A School-Based Randomized Controlled Trial to Promote Cycling to School in Adolescents: The PACO Study
Ontology highlight
ABSTRACT:
SUBMITTER: Chillon P
PROVIDER: S-EPMC7923771 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Similar Datasets
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: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: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:BackgroundAlthough 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.PurposeThe 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.DesignA cluster RCT was conducted. Data were collected from January 2010 to May of 2012 and analyzed in 2012-2013.Setting/participantsA total of 779 culturally diverse adolescents in the U.S. Southwest participated in the trial.InterventionCOPE 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 measuresPrimary 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.ResultsPost-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).ConclusionsCOPE can improve short- and more long-term outcomes in high school teens.Trial registrationThis 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:BackgroundActive travel and school settings are considered ideal for promoting physical activity. However, previous research suggests limited effect of school-based interventions on overall physical activity levels among adolescents. The relationship between physical activity in different domains remains inconclusive. In this study, we examined the effects of adding two weekly hours of school-based physical activity on active travel rates.MethodWe analyzed data from 1370 pupils in the 9th-grade participating in the cluster RCT; the School In Motion (ScIM) project. Intervention schools (n = 19) implemented 120 min of class-scheduled physical activity and physical education, in addition to the normal 2 hours of weekly physical education in the control schools (n = 9), for 9 months. Active travel was defined as pupils who reported walking or cycling to school, while motorized travel was defined as pupils who commuted by bus or car, during the spring/summer half of the year (April-September), or autumn/winter (October-February). The participants were categorized based on their travel mode from pretest to posttest as; maintained active or motorized travel ("No change"), changing to active travel (motorized-active), or changing to motorized travel (active-motorized). Multilevel logistic regression was used to analyze the intervention effect on travel mode.ResultsDuring the intervention period, most participants maintained their travel habits. In total, 91% of pupils maintained their travel mode to school. Only 6% of pupils switched to motorized travel and 3% switched to active travel, with small variations according to season and trip direction. The intervention did not seem to influence the likelihood of changing travel mode. The odds ratios for changing travel habits in spring/summer season were from active to motorized travel 1.19 [95%CI: 0.53-2.15] and changing from motorized to active travel 1.18 [0.30-2.62], compared to the "No change" group. These findings were consistent to and from school, and for the autumn/winter season.ConclusionThe extra school-based physical activity does not seem to affect rates of active travel among adolescents in the ScIM project.Trial registrationClinicaltrials.gov ID nr: NCT03817047. Registered 01/25/2019' retrospectively registered'.
| S-EPMC10664674 | biostudies-literature
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:BackgroundCurrent global trend of insufficient physical activity (PA) among children and adolescents highlights the necessity of finding effective ways to promote PA in childhood. Self-determination theory (SDT) has demonstrated efficacy as a conceptual framework for developing interventions aimed at promoting diverse health behaviours. Parents have potential to influence children's health behaviours to a great extent, which could be enhanced from an online, self-paced training to gain knowledge on how to support children's intrinsic motivation towards particular health behaviour. In this pilot study, we developed and tested an online SDT-informed need-supportive training for parents, enabling them to interact with their children in a way to support their intrinsic motivation towards leisure-time physical activity.MethodsSixty eight students (Mage = 12.5 ± 0.72) and one parent for each child were randomly assigned to the 6-week intervention condition or control condition. Students completed psychological measures (i.e., perceptions of parents' need-supportive behaviours, basic psychological need satisfaction and frustration, autonomous and controlled forms of motivation, as well as social cognition beliefs towards leisure-time PA) and self-reported PA pre-intervention, post-intervention, and one-month after the intervention. Repeated measures ANOVAs were conducted to test the effects of the intervention condition and time.ResultsWhile a statistically significant intervention effect on children's leisure-time PA was not found, students in the intervention group reported higher, albeit marginal, perceptions of intrinsic motivation (F(2, 84) = 3.095, p = 0.050) and lower perceptions of introjected regulation (F(2, 88) = 3.107, p = 0.050) and autonomy frustration (F(2, 84) = 2.987, p = 0.056) at follow-up. Contrary to expectations, children in the control group demonstrated higher perceptions of intention (F(2, 84) = 4.838, p = 0.010) and effort (F(2, 80) = 3.473, p = 0.036) towards leisure-time physical activity at follow-up. No significant changes were found in perceptions of need-supportive behaviour from parents, attitude, and perceived behavioural control.ConclusionsOur pilot study highlights the importance of parental training and the potential for SDT-informed interventions to support children's intrinsic motivation towards physical activity. Further research is needed to test the intervention in other domains and combine interventions in several domains to have the highest impact.Trial registrationThis pilot study is part of preparation for the main study, prospectively registered in ISRCTN registry as ISRCTN78373974 (15.12.2022). The current stage of the main study is 'recruiting'.
| S-EPMC10463639 | biostudies-literature