Physical ActivityNCT07177248
12-Week Family-Based Multicomponent Program to Improve 24-Hour Movement Behaviors in Parents and Children
A study testing Family-Based 12-Week Multicomponent Program in people with Physical Activity and Sedentary Behaviors, run by Pontificia Universidad Catolica de Valparaiso at 1 site in Chile.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sedentary Behaviors, Exercise
- What is being tested?
- Family-Based 12-Week Multicomponent Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChile
- Study dates
- 1 May 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent-child dyad from a participating primary school (child typically in grades 3-6).
- Parent/legal guardian aged ≥18 years; child aged ≥8 years at enrollment.
- Able to take part safely in light-to-moderate physical activity (medical clearance as needed).
- Access to a mobile phone with WhatsApp and/or email for weekly digital materials.
- Signed informed consent from the parent/legal guardian and assent from the child.
- Availability to attend the three scheduled in-person family sessions and complete baseline and post-intervention assessments.
Who cannot join
- Any medical condition, injury, or disability that, in the investigator's judgment, would make participation unsafe or preclude planned activities.
- Current participation in another structured physical activity or lifestyle intervention trial.
- Inability to comply with the study schedule, procedures, or outcome assessments.
- Lack of access to WhatsApp/email for receiving digital materials.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Católica de Valparaíso - School of Physical Education
Viña del Mar, Valparaiso, 2200055
About this study
Official title: Effects of a 12-Week Multicomponent Intervention on 24-Hour Movement Behaviour and Physical Fitness in Parents and Their Children: A Mediation Analysis
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.
Read more
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.
Read the detailed description
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
- Primary: Determine whether a 12-week multicomponent, family-based program increases children's out-of-school MVPA compared with usual activities.
- Secondary: Evaluate effects on children's in-school and weekend MVPA, sedentary time, and sleep; parents' MVPA and sedentary time; and perceived physical fitness (parents and children).
- Exploratory: Conduct a mediation analysis to explore potential pathways (e.g., changes in sedentary time, sleep, or perceived fitness) through which the intervention may influence children's MVPA.
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)
- Format \& Dose: 12 weeks combining weekly digital materials for parents and three on-site family sessions.
- Digital component (Weeks 4-15): Short infographics/videos and practical suggestions were delivered via email/WhatsApp each week (brief educational content early in the week and follow-up prompts later in the week).
- In-person sessions: (i) Functional training class for parents and children (school gym), (ii) modified games session (school gym), and (iii) outdoor trekking activity. Each lasted ~90 minutes and was supervised by a Physical Education teacher with assistance from the school's sports department.
- Implementation timeline (abridged): Week 1 school authorization; Week 2 information sessions and consent/assent; Week 3 baseline questionnaires and anthropometry; Weeks 4-15 digital materials; Weeks 7, 11, and 15 in-person sessions; Week 16 post-test; Week 17 feedback meetings with families and school authorities.
- Adherence \& Fidelity: Delivery logs for digital materials and attendance records for on-site sessions were maintained; activities were adapted to accommodate varied fitness levels.
Comparator Participants in the comparison group maintained their usual activities and were measured on the same schedule as the intervention group.
Outcomes and Measurements
- Primary outcome: Children's out-of-school MVPA (min/day) estimated with the YAP-SL, which uses context-specific items and established calibration procedures to model daily MVPA.
- Secondary outcomes: Children's in-school and weekend MVPA (YAP-SL); sedentary time (hours/day, YAP-SL); sleep duration computed from weekday/weekend bed/wake times (average across the week); parents' MVPA and sedentary time derived from the IPAQ-Short Form; and perceived physical fitness for both parents and children using the International Fitness Scale (IFIS) (higher scores reflect better perceived fitness).
- Safety monitoring: Any intervention-related adverse events (e.g., musculoskeletal complaints, dizziness, falls) were recorded during face-to-face sessions and via parent reports between sessions.
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.
- Conditions
- Physical Activity, Sedentary Behaviors, Exercise, Sleep, Physical Fitness, Health Promotion
- Being tested
- Family-Based 12-Week Multicomponent Program
- Keywords
- Physical Activity, Sedentary Behavior, Sleep
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Based 12-Week Multicomponent ProgramBehavioural
Also called Family Physical Activity Program
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Family-Based Multicomponent Program | Experimental | 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. Receives: Behavioral: Family-Based 12-Week Multicomponent Program |
| No Intervention: Usual Activities | No intervention | Participants continue usual routines; same assessment schedule as the experimental arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Secondary outcomes (8)
Change in children's in-school MVPA, min/day
Minutes/day of MVPA during school time estimated with YAP-SL calibration; higher = more MVPA.
Measured: 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.
Measured: (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion (up to 16 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 May 2023
- Primary completion31 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized, two-arm, parallel study conducted in Chilean primary schools. Parent-child dyads were assigned by school-level scheduling/feasibility to either the multicomponent family-based program or usual activities. The intervention combined weekly digital guidance for parents and three family in-person sessions led by a Physical Education teacher. Outcomes were assessed at baseline and post-intervention (\~Week 16). Analyses compare change scores between groups, adjusting for baseline and design features appropriate to non-randomized allocation.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Sponsor
- Investigators
- Fernando Javier Rodríguez-Rodríguez, PhD, Principal investigator, Pontificia Universidad Católica de Valparaíso (PUCV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177248
- Sponsor's protocol ID
- ACTIBESE/FONDECYT 2023/1230801
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Guagliano JM, Armitage SM, Brown HE, Coombes E, Fusco F, Hughes C, Jones AP, Morton KL, van Sluijs EMF. A whole family-based physical activity promotion intervention: findings from the families reporting every step to health (FRESH) pilot randomised controlled trial. Int J Behav Nutr Phys Act. 2020 Sep 22;17(1):120. doi: 10.1186/s12966-020-01025-3.
PubMed 32962724Hayes AF. Introduction to Mediation, Moderation, and Conditional Process Analysis: A Regression-Based Approach. 2nd ed. New York: Guilford Press; 2017.
Zhao X, Lynch JG, Chen Q. Reconsidering Baron and Kenny: Myths and truths about mediation analysis. J Consum Res. 2010;37(2):197-206. https://doi.org/10.1086/651257
Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.
PubMed 21441238Fairclough SJ, Christian DL, Saint-Maurice PF, Hibbing PR, Noonan RJ, Welk GJ, Dixon PM, Boddy LM. Calibration and Validation of the Youth Activity Profile as a Physical Activity and Sedentary Behaviour Surveillance Tool for English Youth. Int J Environ Res Public Health. 2019 Oct 2;16(19):3711. doi: 10.3390/ijerph16193711.
PubMed 31581617Brand C, Zurita-Corvalan N, Batista Lemes V, Villa-Gonzalez E, Aguilar-Farias N, Rodriguez-Rodriguez F. Reliability, reproducibility, and feasibility of youth activity profile (YAP) questionnaire in Chilean children and adolescents. J Sports Sci. 2024 Oct;42(20):1959-1966. doi: 10.1080/02640414.2024.2419278. Epub 2024 Oct 24.
PubMed 39445725Saint-Maurice PF, Welk GJ. Validity and Calibration of the Youth Activity Profile. PLoS One. 2015 Dec 2;10(12):e0143949. doi: 10.1371/journal.pone.0143949. eCollection 2015.
PubMed 26630346Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Tremblay MS, Carson V, Chaput JP, Connor Gorber S, Dinh T, Duggan M, Faulkner G, Gray CE, Gruber R, Janson K, Janssen I, Katzmarzyk PT, Kho ME, Latimer-Cheung AE, LeBlanc C, Okely AD, Olds T, Pate RR, Phillips A, Poitras VJ, Rodenburg S, Sampson M, Saunders TJ, Stone JA, Stratton G, Weiss SK, Zehr L. Canadian 24-Hour Movement Guidelines for Children and Youth: An Integration of Physical Activity, Sedentary Behaviour, and Sleep. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S311-27. doi: 10.1139/apnm-2016-0151.
PubMed 27306437Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-Week Multicomponent Intervention on 24-Hour Movement Behaviour and Physical Fitness in Parents and Their Children: A Mediation Analysis
- ClinicalTrials.gov ID
- NCT07177248
- Acronym / sponsor ID
- ACTIBESE/FONDECYT 2023/1230801
- Conditions
- Physical Activity, Sedentary Behaviors, Exercise, Sleep, Physical Fitness, Health Promotion
- Keywords
- Physical Activity, Sedentary Behavior, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ValparaisoUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Primary: Determine whether a 12-week multicomponent, family-based program increases children's out-of-school MVPA compared with usual activities.
- Secondary: Evaluate effects on children's in-school and weekend MVPA, sedentary time, and sleep; parents' MVPA and sedentary time; and perceived physical fitness (parents and children).
- Exploratory: Conduct a mediation analysis to explore potential pathways (e.g., changes in sedentary time, sleep, or perceived fitness) through which the intervention may influence children's MVPA.
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)
- Format \& Dose: 12 weeks combining weekly digital materials for parents and three on-site family sessions.
- Digital component (Weeks 4-15): Short infographics/videos and practical suggestions were delivered via email/WhatsApp each week (brief educational content early in the week and follow-up prompts later in the week).
- In-person sessions: (i) Functional training class for parents and children (school gym), (ii) modified games session (school gym), and (iii) outdoor trekking activity. Each lasted ~90 minutes and was supervised by a Physical Education teacher with assistance from the school's sports department.
- Implementation timeline (abridged): Week 1 school authorization; Week 2 information sessions and consent/assent; Week 3 baseline questionnaires and anthropometry; Weeks 4-15 digital materials; Weeks 7, 11, and 15 in-person sessions; Week 16 post-test; Week 17 feedback meetings with families and school authorities.
- Adherence \& Fidelity: Delivery logs for digital materials and attendance records for on-site sessions were maintained; activities were adapted to accommodate varied fitness levels.
Comparator Participants in the comparison group maintained their usual activities and were measured on the same schedule as the intervention group.
Outcomes and Measurements
- Primary outcome: Children's out-of-school MVPA (min/day) estimated with the YAP-SL, which uses context-specific items and established calibration procedures to model daily MVPA.
- Secondary outcomes: Children's in-school and weekend MVPA (YAP-SL); sedentary time (hours/day, YAP-SL); sleep duration computed from weekday/weekend bed/wake times (average across the week); parents' MVPA and sedentary time derived from the IPAQ-Short Form; and perceived physical fitness for both parents and children using the International Fitness Scale (IFIS) (higher scores reflect better perceived fitness).
- Safety monitoring: Any intervention-related adverse events (e.g., musculoskeletal complaints, dizziness, falls) were recorded during face-to-face sessions and via parent reports between sessions.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized, two-arm, parallel study conducted in Chilean primary schools. Parent-child dyads were assigned by school-level scheduling/feasibility to either the multicomponent family-based program or usual activities. The intervention combined weekly digital guidance for parents and three family in-person sessions led by a Physical Education teacher. Outcomes were assessed at baseline and post-intervention (~Week 16). Analyses compare change scores between groups, adjusting for baseline and design features appropriate to non-randomized allocation.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Family-Based Multicomponent Program | Experimental | Behavioral: Family-Based 12-Week Multicomponent Program12-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. |
| No Intervention: Usual Activities | No intervention | –Participants continue usual routines; same assessment schedule as the experimental arm. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Parent-child dyad from a participating primary school (child typically in grades 3-6).
- Parent/legal guardian aged ≥18 years; child aged ≥8 years at enrollment.
- Able to take part safely in light-to-moderate physical activity (medical clearance as needed).
- Access to a mobile phone with WhatsApp and/or email for weekly digital materials.
- Signed informed consent from the parent/legal guardian and assent from the child.
Key exclusion criteria (4 listed)
- Any medical condition, injury, or disability that, in the investigator's judgment, would make participation unsafe or preclude planned activities.
- Current participation in another structured physical activity or lifestyle intervention trial.
- Inability to comply with the study schedule, procedures, or outcome assessments.
- Lack of access to WhatsApp/email for receiving digital materials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-Based 12-Week Multicomponent ProgramAlso: Family Physical Activity ProgramWeekly 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. | Behavioural | Experimental: Family-Based Multicomponent Program |
Primary outcome
Change in children's out-of-school moderate-to-vigorous physical activity (MVPA), min/day
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
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.
8 secondary outcomes
Change in children's in-school MVPA, min/day
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in children's weekend MVPA, min/day
Time frame: (Weeks 1-3) and Post-intervention (~Week 16)
Change in children's sedentary time, hours/day
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in children's sleep duration, hours/day
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in parents' MVPA, min/week
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in parents' sedentary time, hours/day
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Change in perceived physical fitness (parents and children), IFIS score (1-5)
Time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)
Participants with intervention-related adverse events
Time frame: Through study completion (up to 16 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 32962724Guagliano JM, Armitage SM, Brown HE, Coombes E, Fusco F, Hughes C, Jones AP, Morton KL, van Sluijs EMF. A whole family-based physical activity promotion intervention: findings from the families reporting every step to health (FRESH) pilot randomised controlled trial. Int J Behav Nutr Phys Act. 2020 Sep 22;17(1):120. doi: 10.1186/s12966-020-01025-3.
- BackgroundHayes AF. Introduction to Mediation, Moderation, and Conditional Process Analysis: A Regression-Based Approach. 2nd ed. New York: Guilford Press; 2017.
- BackgroundZhao X, Lynch JG, Chen Q. Reconsidering Baron and Kenny: Myths and truths about mediation analysis. J Consum Res. 2010;37(2):197-206. https://doi.org/10.1086/651257
- Background: PubMed 21441238Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.
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- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Javier Rodríguez-Rodríguez, PhD principal investigator
Pontificia Universidad Católica de Valparaíso (PUCV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Based 12-Week Multicomponent Program in people with Physical Activity and Sedentary Behaviors, run by Pontificia Universidad Catolica de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in children's out-of-school moderate-to-vigorous physical activity (MVPA), min/day (time frame: Baseline (Weeks 1-3) and Post-intervention (~Week 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07177248, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.