parenting behaviour. Secondary outcomes also include the reduction in psychological distress of the participant’s child. Discussion The trial aims to deliver a template for affordable and scalable psychosocial interventions that can readily be implemented in refugee settings, and that can benefit both the participant and their child. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12619001386123 . Registered prospectively on 10/10/2019.