Instituto Politécnico de Setúbal
Setúbal, 2914-504, Portugal
Location contact
Carolina Alexandra Cabo, Master
CONTACT
Susana Garradas, PhD
CONTACT
NCT Number: NCT07523945
Children today spend many hours sitting at school and at home, often in front of screens. Prolonged sitting in childhood increases the risk of future health problems such as diabetes, heart disease and poor mental wellbeing. MAFF is a simple school-to-home programme that teaches short, practical movement breaks in the classroom and encourages families to repeat them together at home through structured weekly challenges. Over 12 weeks, we will compare classes using MAFF with classes continuing as usual to assess whether children sit less, move more and improve their wellbeing. If effective, MAFF will provide schools and communities with an easy-to-implement toolkit to promote healthier and more active families.
Trial opening soon.
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Interventional
Not applicable
Setúbal, 2914-504, Portugal
Carolina Alexandra Cabo, Master
CONTACT
Susana Garradas, PhD
CONTACT
Sedentary behaviour is an independent risk factor for cardiometabolic disease and poor mental health, even among individuals meeting physical activity recommendations. In children, prolonged sitting is associated with impaired metabolic regulation, increased adiposity risk, lower psychological wellbeing and behavioural tracking into adolescence and adulthood. Early intervention targeting sedentary patterns is therefore essential for primary prevention.
Most school-based interventions focus on increasing moderate-to-vigorous physical activity (MVPA) during school hours, with limited transfer to home environments and weak sustainability. Many also require specialised personnel or equipment, limiting scalability and equity.
The MAFF (Methodology for Family Physical Activity) model is grounded in the Socio-Ecological Model and the COM-B framework (Capability, Opportunity, Motivation-Behaviour). It targets:
Its innovation lies in the structured school-to-home transfer mechanism and the focus on sedentary behaviour fragmentation through short, repeated movement bouts integrated into daily life.
Preliminary feasibility observations in school settings indicate high acceptability of micro-activity breaks among teachers and students, with minimal curricular disruption. Informal caregiver feedback suggests that structured home challenges are manageable and motivating. These observations support feasibility assumptions.
The trial will be prospectively registered in an international clinical trial registry.
Study Design A cluster randomized controlled trial (CRT) with class-level randomization will be conducted to minimize contamination. Classes will be stratified by school cycle (primary vs preparatory) before allocation.
Approximately eight classes (n≈200 children) will be recruited. The intervention will last 12 weeks, followed by a 3-month follow-up. Parental consent and child assent will be obtained.
Allocation will be performed by an independent researcher using computer-generated random sequences.
Intervention
The MAFF intervention includes:
Outcomes and Measurement
Primary outcomes:
Secondary outcomes:
Process Evaluation A RE-AIM framework will assess reach, adoption, implementation fidelity, dose delivered/received, and maintenance at follow-up. Adherence will be quantified through logs and session tracking.
Statistical Analysis All analyses will follow the intention-to-treat principle. Multilevel mixed-effects models will account for clustering (children nested within classes). Baseline covariates (cycle, sex, socioeconomic status) will be included where appropriate.
Primary analyses will test group × time interaction effects on sedentary time and MVPA. Secondary analyses will examine mediation (family cohesion; adherence) and moderation (sex; school cycle). Sensitivity analyses using multiple imputation will address missing data. Effect sizes and 95% confidence intervals will be reported.
Power Calculation A priori sample size estimation assumed a moderate effect size (Cohen's d = 0.40) for sedentary time reduction, α = 0.05 and power = 0.80. Assuming an intraclass correlation coefficient (ICC) of 0.03 and an average cluster size of 25 students, eight clusters (≈200 participants) provide adequate power. Allowing for 15% attrition, the study remains sufficiently powered under intention-to-treat analysis.
Data Management and Quality Assurance Data will be stored securely in compliance with GDPR. Predefined analysis protocols will be established prior to statistical modelling. Measurement staff will be trained and standardized.
Contribution to the Evidence Base By integrating ecological behavioural theory, cluster randomized design, objective measurement and mediation analysis, this project generates causal evidence on scalable sedentary behaviour reduction strategies in children and strengthens the preventive public health evidence base.
The project directly aligns with preventive health priorities aimed at reducing behavioural risk factors early in life.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MAFF is a low-cost, scalable behavioural intervention designed to reduce sedentary time and increase physical activity in children through a school-to-home transfer model.
It integrates:
Structured micro-activity breaks in classroom settings Family-based movement challenges to reinforce behaviour at home Behavioural mechanisms grounded in the COM-B model (capability, opportunity, motivation) Ecological reinforcement through repeated exposure across contexts (school and family)
No specialised equipment is required.
Time frame: Baseline (T0), Post-intervention (12 weeks, T1), 3-month follow-up (T2)
Daily sedentary time measured via validated self-report instruments and accelerometry (subsample).
Moderate-to-vigorous physical activity (MVPA) assessed using validated questionnaires and accelerometry (subsample).
Assessment time points: baseline (T0), post-intervention at 12 weeks (T1), and 3-month follow-up (T2).
Time frame: Baseline (T0), post-intervention at 12 weeks (T1), and 3-month follow-up (T2) for screen time, sleep, psychological distress, family cohesion, and anthropometrics; adherence tracked during the intervention.
Screen Time: Self-reported daily screen exposure. Sleep: Assessed using a validated sleep questionnaire. Psychological Distress: Measured using the DASS-21. Family Cohesion: Assessed with FACES IV (Portuguese version). Anthropometrics (Exploratory): BMI percentile and waist circumference. Adherence to Intervention: Based on session attendance and home challenge completion logs.
Assessment Time Points: Baseline (T0), post-intervention 12 weeks (T1), 3-month follow-up (T2); adherence tracked during intervention.
Contact information is provided by the study sponsor or research team.
Carolina Dr Cabo, Master
CONTACT
Susana Dr. Garradas, PhD
CONTACT
Instituto Politécnico de Setúbal
Other
MAFF-CRT: School-to-Home Trial to Reduce Sedentary Behaviour in Children
Acronym: MAFF-CRT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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