An interventional study of Family-Based 12-Week Multicomponent Program in Physical Activity, Sedentary Behaviors and Exercise, sponsored by Pontificia Universidad Catolica de Valparaiso. Completed at 1 site in Chile. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Pontificia Universidad Catolica de Valparaiso · Not applicable, Interventional, and Prevention
This study assessed a 12-week, family-oriented program intended to promote healthier 24-hour movement patterns among school-age children and their parents in Chile. Parent-child pairs volunteered from two private schools and one public school, and schools were used to determine group assignment in a parallel, non-randomized, open-label design.
The intervention blended brief weekly digital guidance for parents (concise infographics/videos and actionable tips sent via email/WhatsApp) with three in-person family sessions (a functional-training class, parent-child modified games, and an outdoor trekking activity) led by a Physical Education teacher with support from school staff. The comparison group continued usual routines and completed the same assessments.
Outcomes were collected at baseline and after the intervention period (post-intervention window around Week 16). The primary outcome was the change in children's out-of-school moderate-to-vigorous physical activity (MVPA) estimated with the Youth Activity Profile-Spain/Latin America version (YAP-SL). Secondary outcomes encompassed children's in-school and weekend MVPA, sedentary time, and sleep duration, as well as parents' MVPA and sedentary time (IPAQ-Short Form) and perceived physical fitness for both parents and children (International Fitness Scale, IFIS). Potential intervention-related adverse events during face-to-face activities and those reported between sessions were monitored.
The institutional ethics committee approved the protocol and the intervention was considered minimal risk. This is a retrospective registration completed after study execution at the request of the sponsor. An exploratory mediation analysis is planned to examine plausible pathways linking the program to changes in MVPA.
Rationale Low physical activity and prolonged sedentary time in childhood are widespread and linked to unfavorable health and developmental outcomes. Engaging parents as agents of change is a promising strategy to support children's daily movement behaviors across the full 24-hour cycle (physical activity, sedentary time, and sleep). In Latin American school settings, pragmatic, scalable formats that combine short digital prompts with occasional on-site family activities may be feasible and impactful.
Objectives
Design and Setting Two-arm, parallel, non-randomized, open-label study conducted in Chilean primary schools. Group assignment was determined at the school level for logistical and feasibility reasons (two private and one public school). Assessments were completed at baseline and post-intervention (\~Week 16).
Participants Eligible units were parent-child pairs recruited through school meetings. Children were primarily 5th-grade students (one school deviated for scheduling reasons). Inclusion required the ability to participate safely in light-to-moderate physical activity and access to email and/or WhatsApp for digital communications. Informed consent (parents) and assent (children) were obtained. Exclusions included medical conditions that would preclude safe participation or concurrent enrollment in another structured physical activity program.
Intervention (summary aligned with TIDieR)
Comparator Participants in the comparison group maintained their usual activities and were measured on the same schedule as the intervention group.
Outcomes and Measurements
Statistical Approach Primary analyses compare change from baseline to post-intervention between groups, with models adjusted for baseline values and additional covariates as appropriate for the non-randomized design. The mediation analysis will estimate indirect effects along pre-specified behavioral/fitness pathways using established regression-based procedures, recognizing design constraints and measured covariates.
Ethics and Oversight The study received approval from the institutional bioethics committee and adhered to the principles of the Declaration of Helsinki. Given the behavioral nature and low risk of the activities, monitoring was conducted by the research team, with procedures specified for reporting serious events to the PI and the ethics board.
Registration Note This is a retrospective registration finalized after data collection at the sponsor's request.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's enrollment of 136 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Pontificia Universidad Catolica de Valparaiso is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Compared within Sedentary Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12-week family-based program combining weekly parent digital guidance (infographics/videos + actionable tips) and three 90-min family sessions (functional training, modified games, outdoor trekking) led by a Physical Education teacher.
Behavioral: Family-Based 12-Week Multicomponent Program
Participants continue usual routines; same assessment schedule as the experimental arm.
Weekly digital materials to parents (email/WhatsApp) + three on-site sessions (\~90 min each: functional training; modified games; outdoor trekking); 12 weeks total; delivered by a Physical Education teacher; attendance and delivery logs for fidelity.
Also known as: Family Physical Activity Program
Change in children's out-of-school moderate-to-vigorous physical activity (MVPA), min/day
Daily minutes of MVPA estimated from the Youth Activity Profile-Spain/Latin America version (YAP-SL), using its established calibration procedure to convert item responses into minutes/day; higher values indicate more MVPA.
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in children's in-school MVPA, min/day
Minutes/day of MVPA during school time estimated with YAP-SL calibration; higher = more MVPA.
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in children's weekend MVPA, min/day
Minutes/day of MVPA on weekend days derived from YAP-SL; higher = more MVPA.
Time frame: (Weeks 1-3) and Post-intervention (~Week 16)
Change in children's sedentary time, hours/day
Average daily sedentary time estimated from YAP-SL items; values expressed in hours/day; lower values indicate less sedentary behavior.
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in children's sleep duration, hours/day
Sleep hours computed from reported bed- and wake-times for weekdays and weekends; weekly average calculated as (weekdayhours×5+weekendhours×2)/7; higher values indicate longer sleep duration.
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in parents' MVPA, min/week
Weekly minutes of MVPA derived from the IPAQ-Short Form, computed as the sum of moderate + vigorous minutes/week in bouts ≥10 min. Per the IPAQ-SF scoring protocol, minutes at each intensity are truncated at 180 min/day to limit outliers; range 0-2 520 min/week; higher values indicate more MVPA.
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in parents' sedentary time, hours/day
Average daily sitting time from the International Physical Activity Questionnaire-Short Form (IPAQ-SF), Sitting item. Reported for a usual weekday and expressed as hours/day; range 0-16 hours/day (equivalently 0-960 min/day). Higher values indicate more sedentary time.
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in perceived physical fitness (parents and children), IFIS score (1-5)
International Fitness Scale (IFIS); five domains rated 1-5. Scores are averaged to obtain a domain-specific perceived fitness score; higher values reflect better perceived fitness.
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Participants with intervention-related adverse events
Count of participants reporting events plausibly related to the program during supervised sessions or between sessions (e.g., musculoskeletal complaints, dizziness, falls); events captured in session logs and via parent reports.
Time frame: Through study completion (up to 16 weeks).
Plan to share: Yes — De-identified individual participant data (IPD) underlying the main results will be shared, including parent-child demographics, group assignment, baseline and post-intervention outcomes (YAP-SL MVPA components, sedentary time, sleep measures), IPAQ-Short Form metrics, International Fitness Scale (IFIS) scores, and adverse event dataset. Direct identifiers will be removed; quasi-identifiers will be generalized (e.g., age in years; site masked). A data dictionary/codebook will accompany the dataset. Requests must be consistent with consent and ethics approvals.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months after the Primary Completion Date and available for 36 months thereafter (extensions considered upon reasonable request).
Access criteria: Available to qualified researchers with IRB/ethics approval and a signed Data Use Agreement. Requests should include a brief proposal and analysis plan and be sent to the Principal Investigator. Approved requests will receive access via a secure file transfer or institutional repository. Re-identification attempts and contact with participants/schools are prohibited; citation of the original study is required.
Ran from May 2023 to primary completion in Oct 2023, 5 months.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 5 months is below that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Valparaiso