Study protocol for the Screen-Free Time with Friends Feasibility Trial.

BACKGROUND: Children are spending less leisure time with their friends in person and an increasing amount of time with digital screens. These changes may negatively affect children's physical and mental health. The Screen-Free Time with Friends Feasibility Trial will test the feasibility, including acceptability and compliance, of an intervention designed to reduce screen media usage and encourage physical interaction with friends during leisure time in 9-11-year-old children. METHODS: A non-randomized single-group feasibility trial will be conducted from March to October 2023 including approximately 75 children (aged 9-11 years) and 75 parents (at least 1 per child) from 3 different schools recruited from 3 different municipalities in Denmark. The Screen-Free Time with Friends intervention is a multicomponent intervention targeting families, afterschool clubs, and local communities. It has been developed using a systematic process guided by the Medical Research Council UK's framework for developing and evaluating complex interventions. With a systems perspective in mind, the intervention and implementation approach has been designed to facilitate adaptation to the specific needs of diverse local communities while maintaining the core components of the intervention. Feasibility and acceptability of the intervention will be assessed during the intervention using process evaluation inspired by the RE-AIM framework including questionnaires and interviews with the municipality project managers, research team members, local ambassadors and stakeholders, parents and school, and afterschool club personnel. In addition, participation, recruitment, retention rate, and compliance to the outcome measurements will be investigated and presented. DISCUSSION: The trial will investigate the feasibility and acceptability of the Screen-Free Time with Friends intervention, the recruitment strategy, and the planned outcome measurements. This feasibility study will investigate necessary refinements before the implementation of the intervention program in a larger cluster randomized controlled trial to evaluate its impact. CLINICALTRIALS: gov, ID: NCT05480085. Registered 29 July 2022. https://clinicaltrials.gov/ct2/show/NCT05480085?cond=Screen+free+time+with+friends&draw=2&rank=1.

Generalizability and performance of methods to detect non-wear with free-living accelerometer recordings.

Wearable physical activity sensors are widely used in research and practice as they provide objective measures of human behavior at a low cost. An important challenge for accurate assessment of physical activity behavior in free-living is the detection non-wear. Traditionally, heuristic algorithms that rely on specific interval lengths have been employed to detect non-wear time; however, machine learned models are emerging. We explore the potential of detecting non-wear using decision trees that combine raw acceleration and skin temperature, and we investigate the generalizability of our models, traditional heuristic algorithms, and recently developed machine learned models by external validation. The Decision tree models were trained using one week of data from thigh- and hip-worn accelerometers from 64 children. External validation was performed using data from wrist-worn accelerometers of 42 adolescents. For non-wear episodes longer than 60 min, the heuristic algorithms performed the best with F1-scores above 0.96. However, regarding episodes shorter than 60 min, the best performing method was the decision tree model including the six most important predictors with F1 scores above 0.74 for all sensor locations. We conclude that for classifying non-wear time, researchers should carefully select an appropriate method and we encourage the use of external validation when reporting on machine learned non-wear models.

Temporal Alignment of Dual Monitor Accelerometry Recordings.

Combining accelerometry from multiple independent activity monitors worn by the same subject have gained widespread interest with the assessment of physical activity behavior. However, a difference in the real time clock accuracy of the activity monitor introduces a substantial temporal misalignment with long duration recordings which is commonly not considered. In this study, a novel method not requiring human interaction is described for the temporal alignment of triaxial acceleration measured with two independent activity monitors and evaluating the performance with the misalignment manually identified. The method was evaluated with free-living recordings using both combined wrist/hip (n = 9) and thigh/hip device (n = 30) wear locations, and descriptive data on initial offset and accumulated day 7 drift in a large-scale population-based study (n = 2513) were calculated. The results from the Bland-Altman analysis show good agreement between the proposed algorithm and the reference suggesting that the described method is valid for reducing the temporal misalignment and thus reduce the measurement error with aggregated data. Applying the algorithm to the n = 2513 samples worn for 7-days suggest a wide and substantial issue with drift over time when each subject wears two independent activity monitors.

Protocol for evaluating the impact of a national school policy on physical activity levels in Danish children and adolescents: the PHASAR study - a natural experiment.

BACKGROUND: In 2014 the Danish Government introduced a wide-ranging school reform that applies to all public schools in Denmark. The reform involves changes in several aspects of the school structure and content. In a physical activity promotion perspective, a distinctive feature of the school reform is that it has become mandatory to integrate an average of 45 min of daily physical activity in the regular school day. The overarching objective of the PHASAR study is to evaluate the implementation and effect of this ambitious policy-driven physical activity promotion initiative on physical activity and overweight. This paper describes in detail the study protocol. METHODS: The evaluation is divided into a quantitative effect evaluation and a combined quantitative and qualitative process evaluation. A total of 31 schools are enrolled in the PHASAR study including more than 2,000 school-aged children. Objectively measured physical activity data are obtained in the PHASAR study in 2017/18 and compared to repeated cross sectional data collected in four historical school-based studies from 1998 to 2012. Body mass index data from 2012 to 2018 will be collected from The Child Database, which includes repeated cross-sectional assessments on approximately 100,000 children annually. In the absence of a control group, interrupted time-series analysis will be used to evaluate pre- and post-reform physical activity and body mass index levels and trends. A characterization of the school environment for physical activity promotion on a political, environmental, organizational and individual level and school implementation processes will be conducted to evaluate the implementation process. Data will be collected using interviews, surveys, document analyses and observations. DISCUSSION: The PHASAR study is a rare opportunity to evaluate the effectiveness of a nation-wide policy-driven school-based physical activity promotion initiative. The use of objectively measured pre- and post-reform physical activity and body mass index data combined with a characterization of the school implementation processes for physical activity promotion will provide a comprehensive source to evaluate the school reform. The study findings have the potential to influence national and international policy makers, health professionals and school staff.

Cost-effectiveness of a day-camp weight-loss intervention programme for children: Results based on a randomised controlled trial with one-year follow-up.

AIMS: The aim was to analyse the cost-effectiveness of an intensive weight-loss intervention for children compared with a low-intensity intervention. METHODS: One hundred and fifteen overweight children (mean age 12.0 ± 0.4) were randomised to either the camp group (CG) ( N=59) or the standard group (SG) ( N=56). Participants in the CG were offered a six-week day-camp weight-loss programme followed by a family-based supportive programme containing four meetings during the succeeding 46 weeks. Participants in the SG were offered a weekly two-hour exercise session for six weeks. Changes in body mass index (BMI) and BMI z-score 12 months after inclusion were used to compare the effects of the two interventions. Incremental cost-effectiveness ratios (ICER) were estimated from the perspective of a Danish municipality. To achieve the required number of participants, an additional intervention was initiated one year later. RESULTS: In comparison with the SG, the CG changed their mean BMI by -1.2 (95% CI -1.8 to -0.5). Compared with the SG children, the CG children changed their BMI z-score by -0.20 (95% CI -0.35 to -0.05). The ICER per decreased BMI point in the CG compared with the SG was DDK 24,928. CONCLUSIONS: Compared with the SG, the CG showed favourable effects after 12 months. However, the CG was more costly. The results observed in the present study may be helpful in guiding decision makers to take more informed decisions when choosing different types of intervention.

The effect of a multi-component camp-based weight-loss program on children's motor skills and physical fitness: a randomized controlled trial.

BACKGROUND: Many weight-loss programs in children are performed without specific foci on training both physical fitness and motor skills. The aim of this study was to describe the effect of a one-year weight-loss program on children's motor skills and physical fitness. METHODS: Participants included 115 overweight fifth-grade children (12.0 years) randomized into either a Day-Camp Intervention Arm (DCIA), with a subsequent family-based support program or a low-intense Standard Intervention Arm (SIA). Physical fitness was assessed by vertical jump, hand grip strength, and a progressive cardio-respiratory fitness test. Motor skills were assessed by the Movement Assessment Battery for Children - second edition (M-ABC-2), age band 3. RESULTS: Loss to follow-up after 52 weeks was 19 % and 32 % in the DCIA and SIA, respectively. Balance skills were improved post-camp, but not after 52 weeks in children from the DCIA compared to the SIA. Contrary to the expected, children from the SIA improved aiming and catching skills relative to the DCIA children. Overall z-scores of the physical fitness components and cardio-respiratory fitness improved more in children from the DCIA compared to children from the SIA. CONCLUSION: In conclusion, the day-camp intervention led to improvements in physical fitness but not in motor skills compared to the standard intervention. Including both motor skills and physical fitness could advantageously be considered in future immersive intervention programmes. TRIAL REGISTRATION: Clinicaltrials NCT01574352, March 26, 2012 (retrospectively registered).

A Multi-Component Day-Camp Weight-Loss Program Is Effective in Reducing BMI in Children after One Year: A Randomized Controlled Trial.

The objective of the present study was to evaluate the effectiveness of a one-year multi-component immersive day-camp weight-loss intervention for children with overweight and obesity. The study design was a parallel-group randomized controlled trial. One hundred fifteen 11-13-year-old children with overweight and obesity were randomized into either: A six-week day-camp intervention arm focusing on increased physical activity, and healthy diet followed by a subsequent one-year family-based intervention, or a standard intervention arm consisting of one weekly exercise session for six weeks. Body mass index (BMI) was the primary outcome. BMI z-score, clustered cardiovascular risk z-score, and body composition were secondary outcomes. All outcomes were measured at baseline, six week-, and 52 week follow-up. After six weeks, children from the day-camp intervention arm had improved their BMI (-2.2 kg/m2 (95% CI -2.6 to -1.7, P<0.001)) and all secondary outcomes when compared to the children from the standard intervention arm. After 52 weeks, the day-camp intervention arm had a lower BMI (-1.2 kg/m2 (95% CI -1.8 to -0.5, P = 0.001)), and BMI z-score (-0.20 (95% CI -0.35 to -0.05, P = 0.008)), and clustered cardiovascular risk z-score (-0.23 (95% CI -0.37 to -0.08, P = 0.002)) compared to the standard intervention arm. No group differences were detected in body composition after 52 weeks. This study shows that the day-camp intervention arm is effective in reducing BMI and improving the metabolic health of children with overweight and obesity. However, the effects seem to be diminishing over time.

Effects of a multi-component camp-based intervention on inflammatory markers and adipokines in children: A randomized controlled trial.

OBJECTIVE: To examine the effects of a multi-component camp-based intervention on inflammatory markers and adipokines in children. METHODS: One hundred and fifteen children were recruited in Odense, Denmark (2012-2014). The participants were randomly allocated to either the day camp intervention arm (DCIA) or the standard intervention arm (SIA). The intervention for the DCIA consisted of a 6-week camp-based intervention and a 46-week family-based intervention. The SIA was offered one weekly physical activity session for 6 weeks and one educational meeting. C-reactive protein (CRP), monocyte chemoattractant protein-1 (MCP1), leptin, and adiponectin were measured in serum at baseline, 6 weeks and 52 weeks. RESULTS: In comparison with the SIA, the reductions in CRP (P=0.003) and leptin (p<0.001) were larger in the DCIA at 6 weeks. The intervention effects on leptin were significantly mediated by the changes in body fat mass. No intervention effects on CRP and leptin were seen at 52 weeks. No between-group differences in changes in MCP1 and adiponectin were observed at 6 weeks or 52 weeks. CONCLUSIONS: The 6-week camp intervention resulted in reductions in CRP and leptin. The intervention effects did not persist to 52 weeks. The intervention effect on leptin was explained by changes in body fat mass.

Effects of an obesity intervention program on cognitive function in children: A randomized controlled trial.

OBJECTIVE: Adiposity may be associated with poorer cognitive function in children. The purpose of the study was to examine the effects of an obesity intervention on cognitive function in children. METHODS: One hundred and fifteen children were randomly allocated to either the Day Camp Intervention Arm (DCIA) or the Standard Intervention Arm (SIA). Children in the DCIA participated in a 6-week day camp intervention and a subsequent 46-week family-based intervention. The camp intervention mainly consisted of physical exercise and health classes. The SIA was offered one weekly physical exercise session for 6 weeks and one educational meeting. Anthropometrics and cognitive function were measured at baseline, 6 weeks, and 52 weeks. RESULTS: At 6 weeks, the improvement in visuospatial construction skills was larger in the DCIA than the SIA (standardized mean difference, 0.47, 95% CI, 0.08 to 0.86, P = 0.02). At 52 weeks, the improvements in emotional control (standardized mean difference, -0.42, 95% CI, -0.68 to -0.16, P = 0.002) and monitoring (standardized mean difference, -0.32, 95% CI, -0.63 to -0.02, P = 0.04) were larger in the DCIA than the SIA. No group differences were observed in changes in other cognitive outcomes. CONCLUSIONS: The obesity intervention may benefit emotional control, monitoring, and visuospatial construction skills in children.

Effectiveness of a one-year multi-component day-camp intervention for overweight children: study protocol of the Odense overweight intervention study (OOIS).

BACKGROUND: Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life. With the high prevalence of overweight in children and adolescents, it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals. The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index (BMI) in overweight children. METHODS: The Odense Overweight Intervention Study is a semi-blinded randomized controlled trial. Overweight children from the Municipality of Odense, Denmark, were invited to participate in the trial. Based on power calculations 98 participants were found to be sufficient to randomize in order to find an effect of minimum 1.5 BMI points. Gender-stratified concealed block randomization with a ratio of 1:1 and random block sizes of two, four, and six ensured balance between study arms. The intervention consisted of a six-week multi-component day camp including increased physical activity, healthy diet and health education followed by 46 weeks of family-based habitual intervention. The standard care arm was offered two weekly hours of physical activity training for six weeks. The outcomes were measured at baseline and at six-week and 52-week follow-ups. Furthermore, BMI will be assessed again at 48-month follow-up. Test personnel were kept blinded. The intervention effect will be evaluated using mixed model analyses. During 2012 and 2013, 115 children were enrolled in the study. Fifty-nine children were randomized to the day-camp intervention arm and 56 to the standard intervention arm. DISCUSSION: This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children, due to the design and the follow-up period. Moreover, it will add to the knowledge on designing and implementing feasible camp settings for preventing overweight in children. TRIAL REGISTRATION: NCT01574352 at http://clinicaltrials.gov on the 8th of March 2012.

Associations between objectively measured physical activity intensity in childhood and measures of subclinical cardiovascular disease in adolescence: prospective observations from the European Youth Heart Study.

BACKGROUND AND AIM: No prospective studies have investigated the association between physical activity (PA) and carotid subclinical cardiovascular disease across childhood. Therefore, the primary aim was to investigate the association between PA intensity across childhood and carotid intima media thickness (cIMT) and stiffness in adolescence. Second, we included a clustered cardiovascular disease risk score as outcome. METHODS: This was a prospective study of a sample of 254 children (baseline age 8-10 years) with a 6-year follow-up. The mean exposure and the change in minutes of moderate-and-vigorous and vigorous PA intensity were measured using the Actigraph activity monitor. Subclinical cardiovascular disease was expressed as cIMT, carotid arterial stiffness and secondarily as a metabolic risk z-score including the homoeostasis model assessment score of insulin resistance, triglycerides, total cholesterol to high-density lipoprotein ratio, inverse of cardiorespiratory fitness, systolic blood pressure and the sum of four skinfolds. RESULTS: No associations were observed between PA intensity variables and cIMT or carotid arterial stiffness (p>0.05). Neither change in PA intensity (moderate-and-vigorous nor vigorous) nor mean minutes of moderate-and-vigorous PA intensity was associated to the metabolic risk z-score in adolescence (p>0.05). However, a significant inverse association was observed between mean minutes of vigorous PA and the metabolic risk z-score in adolescence independent of gender and biological maturity (standard ß=-0.19 p=0.007). CONCLUSIONS: A high mean exposure to, or changes in, minutes spent at higher PA intensities across childhood was not associated to cIMT or stiffness in the carotid arteries in adolescence. Our observations suggest that a high volume of vigorous PA across childhood independently associated with lower metabolic cardio vascular disease risk in adolescence.