A School-Based Randomized Controlled Trial to Promote Cycling to School in Adolescents: The PACO Study
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SUBMITTER: Chillon P
PROVIDER: S-EPMC7923771 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
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Project description:Given the dramatic increase in adolescent overweight and obesity, models are needed for implementing weight management treatment through readily accessible venues. We evaluated the acceptability and efficacy of a school-based intervention consisting of school nurse-delivered counseling and an afterschool exercise program in improving diet, activity, and body mass index (BMI) among overweight and obese adolescents.A pair-matched cluster-randomized controlled school-based trial was conducted in which 8 public high schools were randomized to either a 12-session school nurse-delivered cognitive-behavioral counseling intervention plus school-based after school exercise program, or 12-session nurse contact with weight management information (control). Overweight or obese adolescents (N = 126) completed anthropometric and behavioral assessments at baseline and 8-month follow-up. Main outcome measures included diet, activity, and BMI. Mixed effects regression models were conducted to examine differences at follow-up.At follow-up, students in intervention compared with control schools were not different in BMI, percent body fat, and waist circumference. Students reported eating breakfast (adjusted mean difference 0.81 days; 95% confidence interval [CI] 0.11-1.52) on more days/week; there were no differences in other behaviors targeted by the intervention.While a school-based intervention including counseling and access to an after-school exercise program is theoretically promising with public health potential, it was not effective in reducing BMI or key obesogenic behaviors. Our findings are important in highlighting that interventions targeted at the individual level are not likely to be sufficient in addressing the adolescent obesity epidemic without changes in social norms and the environment.
| S-EPMC5033122 | biostudies-literature
Project description:Schools provide a natural context to promote children's mental health. However, there is a need for more evidence-based, high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods. The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the "Together at School" intervention program. The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum, work environment of school staff, and parent-teacher collaboration methods.The evaluation study examines the effects of the intervention on children's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1) an intervention group and 2) an active control group. Altogether 79 primary school participated at baseline. A multi-informant setting involves the children themselves, their parents, and teachers. The primary outcomes are measured using parent and teacher ratings of children's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale. Secondary outcomes for the children include emotional understanding, altruistic behavior, and executive functions (e.g. working memory, planning, and inhibition). Secondary outcomes for the teachers include ratings of e.g. school environment, teaching style and well-being. Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy, child rearing practices, and teacher-parent collaboration. The data was collected at baseline (autumn 2013), 6 months after baseline, and will be collected also 18 months after baseline from the same participants.This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a contextually developed and carefully tested intervention program which is tailored to fit a national school system. Identification of effective intervention elements to promote children's mental health in early school years is crucial for optimal later development.ClinicalTrials.gov register: NCT02178332.
| S-EPMC4201723 | biostudies-other
Project description:Effective lifestyle interventions are needed to prevent noncommunicable diseases in low- and middle-income countries. We analyzed the effects of a school-based health promotion intervention on physical fitness after 28 months and explored if the effect varied with important school characteristics. We also assessed effects on screen time, physical activity and BMI.We performed a cluster-randomized pair matched trial in schools in urban Ecuador. The intervention included an individual and environmental component tailored to the local context and resources. Primary outcomes were physical fitness (EUROFIT battery), screen time (questionnaires) and physical activity (accelerometers). Change in BMI was a secondary outcome. A total of 1440 grade 8 and 9 adolescents (intervention: n = 700, 48.6%) and 20 schools (intervention: n = 10, 50%) participated. Data of 1083 adolescents (intervention: n = 550, 50.8%) from 20 schools were analyzed.A school-based intervention with an individual and environment component can improve physical fitness and can minimize the decline in physical activity levels from childhood into adolescence in urban Ecuador.Clinicaltrials.gov identifier NCT01004367.
| S-EPMC4272792 | biostudies-literature
Project description:BACKGROUND:Although obesity and mental health disorders are two major public health problems in adolescents that affect academic performance, few rigorously designed experimental studies have been conducted in high schools. PURPOSE:The goal of the study was to test the efficacy of the COPE (Creating Opportunities for Personal Empowerment) Healthy Lifestyles TEEN (Thinking, Emotions, Exercise, Nutrition) Program, versus an attention control program (Healthy Teens) on: healthy lifestyle behaviors, BMI, mental health, social skills, and academic performance of high school adolescents immediately after and at 6 months post-intervention. DESIGN:A cluster RCT was conducted. Data were collected from January 2010 to May of 2012 and analyzed in 2012-2013. SETTING/PARTICIPANTS:A total of 779 culturally diverse adolescents in the U.S. Southwest participated in the trial. INTERVENTION:COPE was a cognitive-behavioral skills-building intervention with 20 minutes of physical activity integrated into a health course, taught by teachers once a week for 15 weeks. The attention control program was a 15-session, 15-week program that covered common health topics. MAIN OUTCOME MEASURES:Primary outcomes assessed immediately after and 6 months post-intervention were healthy lifestyle behaviors and BMI. Secondary outcomes included mental health, alcohol and drug use, social skills, and academic performance. RESULTS:Post-intervention, COPE teens had a greater number of steps per day (p=0.03) and a lower BMI (p=0.01) than did those in Healthy Teens, and higher average scores on all Social Skills Rating System subscales (p-values <0.05). Teens in the COPE group with extremely elevated depression scores at pre-intervention had significantly lower depression scores than the Healthy Teens group (p=0.02). Alcohol use was 12.96% in the COPE group and 19.94% in the Healthy Teens group (p=0.04). COPE teens had higher health course grades than did control teens. At 6 months post-intervention, COPE teens had a lower mean BMI than teens in Healthy Teens (COPE=24.72, Healthy Teens=25.05, adjusted M=-0.34, 95% CI=-0.56, -0.11). The proportion of those overweight was significantly different from pre-intervention to 6-month follow-up (chi-square=4.69, p=0.03), with COPE decreasing the proportion of overweight teens, versus an increase in overweight in control adolescents. There also was a trend for COPE Teens to report less alcohol use at 6 months (p=0.06). CONCLUSIONS:COPE can improve short- and more long-term outcomes in high school teens. TRIAL REGISTRATION:This study is registered at www.clinicaltrials.gov NCT01704768.
| S-EPMC4285557 | biostudies-literature
Project description:BackgroundThis study evaluated the effect of the school-based intervention Charge Your Brainzzz on adolescents' social-cognitive determinants, sleep hygiene and sleep duration and quality.MethodsA cluster-randomized controlled trial was conducted with 972 students from 10 Dutch high schools. Schools were randomly allocated to the intervention (N = 5) or control condition (N = 5). Outcomes were measured with the digital Consensus Sleep Diary and via a digital questionnaire, based on valid measures. Data were collected at baseline (T0), ±1.5 weeks post-intervention (T1) and ±3 months post-intervention (T2). Mixed model analyses were performed to estimate the effects on social-cognitive determinants, sleep hygiene, and sleep outcomes.ResultsThe intervention increased sleep knowledge post-intervention (b = 1.91; 95%CI: 1.22-2.60) and at follow up (b = 1.40; 95%CI: 0.70-2.10). The intervention was also effective in changing adolescents' attitudes (b = 0.10; 95%CI: 0.01-0.19) and perceived behavioral control (b = 0.11; 95%CI: 0.01-0.22) post-intervention. No positive changes were found regarding subjective norms, behavioral intentions, sleep hygiene, or sleep outcomes.ConclusionsThe intervention improved adolescents' sleep knowledge, attitude, and perceived behavioral control. To significantly impact sleep health, theoretically sound and systematically developed interventions are needed which take into account the interplay between sleep, sleep-related behaviors, and adolescents' social and physical environment.Clinical trial registrationTrial name: Evaluation of the school-based intervention Charge Your Brainzzz promoting sleep in adolescents; URL: https://doi.org/10.1186/ISRCTN36701918; ID: ISRCTN36701918.
| S-EPMC9314837 | biostudies-literature
Project description:BACKGROUND:Given the documented decline in levels of physical activity in early adolescence, promoting physical activity in young people is a priority for health promotion. School physical education (PE) is an important existing network in which participation in physical activity beyond school can be promoted to the captive young people. The objective of current article is to present the protocol for a PE teacher-delivered theory-based trial to promote secondary school students' participation in physical activity out-of-school contexts. The intervention will be guided by the trans-contextual model explaining the processes by which PE teachers' support for autonomous motivation in the classroom promotes students' motivation to engage in out-of-school physical activity. We hypothesize that school students receiving the teacher-delivered intervention to promote autonomous motivation toward physical activity will exhibit greater participation in physical activities outside of school, relative to students receiving a control intervention. METHODS:The trial will adopt a waitlist-control design with cluster-randomization by school. PE teachers assigned to the intervention condition will receive a two-week, 12-h training program comprising basic information on how to promote out-of-school physical activity and theory-based training on strategies to promote students' autonomous motivation toward physical activity. Teachers assigned to the waitlist control condition will receive an alternative training on how to monitor physical functional capacity in children with special needs. PE teachers (n?=?29) from eleven schools will apply the intervention program to students (n?=?502) in PE classes for one month. Physical activity participation, the primary outcome variable, and psychological mediators from the trans-contextual model will be measured at pre-trial, post-trial, and at one-, three- and six-months post-trial. We will also assess teachers' autonomy-supportive techniques and behaviours by observation. DISCUSSION:The study will make a unique contribution to the literature by testing a theory-based intervention delivered by PE teachers to promote school students' participation in out-of-school physical activity. Information will be useful for educators, community stakeholders and policy makers interested in developing programs to promote students' out-of-school physical activity. TRIAL REGISTRATION:ISRCTN39374060 . Registered 19.7.2018.
| S-EPMC6364480 | biostudies-other
Project description:BackgroundSchool-based physical activity interventions evaluating the effect on academic performance usually includes children. We aimed to investigate the effect of a nine-month, school-based physical activity intervention titled School in Motion (ScIM) on academic performance in adolescents.MethodsThirty secondary schools in Norway were cluster-randomized into three groups: the Physically active learning (PAL) group (n = 10), the Don't worry - Be Happy (DWBH) group (n = 10) or control (n = 10). Target dose in both intervention groups was 120 min/week of additional PA during school hours. Parental consent was obtained from 2084 adolescent students (76%). Standardized national tests in reading and numeracy was conducted at baseline and at the end of the intervention. We used linear mixed model to test intervention effects. We found significant intervention effects in numeracy and reading among students in both interventions when compared with controls.ResultsThe mean difference in change in numeracy was 1.7 (95% CI: 0.9 to 2.5; Cohen's d = 0.12) and 2.0 (95% CI: 1.4 to 2.7; Cohen's d = 0.23) points in favour of students in the PAL and DWBH intervention, respectively. Similar results were found for reading, where the mean difference in change was 0.9 (95% CI 0.2 to 1.6; Cohen's d = 0.06) and 1.1 (95% CI 0.3 to 1.9; Cohen's d = 0.18) points in favour of students in the PAL and DWBH intervention, respectively. When conducting intention to treat analysis with imputed data the estimates were attenuated and some no longer significant.ConclusionThe ScIM study demonstrates that two different school-based PA interventions providing approximately 120 min of additional PA weekly over nine months, significantly improved numeracy and reading performance in 14-year old students compared with controls. However, the results should be interpreted with caution as the effect sizes reported were very small or small and the estimates were attenuated when conducting intention to treat analysis. Despite this, our results are still positive and suggest that PA interventions are viable models to increase academic performance among adolescents.Trial registrationRetrospectively registered (25/01/2019): NCT03817047 .
| S-EPMC8101111 | biostudies-literature
Project description:ImportanceSchool-based interventions offer an opportunity for health promotion in adolescence.ObjectiveTo assess the effect of 2 multicomponent educational health promotion strategies of differing duration and intensity on adolescents' cardiovascular health (CVH).Design, setting, and participantsThe SI! Program for Secondary Schools is a 4-year cluster randomized clinical intervention trial conducted in 24 secondary schools from Barcelona and Madrid, Spain, from September 7, 2017, to July 31, 2021. Eligible participants were adolescents enrolled in the first grade of secondary school.InterventionsSchools and their participants were randomized to receive a health promotion intervention (SI! Program) over 4 school years (long-term intervention [LTI], 8 schools, 412 adolescents) or 2 school years (short-term intervention [STI], 8 schools, 504 adolescents) or to receive the standard curriculum (control, 8 schools, 441 adolescents).Main outcome and measuresThe primary end point was the between-group difference at 2 and 4 years in the change from baseline of the overall CVH score, as defined by the American Heart Association (range, 0-14 points, with a higher score indicating a healthier CVH profile). Intervention effects were tested with multilevel mixed-effects models. A complete-case intention-to-treat analysis was performed as the primary analysis.ResultsOf the randomized students, the study enrolled 1326 adolescents (684 [51.6%] boys, mean [SD] age, 12.5 [0.4] years at recruitment) with a study completion rate of 86.0%. Baseline overall CVH scores were 10.3 points in the LTI group, 10.6 points in the STI group, and 10.5 points in the control group. After 2 years, at halfway through the LTI and at the end of the STI, the difference in the CVH score change was 0.44 points (95% CI, 0.01-0.87; P = .04) between the LTI group and the control group and 0.18 points (95% CI, -0.25 to 0.61; P = .39) between the STI group and the control group. At 4 years, differences for the LTI and STI groups vs control were 0.12 points (LTI: 95% CI, -0.19 to 0.43; P = .42) and 0.13 points (STI: 95% CI, -0.17 to 0.44; P = .38). No adverse events were reported.Conclusions and relevanceOverall, the tested school-based health promotion strategies in this randomized clinical trial had a neutral effect on the CVH of the adolescents. Although there was evidence of a marginal beneficial effect at a point halfway through implementation in the LTI group, such a benefit was not noted at 4 years. Further research is warranted into the efficacy of school-based health promotion programs.Trial registrationClinicalTrials.gov Identifier: NCT03504059.
| S-EPMC10398546 | biostudies-literature
Project description:Adolescents who engage in non-opioid substance misuse and/or experience mental health symptoms are at greater risk of misusing opioids and/or developing opioid use disorder. Adolescence is a critical developmental period to both prevent the initiation of opioid misuse and target mental health. To date, there are no digital health games targeting both conditions. We describe the protocol for a randomized controlled trial designed to assess the efficacy of an original digital health game, PlaySmart. Five hundred and thirty-two adolescents aged 16-19 years old, who are at greater risk for initiating opioid misuse are recruited from 10 Connecticut school-based health sites. Participants are randomized to PlaySmart or a set of time/attention control videogames. Randomization was stratified by sex at birth and school grade. Participants play their assigned game or games for up to six weeks (300 minutes) and complete assessment questions over a 12-month period (baseline, post-gameplay, 3, 6, and 12 months). The primary outcome is perception of risk of harm of opioid misuse at 3 months. Secondary outcome measures specific to opioid misuse include intentions, self-efficacy, attitudes, knowledge, and perceived norms. Mental health outcomes include measures of depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), help-seeking behaviors, stigma, measures of self-regulation, self-efficacy to seek professional help for mental health, and knowledge around coping skills. PlaySmart has the potential to significantly reduce the risk of initiation of opioid misuse, improve mental health outcomes, and given its high levels of engagement and accessibility, holds the promise for extensive reach, scale, and impact for adolescents. Trial registration: ClinicalTrials.gov: NCT04941950. Registered on 23 June 2021.
| S-EPMC10490848 | biostudies-literature
Project description:In Ecuador, adolescents' food intake does not comply with guidelines for a healthy diet. Together with abdominal obesity adolescent's inadequate diets are risk factors for non-communicable diseases. We report the effectiveness of a school-based intervention on the dietary intake and waist circumference among Ecuadorian adolescents.A pair-matched cluster randomized controlled trial including 1430 adolescents (12-14 years old) was conducted. The program aimed at improving the nutritional value of dietary intake, physical activity (primary outcomes), body mass index, waist circumference and blood pressure (secondary outcomes). This paper reports: (i) the effect on fruit and vegetable intake, added sugar intake, unhealthy snacking (consumption of unhealthy food items that are not in line with the dietary guidelines eaten during snack time; i.e. table sugar, sweets, salty snacks, fast food, soft drinks and packaged food), breakfast intake and waist circumference; and, (ii) dose and reach of the intervention. Dietary outcomes were estimated by means of two 24-h recall at baseline, after the first 17-months (stage one) and after the last 11-months (stage two) of implementation. Dose and reach were evaluated using field notes and attendance forms. Educational toolkits and healthy eating workshops with parents and food kiosks staff in the schools were implemented in two different stages. The overall effect was assessed using linear mixed models and regression spline mixed effect models were applied to evaluate the effect after each stage.Data from 1046 adolescents in 20 schools were analyzed. Participants from the intervention group consumed lower quantities of unhealthy snacks (-23.32 g; 95% CI: -45.25,-1.37) and less added sugar (-5.66 g; 95% CI: -9.63,-1.65) at the end of the trial. Daily fruit and vegetable intake decreased in both the intervention and control groups compared to baseline, albeit this decrease was 23.88 g (95% CI: 7.36, 40.40) lower in the intervention group. Waist circumference (-0.84 cm; 95% CI: -1.68, 0.28) was lower in the intervention group at the end of the program; the effect was mainly observed at stage one. Dose and reach were also higher at stage one.The trial had positive effects on risk factors for non-communicable diseases, i.e. decreased consumption of unhealthy snacks. The program strategies must be implemented at the national level through collaboration between the academia and policy makers to assure impact at larger scale.ClinicalTrial.gov-NCT01004367 .
| S-EPMC5725778 | biostudies-literature