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Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children

NCT06802302 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-01-31

No results posted yet for this study

Summary

School-based programs are an essential strategy for preventing obesity, yet the most effective way to implement them remains unclear. This study aims to evaluate the effectiveness of a school-based obesity prevention program, delivered by different implementers, in comparison to a control group, focusing on body fat reduction in Mexican children. This is a cluster randomized controlled trial. Approximately six public elementary schools (240 children) in Hermosillo, Mexico, will be invited to participate. Schools will be randomly assigned to one of three groups: a program implemented by advanced undergraduate students in Nutrition and Physical Activity (NUT-PA), a program implemented by Physical Education teachers and Physical Activity students (PEST-PA), or a control group. The intervention will consist of a 6-month obesity prevention program that includes nutrition education, physical activity sessions, and parent participation. The control group will continue with their regular school activities. The primary outcome will be the difference in body fat percentage at 6 months between the NUT-PA group and the control group, as well as between the PEST-PA group and the control group. Secondary outcomes will include BMI Z-score, waist circumference, and various lifestyle parameters. A mixed-effects linear analysis will be conducted using an intention-to-treat approach.

Conditions

  • Childhood Obesity Pevention

Interventions

BEHAVIORAL

Planet Nutrition Program

The intervention in this study will be the same for both intervention groups, both based on the previously designed and tested "Planet Nutrition" Program (PNP). The program components include: nutrition education lessons (one 1-hour session per week), physical activity classes (two 1-hour sessions per week), and nutrition information for parents. The intervention will be implemented from February to June 2025.

Sponsors & Collaborators

  • Centro de Investigación en Alimentación y Desarrollo A.C.

    collaborator OTHER

  • Instituto Nacional de Geriatria, Mexico

    collaborator OTHER_GOV

  • Universidad de Sonora

    lead OTHER

Principal Investigators

  • Rolando G Díaz Zavala · Universidad de Sonora

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2025-06-13
Completion
2025-06-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06802302 on ClinicalTrials.gov