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Background: Exposure to sunlight can have both positive and negative health impacts. Excessive exposure to ultra-violet (UV) radiation from the sun can cause skin cancer, however insufficient exposure to sunlight has a detrimental effect on production of Vitamin D. In the construction industry there are onsite proactive behaviours for safety, but sun-safety remains a low priority. There is limited research on understanding the barriers to adopting sun-safe behaviours and the association this may have with Vitamin D production. This paper reports a protocol for an intervention study, using text messaging in combination with a supportive smartphone App. The intervention aims to both reduce UV exposure during months with higher UV levels and promote appropriate dietary changes to boost Vitamin D levels during months with low UV levels.Method/design: Approximately 60 construction workers will be recruited across the United Kingdom. A randomised control crossover trial (RCCT) will be used to test the intervention, with randomisation at site level - i.e. participants will receive both the control (no text messages or supportive App support) and intervention (daily text messages and supportive App). Using the Theory of Planned Behaviour (TPB) the intervention focuses on supporting sun-safety and healthy dietary decisions in relation to Vitamin D intake. The intervention emphasises cultivating the perception of normative support in the workplace, increasing awareness of control and self-efficacy in taking sun-protective behaviours, making healthier eating choices to boost Vitamin D, and tackling stigmas attached to image and group norms. Each study epoch will last 21 days with intervention text messages delivered on workdays only. The supportive App will provide supplementary information about sun protective behaviours and healthy dietary choices. The primary outcome measure is 25-hydroxy-Vitamin D [25(OH)D] level (obtained using blood spot sampling), which will be taken pre and post control and intervention periods. Secondary outcome measures are two-fold, (1) using the TPB to detect changes in behaviour, and (2) quantifying UV exposure during the UK peak radiation season (April-September) using body-mounted UV sensors.Discussion: This study will provide important information about the effectiveness of a technology-based intervention to promote sun-safety and healthy behaviours in outdoor construction workers.Trial Registration: ISRCTN15888934 retrospectively registered 15.01.2018. [ABSTRACT FROM AUTHOR]

Background: Around a fifth of children starting school in England are now overweight/obese. There is a paucity of interventions with the aim of obesity prevention in preschool-age children in the UK. Previous research has demonstrated some positive results in changing specific health behaviours, however, positive trends in overall obesity rates are lacking. Preschool settings may provide valuable opportunities to access children and their families not only for promoting healthy lifestyles, but also to develop and evaluate behaviour-change interventions.Methods: This paper presents a cluster randomised feasibility study of a theory based behaviour-change preschool practitioner-led intervention tested in four preschool centres in the North East of England. The primary outcome measures were to test the acceptability and feasibility of the data collection measures and intervention. Secondary measures were collected and reported for extra information. At baseline and post intervention, children's anthropometric, dietary and physical activity measures as well as family 'active' time data were collected. The preschool practitioner-led intervention included family intervention tasks such as 'family goal-setting activities' and 'cooking challenges'. Preschool activities included increasing physical activity and providing activities with the potential to change behaviour with increased knowledge of and acceptance of healthy eating. The process evaluation was an on-going monthly process and was collected in multiple forms such as questionnaires, photographs and verbal feedback.Results: 'Gatekeeper' permission and lower-hierarchal adherence were initially a problem for recruitment and methods acceptance. However, at intervention end the preschool teachers and parents stated they found most intervention methods and activities acceptable, and some positive changes in family health behaviours were reported. However, the preschool centres appeared to have difficulties with enforcing everyday school healthy eating policies.Conclusions: The findings from the current study may have implications for nursery practitioners, nursery settings, Local Educational Authorities and policy makers, and contributes to the body of literature. However, further work with preschool practitioners is required to determine how personal attitudes and school policy application can be supported to implement successfully such an intervention.Trial Registration: ISRCTN12345678 (16/02/17) retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Norway implemented a regular cervical cancer screening program based on triennial screening in 1995, recommending participation of all women between 25 and 69 years of age. Somali and Pakistani women have the lowest participation in cervical cancer screening in Norway. This study evaluates the effect of a community-based intervention aimed at increasing participation in the screening program among women from these two groups.Methods: The intervention consisted of an oral 20-25 min presentation in Urdu and Somali on cervical cancer and screening and practical information on how to make an appointment and payment for the test. The participants were invited to pose questions related to the topic after the presentation. This study was carried out in four geographical areas surrounding the capital Oslo between February and October 2017, among women aged 25-69 years from Pakistan and Somalia. We recruited women in the intervention group directly from different community institutions, households, and religious sites. Women from Pakistan and Somalia residing in Oslo were the controls. The absolute intervention effect was measured as difference in absolute proportion of women screened and estimated as the interaction between time and group allocation in a generalized estimation equation model with binomial distribution and identity link function.Results: The percentage of women screened in the intervention group increased, from 46 to 51%. The corresponding increase in proportion in the control group was from 44 to 45.5%. After adjustment for potential confounders the intervention group showed a significant larger increase in participation in the screening program as compared to the control group with an absolute difference in change in proportion screened of 0.03 (95% CI; 0.02- 0.06).Conclusions: Our findings suggest that theory-based, culturally and linguistically sensitive educational interventions can raise awareness and motivate immigrant women to participate in cervical cancer screening program. In addition, approaching health professionals as well as immigrant women, might improve participation even more.Trial Registration: NCT03155581 . Retrospectively registered, on 16 May 2017. [ABSTRACT FROM AUTHOR]

Background: The importance of physical activity on health is clear, but changing behaviour is difficult. Successful interventions aiming to improve physical activity and reduce sedentary behaviour is therefore of importance. The aim of this study was to evaluate effects on motivation, self-efficacy and barriers to change behaviour from two different behavioural intervention focusing either on reducing sedentary behaviour or on increasing physical activity as compared to a waiting list control group.Methods: The study was designed as a cluster randomized control trial (RCT) within two private companies. Self-efficacy, motivation and perceived barriers were together with demographic variables assessed before and after a 6-month intervention. Participant cluster teams were randomly allocated to either the physical activity intervention (iPA), the sedentary behaviour intervention (iSED), or control group. The intervention was multi componential and included motivational counselling based on Cognitive behaviour therapy and Motivational interviewing, group activities and management involvement. Group differences were determined using Bayesian multilevel modelling (parameter estimate; credible interval (CI)), analysing complete cases and those who adhered to the protocol by adhering to at least 3 out of 5 intervention sessions.Results: After the intervention, the complete cases analysis showed that the iPA group had significantly higher autonomous motivation (0.33, CI: 0.05-0.61) and controlled motivation (0.27, CI: 0.04-0.51) for physical activity compared with the control group. The iSED group scored less autonomous and controlled motivation compared to the iPA group (0.38, CI: - 0.69- -0.087 respectively - 0.32, CI: - 0.57-0.07) but no significant differences compared with the control group. Among individuals that adhered to the protocol, the results showed higher scores on Exercise (3.03, CI: 0.28-6.02) and Sedentary self-efficacy (3.59, CI: 0.35-7.15) for individuals in the iPA group and on Sedentary self-efficacy (4.77, CI: 0.59-9.44) for the iSED group compared to the control group.Conclusion: These findings indicate that the interventions were successful in increasing self-efficacy in each intervention group and autonomous motivation for exercise in the iPA group, in particular when actively participating in the motivational counselling sessions. [ABSTRACT FROM AUTHOR]

Background: Worldwide, most adolescent girls do not meet physical activity (PA) recommendations and very few PA programs are tailored specifically towards them. Even fewer information exists about the long-term effects of such programs. Some Canadian schools have implemented the FitSpirit PA intervention designed specifically for girls aged 12 to 17 years old. This paper describes the protocol of a quasi-experimental study evaluating long-term changes in health behaviours and outcomes following FitSpirit participation.Methods: The study is conducted among schools that partner with FitSpirit every year. It started in 2018 and will be completed in 2022. The intervention comprises motivational talks, a turnkey running program, PA sessions and special events. Study participants fill out an online questionnaire twice a year. Follow-up questionnaires are sent at the end of each school year to the study participants who dropout from FitSpirit. The main outcome, changes in PA levels, is evaluated using questions validated for adolescents. Secondary outcomes are health (perceived health); lifestyle habits (sedentary activities, eating and sleeping habits); psychosocial outcomes (physical self-efficacy and body satisfaction); and FitSpirit appreciation (activity participation and satisfaction). Most questions originate from questionnaires validated for the adolescent population. Cross-sectional and longitudinal analyses will be performed.Discussion: This study will provide one of the first longitudinal reports on the impact of a large extra-curricular PA intervention designed specifically for adolescent girls. The current study will uniquely contribute to PA research by assessing outcomes additional to PA levels, including markers of health, lifestyle habits and psychosocial determinants.Trial Registration: NCT, NCT03804151 , Registered on January 22, 2019; retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Children from racial and ethnic minority groups, low-income households, and those with overweight or obesity gain more weight during the summer than the school year. Summer day camps, which offer routine opportunities for physical activity and regular meal and snack times, have potential to mitigate excess weight gain. This randomized controlled trial was done to determine the feasibility and preliminary effectiveness of summer camp in preventing excess summer weight gain among youth from low-income households.Methods: Children, ages 6 to 12 years, were randomized to attend 8-weeks of summer day camp (CAMP) or to experience an unstructured summer as usual (SAU) in 2017-2018. Primary feasibility outcomes included retention, engagement and completion of midsummer measures. Secondary outcomes included changes in BMIz, engagement in moderate to vigorous physical activity (MVPA) and sedentary behavior, and diet quality and energy intake from the school year to summer. Multivariable linear mixed models were used to assess group differences.Results: Ninety-four participants were randomized to CAMP (n = 46) or SAU (n = 48), of whom 93.0 and 91.6% completed end of school and end of summer assessments, respectively. While CAMP participants attended only 50% of camp days offered, on average, they lost - 0.03 BMIz units while those in SAU gained 0.07 BMIz units over the summer (b = 0.10; p = .02). Group differences in change in energy intake from the school year to summer were borderline significant, as energy intake remained relatively unchanged in CAMP participants but increased among participants in SAU (p = 0.07).Conclusions: Randomizing children to attend summer day camp or experience an unstructured summer as usual was effective in this low-income sample. Our findings support the potential for summer camps in mitigating excess summer weight gain. A larger randomized trial is needed explore efficacy, cost-effectiveness and longer-term effects of attending summer camp on weight and weight-related behaviors.Trial Registration: ClinicalTrials.gov Registration: NCT04085965 (09/2019, retrospective registration). [ABSTRACT FROM AUTHOR]

Background: Dating violence has an alarming prevalence among Brazilian adolescents. School-based preventive programs have been implemented, but remain isolated initiatives with low reach. Health communication strategies based on innovative technologies with a high potential of diffusion are urgent. This study aimed to develop a computer-tailored intervention to prevent victimization and perpetration of dating violence among Brazilian youth.Methods: The intervention, called Dating SOS (SOS Namoro), is based on the I-Change Model and attachment theory and is a comprehensive preventive program targeted to young people with a current partner. The intervention design included the stages of needs assessment; definition of objectives of change; development of the library of messages; elaboration of a questionnaire for tailoring feedbacks according to the relevant variables; integration of the content in the software Tailor Builder; pre-testing; and usability and efficacy evaluation planning. Dating SOS is composed of four online sessions. The first session gives a tailored orientation on attachment style and risk perception of violence. The second session addresses knowledge on conflict management, positive and negative social models of intimate relationships and an action plan to improve everyday interactions. The third session covers social norms, self-efficacy and an action plan to cope with conflicts. The fourth session discusses attitudes, social support and an action plan to protect from violence. Improvements on the interface and tailoring refinement was done after pre-testing to improve attractiveness and decrease risk of iatrogenic effects.Discussion: The principal merit of the present study resides in the development of an innovative strategy based on the qualified use of the internet for education surrounding romantic relationships and the prevention of dating violence among adolescent and young Brazilians, a hitherto unaddressed need in the field. The intervention usability and efficacy should be investigated in further studies.Trial Registration: Brazilian Registry of Clinical Trials. RBR-9frj8q. Prospectively registered on July 25, 2019. http://www.ensaiosclinicos.gov.br/rg/RBR-9frj8q/. [ABSTRACT FROM AUTHOR]

Background: Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases.Methods: A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months.Discussion: This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare.Trial Registration: The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ). [ABSTRACT FROM AUTHOR]

Background: The efficacy of home fortification with iron-containing micronutrient powders varies between trials, perhaps in part due to population differences in adherence. We aimed to assess to what extent adherence measured by sachet count or self-reporting forms is in agreement with adherence measured by electronic device. In addition, we explored how each method of adherence assessment (electronic device, sachet count, self-reporting forms) is associated with haemoglobin concentration measured at the end of intervention; and to what extent baseline factors were associated with adherence as measured by electronic device.Methods: Three hundred thirty-eight rural Kenyan children aged 12-36 months were randomly allocated to three treatment arms (home fortification with two different iron formulations or placebo). Home fortificants were administered daily by parents or guardians over a 30 day-intervention period. We assessed adherence using an electronic device that stores and provides information of the time and day of opening of the container that was used to store the fortificants sachets in each child's residence. In addition, we assessed adherence by self-reporting and sachet counts. We also measured haemoglobin concentration at the end of intervention.Results: Adherence, defined as having received at least 24 sachets (≥ 80%), during the 30-day intervention period was attained by only 60.6% of children as assessed by the electronic device. The corresponding values were higher when adherence was assessed by self-report (83.9%; difference: 23.3%, 95% CI: 18.8% to 27.8%) or sachet count (86.3%; difference: 25.7%, 95% CI: 21.0% to 30.4%). Among children who received iron, each 10 openings of the electronic cap of the sachet storage container were associated with an increase in haemoglobin concentration at the end of intervention by 1.2 g/L (95% CI: 0.0 to 1.9 g/L). Adherence was associated with the age of the parent but not with intervention group; with age, sex or anthropometric indices of the child; or with age or sex of the parent or guardian.Conclusions: The use of self -reporting and sachet count may lead to overestimates of adherence to home fortification.Trial Registration: The trial was registered with ClinicalTrials.gov ( NCT02073149 ) on 25 February 2014. [ABSTRACT FROM AUTHOR]

Background: Understanding the breeding patterns of Aedes aegypti in households and the factors associated with infestation are important for implementing vector control. The baseline survey of a cluster randomised controlled trial of community mobilisation for dengue prevention in Mexico and Nicaragua collected information about the containers that are the main breeding sites, identified possible actions to reduce breeding, and examined factors associated with household infestation. This paper describes findings from the Mexican arm of the baseline survey.Methods: In 2010 field teams conducted household surveys and entomological inspections in 11,995 households from 90 representative communities in the three coastal regions of Guerrero State, Mexico. We characterized Ae. aegypti breeding sites and examined the effect of two preventive measures: temephos application in water containers, and keeping the containers covered. We examined associations with household infestation, using bivariate and multivariate analysis adjusted for clustering effects.Results: We conducted entomological inspections in 11,995 households. Among 45,353 water containers examined, 6.5% (2958/45,353) were positive for larvae and/or pupae. Concrete tanks (pilas) and barrels (tambos) together accounted for 74% of pupal productivity. Both covering water containers and inserting temephos were independently associated with a lower risk of presence of larvae or pupae, with the effect of covering (OR 0.22; 95% CIca 0.15-0.27) stronger than that of temephos (OR 0.66; 95% CIca 0.53-0.84). Having more than four water containers was associated with household infestation in both rural areas (OR 1.42; 95% CIca 1.17-1.72) and urban areas (1.81; 1.47-2.25), as was low education of the household head (rural: 1.27; 1.11-1.46, and urban: 1.39; 1.17-1.66). Additional factors in rural areas were: household head without paid work (1.31; 1.08-1.59); being in the Acapulco region (1.91; 1.06-3.44); and using anti-mosquito products (1.27; 1.09-1.47). In urban areas only, presence of temephos was associated with a lower risk of household infestation (0.44; 0.32-0.60).Conclusion: Concrete tanks and barrels accounted for the majority of pupal productivity. Covering water containers could be an effective means of Ae. aegypti vector control, with a bigger effect than using temephos. These findings were useful in planning and implementing the Camino Verde trial intervention in Mexico. [ABSTRACT FROM AUTHOR]

Background: The Self-determined Exercise and Learning For FITness (SELF-FIT) is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students' moderate-to-vigorous physical activity (MVPA) during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students' MVPA during school physical education.Methods: Secondary 2 students (approximately aged 14 years) from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students' MVPA during PE lessons. Secondary outcomes include students' leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness). Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students' perceptions of the intervention.Discussion: The SELF-FIT intervention has been designed to improve students' health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable interventions based on SELF-FIT could be applied in physical education at large.Trial Registration: The trial is registered at the Australia New Zealand Clinical Trial Registry (Trial ID: ACTRN12615000633583 ; date of registration: 18 June 2015). [ABSTRACT FROM AUTHOR]

Background: Reducing alcohol related harms in Australian Defence Force (ADF) trainees has been identified as a priority, but there are few evidence-based prevention programs available for the military setting. The study aims to test whether the P.A.R.T.Y. program delivered in-hospital or on-base, can reduce harmful alcohol consumption among ADF trainees.Methods/design: The study is a 3-arm randomized controlled trial, involving 953 Royal Australian Navy trainees from a single base. Trainees, aged 18 to 30 years, will be randomly assigned to the study arms: i. in-hospital P.A.R.T.Y.; ii. On-base P.A.R.T.Y.; and iii.Control Group: All groups will receive the routine ADF annual alcohol awareness training. The primary outcome is the proportion of participants reporting an Alcohol Use Disorders Identification Test (AUDIT) score of 8 or above at 12 months' post-intervention. The secondary outcome is the number of alcohol related incidents reported to the Royal Australian Navy (RAN) in the 12 months' post-intervention.Discussion: This is the first trial of the use of the P.A.R.T.Y. program in the military. If the proposed intervention proves efficacious, it may be a useful program in the early education of RAN trainees.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001332617 , date of registration: 18/12/2014 'retrospectively registered'. [ABSTRACT FROM AUTHOR]

Background: Involuntary exposure to secondhand smoke (SHSe) is an important cause of morbidity in children who present to the pediatric emergency department (PED) and urgent care (UC). SHSe interventions delivered in the PED and UC would benefit both the smoker and child, but there have been no large trials testing the efficacy of such interventions. The Healthy Families program is the first randomized controlled trial to test whether a screening, brief intervention, and referral to treatment (SBIRT) intervention delivered in the PED and UC will be effective in decreasing SHSe in children and increasing cessation in smokers.Methods/design: This trial uses a randomized, two-group design in which caregiver-smokers of children 0-17 years old are recruited from the PED and UC. Eligible caregiver-smokers are randomized to either the: 1) SBIRT Condition with face-to-face, tailored counseling that focuses on the child's illness, the importance of reducing child SHSe, caregiver smoking cessation, and the option to receive nicotine replacement therapy; or 2) Healthy Habits Control Condition which includes face-to-face, tailored attention control "5-2-1-0" counseling that focuses on improving the child's health. Dyadic assessments are conducted in-person at baseline, and via email, phone, or in-person at 6-weeks and 6-months. The primary outcomes are biochemically-verified, 7-day point prevalence and prolonged smoking abstinence. Secondary outcomes are cigarettes smoked per week, 24 h quit attempts, and biochemically validated child SHSe at each time point. The costs of this intervention will also be analyzed.Discussion: This study will test an innovative, multilevel intervention designed to reduce child SHSe and increase smoking cessation in caregivers. If effective and routinely used, this SBIRT model could reach at least one million smokers a year in the U.S., resulting in significant reductions in caregivers' tobacco use, SHSe-related pediatric illness, and healthcare costs in this population of children.Trial Registration: ClinicalTrials.gov Identifier: NCT02531594. Date of registration: August 4, 2015. [ABSTRACT FROM AUTHOR]

Background: The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training - concomitant with lifestyle counselling - as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus).Methods/design: Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up). Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise. The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at follow-up. We estimate to recruit 35 participants per group.Discussion: The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle.Trial Registration: Clinical trials.gov. NTC02832453 . Registered 6 July 2016 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Addressing children's tobacco smoke exposure (TSE) remains a public health priority. However, there is low uptake and ineffectiveness of treatment, particularly in low-income populations that face numerous challenges to smoking behavior change. A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), combined with nicotine replacement and intensive multimodal, individual-level behavioral intervention may improve TSE control efforts in such high-risk populations.Methods/design: This trial uses a randomized two-group design with three measurement points: baseline, 3-month and 12-month follow-up. The primary outcome is bioverified child TSE; the secondary outcome is bioverified maternal quit status. Smoking mothers of children less than 6 years old are recruited from WIC clinics. All participants receive WIC system-level intervention based on the "Ask, Advise, Refer (AAR)" best practices guidelines for pediatrics clinics. It includes training all WIC staff about the importance of maternal tobacco control; and detailing clinics with AAR intervention prompts in routine work flow to remind WIC nutrition counselors to ask all mothers about child TSE, advise about TSE harms and benefits of protection, and refer smokers to cessation services. After receiving the system intervention, mothers are randomized to receive 3 months of additional treatment or an attention control intervention: (1) The multimodal behavioral intervention (MBI) treatment includes telephone counseling sessions about child TSE reduction and smoking cessation, provision of nicotine replacement therapy, a mobile app to support cessation efforts, and multimedia text messages about TSE and smoking cessation; (2) The attention control intervention offers equivalent contact as the MBI and includes nutrition-focused telephone counseling, mobile app, and multimedia text messages about improving nutrition. The control condition also receives a referral to the state smoking cessation quitline.Discussion: This study tests an innovative community-based, multilevel and integrated multimodal approach to reducing child TSE in a vulnerable, low-income population. The approach is sustainable and has potential for wide reach because WIC can integrate the tobacco intervention prompts into routine workflow and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines.Trial Registration: Clinicaltrials.gov NCT02602288 . Registered 9 November 2015. [ABSTRACT FROM AUTHOR]

Background: Mental disorders are associated with high costs for productivity loss, sickness absence and unemployment. A participatory supportive return to work (RTW) program was developed in order to improve RTW among workers without an employment contract, sick-listed due to a common mental disorder. The program contained a participatory approach, integrated care and direct placement in a competitive job. The aim of this study was to evaluate the cost-effectiveness and cost-utility of this new program, compared to usual care. In addition, its return on investment was evaluated.Methods: An economic evaluation was conducted alongside a 12-month randomized controlled trial. A total of 186 participants was randomly allocated to the new program (n = 94) or to usual care (n = 92). Effect measures were the duration until sustainable RTW in competitive employment and quality-adjusted life years (QALYs) gained. Costs included intervention costs, medical costs and absenteeism costs. Registered data of the Dutch Social Security Agency were used to assess the duration until sustainable RTW, intervention costs and absenteeism costs. QALYs and medical costs were assessed using three- or six-monthly questionnaires. Missing data were imputed using multiple imputations. Cost-effectiveness analysis and cost-utility analysis were conducted from the societal perspective. A return on investment analysis was conducted from the social insurer's perspective. Various sensitivity analyses were performed to assess the robustness of the results.Results: The new program had no significant effect on the duration until sustainable RTW and QALYs gained. Intervention costs and medical costs were significantly higher in the intervention group. From the societal perspective, the maximum probability of cost-effectiveness for duration until sustainable RTW was 0.64 at a willingness to pay of about €10 000/day, and 0.27 for QALYs gained, regardless of the willingness to pay. From the social insurer's perspective, the probability of financial return was 0.18.Conclusions: From the societal perspective, the new program was neither cost-effective in improving sustainable RTW nor in gaining QALYs. From the social insurer's perspective, the program did not result in a positive financial return. Therefore, the present study provided no evidence to support its implementation.Trial Registration: The trial was listed at the Dutch Trial Register (NTR) under NTR3563 on August 7, 2012. [ABSTRACT FROM AUTHOR]

Background: Behavioural brief interventions (BI) can support people to reduce harmful drinking but multiple barriers impede the delivery and equitable access to these. To address this challenge, we developed YourCall™, a novel short message service (SMS) text message intervention incorporating BI principles. This protocol describes a trial evaluating the effectiveness of YourCall™ (compared to usual care) in reducing hazardous drinking and alcohol related harm among injured adults who received in-patient care.Methods/design: Participants recruited to this single-blind randomised controlled trial comprised patients aged 16-69 years in three trauma-admitting hospitals in Auckland, New Zealand. Those who screened positive for moderately hazardous drinking were randomly assigned by computer to usual care (control group) or the intervention. The latter comprised 16 informational and motivational text messages delivered using an automated system over the four weeks following discharge. The primary outcome is the difference in mean AUDIT-C score between the intervention and control groups at 3 months, with the maintenance of the effect examined at 6 and 12 months follow-up. Secondary outcomes comprised the health and social impacts of heavy drinking ascertained through a web-survey at 12 months, and further injuries identified through probabilistic linkage to national databases on accident insurance, hospital discharges, and mortality. Research staff evaluating outcomes were blinded to allocation. Intention-to-treat analyses will include assessment of interactions based on ethnicity (Māori compared with non-Māori).Discussion: If found to be effective, this mobile health strategy has the potential to overcome current barriers to implementing equitably accessible interventions that can reduce harmful drinking.Trial Registration: Universal Trial Number (UTN) U1111-1134-0028. ACTRN12612001220853 . Submitted 8 November 2012 (date of enrolment of first participant); Version 1 registration confirmed 19 November 2012. Retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk.Methods: NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm.Discussion: The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice.Trial Registration: ISRCTN34805606 (Retrospectively registered 16.3.16). [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess the effectiveness of an EPI smartphone application (EPI app) on improving vaccination coverage in rural Sichuan Province, China.Methods: This matched-pair cluster randomized controlled study included 32 village doctors, matched in 16 pairs, and took place from 2013 to 2015. Village doctors in the intervention group used the EPI app and reminder text messages while village doctors in the control group used their usual procedures and text messages. The primary outcome was full vaccination coverage with all five vaccines (1 dose of BCG, 3 doses of hepatitis B, 3 doses of OPV, 3 doses of DPT and 1 dose of measles vaccine), and the secondary outcome was coverage with each dose of the five individual vaccines. We also conducted qualitative interviews with village doctors to understand perceptions on using the EPI app and how this changed their vaccination work.Results: The full vaccination coverage increased statistically significant from baseline to end-line in both the intervention (67 % [95 % CI:58-75 %] to 84 % [95 % CI:76-90 %], P = 0.028) and control group (71 % [95 % CI:62-79 %] to 82 % [95 % CI:74-88 %], P = 0.014). The intervention group had higher increase in full vaccination coverage from baseline to end-line compared to the control group (17 % vs 10 %), but this was not statistically significant (P = 0.164). Village doctors found it more convenient to use the EPI app to manage child vaccination and also reported saving time by looking up information of caregivers and contacting caregivers for overdue vaccinations quicker. However, village doctors found it hard to manage children who migrated out of the counties.Conclusions: This study showed that an app and text messages can be used by village doctors to improve full vaccination coverage, though no significant increase in vaccination coverage was found when assessing the effect of the app on its own. Village doctors using EPI app reported having improved their working efficiency of managing childhood vaccination. Future studies should be conducted to evaluate the impact of more integrated approach of mHealth intervention on child immunization.Trial Registration: Chinese Clinical Trials Registry (ChiCTR): ChiCTR-TRC- 13003960 , registered on December 6, 2013. [ABSTRACT FROM AUTHOR]

Background: Lyme disease (LD) has become the most common vector borne illness in the Northern hemisphere. Prevention relies predominantly on fostering protective behaviors (e.g., avoiding tick areas, using protective clothing and repellent, and doing routine tick checks post-exposure). The objective of this study was to evaluate the effectiveness (in terms of knowledge, perceived severity and susceptibility, self-efficacy, response efficacy, intention, and behavior over time) and appreciation of a leaflet and a movie as tools for informing the public in the Netherlands about ticks and LD protective behaviors.Methods: Participants (1,677 at t1 and 361 extra at t2) were members of a representative Internet panel (adults aged 18 years and above). A four group randomized controlled design was used to test the effect of an information leaflet and a movie (two intervention groups), compared to a control group and a follow-up only control group. Data were collected over two periods: July 15-29, 2013 (t1) and at follow-up 4 weeks later, August 16-31, 2013 (t2).Results: Post-intervention results show all respondents in all groups possess good general basic knowledge of ticks and LD. Respondents in both the leaflet and movie groups knew more than respondents in the control group, and had greater awareness of best practices after a tick bite. Intention to perform protective behavior in future was stronger among respondents in the intervention groups. While respondents generally appreciated both the movie and the leaflet, they found the movie ran too long. Follow-up revealed no lasting positive effects from either the leaflet or the movie.Conclusions: Our results suggest that both the movie and the leaflet are valued and effective intervention tools for improving knowledge about tick bites and strengthening self-efficacy and intentions to perform protective behavior against ticks and LD . Achieving lasting effects, however, calls for more action. [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis is the most common reason for pain in older adults, and the individual and economic burden of this disease is immense. The chronic character of osteoarthritis requires a long-term therapeutic treatment. In this regard life-style interventions such as physical exercises that can be carried out by the patient himself are recommended as first line treatment. There is evidence for the short-term benefit of exercise therapy in terms of pain reduction and physical functioning. Nonetheless research agendas highlight the need for multifaceted interventions that incorporate exercise strategies into patient care. Studies should be conducted with appropriate sample sizes and should allow statements on long-term effects as well as cost-utility and safety. These open questions are under the scope of this study.Methods/design: This is a controlled study in the context of health services research. The study population consists of n = 1400 subjects with hip or knee osteoarthritis. The intervention group will be recruited from participants of a country-wide health insurance offer for people with hip or knee osteoarthritis. Potential participants for the control group (ratio 10:1 (control vs. intervention) will be filtered out from the insurance data base according to pre-defined matching criteria and asked by letter for their participation. The final statistical twins from the responders (1:1) will be determined via propensity score matching. The progressive training intervention comprises 8 supervised group sessions, supplemented by home exercises (2/week over 11 weeks). Exercises include mobilization, strengthening and training of postural control. Primary outcomes are pain and function measured with the WOMAC Index immediately after the intervention period. Among other things, health related quality of life, self-efficacy, cost utility and safety will be evaluated as secondary outcomes. Participants will be followed up 6, 12 and 24 month after baseline.Discussion: Results of this trial will document the effects of clinical as well as economic outcomes in a regular health care setting on the basis of a large sample size. As such, results of this trial might have great impact on future implementations of group- and home-based exercises in hip or knee osteoarthritis.Trail Registration: German Clinical Trial Register DRKS00009251 . Registered 10 September 2015. [ABSTRACT FROM AUTHOR]

Background: American Indian adults are more likely to experience co-occurring mental health and substance use disorders than adults of other racial/ethnic groups and are disproportionately burdened by the most common sexually transmitted infections, namely chlamydia and gonorrhea. Several behavioral interventions are proven efficacious in lowering risk for sexually transmitted infection in various populations and, if adapted to address barriers experienced by American Indian adults who suffer from mental health and substance use problems, may be useful for dissemination in American Indian communities. The proposed study aims to examine the efficacy of an adapted evidence-based intervention to increase condom use and decrease sexual risk-taking and substance use among American Indian adults living in a reservation-based community in the Southwestern United States.Methods/design: The proposed study is a randomized controlled trial to test the efficacy of an adapted evidence-based intervention compared to a control condition. Participants will be American Indian adults ages 18-49 years old who had a recent episode of binge substance use and/or suicide ideation. Participants will be randomized to the intervention, a two-session risk-reduction counseling intervention or the control condition, optimized standard care. All participants will be offered a self-administered sexually transmitted infection test. Participants will complete assessments at baseline, 3 and 6 months follow-up. The primary outcome measure is condom use at last sex.Discussion: This is one of the first randomized controlled trials to assess the efficacy of an adapted evidence-based intervention for reducing sexual risk behaviors among AI adults with substance use and mental health problems. If proven successful, there will be an efficacious program for reducing risk behaviors among high-risk adults that can be disseminated in American Indian communities as well as other rural and under-resourced health systems.Trial Registration: Clinical Trials NCT02513225. [ABSTRACT FROM AUTHOR]

Background: Intimate partner violence (IPV) poses a major public health concern. To date there are few rigorous economic evaluations of interventions aimed at preventing IPV in low-income settings. This study provides a cost and cost effectiveness analysis of SASA!, a community mobilisation intervention to change social norms and prevent IPV.Methods: An economic evaluation alongside a cluster randomised controlled trial. Both financial and economic costs were collected retrospectively from the provider's perspective to generate total and unit cost estimates over four years of intervention programming. Univariate sensitivity analysis is conducted to estimate the impact of uncertainty in cost and outcome measures on results.Results: The total cost of developing the SASA! Activist Kit is estimated as US$138,598. Total intervention costs over four years are estimated as US$553,252. The annual cost of supporting 351 activists to conduct SASA! activities was approximately US$389 per activist and the average cost per person reached in intervention communities was US$21 over the full course of the intervention, or US$5 annually. The primary trial outcome was past year experience of physical IPV with an estimated 1201 cases averted (90% CI: 97-2307 cases averted). The estimated cost per case of past year IPV averted was US$460.Conclusion: This study provides the first economic evaluation of a community mobilisation intervention aimed at preventing IPV. SASA! unit costs compare favourably with gender transformative interventions and support services for survivors of IPV.Trial Registration: ClinicalTrials.gov # NCT00790959. [ABSTRACT FROM AUTHOR]

Background: University students have high rates of depression, and friends are often the most commonly-used source of support for emotional distress in this population. This study aimed to explore students' ability to provide effective support for their peers with depressive symptoms and the factors influencing the quality of their mental health first aid (MHFA) skills, including students' gender, course of study, and gender of student experiencing depression.Methods: Via an online survey, students at two British universities (N = 483) were quasi-randomly allocated to view a video vignette of either a male or female student depicting symptoms of depression. An open-ended question probed MHFA actions they would take to help the vignette character, which were rated using a standardised scoring scheme based on MHFA guidelines.Results: Students reported low MHFA scores (mean 2.89, out of possible 12). The most commonly reported action was provision of support and information, but only eight (1.6%) students stated an intention to assess risk of harm. Those studying clinically non-relevant degrees with limited mental health content reported poorer MHFA (p = <0.001) and were less confident about their ability to support a friend with depression (p = 0.04). There was no main effect of vignette gender, but within the group of students on non-relevant courses the male vignette received significantly poorer MHFA than the female vignette (p = 0.02). A significant three-way interaction found that male participants studying non-relevant degrees who viewed a male vignette had poorer MHFA compared to females studying non-relevant degrees who viewed the female vignette (p = 0.005).Conclusions: Most students lack the necessary MHFA skills to support friends suffering from symptoms of depression, or to help them get appropriate support and prevent risk of harm. Students on courses which do not include mental health related content are particularly ill-equipped to support male students, with male students receiving the poorest quality MHFA from fellow male students on these courses. MHFA training has the potential to improve outcomes for students with depression, and could have a valuable role in reducing the excess risk of harm seen in male students. [ABSTRACT FROM AUTHOR]

Background: Imbalance between individual resources and work demands can lead to musculoskeletal disorders and reduced work ability. The purpose of this study was to investigate the effect of workplace- versus home-based physical exercise on work ability among healthcare workers.Methods: Two hundred female healthcare workers (Age: 42.0, BMI: 24.1, work ability index [WAI]: 43.1) from 18 departments at three Danish hospitals participated (Copenhagen, Denmark, Aug 2013-Jan 2014). Participants were randomly allocated at the cluster level to 10 weeks of: 1) workplace physical exercise (WORK) performed during working hours for 5x10 min per week and up to 5 group-based coaching sessions on motivation for regular physical exercise, or 2) home-based physical exercise (HOME) performed during leisure time for 5x10 min per week. Both groups received ergonomic counseling on patient handling and use of lifting aides. The main outcome measure was the change from baseline to 10-week follow-up in WAI.Results: Significant group by time interaction was observed for WAI (p < 0.05). WAI at follow-up was 1.1 (0.3 to 1.8) higher in WORK compared with HOME corresponding to a small effect size (Cohens'd = 0.24). Within-group changes indicated that between-group differences were mainly caused by a reduction in WAI in HOME. Of the seven items of WAI, item 2 (work ability in relation to the demands of the job) and item 5 (sickness absence during the past year) were improved in WORK compared with HOME (P < 0.05).Conclusions: Performing physical exercise together with colleagues at the workplace prevents deterioration of work ability among female healthcare workers.Trial Registration Number: ClinicalTrials.gov NCT01921764 . Registered 10 August 2013. [ABSTRACT FROM AUTHOR]

Background: Tobacco use remains the leading cause of premature morbidity and mortality in the United States. Young adults are less successful at quitting, use cessation treatment less often than smokers of other ages, and can be a challenge to retain in treatment. Social media, integrated into the lives of many young adults, represents a promising strategy to deliver evidence-based smoking cessation treatment to a large, diverse audience. The goal of this trial is to test the efficacy of a stage-based smoking cessation intervention on Facebook for young adults age 18 to 25 on smoking abstinence, reduction in cigarettes smoked, and thoughts about smoking abstinence.Methods/design: This is a randomized controlled trial. Young adult smokers throughout the United States are recruited online and randomized to either the 3 month Tobacco Status Project intervention on Facebook or a referral to a smoking cessation website. The intervention consists of assignment to a secret Facebook group tailored to readiness to quit smoking (precontemplation, contemplation, preparation), daily Facebook contacts tailored to readiness to quit smoking, weekly live counseling sessions, and for those in preparation, weekly Cognitive Behavioral Therapy counseling sessions on Facebook. Primary outcome measure is biochemically-verified 7-day point prevalence abstinence from smoking at posttreatment (3 months), 6, and 12 months. Secondary outcome measures are reduction of 50 % or more in cigarettes smoked, 24 h quit attempts, and commitment to abstinence at each time point. A secondary aim is to test, within the TSP condition, the effect of a monetary incentive at increasing engagement in the intervention.Discussion: This randomized controlled trial is testing a novel Facebook intervention for treating young adults' tobacco use. If efficacious, the social media intervention could be disseminated widely and expanded to address additional health risks.Trial Registration: ClinicalTrials.gov: NCT02207036 , May 13, 2014. [ABSTRACT FROM AUTHOR]

Background: The National Human Papillomavirus (HPV) Vaccination Program in Australia commenced in 2007 for females and in 2013 for males, using the quadrivalent HPV vaccine (HPV 6,11,16,18). Thus far, we have demonstrated very substantial reductions in genital warts and in the prevalence of HPV among young Australian women, providing early evidence for the success of this public health initiative. Australia has a long history of school-based vaccination programs for adolescents, with comparatively high coverage. However, it is not clear what factors promote success in a school vaccination program. The HPV.edu study aims to examine: 1) student knowledge about HPV vaccination; 2) psycho-social outcomes and 3) vaccination uptake.Methods/design: HPV.edu is a cluster randomised trial of a complex intervention in schools aiming to recruit 40 schools with year-8 enrolments above 100 students (approximately 4400 students). The schools will be stratified by Government, Catholic, and Independent sectors and geographical location, with up to 20 schools recruited in each of two states, Western Australia (WA) and South Australia (SA), and randomly allocated to intervention or control (usual practice). Intervention schools will receive the complex intervention which includes an adolescent intervention (education and distraction); a decisional support tool for parents and adolescents and logistical strategies (consent form returns strategies, in-school mop-up vaccination and vaccination-day guidelines). Careful process evaluation including an embedded qualitative evaluation will be undertaken to explore in depth possible mechanisms for any observed effect of the intervention on primary and secondary outcomes.Discussion: This study is the first to evaluate the relative effectiveness of various strategies to promote best practice in school-based vaccination against HPV. The study aims to improve vaccination-related psychosocial outcomes, including adolescent knowledge and attitudes, decision-making involvement, self-efficacy, and to reduce fear and anxiety. The study also aims to improve school vaccination program logistics including reduction in time spent vaccinating adolescents and increased number of consent forms returned (regardless of decision). Less anxiety in adolescents will likely promote more efficient vaccination, which will be more acceptable to teachers, nurses and parents. Through these interventions, it is hoped that vaccination uptake will be increased.Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12614000404628 , 14.04.2014. [ABSTRACT FROM AUTHOR]

Background: Although insufficient sleep has emerged as a strong, independent risk factor for obesity in children, the mechanisms by which insufficient sleep leads to weight gain are uncertain. Observational research suggests that being tired influences what children eat more than how active they are, but only experimental research can determine causality. Few experimental studies have been undertaken to determine how reductions in sleep duration might affect indices of energy balance in children including food choice, appetite regulation, and sedentary time. The primary aim of this study is to objectively determine whether mild sleep deprivation increases energy intake in the absence of hunger.Methods: The Daily, Rest, Eating, and Activity Monitoring (DREAM) study is a randomized controlled trial investigating how mild sleep deprivation influences eating behaviour and activity patterns in children using a counterbalanced, cross-over design. One hundred and ten children aged 8-12 years, with normal reported sleep duration of 8-11 h per night will undergo 2 weeks of sleep manipulation; seven nights of sleep restriction by going to bed 1 hr later than usual, and seven nights of sleep extension going to bed 1 hr earlier than usual, separated by a washout week. During each experimental week, 24-h movement behaviours (sleep, physical activity, sedentary behaviour) will be measured via actigraphy; dietary intake and context of eating by multiple 24-h recalls and wearable camera images; and eating behaviours via objective and subjective methods. At the end of each experimental week a feeding experiment will determine energy intake from eating in the absence of hunger. Differences between sleep conditions will be determined to estimate the effects of reducing sleep duration by 1-2 h per night.Discussion: Determining how insufficient sleep predisposes children to weight gain should provide much-needed information for improving interventions for the effective prevention of obesity, thereby decreasing long-term morbidity and healthcare burden.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001671257 . Registered 10 October 2018. [ABSTRACT FROM AUTHOR]

Background: Increasing physical activity in children is a health priority. The Healthy Active Peaceful Playgrounds for Youth (HAPPY) study aimed to examine a multi-component playground intervention designed to increase the proportion of physical activity during recess and lunch of primary school students.Methods: The 2016 Australian focused HAPPY Study was a 12-month, metropolitan primary school based intervention, which was evaluated using a stepped wedge design. The intervention combined teacher development, environmental modifications, and peer support, with the outcomes of increasing physical activity, and analysing students' sources of social support to be physically active.Results: Between baseline and follow-up, the proportion of students involved in vigorous activities during recess and lunch times increased significantly from 15 to 25% (p < 0.001). No differences were recorded in sources of social support.Conclusions: The HAPPY project demonstrated an increase in the proportion of physical activity intensity during recess and lunch times in primary schools, although further investigation is required to determine what components of the study had the greatest effect.Trial Registration: This study was retrospectively registered with the Australian and New Zealand Clinical Trials Registry ACTRN12616000575437 . Date of registration: 4 May 2016. [ABSTRACT FROM AUTHOR]

Background: Several studies have now demonstrated the benefits of peer support in promoting diabetes control. The aim of this study is to evaluate the implementation of a cluster randomised controlled trial of a group-based, peer support program to improve diabetes self-management and thereby, diabetes control in people with Type 2 Diabetes in Victoria, Australia.Methods: The intervention program was designed to address four key peer support functions i.e. 1) assistance in daily management, 2) social and emotional support, 3) regular linkage to clinical care, and 4) ongoing and sustained support to assist with the lifelong needs of diabetes self-care management. The intervention participants attended monthly group meetings facilitated by a trained peer leader for 12 months. Data was collected on the intervention's reach, participation, implementation fidelity, groups' effectiveness and participants' perceived support and satisfaction with the intervention. The RE-AIM and PIPE frameworks were used to guide this evaluation.Results: The trial reached a high proportion (79%) of its target population through mailed invitations. Out of a total of 441 eligible individuals, 273 (61.9%) were willing to participate. The intervention fidelity was high (92.7%). The proportion of successful participants who demonstrated a reduction in 5 years cardiovascular disease risk score was 65.1 and 44.8% in the intervention and control arm respectively. Ninety-four percent (94%) of the intervention participants stated that the program helped them manage their diabetes on a day to day basis. Overall, attending monthly group meetings provided 'a lot of support' to 57% and 'moderate' support to 34% of the participants.Conclusion: Peer support programs are feasible, acceptable and can be used to supplement treatment for patients motivated to improve behaviours related to diabetes. However, program planners need to focus on the participation component in designing future programs. The use of two evaluation frameworks allowed a comprehensive evaluation of the trial from the provider-, participant- and public health perspective. The learnings gained from this evaluation will guide and improve future implementation by improving program feasibility for adoption and acceptability among participants, and will ultimately increase the likelihood of program effectiveness for the participants.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000469213 . Registered 16 June 2009. [ABSTRACT FROM AUTHOR]

Background: A substantial minority of American adults continue to hold influential misperceptions about childhood vaccine safety. Growing public concern and refusal to vaccinate poses a serious public health risk. Evaluations of recent pro-vaccine health communication interventions have revealed mixed results (at best). This study investigated whether highlighting consensus among medical scientists about childhood vaccine safety can lower public concern, reduce key misperceptions about the discredited autism-vaccine link and promote overall support for vaccines.Methods: American adults (N = 206) were invited participate in an online survey experiment. Participants were randomly assigned to either a control group or to one of three treatment interventions. The treatment messages were based on expert-consensus estimates and either normatively described or prescribed the extant medical consensus: "90 % of medical scientists agree that vaccines are safe and that all parents should be required to vaccinate their children".Results: Compared to the control group, the consensus-messages significantly reduced vaccine concern (M = 3.51 vs. M = 2.93, p < 0.01) and belief in the vaccine-autism-link (M = 3.07 vs M = 2.15, p < 0.01) while increasing perceived consensus about vaccine safety (M = 83.93 vs M = 89.80, p < 0.01) and public support for vaccines (M = 5.66 vs M = 6.22, p < 0.01). Mediation analysis further revealed that the public's understanding of the level of scientific agreement acts as an important "gateway" belief by promoting public attitudes and policy support for vaccines directly as well as indirectly by reducing endorsement of the discredited autism-vaccine link.Conclusion: These findings suggest that emphasizing the medical consensus about (childhood) vaccine safety is likely to be an effective pro-vaccine message that could help prevent current immunization rates from declining. We recommend that clinicians and public health officials highlight and communicate the high degree of medical consensus on (childhood) vaccine safety when possible. [ABSTRACT FROM AUTHOR]