Consolidated guidance for behavioral intervention pilot and feasibility studies.

BACKGROUND: In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of a larger-scale trial. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All of these publications offer some form of guidance on PFS, but many focus on one or a few topics. This makes it difficult for researchers wanting to gain a broader understanding of all the relevant and important aspects of PFS and requires them to seek out multiple sources of information, which increases the risk of missing key considerations to incorporate into their PFS. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences. METHODS: To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS and backward/forward citation tracking of a well-known PFS literature (e.g., CONSORT Ext. for PFS). Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences. RESULTS: A total of 496 authors were invited to take part in the three-round Delphi survey (round 1, N = 46; round 2, N = 24; round 3, N = 22). A set of twenty considerations, broadly categorized into six themes (intervention design, study design, conduct of trial, implementation of intervention, statistical analysis, and reporting) were generated from a review of the 161 PFS-related publications as well as a synthesis of feedback from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading. CONCLUSION: We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable and universal resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS, with the hope of creating and disseminating interventions with broad public health impact.

The Health4Life e-health intervention for modifying lifestyle risk behaviours of adolescents: secondary outcomes of a cluster randomised controlled trial.

OBJECTIVES: To investigate the effectiveness of a school-based multiple health behaviour change e-health intervention for modifying risk factors for chronic disease (secondary outcomes). STUDY DESIGN: Cluster randomised controlled trial. SETTING, PARTICIPANTS: Students (at baseline [2019]: year 7, 11-14 years old) at 71 Australian public, independent, and Catholic schools. INTERVENTION: Health4Life: an e-health school-based multiple health behaviour change intervention for reducing increases in the six major behavioural risk factors for chronic disease: physical inactivity, poor diet, excessive recreational screen time, poor sleep, and use of alcohol and tobacco. It comprises six online video modules during health education class and a smartphone app. MAIN OUTCOME MEASURES: Comparison of Health4Life and usual health education with respect to their impact on changes in twelve secondary outcomes related to the six behavioural risk factors, assessed in surveys at baseline, immediately after the intervention, and 12 and 24 months after the intervention: binge drinking, discretionary food consumption risk, inadequate fruit and vegetable intake, difficulty falling asleep, and light physical activity frequency (categorical); tobacco smoking frequency, alcohol drinking frequency, alcohol-related harm, daytime sleepiness, and time spent watching television and using electronic devices (continuous). RESULTS: A total of 6640 year 7 students completed the baseline survey (Health4Life: 3610; control: 3030); 6454 (97.2%) completed at least one follow-up survey, 5698 (85.8%) two or more follow-up surveys. Health4Life was not statistically more effective than usual school health education for influencing changes in any of the twelve outcomes over 24 months; for example: fruit intake inadequate: odds ratio [OR], 1.08 (95% confidence interval [CI], 0.57-2.05); vegetable intake inadequate: OR, 0.97 (95% CI, 0.64-1.47); increased light physical activity: OR, 1.00 (95% CI, 0.72-1.38); tobacco use frequency: relative difference, 0.03 (95% CI, -0.58 to 0.64) days per 30 days; alcohol use frequency: relative difference, -0.34 (95% CI, -1.16 to 0.49) days per 30 days; device use time: relative difference, -0.07 (95% CI, -0.29 to 0.16) hours per day. CONCLUSIONS: Health4Life was not more effective than usual school year 7 health education for modifying adolescent risk factors for chronic disease. Future e-health multiple health behaviour change intervention research should examine the timing and length of the intervention, as well as increasing the number of engagement strategies (eg, goal setting) during the intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12619000431123 (prospective).

Associations between muscular strength and mental health in cognitively normal older adults: a cross-sectional study from the AGUEDA trial.

Objective: To examine the associations between muscular strength and mental health. Design: We used baseline data of 91 cognitively healthy older adults (71.69 ± 3.91 years old, 57 % women) participating in the AGUEDA randomized controlled trial. Methods: Muscular strength was assessed using both objective (i.e., handgrip strength, biceps curl, squats, and isokinetic test) and perceived (i.e., International Fitness Scale) indicators. Psychological ill-being indicators: anxiety, depression, stress, and loneliness; and psychological well-being indicators: satisfaction with life, self-esteem, and emotional well-being) were assessed using a set of valid and reliable self-reported questionnaires. Linear regression analyses were performed adjusting for sex, age, years of education, body mass index , alcohol, diet, and smoking (model 1), and additionally by cardiorespiratory fitness (model 2). Results: Elbow extension was positively associated with stress in model 1 (ß = 0.252, 95 % Confidence Interval [95 % CI] = 0.007 to 0.497, p = 0.044), and even after further adjustment for cardiorespiratory fitness (ß = 0.282, 95 % CI = 0.032 to 0.532, p = 0.028). Perceived strength was negatively associated with depressive symptoms in model 1 (ß = -0.271, 95 % CI = -0.491 to -0.049, p = 0.017) and model 2 reported associations tending towards significant (ß = -0.220, 95 % CI = -0.445 to 0.005, p = 0.055). Handgrip strength was positively associated with self-esteem in model 1 (ß = 0.558, 95 % CI = 0.168 to 0.949, p = 0.006) and model 2 (ß = 0.546, 95 % CI = 0.135 to 0.956, p = 0.010). No further associations were found among other muscular strength and mental health variables. Conclusion: Handgrip had a moderate association with self-esteem and there was a small association between perceived strength with depressive symptoms and elbow extension with stress. No other associations were observed between muscular strength and mental health outcomes in cognitively normal older adults.

Are the Risk of Generalizability Biases Generalizable? A Meta-Epidemiological Study.

Background: Preliminary studies (e.g., pilot/feasibility studies) can result in misleading evidence that an intervention is ready to be evaluated in a large-scale trial when it is not. Risk of Generalizability Biases (RGBs, a set of external validity biases) represent study features that influence estimates of effectiveness, often inflating estimates in preliminary studies which are not replicated in larger-scale trials. While RGBs have been empirically established in interventions targeting obesity, the extent to which RGBs generalize to other health areas is unknown. Understanding the relevance of RGBs across health behavior intervention research can inform organized efforts to reduce their prevalence. Purpose: The purpose of our study was to examine whether RGBs generalize outside of obesity-related interventions. Methods: A systematic review identified health behavior interventions across four behaviors unrelated to obesity that follow a similar intervention development framework of preliminary studies informing larger-scale trials (i.e., tobacco use disorder, alcohol use disorder, interpersonal violence, and behaviors related to increased sexually transmitted infections). To be included, published interventions had to be tested in a preliminary study followed by testing in a larger trial (the two studies thus comprising a study pair). We extracted health-related outcomes and coded the presence/absence of RGBs. We used meta-regression models to estimate the impact of RGBs on the change in standardized mean difference (ΔSMD) between the preliminary study and larger trial. Results: We identified sixty-nine study pairs, of which forty-seven were eligible for inclusion in the analysis (k = 156 effects), with RGBs identified for each behavior. For pairs where the RGB was present in the preliminary study but removed in the larger trial the treatment effect decreased by an average of ΔSMD=-0.38 (range - 0.69 to -0.21). This provides evidence of larger drop in effectiveness for studies containing RGBs relative to study pairs with no RGBs present (treatment effect decreased by an average of ΔSMD =-0.24, range - 0.19 to -0.27). Conclusion: RGBs may be associated with higher effect estimates across diverse areas of health intervention research. These findings suggest commonalities shared across health behavior intervention fields may facilitate introduction of RGBs within preliminary studies, rather than RGBs being isolated to a single health behavior field.

Effectiveness of Intervention Strategies to Increase Adolescents' Physical Activity and Reduce Sedentary Time in Secondary School Settings, Including Factors Related to Implementation: A Systematic Review and Meta-Analysis.

BACKGROUND: Globally, just one in five adolescents meet physical activity guidelines and three-quarters of the school day is spent sitting. It is unclear which types of school-based interventions strategies increase physical activity and reduce sedentary time among adolescents, or how these interventions are implemented influences their effectiveness. OBJECTIVE: The three aims of our systematic review were to (a) identify intervention strategies used within secondary school settings to improve students' movement behaviours throughout school-based initiatives, delivered at or by the school; (b) determine the overall effect of the interventions (meta-analysis) on physical activity (all intensities), sedentary time, cognitive/academic, physical health and/or psychological outcomes; and (c) describe factors related to intervention implementation. METHODS: Searches were conducted in MEDLINE complete, EMBASE, CINAHL, SPORTDiscus, APA PsycINFO, and ERIC in January 2023 for studies that (a) included high school-aged adolescents; (b) involved a school-based intervention to increase physical activity and/or decrease sedentary time; and (c) were published in English. Reported effects were pooled in meta-analyses where sufficient data were obtained. RESULTS: Eighty-five articles, representing 61 interventions, met the inclusion criteria, with 23 unique intervention strategies used. Interventions that involved whole-school approaches (i.e., physical activity sessions, environmental modifications, teacher training, peer support and/or educational resources) were favourably associated with most of the outcomes. The meta-analyses showed: (a) non-significant effects for sedentary time (Standardized mean difference [SMD] = -0.02; 95%CI, -0.14, 0.11), physical activity at all intensities (light: SMD= -0.01; 95%CI, -0.08, 0.05; moderate: SMD = 0.06; 95%CI, -0.09, 0.22; vigorous: SMD = 0.08; 95%CI, -0.02, 0.18; moderate-to-vigorous: SMD = 0.05; 95%CI, -0.01, 0.12) and waist circumference (SMD = 0.09; 95%CI, -0.03, 0.21), and (b) a small statistically significant decrease in body mass index (SMD= -0.09, 95%CI -0.16, -0.0). Factors related to intervention implementation were reported in 51% of the articles. CONCLUSION: While some intervention approaches demonstrated promise, small or null effects were found in meta-analyses. Future school-based interventions should utilize a whole-school approach designed to increase adolescents' activity across the day. Consistent reporting of implementation will increase understanding of how interventions are adopted, implemented and sustained. REGISTRATION: PROSPERO (CRD42020169988).

A Mobile Health Resistance Training Intervention Using Outdoor Gym Equipment: Process Evaluation of the Ecofit Effectiveness Randomized Controlled Trial.

BACKGROUND: Few mobile health resistance-based physical activity interventions have targeted community-dwelling adults. "Ecofit" is a multicomponent intervention that promotes resistance and aerobic activities using smartphone technology, outdoor gyms, and social support. This study evaluated process evaluation outcomes of the ecofit randomized controlled trial: (1) the acceptability and usability of the ecofit smartphone app and app user workouts; (2) perceptions of factors influencing outdoor gym use; and (3) the fidelity, reach, recruitment, and dose received of the ecofit program. METHODS: Process data were collected through program evaluation surveys at 3 months, and app usage data were collected via the intervention platform for up to 3 months. Data were analyzed using descriptive statistics. RESULTS: The survey was completed by 57% (n = 69) of eligible participants. The majority (93%) believed the app provided them with sufficient information to perform muscle-strengthening activities. Approximately half (51%) agreed that the goal-setting function encouraged them to complete their workouts, and 42% agreed that the self-assessment helped them monitor progress. "Proximity" to outdoor gyms emerged as the most important factor for choosing locations to workout (mean = 5.5, SD = 1.1). Participants logged a median of 5.5 (interquartile range = 19) workouts and 1 (interquartile range = 1) upper- and lower-body muscular fitness self-assessment. CONCLUSIONS: The ecofit app provided participants with sufficient skills to perform unsupervised resistance training exercises using mobile health. Only half of the participants regarded self-assessments and goal setting as useful, suggesting a need for modifications to how these are implemented. Mobile health remains a promising delivery platform to promote unsupervised resistance training, although more research is needed to improve uptake.

The Development and Evaluation of Netball-Specific High-Intensity Interval Training Sessions: The Netball-HIIT Study.

This two-phase study involved the design, development, and evaluation of netball-specific high-intensity interval training sessions (Netball-HIIT) for use with netballers of varied ages and abilities. In Phase 1 (2020), a systematic analysis of netball GPS data from 30 netball players and gameplay video footage (10 h) was conducted, followed by the design and testing of five 8 min Netball-HIIT sessions involving 100 netball players (age 21 ± 8.44 years; Australia). In Phase 2 (2021), the feasibility and preliminary efficacy of delivering one Netball-HIIT session each week for five weeks was assessed using a two-armed, dose-matched, randomized, controlled feasibility study with netball players (born in 2010) (Netball HIIT n = 15; Netball Knee Program: NKP n = 15). Cardiorespiratory and muscular fitness was assessed at baseline and 6 weeks. Data were analyzed using linear mixed models and Cohen's d effect sizes. Netball-HIIT sessions were highly rated by players, and higher average (139 bpm) and peak heart rates (156 bpm) were detected amongst Netball-HIIT participants (KNP = 127 bpm and 152 bpm). We observed a large effect for cardiorespiratory fitness (+2.4 laps, d = 0.89), and a small to medium effect for muscular fitness (push-ups +1.2, d = 0.49; standing jump +0.8 cm, d = 0.36) in favor of Netball-HIIT, suggesting that coach-led Netball-HIIT may provide a time-efficient and effective training component for use in netball.

Acute effect of physical activity on academic outcomes in school-aged youth: A systematic review and multivariate meta-analysis.

BACKGROUND: There has been an increase in the number of studies examining the effect of acute and chronic physical activity on academic outcomes in children and adolescents in the last two decades. We aimed to systematically determine the acute effects of physical activity on academic outcomes in school-aged youth and to examine possible moderators. METHODS: We conducted a systematic search using PubMed, Web of Science, SPORTDiscus, and PsycINFO databases (from inception to 11th January 2023) for studies assessing the acute effects of physical activity on academic performance-related outcomes in school-aged youth. A univariate and multivariate meta-analysis was conducted based on a random-effects model with restricted maximum likelihood used to pool the academic outcomes results (Hedge's g). RESULTS: We included 11 articles (803 children and adolescents [range: 6-16 years]) in the systematic review. Overall, acute physical activity increased academic outcomes (Hedge's g = 0.35, 95% CI: 0.20-0.50). Multivariate meta-analyses revealed that physical activity increased academic performance in mathematics (Hedge's g = 0.29, 95% CI: 0.16-0.42) and language (Hedge's g = 0.28, 95% CI: 0.09-0.47). Only behavior change techniques (Hedge's g = 0.54, 95% CI, 0.18-0.90, p < 0.001) played a significant role in this relationship. CONCLUSIONS: A single bout of physical activity can improve academic outcomes in school-aged youth, which may serve as a complementary tool for the educational field. However, the observed heterogeneity in the results indicates that we should interpret the findings obtained with caution.

Which indices of cardiorespiratory fitness are more strongly associated with brain health in children with overweight/obesity?

PURPOSE: To compare the strength of associations between different indices of cardiorespiratory fitness (CRF) and brain health outcomes in children with overweight/obesity. METHODS: Participants were 100 children aged 8-11 years. CRF was assessed using treadmill exercise test (peak oxygen uptake [V̇O2peak ], treadmill time, and V̇O2 at ventilatory threshold) and 20-metre shuttle run test (20mSRT, laps, running speed, estimated V̇O2peak using the equations by Léger et al., Mahar et al., and Matsuzaka et al.). Intelligence, executive functions, and academic performance were assessed using validated methods. Total gray matter and hippocampal volumes were assessed using structural MRI. RESULTS: V̇O2peak /body mass (ß = 0.18, 95% CI = 0.01-0.35) and treadmill time (ß = 0.18-0.21, 95% CI = 0.01-0.39) were positively associated with gray matter volume. 20mSRT laps were positively associated with executive functions (ß = 0.255, 95% CI = 0.089-0.421) and academic performance (ß = 0.199-0.255, 95% CI = 0.006-0.421), and the running speed was positively associated with executive functions (ß = 0.203, 95% CI = 0.039-0.367). Estimated V̇O2peak/Léger et al. was positively associated with intelligence, executive functions, academic performance, and gray matter volume (ß = 0.205-0.282, 95% CI = 0.013-0.500). Estimated V̇O2peak/Mahar et al. and V̇O2peak/Matsuzaka et al. (speed) were positively associated with executive functions (ß = 0.204-0.256, 95% CI = 0.031-0.436). CONCLUSION: Although V̇O2peak is considered the gold standard indicator of CRF in children, peak performance (laps or running speed) and estimated V̇O2peak/Léger et al. derived from 20mSRT had stronger and more consistent associations with brain health outcomes than other indices of CRF in children with overweight/obesity.

Supporting adolescents' participation in muscle-strengthening physical activity: protocol for the 'Resistance Training for Teens' (RT4T) hybrid type III implementation-effectiveness trial.

INTRODUCTION: In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the 'Resistance Training for Teens' (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear. OBJECTIVE: To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T. METHODS AND ANALYSIS: We will conduct a hybrid type III implementation-effectiveness trial involving grade 9 and 10 (aged 14-16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) 'low' (training and resources), (2) 'moderate' (training and resources+external support) or 'high' (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p<0.025 for the outcomes and cost comparisons of the moderate and high support arms against the low support arm. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers. TRIAL REGISTRATION NUMBER: ACTRN12622000861752.

Rates of compliance and adherence to high-intensity interval training: a systematic review and Meta-analyses.

BACKGROUND: To determine rates of compliance (i.e., supervised intervention attendance) and adherence (i.e., unsupervised physical activity completion) to high-intensity interval training (HIIT) among insufficiently active adults and adults with a medical condition, and determine whether compliance and adherence rates were different between HIIT and moderate-intensity continuous training (MICT). METHODS: Articles on adults in a HIIT intervention and who were either insufficiently active or had a medical condition were included. MEDLINE, EMBASE, PsychINFO, SPORTDiscus, CINAHL, and Web of Science were searched. Article screening and data extraction were completed by two independent reviewers. Risk of bias was assessed using RoB 2.0 or ROBINS-I. Meta-analyses were conducted to discern differences in compliance and adherence between HIIT vs. MICT. Sensitivity analyses, publication bias, sub-group analyses, and quality appraisal were conducted for each meta-analysis. RESULTS: One hundred eighty-eight unique studies were included (n = 8928 participants). Compliance to HIIT interventions averaged 89.4% (SD:11.8%), while adherence to HIIT averaged 63% (SD: 21.1%). Compliance and adherence to MICT averaged 92.5% (SD:10.6%) and 68.2% (SD:16.2%), respectively. Based on 65 studies included in the meta-analysis, compliance rates were not different between supervised HIIT and MICT interventions [Hedge's g = 0.015 (95%CI: - 0.088-0.118), p = .78]. Results were robust and low risk of publication bias was detected. No differences were detected based on sub-group analyses comparing medical conditions or risk of bias of studies. Quality of the evidence was rated as moderate over concerns in the directness of the evidence. Based on 10 studies, adherence rates were not different between unsupervised HIIT and MICT interventions [Hedge's g = - 0.313 (95%CI: - 0.681-0.056), p = .096]. Sub-group analysis points to differences in adherence rates dependent on the method of outcome measurement. Adherence results should be interpreted with caution due to very low quality of evidence. CONCLUSIONS: Compliance to HIIT and MICT was high among insufficiently active adults and adults with a medical condition. Adherence to HIIT and MICT was relatively moderate, although there was high heterogeneity and very low quality of evidence. Further research should take into consideration exercise protocols employed, methods of outcome measurement, and measurement timepoints. REGISTRATION: This review was registered in the PROSPERO database and given the identifier CRD42019103313.

Scaling up a school-based intervention to increase physical activity and reduce sedentary behaviour in children: protocol for the TransformUs hybrid effectiveness-implementation trial.

INTRODUCTION: Efficacious programmes require implementation at scale to maximise their public health impact. TransformUs is an efficacious behavioural and environmental intervention for increasing primary (elementary) school children's (5-12 years) physical activity and reducing their sedentary behaviour within school and home settings. This paper describes the study protocol of a 5-year effectiveness-implementation trial to assess the scalability and effectiveness of the TransformUs programme. METHODS AND ANALYSIS: A type II hybrid implementation-effectiveness trial, TransformUs is being disseminated to all primary schools in the state of Victoria, Australia (n=1786). Data are being collected using mixed methods at the system (state government, partner organisations), organisation (school) and individual (teacher, parent and child) levels. Evaluation is based on programme Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. RE-AIM domains are being measured using a quasi-experimental, pre/post, non-equivalent group design, at baseline, 12 and 24 months. Effectiveness will be determined in a subsample of 20 intervention schools (in Victoria) and 20 control schools (in New South Wales (NSW), Australia), at baseline, 12 and 24 months. Primary outcomes include TransformUs Reach, Adoption, Implementation and organisational Maintenance (implementation trial), and children's physical activity and sedentary time assessed using accelerometers (effectiveness trial). Secondary outcomes include average sedentary time and moderate to vigorous-intensity physical activity on weekdays and during school hours, body mass index z-scores and waist circumference (effectiveness trial). Linear mixed-effects models will be fitted to compare outcomes between intervention and control participants accounting for clustering of children within schools, confounding and random effects. ETHICS AND DISSEMINATION: The trial was approved by the Deakin University Human Research Ethics Committee (HEAG-H 28_2017), Victorian Department of Education, the NSW Department of Education, Australian Catholic University (2017-145R), Melbourne Archdiocese Catholic Schools and Catholic Schools NSW. Partners, schools/teachers and parents will provide an informed signed consent form prior to participating. Parents will provide consent for their child to participate in the effectiveness trial. Findings will be disseminated via peer-reviewed publications, scientific conferences, summary reports to schools and our partner organisations, and will inform education policy and practice on effective and sustainable ways to promote physical activity and reduce sedentary behaviours population-wide. TRIAL REGISTRATION NUMBER: Australian Clinical Trials Registration Registry (ACTRN12617000204347).

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).

Mediating effects of sleep on mental health in older adolescents: Findings from the Burn 2 Learn randomized controlled trial.

PURPOSE: Our study explored the mediating effect of sleep-related variables on older adolescents' mental health in the context of a school-based physical activity intervention. METHODS: We evaluated the Burn 2 Learn (B2L) intervention using a cluster randomized controlled trial, which included two cohorts. Participants for this sub-study were from the second cohort, which included 292 older adolescents (16.0 ± 0.5 years) from 10 secondary schools in New South Wales, Australia. Teachers at intervention schools delivered two high-intensity activity breaks (approximately 10 mins) per week to students during academic lessons. Participants completed measures of mental health (i.e., perceived stress and internalizing problems) and hypothesized mediators (i.e., sleep duration, sleep latency, awakenings, and daytime sleepiness) at baseline (February-April 2019) and post-intervention (August-September 2019). Single mediation analyses were conducted to explore the potential mediating effects of sleep variables on mental health outcomes using a product-of-coefficient test. RESULTS: We observed a small statistically significant effect for perceived stress (ß = -0.11, SE = 0.034, p = 0.002), but not for internalizing problems (ß = 0.02, SE = 0.051, p = 0.760). There were no significant intervention effects for sleep-related variables. Several sleep-related variables were associated with mental health outcomes but no mediated effects were found. CONCLUSION: The B2L intervention had a small beneficial effect on perceived stress, however our mediation analyses suggest this was not explained by changes in sleep-related variables. Markers of sleep were associated with mental health constructs, highlighting the importance of sleep for good psychological health. However, in the context of a physical activity intervention, effects on mental health may be driven by other behavioral, neurobiological, or psychosocial mechanisms.

Mechanisms Linking Physical Activity with Psychiatric Symptoms Across the Lifespan: A Systematic Review.

BACKGROUND: Physical activity has been suggested as a protective factor against psychiatric symptoms. While numerous studies have focused on the magnitude of physical activity's effect on psychiatric symptoms, few have examined the potential mechanisms. OBJECTIVE: The current review aimed to synthesize scientific evidence of the mechanisms through which physical activity might reduce psychiatric symptoms across the lifespan. METHODS: We included articles that were published before March 2022 from five electronic databases (MEDLINE, Web of Science, PsycINFO, Embase, and Cochrane). A qualitative synthesis of studies was conducted. The risk of bias assessment was performed using The Joanna Briggs Institute Critical Appraisal Tool for Systematic Reviews. Studies were included if they explored the possible mechanisms through which physical activity influences psychiatric symptoms (i.e., internalizing and externalizing symptoms) across the lifespan. RESULTS: A total of 22 articles were included (three randomized controlled trials, four non-randomized controlled trials, three prospective longitudinal studies, and 12 cross-sectional studies). Overall, most of the studies focused on children, adolescents, and young adults. Our findings showed that self-esteem, self-concept, and self-efficacy were the only consistent paths through which physical activity influences psychiatric symptoms (specifically depressive and anxiety symptoms) across the lifespan. There were insufficient studies to determine the role of neurobiological mechanisms. CONCLUSIONS: Overall, future physical activity interventions with the purpose of improving mental health should consider these mechanisms (self-esteem, self-concept, self-efficacy) to develop more effective interventions. CLINICAL TRIAL REGISTRATION: The protocol of this study was registered in the PROSPERO database (registration number CRD42021239440) and published in April 2022.

Effects of an Exercise Program on Cardiometabolic and Mental Health in Children With Overweight or Obesity: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Childhood obesity is a risk factor associated with type 2 diabetes, cardiovascular disease, and mental disorders later in life. Investigation of the parallel effects of a defined exercise program on cardiometabolic and mental health in children with overweight or obesity may provide new insights on the potential benefits of exercise on overall health. Objective: To investigate the effects of a 20-week exercise program on cardiometabolic and mental health in children with overweight or obesity. Design, Setting, and Participants: This secondary analysis of a parallel-group randomized clinical trial was conducted in Granada, Spain, from November 1, 2014, to June 30, 2016. Data analyses were performed between February 1, 2020, and July 14, 2022. Children with overweight or obesity aged 8 to 11 years were eligible, and the study was performed in an out-of-school context. Intervention: The exercise program included 3 to 5 sessions/wk (90 min/session) of aerobic plus resistance training for 20 weeks. The wait-list control group continued with their usual routines. Main Outcomes and Measures: Cardiometabolic outcomes as specified in the trial protocol included body composition (fat mass, fat-free mass, and visceral adipose tissue), physical fitness (cardiorespiratory, speed-agility, and muscular), and traditional risk factors (waist circumference, blood lipid levels, glucose levels, insulin levels, and blood pressure). Cardiometabolic risk score (z score) was calculated based on age and sex reference values for levels of triglycerides, inverted high-density lipoprotein cholesterol, and glucose, the mean of systolic and diastolic blood pressure, and waist circumference. An additional cardiometabolic risk score also included cardiorespiratory fitness. Mental health outcomes included an array of psychological well-being and ill-being indicators. Results: The 92 participants included in the per-protocol analyses (36 girls [39%] and 56 boys [61%]) had a mean (SD) age of 10.0 (1.1) years. The exercise program reduced the cardiometabolic risk score by approximately 0.38 (95% CI, -0.74 to -0.02) SDs; decreased low-density lipoprotein cholesterol level by -7.00 (95% CI, -14.27 to 0.37) mg/dL (to convert to mmol/L, multiply by 0.0259), body mass index (calculated as weight in kilograms divided by height in meters squared) by -0.59 (95% CI, -1.06 to -0.12), fat mass index by -0.67 (95% CI, -1.01 to -0.33), and visceral adipose tissue by -31.44 (95% CI, -58.99 to -3.90) g; and improved cardiorespiratory fitness by 2.75 (95% CI, 0.22-5.28) laps in the exercise group compared with the control group. No effects were observed on mental health outcomes. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, an aerobic plus resistance exercise program improved cardiometabolic health in children with overweight or obesity but had no effect on mental health. Trial Registration: ClinicalTrials.gov Identifier: NCT02295072.

Effects of Resistance Training on Academic Outcomes in School-Aged Youth: A Systematic Review and Meta-Analysis.

BACKGROUND: The primary aim of our systematic review and meta-analysis was to investigate the effect of resistance training on academic outcomes in school-aged youth. METHODS: We conducted a systematic search of six electronic databases (CINAHL Complete, PsycINFO, SCOPUS, Ovid MEDLINE, SPORTDiscus and EMBASE) with no date restrictions. Studies were eligible if they: (a) included school-aged youth (5-18 years), and (b) examined the effect of resistance training on academic outcomes (i.e., cognitive function, academic achievement, and/or on-task behaviour in the classroom). Risk of bias was assessed using the appropriate Cochrane Risk of Bias Tools, funnel plots and Egger's regression asymmetry tests. A structural equation modelling approach was used to conduct the meta-analysis. RESULTS: Fifty-three studies were included in our systematic review. Participation in resistance training (ten studies with 53 effect sizes) had a small positive effect on the overall cognitive, academic and on-task behaviours in school-aged youth (standardized mean difference (SMD) 0.19, 95% confidence interval (CI) 0.05-0.32). Resistance training was more effective (SMD 0.26, 95% CI 0.10-0.42) than concurrent training, i.e., the combination of resistance training and aerobic training (SMD 0.11, 95% CI - 0.05-0.28). An additional 43 studies (including 211 effect sizes) examined the association between muscular fitness and cognition or academic achievement, also yielding a positive relationship (SMD 0.13, 95% CI 0.10-0.16). CONCLUSION: This review provides preliminary evidence that resistance training may improve cognitive function, academic performance, and on-task behaviours in school-aged youth. PROSPERO REGISTRATION: CRD42020175695.

Rethinking children's physical activity interventions at school: A new context-specific approach.

Physical activity is important for children's health. However, evidence suggests that many children and adults do not meet international physical activity recommendations. Current school-based interventions have had limited effect on physical activity and alternative approaches are needed. Context, which includes school setting, ethos, staff, and sociodemographic factors, is a key and largely ignored contributing factor to school-based physical activity intervention effectiveness, impacting in several interacting ways. Conceptualization: Current programs focus on tightly-constructed content that ignores the context in which the program will be delivered, thereby limiting effectiveness. We propose a move away from uniform interventions that maximize internal validity toward a flexible approach that enables schools to tailor content to their specific context. Evaluation designs: Evaluation of context-specific interventions should explicitly consider context. This is challenging in cluster randomized controlled trial designs. Thus, alternative designs such as natural experiment and stepped-wedge designs warrant further consideration. Primary outcome: A collective focus on average minutes of moderate-to-vigorous intensity physical activity may not always be the most appropriate choice. A wider range of outcomes may improve children's physical activity and health in the long-term. In this paper, we argue that greater consideration of school context is key in the design and analysis of school-based physical activity interventions and may help overcome existing limitations in the design of effective interventions and thus progress the field. While this focus on context-specific interventions and evaluation is untested, we hope to stimulate debate of the key issues to improve future physical activity intervention development and implementation.

The Provision and Experience of Variety in Physical Activity Settings: A Systematic Review of Quantitative and Qualitative Studies.

BACKGROUND: Emerging evidence indicates that the provision or experience of "variety" may be an important determinant of physical activity behavior. Variety refers to diverse endeavors, opportunities, or tasks and, in the context of physical activity, has been examined as a feature of an activity or environment (i.e., variety support) and an experience (i.e., one's felt experience or perceived variety). OBJECTIVE: The primary aim of our review was to synthesize studies investigating the provision or experience of variety in physical activity settings on health and well-being, behaviors, and motivation. Our secondary aim was to examine quantitative data reporting on different facets of variety in physical activity settings. METHODS: We conducted a systematic search of five electronic databases (Scopus, SPORTDiscus, Science Direct, MEDLINE, and the Human Kinetics Library) to identify studies providing a quantitative or qualitative assessment of variety in physical activity settings. RESULTS: We identified 5,576 potentially relevant articles to examine. After title and abstract screening (and removal of duplicates), 74 articles remained for full-text screening, from which 28 studies were deemed eligible. Our findings from qualitative and quantitative (experimental and cross-sectional) studies demonstrate that the provision and experience of variety relates to participation and engagement in physical activity, motivation for exercise and physical activity, and well-being outcomes. Our results also indicate that the provision of variety can increase enjoyment, interest (i.e., motivation), and adherence to a physical activity program. CONCLUSION: Our findings support the assertion that variety should be considered during planning, implementation, and evaluation of physical activity programs. Additional experimental studies are needed to gain a better understanding of how elements of physical activity and exercise programs, delivery, and environment can be manipulated to increase variety and foster participation in physical activity.

A scalable school-based intervention to increase early adolescents' motor competence and health-related fitness.

Schools are key settings for the promotion of students' physical activity, fitness, and motor competence. The purpose of our study was to investigate the efficacy of a 5-month-long intervention program that aimed to increase students' motor competence and health-related fitness during school days. We conducted a quasi-experimental study with 325 Finnish Grade 5 (Mage = 11.26, SD = 0.33) students from five schools. Two schools were allocated to the intervention group and three schools to the control group. The intervention consisted of three components: (a) weekly 20 min session during regular PE lessons, (b) weekly 20 min session during recess, and (c) daily 5-minute-long classroom activity breaks. All activities were designed to systematically develop different elements of motor competence and fitness. The following assessments were conducted at baseline and 5-months: cardiorespiratory fitness levels were measured by 20-meter shuttle run test, muscular fitness by curl-up and push-up tests, and motor competence by 5-leaps and throwing-catching combination tests. We analyzed the data using a multi-group latent change score modeling. Results showed that students in the intervention group developed significantly better in 20-meter shuttle run test (ß = 0.269, p = 0.000, 95% CI [0.141, 0.397]; +5.0 laps), push-up (ß = 0.442, p = 0.000, 95% CI [0.267, 0.617]; +6.5 repetitions), curl-up (ß = 0.353, p = 0.001, 95% CI [0.154, 0.552]; +7.8 repetitions), and throwing-catching combination tests (ß = 0.195, p = 0.019, 95% CI [0.033, 0.356]; +1.1 repetitions) than students in the control group. The intervention program appeared to be feasible and effective in increasing students' cardiorespiratory fitness, muscular fitness, and object control skills. This indicates that guided school-based physical activity programs can be influential in promoting physical fitness and motor competence among early adolescent students.