A systematic review to determine the effect of strategies to sustain chronic disease prevention interventions in clinical and community settings: study protocol.

BACKGROUND: The primary purpose of this review is to synthesise the effect of strategies aiming to sustain the implementation of evidenced-based interventions (EBIs) targeting key health behaviours associated with chronic disease (i.e. physical inactivity, poor diet, harmful alcohol use, and tobacco smoking) in clinical and community settings. The field of implementation science is bereft of an evidence base of effective sustainment strategies, and as such, this review will provide important evidence to advance the field of sustainability research. METHODS: This systematic review protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) checklist. Methods will follow Cochrane gold-standard review methodology. The search will be undertaken across multiple databases, adapting filters previously developed by the research team, data screening and extraction will be performed in duplicate, strategies will be coded using an adapted sustainability-explicit taxonomy, and evidence will be synthesised using appropriate methods (i.e. meta-analytic following Cochrane or non-meta-analytic following SWiM guidelines). We will include any randomised controlled study that targets any staff or volunteers delivering interventions in clinical or community settings. Studies which report on any objective or subjective measure of the sustainment of a health prevention policy, practice, or programme within any of the eligible settings will be included. Article screening, data extraction, risk of bias, and quality assessment will be performed independently by two review authors. Risk of bias will be assessed using Version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). A random-effect meta-analysis will be conducted to estimate the pooled effect of sustainment strategies separately by setting (i.e. clinical and community). Sub-group analyses will be undertaken to explore possible causes of statistical heterogeneity and may include the following: time period, single or multi-strategy, type of setting, and type of intervention. Differences between sub-groups will be statistically compared. DISCUSSION/CONCLUSION: This will be the first systematic review to determine the effect of strategies designed to support sustainment on sustaining the implementation of EBIs in clinical and community settings. The findings of this review will directly inform the design of future sustainability-focused implementation trials. Further, these findings will inform the development of a sustainability practice guide for public health practitioners. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022352333.

A cluster randomised controlled trial to assess the effectiveness of a multi-strategy sustainability intervention on teachers' sustained implementation of classroom physical activity breaks (energisers): study protocol.

BACKGROUND: Governments internationally have invested hugely in the implementation and scale-up of school-based physical activity interventions, but have little evidence of how to best sustain these interventions once active implementation support ceases. This study will assess the effectiveness of a multi-strategy sustainability intervention on classroom teachers' sustainment of energisers (short 3-5 min physical activity breaks during class-time) scheduled across the school day from baseline to 12 and 24-month follow-up. METHODS: A cluster randomised controlled trial will be conducted in 50 primary schools within the Hunter New England, Illawarra Shoalhaven, Murrumbidgee and Northern New South Wales (NSW) Local Health Districts of NSW Australia. Schools will be randomly allocated to receive either usual support or the multi-strategy sustainability intervention that includes: centralised technical assistance from a trained project officer; formal commitment and mandated change obtained from school principals; training in-school champions; reminders for teachers; educational materials provided to teachers; capturing and sharing local knowledge; and engagement of parents, carers and the wider school community. The primary trial outcome will be measured via a teacher logbook to determine the between-group difference in the change in mean minutes of energisers scheduled across the school day at 12 and 24-month follow-up compared to baseline. Analyses will be performed using an intention to treat framework. Linear mixed models will be used to assess intervention effects on the primary outcome at both follow-up periods. DISCUSSION: This study will be one of the first randomised controlled trials to examine the impact of a multi-strategy sustainability intervention to support schools' sustainment of a physical activity intervention. The proposed research will generate new evidence needed for the partnering organisations to protect their considerable investments to date in physical activity promotion in this setting and will provide seminal evidence for the field globally. TRIAL REGISTRATION: ACTRN12620000372987 version 1 registered 17th March 2020. Version 3 (current version) updated 4th August 2023.

Effects of a father-daughter physical activity intervention delivered by trained facilitators in the community setting on girls' social-emotional well-being: A randomized controlled trial.

This study evaluated the effect of the Dads And Daughters Exercising and Empowered (DADEE) program on daughters' social-emotional well-being when delivered by trained facilitators. Fathers (n = 158; Mage = 41.95 ± 5.32 years; 86% Australian born) and daughters (n = 193; Mage = 8.35 ± 1.85 years) from Newcastle, New South Wales, Australia, were randomized into (a) the DADEE intervention or (b) a wait-list control. At baseline and 3 months, fathers, daughters, and mothers completed validated scales of daughters' social-emotional well-being (main outcome of interest), daughters' self-esteem, and other family-related outcomes. Intervention daughters improved their social-emotional well-being from father and mother perspectives compared to the control group (d = 0.51-0.64). Intervention effects were observed for the father-daughter relationship, indicators of father involvement, fathering warmth, coparenting, and family-related well-being, but not daughters' self-reported self-esteem and family-related well-being. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

A systematic review to determine the effect of strategies to sustain chronic disease prevention interventions in clinical and community settings: study protocol.

Background: The primary purpose of this review is to synthesise the effect of strategies aiming to sustain the implementation of evidenced based interventions (EBIs) targeting key health behaviours associated with chronic disease (i.e., physical inactivity, poor diet, harmful alcohol use and tobacco smoking) in clinical and community settings. The field of implementation science is bereft of an evidence base of effective sustainment strategies, and as such this review will provide important evidence to advance the field of sustainability research. Methods: This systematic review protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis Protocol (PRISMA-P) checklist (Additional file 1). Methods will follow Cochrane gold-standard review methodology. The search will be undertaken across multiple databases, adapting filters previously developed by the research team; data screening and extraction will be performed in duplicate; strategies will be coded using an adapted sustainability-explicit taxonomy; evidence will be synthesised using appropriate methods (i.e. meta-analytic following Cochrane or non-meta-analytic following SWiM guidelines). We will include any randomised controlled study that targets any staff or volunteers delivering interventions in clinical or community settings. Studies which report on any objective or subjective measure of the sustainment of a health prevention policy, practice, or program within any of the eligible settings will be included. Article screening, data extraction, risk of bias and quality assessment will be performed independently by two review authors. Risk of bias will be assessed using Version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). A random effect meta-analysis will be conducted to estimate the pooled effect of sustainment strategies separately by setting (i.e. clinical and community). Sub-group analyses will be undertaken to explore possible causes of statistical heterogeneity and may include: time period, single or multi strategy, type of setting and type of intervention. Differences between sub-groups will be statistically compared. Discussion/Conclusion: This will be the first systematic review to determine the effect of strategies designed to support sustainment on sustaining the implementation of EBIs in clinical and community settings. The findings of this review will directly inform the design of future sustainability-focused implementation trials. Further, these findings will inform the development of a sustainability practice guide for public health practitioners. Registration: This review was prospectively registered with PROSPERO (registration ID: CRD42022352333).

Impact of the 'Healthy Youngsters, Healthy Dads' program on physical activity and other health behaviours: a randomised controlled trial involving fathers and their preschool-aged children.

BACKGROUND: Targeting fathers may be a key strategy to increase physical activity among their preschool-aged children, but limited research exists in this area. The primary study aim was to examine the impact of a lifestyle program for fathers and their preschool-aged children on child physical activity levels. METHODS: A total of 125 fathers (aged: 38 ± 5.4 years, BMI: 28.1 ± 4.9 kg/m2) and 125 preschool-aged children (aged: 3.9 ± 0.8 years, BMI z-score: 0.3 ± 0.9, 39.2% girls) recruited from Newcastle, Australia, NSW were randomised to (i) the Healthy Youngsters, Healthy Dads (HYHD) program, or (ii) wait-list control group. The program included two fathers-only workshops (2 h each) and eight father-child weekly educational and practical sessions (75 min each), plus home-based activities targeting family physical activity and nutrition. Assessments took place at baseline, 10-weeks (post-intervention) and 9-months follow-up. The primary outcome was the children's mean steps/day at 10-weeks. Secondary outcomes included: co-physical activity, fathers' physical activity levels and parenting practices for physical activity and screen time behaviours, children's fundamental movement skill (FMS) proficiency, plus accelerometer based light physical activity (LPA) and moderate-to-vigorous physical activity (MVPA), screen time and adiposity for fathers and children. Process measures included; attendance, satisfaction, fidelity and retention. Linear mixed models estimated the treatment effect at all time-points for all outcomes. RESULTS: Intention-to-treat analyses revealed a significant group-by-time effect for steps per day at 10-weeks (+ 1417, 95%CI: 449, 2384) and 9-months follow-up (+ 1480, 95%CI: 493, 2467) in intervention children compared to control. There were also favourable group-by-time effects for numerous secondary outcomes including fathers' physical activity levels, children's FMS proficiency, and several parenting constructs. No effects were observed for both fathers' and children's accelerometer based LPA or MVPA, co-physical activity, screen-time and adiposity measures. Process evaluation data revealed very high levels of satisfaction, attendance, retention, and intervention fidelity. CONCLUSION: Engaging fathers in a lifestyle program is a promising strategy to increase physical activity among preschool-aged children. Additional benefits to fathers' physical activity levels, children's FMS proficiency and parenting practices further support the importance of engaging fathers to improve family health outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12619000105145 . Registered 24/01/2019.

Establishing Effectiveness of a Community-based, Physical Activity Program for Fathers and Daughters: A Randomized Controlled Trial.

BACKGROUND: The 'Dads And Daughters Exercising and Empowered' (DADEE) program significantly improved physical activity levels of fathers and their daughters in an efficacy trial. However, the effectiveness of interventions when delivered in real-world settings needs to be established. PURPOSE: To evaluate the effectiveness of the DADEE intervention when delivered in community settings by trained facilitators. METHODS: We conducted a two-arm RCT, (baseline and 3-months post-intervention assessments), in Newcastle, Australia. In 2016, 155 fathers (27-60 years) and 189 primary-school-aged daughters (4-12 years) (n = 344) were randomly allocated to the intervention (78 fathers, 95 daughters) or waitlist-control (77 fathers, 94 daughters) groups. Trained facilitators delivered the 9-week DADEE program (weekly sessions plus home-based tasks). Primary outcomes were fathers' and daughters' physical activity (steps/day). Secondary outcomes included screen-time, weight status, daughters' fundamental movement skill (FMS) proficiency, perceived sports competence, and fathers' parenting practices. Effects were assessed using linear mixed models. RESULTS: Primary outcome follow-up data were collected from 88% of fathers and 89% of daughters. Significant group-by-time differences in mean daily steps were found for fathers' (adjusted difference = +1,638; 95% CI: 833, 2,443, d = 0.7) and daughters' (adjusted difference = +1,023 steps/day; 95% CI: 259, 1,787; d = 0.4) physical activity. Significant effects were observed for daughters' screen-time, FMS, and some parenting practices. No significant effects were identified for weight status, or fathers'screen-time or self-reported MVPA. Program attendance, satisfaction and fidelity were very high. CONCLUSION: This study established the effectiveness of the DADEE intervention when delivered in community settings by trained facilitators. Importantly, the findings were comparable to those of the efficacy RCT delivered by the research team. To maximize public health benefits, a larger-scale dissemination of the program appears warranted.Trial Registration Australian New Zealand Clinical Trial Registry: ACTRN12616001270404 Human Research Ethics Committee: H-2014-0330.

Dietary Outcomes of the 'Healthy Youngsters, Healthy Dads' Randomised Controlled Trial.

(1) Background: The effect of fathers on dietary intake in preschool-aged children is under-explored. The aims were to: (i) evaluate the efficacy of a family-based lifestyle intervention, Healthy Youngsters, Healthy Dads, on change in dietary intake in fathers and their preschool-aged children post-intervention (10 weeks) and at 9 months follow-up compared to a waitlist control group and (ii) investigate associations in father-child dietary intakes. (2) Methods: Linear mixed models estimated group-by-time effects for all dietary outcomes, measured by food frequency questionnaires. Cohen's d determined effect sizes, while correlation tests determined associations in father-child dietary intakes. (3) Results: For children, medium group-by-time effects sizes were identified at 10 weeks for sodium intake (d = 0.38) and percentage energy from core foods (d = 0.43), energy-dense, nutrient-poor (EDNP) foods (d = 0.43) and prepacked snacks (d = 0.45). These findings were sustained at 9 months follow-up. For fathers, medium to large, group-by-time effect sizes were identified at 10 weeks for energy intake (d = 0.55), sodium intake (d = 0.64) and percentage energy from core foods (d = 0.49), EDNP foods (d = 0.49), and confectionary (d = 0.36). For all of these dietary variables, except sodium, effects were sustained at 9 months. Moderate to strong associations existed in father-child dietary intakes for some of the dietary variables. (4) Conclusions: Although further research is required, this study provides preliminary support for targeting fathers as agents of change to improve dietary intakes in their preschool-aged children.

Engaging Fathers to Improve Physical Activity and Nutrition in Themselves and in Their Preschool-Aged Children: The "Healthy Youngsters, Healthy Dads" Feasibility Trial.

BACKGROUND: Few lifestyle programs for young children have targeted fathers. This study examined the feasibility of a lifestyle intervention for fathers and their preschool-aged children. METHOD: A total of 24 father/preschool child dyads were recruited from Newcastle, Australia, into a single-arm, feasibility trial (baseline and 3-mo postbaseline assessments). The 9-session program aimed to improve physical activity and dietary habits of fathers and children. A priori feasibility benchmarks targeted recruitment (15 dyads), eligibility rate (>60%), attendance (80%), retention (≥85%), and program acceptability (≥4 out of 5). Acceptability of data collection procedures, research team program/resource management, home-program compliance, and preliminary intervention outcomes were also assessed. RESULTS: Feasibility benchmarks were surpassed for recruitment (24 dyads), eligibility rate (61.5%), attendance (89%), retention (100%), and program acceptability (4.6 out of 5). Data collection procedures were acceptable. Challenges included mothers reporting their own dietary intake rather than their child's, children moving during body composition measurement, and resetting pedometers. Resource and program management were excellent. Most families met home-program requirements (83%). Preliminary intervention outcomes were encouraging for fathers and children. CONCLUSION: Program feasibility was demonstrated by excellent recruitment, attendance, acceptability, retention, program administration, and promising preliminary intervention outcomes. A few data collection difficulties were identified. A larger scale efficacy trial is warranted.

Impact of male-only lifestyle interventions on men's mental health: A systematic review and meta-analysis.

Despite rising mental health problems worldwide, engaging men to seek mental health support is challenging. Male-only lifestyle interventions have shown promise for improving men's physical health, but the overall impact of these programs on psychological outcomes is unclear. This review aimed to evaluate the impact of male-only lifestyle interventions on men's mental health and to identify if any study or intervention features were associated with effectiveness. A systematic literature search with no date restrictions was conducted across four databases and returned 15 946 citations. Nine studies were eligible for inclusion, representing 1427 participants. Risk of bias was generally low across studies, although none were specifically powered to detect changes in mental health. Overall, significant group-by-time effects were reported for 26% of mental health outcomes examined. In the fixed-effects meta-analyses, small-to-medium intervention effects were observed for mental health-related quality of life (SMD = 0.24), self-esteem (SMD = 0.51), and positive affect (SMD = 0.58). Insights into effective study or intervention features were limited because of the low number of heterogeneous studies. Although male-only lifestyle interventions have improved men's mental health in some circumstances, studies that are specifically powered to detect long-term changes are urgently required, particularly in groups with pre-existing mental health concerns.

Twelve-month outcomes of a father-child lifestyle intervention delivered by trained local facilitators in underserved communities: The Healthy Dads Healthy Kids dissemination trial.

Healthy Dads Healthy Kids (HDHK) was the first program internationally to specifically target overweight and obese fathers to improve their children's health. In previous randomized controlled trials, HDHK generated meaningful short-term improvements in the adiposity, physical activity, and eating behaviors of both fathers and children. The aim of this dissemination trial was to evaluate the 12-month impact of HDHK when delivered by trained facilitators across four low socioeconomic and regional communities in the Hunter Region, Australia. The study was a nonrandomized, prospective trial with minimal eligibility criteria (i.e., father body mass index [BMI] ≥ 25 kg/m2 and children aged 4-12 years). HDHK included eight weekly practical and theoretical sessions. Assessments were baseline, 3 months (post-intervention), 6-months, and 12-months. The primary outcome was fathers' weight. Secondary outcomes included child BMI z-score and validated lifestyle behavior measures (e.g., physical activity, diet). Overall, 189 fathers (mean age: 40.2 years, BMI: 32.6 kg/m2) and 306 children (mean age: 8.1 years) participated in one of 10 HDHK programs in four areas. Intention-to-treat linear mixed models revealed a significant mean reduction in fathers' weight at post-intervention (-3.6 kg, 95% confidence interval: -4.3, -2.9), which was maintained at 12 months (71% retention). Corresponding improvements were also detected in children's BMI z-score and a range of lifestyle behaviors for both fathers and children. Attendance and satisfaction levels were high. Positive intervention effects observed in previous randomized controlled trials were largely replicated and sustained for 12 months when HDHK was delivered by trained local facilitators in underserved communities. Further investigation into the key systems, processes, and contextual factors required to deliver HDHK at scale appears warranted.

Impact of a father-daughter physical activity program on girls' social-emotional well-being: A randomized controlled trial.

OBJECTIVE: To increase girls' well-being, strategies are needed to optimize their social-emotional competence during childhood. Although positive fathering is important for girls, many fathers discount their unique influence and few participate in interventions. The Dads And Daughters Exercising and Empowered (DADEE) program was developed to engage fathers and their daughters through shared physical activity experiences. This study examined the program's impact on girls' well-being and the father-daughter relationship. METHOD: Overall, 115 fathers (age range: 29-53 years) and 153 daughters (age range: 4-12 years) were randomized to (1) the DADEE program (9 weekly educational and practical sessions plus home-based challenges) or (2) a wait-list control. Assessments were baseline, 2 months (postintervention), and 9 months (94% retention). Daughters' social-emotional well-being was measured with the Devereux Student Strengths Assessment composite. Secondary outcomes included additional well-being indicators (e.g., global self-perception) plus validated measures of father involvement and father-daughter relationship quality. RESULTS: At 2 months, intervention daughters showed a medium-to-large improvement in overall well-being (+24.9 units, 95% CI [8.6, 41.1], d = 0.6), when compared with controls. Intervention daughters were also more likely to show clinically meaningful improvements in well-being (54%) than controls (18%). Medium-to-large effects were observed for: seven of eight social-emotional competencies (e.g., personal responsibility, d = 0.4-0.9), father-daughter relationship quality (d = 0.8, father-report; d = 0.5, daughter-report), daughters' prosocial behavior (d = 0.3) and several indicators of father involvement. Most outcomes had improved by 9 months. No effects were observed for daughters' emotional difficulties or global self-perception. CONCLUSIONS: This study provided the first experimental evidence that father-daughter physical activity programs may improve girls' well-being and the father-daughter relationship. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Engaging Fathers to Increase Physical Activity in Girls: The "Dads And Daughters Exercising and Empowered" (DADEE) Randomized Controlled Trial.

Background: Existing strategies to increase girls' physical activity levels have seen limited success. Fathers may influence their children's physical activity, but often spend more time with their sons and rarely participate in family-based programs. Purpose: To test a novel program designed to increase the physical activity levels of fathers and their daughters. Methods: In a two-arm RCT, 115 fathers (29-53 years) and 153 daughters (4-12 years) were randomized to (i) the "Dads And Daughters Exercising and Empowered" (DADEE) program, or (ii) a wait-list control. The 8-week program included weekly educational and practical sessions plus home tasks. Assessments were at baseline, 2 months (postintervention), and 9 months. The primary outcomes were father-daughter physical activity levels (pedometry). Secondary outcomes included screen-time, daughters' fundamental movement skill proficiency (FMS: perceived and objective), and fathers' physical activity parenting practices. Results: Primary outcome data were obtained from 88% of daughters and 90% of fathers at 9 months. Intention-to-treat analyses revealed favorable group-by-time effects for physical activity in daughters (p = .02, d = 0.4) and fathers (p < .001, d = 0.7) at postintervention, which were maintained at 9 months. At postintervention and follow-up, significant effects (p < .05) were also identified for daughters' FMS competence (objective: d = 1.1-1.2; perceived: d = 0.4-0.6), a range of fathers' physical activity parenting practices (d = 0.3-0.8), and screen-time for daughters (d = 0.5-0.8) and fathers (d = 0.4-0.6, postintervention only). Program satisfaction and attendance were very high. Conclusions: This study provided the first experimental evidence that efforts to increase physical activity behavior in preadolescent girls would benefit from a meaningful engagement of fathers. Clinical Trial information: Australian New Zealand Clinical Trials Registry: ACTRN12615000022561.

Fundamental movement skills: Where do girls fall short? A novel investigation of object-control skill execution in primary-school aged girls.

Fundamental movement skill (FMS) proficiency is positively associated with a range of health outcomes, and is a predictor of lifelong participation in physical activities and sport. Yet low FMS proficiency levels in children prevail, particularly among girls performing object-control skills (e.g., kicking, catching). To identify where girls require the most support and inform future teaching resources and interventions, this cross-sectional study investigated proficiency levels of object-control skills and their specific performance components (subskills) in girls; and aimed to determine whether patterns in subskill mastery were evident in girls from two different developmental stages. This study included 153 girls (aged 4-12 years; mean age = 7.7, SD = 1.8) from the Hunter Region, Australia. Six object-control skills were video-assessed using the Test of Gross Motor Development (TGMD-2, TGMD-3); overall skill proficiency levels and mastery levels of subskills were determined. In summary, <5% (of the total group, 4-8 years or 9-12 years) demonstrated mastery or advanced skill level in the strike, stationary dribble, overhand throw or kick. Mastery levels were also poor for the majority of the 24 subskills, with mastery levels below 40% for the total group for 17 of the 24 subskills. Deficiencies in specific subskills were evident in the preparation, action and recovery phases of the six object-control skills. Only 6 of the 24 subskills mastery levels were significantly higher in the older age-group. Our investigation provides new evidence that may be useful for practitioners and researchers looking to support the optimal development of FMS proficiency among girls. Australian New Zealand Clinical Trials Registry: ACTRN12615000022561.

Implementing Resistance Training in Secondary Schools: A Cluster Randomized Controlled Trial.

PURPOSE: Guidelines recommend that young people engage in muscle-strengthening activities on at least 3 d·wk. The purpose of this study was to examine the effect of a school-based intervention focused on resistance training (RT) for adolescents. METHODS: The "Resistance Training for Teens" intervention was evaluated using a cluster-randomized, controlled trial with 607 adolescents (50.1% girls; 14.1 ± 0.5 yr) from 16 secondary schools. Teachers were trained to deliver the intervention, which included the following: (i) an interactive student seminar; (ii) a structured physical activity program, focused on RT; (iii) lunchtime fitness sessions; and (iv) Web-based smartphone apps. The primary outcome was muscular fitness (MF) and secondary outcomes included body mass index, RT skill competency, flexibility, physical activity, self-efficacy, and motivation. Assessments were conducted at baseline, 6 months (postprogram; primary end point), and 12 months (follow-up). Outcomes were assessed using linear mixed models, with three potential moderators tested using interaction terms (and subgroup analyses where appropriate). RESULTS: For the primary outcome (MF), a group-time effect was observed at 6 months for the upper body (2.0 repetitions; 95% confidence interval (CI), 0.8-3.2), but not the lower body (-1.4 cm; 95% CI, -4.7-1.9). At 6 months, there were intervention effects for RT skill competency and self-efficacy, but no other secondary outcomes. Effects for upper body MF and RT skill competency were sustained at 12 months. Despite overall no effect for body mass index, there was a group-time effect at 12 months among students who were overweight/obese at baseline (-0.55 kg·m; 95% CI, -1.01 to -0.08). CONCLUSIONS: The school-based RT intervention resulted in immediate and sustained improvements in upper body MF and RT skill competency, demonstrating an effective and scalable approach to delivering RT within secondary schools.

Intervention to reduce recreational screen-time in adolescents: Outcomes and mediators from the 'Switch-Off 4 Healthy Minds' (S4HM) cluster randomized controlled trial.

INTRODUCTION: The primary objective was to evaluate the impact of the 'Switch-off 4 Healthy Minds' (S4HM) intervention on recreational screen-time in adolescents. METHODS: Cluster randomized controlled trial with study measures at baseline and 6-months (post-intervention). Eligible participants reported exceeding recreational screen-time recommendations (i.e., >2h/day). In total, 322 adolescents (mean age=14.4±0.6years) from eight secondary schools in New South Wales, Australia were recruited. The S4HM intervention was guided by Self-Determination Theory and included: an interactive seminar, eHealth messaging, a behavioral contract and parental newsletters. The primary outcome was recreational screen-time. Secondary outcomes included mental health (i.e., well-being, psychological distress, self-perceptions), objectively measured physical activity, and body mass index (BMI). Outcome analyses were conducted using linear mixed models and mediation was examined using a product-of-coefficients test. RESULTS: At post-intervention, significant reductions in screen-time were observed in both groups, with a greater reduction observed in the intervention group (-50min/day versus -29min, p<0.05 for both). However, the adjusted difference in change between groups was not statistically significant (mean=-21.3min/day, p=0.255). There were no significant intervention effects for mental health outcomes, physical activity or BMI. Significant mediation effects for autonomous motivation were found. CONCLUSIONS: Participants in both the S4HM intervention and control groups significantly reduced their screen-time, with no group-by-time effects. Enhancing autonomous motivation might be a useful intervention target for trials aimed at reducing adolescents' recreational screen-time. TRIAL REGISTRATION: ACTRN12614000163606.

A school-based intervention incorporating smartphone technology to improve health-related fitness among adolescents: rationale and study protocol for the NEAT and ATLAS 2.0 cluster randomised controlled trial and dissemination study.

INTRODUCTION: Physical inactivity has been described as a global pandemic. Interventions aimed at developing skills in lifelong physical activities may provide the foundation for an active lifestyle into adulthood. In general, school-based physical activity interventions targeting adolescents have produced modest results and few have been designed to be 'scaled-up' and disseminated. This study aims to: (1) assess the effectiveness of two physical activity promotion programmes (ie, NEAT and ATLAS) that have been modified for scalability; and (2) evaluate the dissemination of these programmes throughout government funded secondary schools. METHODS AND ANALYSIS: The study will be conducted in two phases. In the first phase (cluster randomised controlled trial), 16 schools will be randomly allocated to the intervention or a usual care control condition. In the second phase, the Reach, Effectiveness, Adoption, Implementation and Maintenance (Re-AIM) framework will be used to guide the design and evaluation of programme dissemination throughout New South Wales (NSW), Australia. In both phases, teachers will be trained to deliver the NEAT and ATLAS programmes, which will include: (1) interactive student seminars; (2) structured physical activity programmes; (3) lunch-time fitness sessions; and (4) web-based smartphone apps. In the cluster RCT, study outcomes will be assessed at baseline, 6 months (primary end point) and 12-months. Muscular fitness will be the primary outcome and secondary outcomes will include: objectively measured body composition, cardiorespiratory fitness, flexibility, resistance training skill competency, physical activity, self-reported recreational screen-time, sleep, sugar-sweetened beverage and junk food snack consumption, self-esteem and well-being. ETHICS AND DISSEMINATION: This study has received approval from the University of Newcastle (H-2014-0312) and the NSW Department of Education (SERAP: 2012121) human research ethics committees. This study is funded by the Australian Research Council (FT140100399) and the NSW Department of Education. TRIAL REGISTRATION NUMBER: ACTRN12615000360516; Pre-results.

Rationale and study protocol for 'Switch-off 4 Healthy Minds' (S4HM): a cluster randomized controlled trial to reduce recreational screen time in adolescents.

INTRODUCTION: Excessive recreational screen time (i.e., screen use for entertainment) is a global public health issue associated with adverse mental and physical health outcomes. Considering the growing popularity of screen-based recreation in adolescents, there is a need to identify effective strategies for reducing screen time among adolescents. The aim of this paper is to report the rationale and study protocol for the 'Switch-off 4 Healthy Minds' (S4HM) study, an intervention designed to reduce recreational screen time among adolescents. METHODS: The S4HM intervention will be evaluated using a cluster randomized controlled trial in eight secondary schools (N=322 students) in New South Wales, Australia. The 6-month multi-component intervention will encourage adolescents to manage their recreational screen time using a range of evidence-based strategies. The intervention is grounded in Self-Determination Theory (SDT) and includes the following components: an interactive seminar for students, eHealth messaging, behavioral contract and parental newsletters. All outcomes will be assessed at baseline and at 6-months (i.e., immediate post-test). The primary outcome is recreational screen time measured by the Adolescent Sedentary Activity Questionnaire (ASAQ). Secondary outcomes include: self-reported psychological well-being, psychological distress, global physical self-concept, resilience, pathological video gaming and aggression, and objectively measured physical activity (accelerometry) and body mass index (BMI). Hypothesized mediators of behavior change will also be explored. DISCUSSION: The S4HM study will involve the evaluation of an innovative, theory-driven, multi-component intervention that targets students and their parents and is designed to reduce recreational screen time in adolescents. The intervention has been designed for scalability and dissemination across Australian secondary schools.

The toxicity of high molecular weight glutenin subunits of wheat to patients with coeliac disease.

OBJECTIVES: The ability of the gliadin fraction of wheat gluten to exacerbate coeliac disease is well documented. We investigated the possible toxicity of high molecular weight glutenin subunits (HMW-GS) in coeliac disease in vitro using gluten-sensitive T cells, and in vivo with challenge studies in patient volunteers. METHODS: A mixture of four HMW-GS was chemically separated from wheat flour and checked for purity by HPLC, SDS-PAGE and ELISA. T-cell lines, grown up from small intestinal biopsies from coeliac patients (n=17), were tested for their reactivity to HMW-GS. Adults with coeliac disease and who were on a gluten-free diet (n=3) underwent in-vivo challenges with HMW-GS. Duodenal biopsies, taken prior to the challenge and at intervals up to 6 h afterwards, were assessed for morphology, intra-epithelial lymphocyte count, and interleukin 15 (IL-15) expression, by immunohistochemistry. RESULTS: T-cell lines from 11 of 17 patients were stimulated by HMW-GS. There was a significant change in small intestinal morphology 4 h after commencing infusions with HMW-GS in all three subjects. For example villus height to crypt depth ratios were reduced in the three patients from 3.0+/-0.5 to 1.29+/-0.2, 2.53+/-0.7 to 0.81+/-0.6 and 3.0+/-0.7 to 1.85+/-0.3, P<0.0001 in all cases. There was increased expression of IL-15 in the small intestine from 2 h after the HMW-GS challenges. CONCLUSION: Mixed HMW-GS stimulate T-cell lines from some coeliac patients and exacerbate coeliac disease in vivo, inducing expression, within 2 h, of IL-15. This suggests an innate immune response to these proteins.