Search

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]

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]

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]

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]

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: 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: This randomised controlled trial (RCT) aimed to investigate the effects of a simple cognitive task intervention on intrusive memories ("flashbacks") and associated symptoms following a traumatic event. Patients presenting to a Swedish emergency department (ED) soon after a traumatic event were randomly allocated (1:1) to the simple cognitive task intervention (memory cue + mental rotation instructions + computer game "Tetris" for at least 20 min) or control (podcast, similar time). We planned follow-ups at one-week, 1-month, and where possible, 3- and 6-months post-trauma. Anticipated enrolment was N = 148. Results: The RCT was terminated prematurely after recruiting N = 16 participants. The COVID-19 pandemic prevented recruitment/testing in the ED because: (i) the study required face-to-face contact between participants, psychology researchers, ED staff, and patients, incurring risk of virus transmission; (ii) the host ED site received COVID-19 patients; and (iii) reduced flow of patients otherwise presenting to the ED in non-pandemic conditions (e.g. after trauma). We report on delivery of study procedures, recruitment, treatment adherence, outcome completion (primary outcome: number of intrusive memories during week 5), attrition, and limitations. The information presented and limitations may enable our group and others to learn from this terminated study. Trial registration ClinicalTrials.gov: NCT04185155 (04-12-2019) [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Given 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.Methods: The 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.Discussion: The 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 Registration: ISRCTN39374060 . Registered 19.7.2018. [ABSTRACT FROM AUTHOR]

Background: According to the principles of Reablement, home care services are meant to be goal-oriented, holistic and person-centred taking into account the capabilities and opportunities of older adults. However, home care services traditionally focus on doing things for older adults rather than with them. To implement Reablement in practice, the 'Stay Active at Home' programme was developed. It is assumed that the programme leads to a reduction in sedentary behaviour in older adults and consequently more cost-effective outcomes in terms of their health and wellbeing. However, this has yet to be proven.Methods/ Design: A two-group cluster randomised controlled trial with 12 months follow-up will be conducted. Ten nursing teams will be selected, pre-stratified on working area and randomised into an intervention group ('Stay Active at Home') or control group (no training). All nurses of the participating teams are eligible to participate in the study. Older adults and, if applicable, their domestic support workers (DSWs) will be allocated to the intervention or control group as well, based on the allocation of the nursing team. Older adults are eligible to participate, if they: 1) receive homecare services by the selected teams; and 2) are 65 years or older. Older adults will be excluded if they: 1) are terminally ill or bedbound; 2) have serious cognitive or psychological problems; or 3) are unable to communicate in Dutch. DSWs are eligible to participate if they provide services to clients who fulfil the eligibility criteria for older adults. The study consists of an effect evaluation (primary outcome: sedentary behaviour in older adults), an economic evaluation and a process evaluation. Data for the effect and economic evaluation will be collected at baseline and 6 and/or 12 months after baseline using performance-based and self-reported measures. In addition, data from client records will be extracted. A mixed-methods design will be applied for the process evaluation, collecting data of older adults and professionals throughout the study period.Discussion: This study will result in evidence about the effectiveness, cost-effectiveness and feasibility of the 'Stay Active at Home' programme.Trial Registration: ClinicalTrials.gov: NCT03293303 , registered on 20 September 2017. [ABSTRACT FROM AUTHOR]

Background: We evaluate the impact of clinic-based PMTCT community support by trained lay health workers in addition to standard clinical care on PMTCT infant outcomes. Methods: In a cluster randomized controlled trial, twelve community health centers (CHCs) in Mpumalanga Province, South Africa, were randomized to have pregnant women living with HIV receive either: a standard care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n = 357), or an enhanced intervention (EI) condition of SC PMTCT plus the "Protect Your Family" intervention (EI; 6 CHCs; n = 342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions and those in the EI, four antenatal and two postnatal PMTCT plus "Protect Your Family" sessions led by trained lay health workers. Maternal PMTCT and HIV knowledge were assessed. Infant HIV status at 6 weeks postnatal was drawn from clinic PCR records; at 12 months, HIV status was assessed by study administered DNA PCR. Maternal adherence was assessed by dried blood spot at 32 weeks, and infant adherence was assessed by maternal report at 6 weeks. The impact of the EI was ascertained on primary outcomes (infant HIV status at 6 weeks and 12 months and ART adherence for mothers and infants), and secondary outcomes (HIV and PMTCT knowledge and HIV transmission related behaviours). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention on study outcomes. Results: In all, 699 women living with HIV were recruited during pregnancy (8-24 weeks), and assessments were completed at baseline, at 32 weeks pregnant (61.7%), and at 6 weeks (47.6%), 6 months (50.6%) and 12 months (59.5%) postnatally. Infants were tested for HIV at 6 weeks and 12 months, 73.5% living infants were tested at 6 weeks and 56.7% at 12 months. There were no significant differences between SC and EI on infant HIV status at 6 weeks and at 12 months, and no differences in maternal adherence at 32 weeks, reported infant adherence at 6 weeks, or PMTCT and HIV knowledge by study condition over time. Conclusion: The enhanced intervention administered by trained lay health workers did not have any salutary impact on HIV infant status, ART adherence, HIV and PMTCT knowledge. Trial registration clinicaltrials.gov: number NCT02085356 [ABSTRACT FROM AUTHOR]

Background: Behaviour change interventions that promote physical activity have major implications for health and well-being. Measuring intervention fidelity is crucial in determining the extent to which an intervention is delivered as intended, therefore increasing scientific confidence about effectiveness. However, we lack a clear overview of how well intervention fidelity is typically assessed in physical activity trials.Methods: A systematic literature search was conducted to identify peer - reviewed physical activity promotion trials that explicitly measured intervention fidelity. Methods used to assess intervention fidelity were categorised, narratively synthesised and critiqued using assessment criteria from NIH Behaviour Change Consortium (BCC) Treatment Fidelity Framework (design, training, delivery, receipt and enactment).Results: Twenty eight articles reporting of twenty one studies used a wide variety of approaches to measure intervention fidelity. Delivery was the most common domain of intervention fidelity measured. Approaches used to measure fidelity across all domains varied from researcher coding of observational data (using checklists or scales) to participant self-report measures. There was considerable heterogeneity of methodological approaches to data collection with respect to instruments used, attention to psychometric properties, rater-selection, observational method and sampling strategies.Conclusions: In the field of physical activity interventions, fidelity measurement is highly heterogeneous both conceptually and methodologically. Clearer articulation of the core domains of intervention fidelity, along with appropriate measurement approaches for each domain are needed to improve the methodological quality of fidelity assessment in physical activity interventions. Recommendations are provided on how this situation can be improved. [ABSTRACT FROM AUTHOR]

Background: People with severe mental ill health are more likely to smoke than those in the general population. It is therefore important that effective smoking cessation strategies are used to help people with severe mental ill health to stop smoking. This study aims to assess the effectiveness and cost-effectiveness of smoking cessation and reduction strategies in adults with severe mental ill health in both inpatient and outpatient settings. Methods: This is an update of a previous systematic review. Electronic databases were searched during September 2016 for randomised controlled trials comparing smoking cessation interventions to each other, usual care, or placebo. Data was extracted on biochemically-verified, self-reported smoking cessation (primary outcome), as well as on smoking reduction, body weight, psychiatric symptom, and adverse events (secondary outcomes). Results: We included 26 trials of pharmacological and/or behavioural interventions. Eight trials comparing bupropion to placebo were pooled showing that bupropion improved quit rates significantly in the medium and long term but not the short term (short term RR = 6.42 95% CI 0.82-50.07; medium term RR = 2.93 95% CI 1.61-5. 34; long term RR = 3.04 95% CI 1.10-8.42). Five trials comparing varenicline to placebo showed that that the addition of varenicline improved quit rates significantly in the medium term (RR = 4.13 95% CI 1.36-12.53). The results from five trials of specialised smoking cessation programmes were pooled and showed no evidence of benefit in the medium (RR = 1.32 95% CI 0.85-0.06) or long term (RR = 1.33 95% CI 0.85-2.08). There was insufficient data to allowing pooling for all time points for varenicline and trials of specialist smoking cessation programmes. Trials suggest few adverse events although safety data were not always reported. Only one pilot study reported cost effectiveness data. Conclusions: Bupropion and varenicline, which have been shown to be effective in the general population, also work for people with severe mental ill health and their use in patients with stable psychiatric conditions. Despite good evidence for the effectiveness of smoking cessation interventions for people with severe mental ill health, the percentage of people with severe mental ill health who smoke remains higher than that for the general population. [ABSTRACT FROM AUTHOR]

Background: Improvement in quality of life is crucial for HIV infected people. Social and behavioral interventions have been implemented in different contexts to improve the quality of life among HIV infected people. This review appraises the evidence for available interventions that focused on quality of life of HIV infected people receiving antiretroviral therapy (ART).Methods: We searched electronic databases for randomized controlled trials of interventions to improve the quality of life of HIV infected people receiving ART. We searched PUBMED and the Cochrane Centre Register of Controlled Trials (CENTRAL) with the terms "social", "behavioral", "educational", "quality of life", "HIV", and "RCT". Searches were conducted for articles published from 1980 to December 16, 2015. Standardized data abstraction methods and searching steps were applied.Results: Twenty-eight studies reported the impact of social or behavioral interventions in quality of life among HIV infected people, of which 15 were conducted in United States of America. A total of 4136 participants were enrolled. Of the 28 studies, four studies included females, two studies included males and remaining studies excluded both males and females. The overall reported methodological quality of the studies was subject to a high risk of bias and the study criteria were unclear in most studies. Twenty-one studies reported a significant intervention effect on at least one quality of life domain. Meta-analyses showed significant improvement in general health, mental health, physical function and environment domains of quality of life among intervention groups. However, the expected impact of the intervention was low to moderate because the rigorousness of the studies was low, information was limited, the sample sizes were small and other the quality of the study designs were poor.Conclusions: Although the available evidence suggests that existing social and behavioral interventions can improve some quality of life domains, the quality of evidence was insufficient to support the notion that these interventions can improve the overall quality of life of HIV infected people receiving ART. Well-designed and rigorous randomized controlled trials with high methodological quality are required. [ABSTRACT FROM AUTHOR]

Background: Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1-2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice.Methods/design: A three-arm, parallel-group, multicentre randomised controlled trial.Objectives: to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation-Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience.Hypotheses: (1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST). Inclusion: chronic constipation in adults (aged 18-70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis.Discussion: This trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone.Trial Registration: International Standard Randomised Controlled Trial Number: ISRCTN11791740. Registered on 16 July 2015. [ABSTRACT FROM AUTHOR]

Background: Autism Spectrum Disorders (ASD) is a disabling and lifelong neuro-developmental disorder. Challenging behaviours such as aggression and self injury are common maladaptive behaviours in ASD which adversely affect the mental health of both the affected children and their caregivers. Although there is evidence-base for parent-delivered behavioural intervention for children with ASD and challenging behaviours, there is no published research on the feasibility of such an intervention in sub-Saharan Africa. This study assessed the feasibility of parent-mediated behavioural intervention for challenging behaviour in children with ASD in Nigeria. Methods: This was a pre-post intervention pilot study involving 20 mothers of children with DSM-5 diagnosis of ASD recruited from a Child and Adolescent Mental Health Service out-patient Unit. All the mothers completed five sessions of weekly manualised group-based intervention from March to April, 2015. The intervention included Functional Behavioural Analysis for each child followed by an individualised behaviour management plan. The primary outcome measure was the Aggression and Self Injury Questionnaire, which assessed both Aggression towards a Person and Property (APP) and Self Injurious Behaviour (SIB). The mothers' knowledge of the intervention content was the secondary outcome. All outcome measures were completed at baseline and after the intervention. The mothers' level of satisfaction with the programme was also assessed. Treatment effect was evaluated with Wilcoxon Signed Rank Tests of baseline and post-intervention scores on outcome measures. Results: The children were aged 3-17 years (mean = 10.7 years, SD 4.6 years), while their mothers' ages ranged from 32 to 52 years (mean 42.8 years, SD 6.4 years). The post intervention scores in all four domains of the APP and SIB were significantly reduced compared with pre-intervention scores. The mothers' knowledge of the intervention content significantly increased post-intervention. The intervention was well received with the vast majority (75 %) of participants being very satisfied and all (100 %) were willing to recommend the programme to a friend whose child has similar difficulties. Conclusions: Parent-mediated behavioural intervention is a feasible and promising treatment for challenging behaviour in children with ASD in Nigeria. Behavioural intervention should be an integral component in scaling up services for children with ASD in Nigeria. [ABSTRACT FROM AUTHOR]

Background: Despite substantial evidence for physical activity (PA) as a management option for type 2 diabetes, there remains a lack of PA behavioural interventions suitable for delivery in primary care. This paper describes the systematic development of an evidence-informed PA behavioural intervention for use during routine primary care consultations.Methods: In accordance with the Medical Research Council Framework for the Development and Evaluation of Complex Interventions, a four-stage systematic development process was undertaken: (1) exploratory work involving interviews and workshop discussions identified training needs of healthcare professionals and support needs of adults with type 2 diabetes; (2) a systematic review with meta- and moderator analyses identified behaviour change techniques and optimal intervention intensity and duration; (3) usability testing identified strategies to increase implementation of the intervention in primary care and (4) an open pilot study in two primary care practices facilitated intervention optimisation.Results: Healthcare professional training needs included knowledge about type, intensity and duration of PA sufficient to improve glycaemic control and acquisition of skills to promote PA behaviour change. Patients lacked knowledge about type 2 diabetes and skills to enable them to make sustainable changes to their level of PA. An accredited online training programme for healthcare professionals and a professional-delivered behavioural intervention for adults with type 2 diabetes were subsequently developed. This multifaceted intervention was informed by the theory of planned behaviour and social cognitive theory and consisted of 15 behaviour change techniques. Intervention intensity and duration were informed by a systematic review. Usability testing resolved technical problems with the online training intervention that facilitated use on practice IT systems. An open pilot study of the intervention with fidelity of delivery assessment informed optimisation and identified mechanisms to enhance implementation of the intervention during routine diabetes consultations.Conclusions: Movement as Medicine for Type 2 diabetes represents an evidence-informed multifaceted behavioural intervention targeting PA for management of type 2 diabetes developed for delivery in primary care. The structured development process undertaken enhances transparency of intervention content, replicability and scalability. Movement as Medicine for Type 2 diabetes is currently undergoing evaluation in a pilot RCT.Trial Registration: ISRCTN67997502. [ABSTRACT FROM AUTHOR]

Background: In China, most of migrant workers work in the small and medium-sized enterprises (SMEs) and are a vulnerable group for occupational health. Migrant workers are at increased risk of occupational health risks due to poor occupational health behaviours such as the low use of personal protective equipment (PPE). However, there is a lack of solid evidence regarding how to improve the use of PPE among migrant workers in SMEs. The current study will assess the effectiveness of a multi-pronged behavioural intervention designed to promote PPE utilization among migrant workers exposed to organic solvents in SMEs.Methods/design: This is a single blind, three-arm cluster randomized trial with 60 SMEs equally randomized to receive a top-down intervention (i.e. general health education and mHealth intervention provided by researchers) or a comprehensive intervention (which includes both top-down intervention and peer education) or a control condition (participants will not receive the intervention, but study measures will be obtained). Interventions will be conducted at the SMEs level for 6 months and all eligible migrant workers in these SMEs will be enrolled into the trial. The primary outcome is effective use of PPE during the last week. The secondary outcomes are occupational health knowledge and attitude and participation in occupational health check-up. Data will be collected and assessed at baseline; 3 months post baseline and the end of the intervention.Discussion: This theory- and evidence based intervention will contribute to the limited evidence of behaviour change intervention in improving PPE utilization of migrant workers in SMEs, and provide timely evidence for the development of basic occupational health services in China and elsewhere with similar industrialization contexts.Trial Registration: ChiCTR-IOR-15006929 . Registered on 16 August 2015. [ABSTRACT FROM AUTHOR]

Background: Food decision-making is a complex process and varies according to the setting, based on cultural and contextual factors. The study aimed to understand the process of food decision-making in households in rural Kerala, India, to inform the design of a dietary behaviour change intervention. Methods: Three focus group discussions (FGDs) and 17 individual interviews were conducted from September 2010 to January 2011 among 13 men and 40 women, between 23 and 75 years of age. An interview guide facilitated the process to understand: 1) food choices and decision-making in households, with particular reference to access; and 2) beliefs about foods, particularly fruits, vegetables, salt, sugar and oil. The interviews and FGDs were transcribed verbatim and analysed using qualitative content analysis. Results: The analysis revealed one main theme: 'Balancing expectations amidst limitations' with two sub-themes: 'Counting and meeting the costs'; and 'Finding the balance'. Food decisions were made at the household level, with money, time and effort costs weighed against the benefits, estimated in terms of household needs, satisfaction and expectations. The most crucial decisional point was affordability in terms of money costs, followed by food preferences of husband and children. Health and the risk of acquiring chronic diseases was not a major consideration in the decision-making process. Foods perceived as essential for children were purchased irrespective of cost, reportedly owing to the influence of food advertisements. The role of the woman as the homemaker has gendered implications, as the women disproportionately bore the burden of balancing the needs and expectations of all the household members within the available means. Conclusions: The food decision-making process occurred at household level, and within the household, by the preferences of spouse and children, and cost considerations. The socio-economic status of households was identified as limiting their ability to manoeuvre this fine balance. The study has important policy implications in terms of the need to raise public awareness of the strong link between diet and chronic non-communicable diseases. [ABSTRACT FROM AUTHOR]

Background: Many people with intellectual disability present with challenging behaviour which often has serious consequences such as the prescription of long term medication, in-patient admissions and disruption of normal daily activities. Small scale studies of Positive Behaviour Support (PBS) delivered by paid carers suggest that it reduces challenging behaviour and costs of care and improves quality of life. This study aims to investigate whether professionals training in the delivery of PBS as part of routine practice is clinically and cost effective compared to treatment as usual in community intellectual disability services. Method: The study is a multi-centre cluster randomised controlled trial involving community intellectual disability services in England and service users with mild to severe intellectual disability and challenging behaviour. The teams will be randomly allocated into one of two conditions, either training and support to deliver PBS or treatment as usual. We will carry out assessments of challenging behaviour, use of services, quality of life, mental health, and family and paid carer burden at six and 12 months. We will monitor treatment fidelity and we will interview a sample of paid and family carers, service users, staff and managers about what they think of the treatment and how best we can deliver it in routine care. The main outcome is reduction in challenging behaviour at one year after randomisation. We will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS. Discussion: The study findings will have significant implications for the delivery of PBS in community based services with the potential for reducing inpatient admissions and out-of-area placements for adults with intellectual disability and challenging behaviour. [ABSTRACT FROM AUTHOR]

Background There are few evidence-based mobile health solutions for treating adolescent obesity. The primary aim of this parallel non-inferiority trial is to assess the effectiveness of an experimental smartphone application in reducing obesity at 12 months, compared to the Temple Street W82GO Healthy Lifestyles intervention. Methods/design The primary outcome measure is change in body mass index standardised deviation score at 12 months. The secondary aim is to compare the effect of treatment on secondary outcomes, including waist circumference, insulin sensitivity, quality of life, physical activity and psychosocial health. Adolescents with a body mass index at or above the 98th percentile (12 to 17 years) will be recruited from the Obesity clinic at Temple Street Children's University Hospital in Dublin, Ireland. W82GO is a family-based lifestyle change intervention delivered in two phases over 12 months. In the current study, participants will be randomised for phase two of treatment to either usual care or care delivered via smartphone application. One hundred and thirty-four participants will be randomised between the two study arms. An intention-to-treat analysis will be used to compare treatment differences between the groups at 12 months. Discussion The results of this study will be disseminated via open access publication and will provide important information for clinicians, patients and policy makers regarding the use of mobile health interventions in the management of adolescent obesity. Trial registration Clinicaltrials.gov NCT01804855. [ABSTRACT FROM AUTHOR]

Background In trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in selfmonitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT). Methods Educators' views were explored through focus groups before and after training (N = 18) and approximately 1 year into the trial (N = 14), and semi-structured telephone interviews at approximately 2 years (N = 7). Analysis was based on the constant comparative method. Results Educators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG. Conclusions The findings provide insight into a previously unexplored group of trial personnel - intervention deliverers in trials of behavioural interventions - which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers' awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT. Trial registration ISRCTN95696668 [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer is the second most common cancer and cancer-killer in Hong Kong with an alarming increasing incidence in recent years. The latest World Cancer Research Fund report concluded that foods low in fibre, and high in red and processed meat cause colorectal cancer whereas physical activity protects against colon cancer. Yet, the influence of these lifestyle factors on cancer outcome is largely unknown even though cancer survivors are eager for lifestyle modifications. Observational studies suggested that low intake of a Western-pattern diet and high physical activity level reduced colorectal cancer mortality. The Theory of Planned Behaviour and the Health Action Process Approach have guided the design of intervention models targeting a wide range of health-related behaviours. Methods/design: We aim to demonstrate the feasibility of two behavioural interventions intended to improve colorectal cancer outcome and which are designed to increase physical activity level and reduce consumption of a Western-pattern diet. This three year study will be a multicentre, randomised controlled trial in a 2x2 factorial design comparing the "Moving Bright, Eating Smart" (physical activity and diet) programme against usual care. Subjects will be recruited over a 12-month period, undertake intervention for 12 months and followed up for a further 12 months. Baseline, interim and three post-intervention assessments will be conducted. Two hundred and twenty-two colorectal cancer patients who completed curative treatment without evidence of recurrence will be recruited into the study. Primary outcome measure will be whether physical activity and dietary targets are met at the end of the 12-month intervention. Secondary outcome measures include the magnitude and mechanism of behavioural change, the degree and determinants of compliance, and the additional health benefits and side effects of the intervention. Discussion: The results of this study will establish the feasibility of targeting the two behaviours (diet and physical activity) and demonstrate the magnitude of behaviour change. The information will facilitate the design of a further larger phase III randomised controlled trial with colorectal cancer outcome as the study endpoint to determine whether this intervention model would reduce colorectal cancer recurrence and mortality. [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis (OA) is the most common joint disorder in the world, as it is appears to be prevalent among 80% of individuals over the age of 75. Although physical activities such as walking have been scientifically proven to improve physical function and arthritic symptoms, individuals with OA tend to adopt a sedentary lifestyle. There is therefore a need to improve knowledge translation in order to influence individuals to adopt effective self-management interventions, such as an adapted walking program. Methods: A single-blind, randomized control trial was conducted. Subjects (n = 222) were randomized to one of three knowledge translation groups: 1) Walking and Behavioural intervention (WB) (18 males, 57 females) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking; 2) Walking intervention (W) (24 males, 57 females) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet; 3) Self-directed control (C) (32 males, 52 females) wherein participants only received the educational pamphlet. One-way analyses of variance were used to test for differences in quality of life, adherence, confidence, and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period. Results: The clinical and quality of life outcomes improved among participants in each of the three comparative groups. However, there were few statistically significant differences observed for quality of life and clinical outcomes at long-term measurements at 12-months end of intervention and at 6- months post intervention (18-month follow-up). Outcome results varied among the three groups. Conclusion: The three groups were equivalent when determining the effectiveness of knowledge uptake and improvements in quality of life and other clinical outcomes. OA can be managed through the implementation of a proven effective walking program in existing community-based walking clubs. Trial registration: Current Controlled Trials IRSCTNO9193542 [ABSTRACT FROM AUTHOR]

Background: The implementation of evidence based clinical practice guidelines on self-management interventions to patients with chronic diseases is a complex process. A multifaceted strategy may offer an effective knowledge translation (KT) intervention to promote knowledge uptake and improve adherence in an effective walking program based on the Ottawa Panel Evidence Based Clinical Practice Guidelines among individuals with moderate osteoarthritis (OA). Methods: A single-blind, randomized control trial was conducted. Patients with mild to moderate (OA) of the knee (n=222) were randomized to one of three KT groups: 1) Walking and Behavioural intervention (WB) (18 males, 57 females) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking for OA; 2) Walking intervention (W) (24 males, 57 females) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet; 3) Self-directed control (C) (32 males, 52 females) wherein participants only received the educational pamphlet. One-way analyses of variance were used to test for differences in quality of life, adherence, confidence, and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period. Results: Short-term program adherence was greater in WB compared to C (p<0.012) after 3 months. No statistical significance (p> 0.05) was observed for long-term adherence (6 to 12 months), and total adherence between the three groups. The three knowledge translation strategies demonstrated equivalent long-term results for the implementation of a walking program for older individuals with moderate OA. Lower dropout rates as well as higher retention rates were observed for WB at 12 and 18 months. Conclusion: The additional knowledge translation behavioural component facilitated the implementation of clinical practice guidelines on walking over a short-term period. More studies are needed to improve the long-term walking adherence or longer guidelines uptake on walking among participants with OA. Particular attention should be taken into account related to patient's characteristic and preference. OA can be managed through the implementation of a walking program based on clinical practice guidelines in existing community-based walking clubs as well as at home with the minimal support of an exercise therapist or a trained volunteer. Trial Registration: Current Controlled Trials IRSCTNO9193542 [ABSTRACT FROM AUTHOR]

Background: Relatively little is known about dietary changes and their relationships with weight change during behavioural weight loss interventions. In a secondary analysis of data from a multicentre RCT, we investigated whether greater improvements in diet would be achieved by overweight adults following a 12 month group-based commercial weight loss programme (CP) than those receiving standard care (SC) in primary practice, and if these dietary changes were associated with greater weight loss.Methods: Adults with a BMI 27-35 kg/m2 and >1 risk factor for obesity-related disorders were recruited in study centres in Australia and the UK during 2007-2008. Dietary intake and body weight were measured at baseline, 6 and 12 months. Linear mixed effects models compared mean changes in dietary macronutrient intake, fibre density and energy density over time between groups, and their relationships with weight loss.Results: The CP group demonstrated greater mean weight loss than the SC group at 6 months (3.3 kg, 95% CI: 2.2, 4.4) and 12 months (3.3 kg, 95% CI: 2.1, 4.5). Diet quality improved in both intervention groups at 6 and 12 months. However, the CP group (n = 228) achieved significantly greater mean reductions in energy intake (mean difference; 95% CI: - 503 kJ/d; - 913, - 93), dietary energy density (- 0.48 MJ/g; - 0.81, - 0.16), total fat (- 6.9 g/d; - 11.9, - 1.8), saturated fat (- 3.3 g/d; - 5.4, - 1.1), and significantly greater mean increases in fibre density (0.30 g/MJ; 0.15, 0.44) at 6 months than the SC group (n = 239). Similar differences persisted at 12 months and the CP group showed greater mean increases in protein density (0.65 g/MJ). In both groups, weight loss was associated with increased fibre density (0.68 kg per g/MJ, 95% CI: 0.08, 1.27) and protein density (0.26 kg per g/MJ, 95% CI: 0.10, 0.41).Conclusions: Following a group-based commercial program led to greater improvements in diet quality than standard care. Increases in dietary protein and fibre density were independently associated with weight loss in both behavioural weight loss interventions. Greater increases in protein and fibre density in the commercial program likely contributed to their greater weight loss.Trial Registration: ISRCTN: ISRCTN85485463 Registered 03/08/2007 Retrospectively Registered. [ABSTRACT FROM AUTHOR]