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

N/ANot Yet RecruitingNCT06802302

Universidad de Sonora240 enrolled

Overview

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.

This is a cluster randomized controlled trial with three parallel groups and a 1:1:1 allocation ratio. The current protocol represents the definitive phase of the study, which was previously registered and approved in clinical trials (NCT05461703). The project has been approved by the Research Ethics Committee of the Nursing Department at the Universidad de Sonora (EPD-007-2022).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 9 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Schools Inclusion Criteria: * School principals, 4th- and 5th- grade teachers willing to participate, availability of space for physical activity classes, and groups with a minimum of 20 students. Exclusion Criteria: * Participating in a similar study. Children Inclusion Criteria: * To be a 4th or 5th grade student (9 to 12 years) in one of the participating schools. To be eligible for this study, parents and children will be required to sign an informed consent and assent form, respectively, and had to complete anthropometric measurements (children) and lifestyle questionnaires (parents). Exclusion Criteria: * A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating. Implementers Inclusion Criteria: -Received 80% of the program training. Satisfactory response to a questionnaire that assessed their knowledge of the program following the training.

Outcomes

Primary Outcomes

Mean difference in body Fat (%)

Body composition will be obtained using electrical bioimpedance RJL Quantum II (Clinton Township, Michigan) following the methodology recommended by the manufacturer. With obtained data (resistance and reactance values in ohms), an equation previously designed to estimate fat-free mass in Mexican children will be used. Fat mass will be obtained by subtracting the kilograms of fat-free mass from the total kilograms of the subject and its percentage with respect to total body weight will be also calculated.