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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorUniversidad de Sonora

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Participating in a similar study.

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).

A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Planet Nutrition Program

    Behavioral

    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.

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: NUT-PA group: intervention delivered by advanced nutrition and physical activity students.Experimental treatment 1 intervention
Group B: PEST-PA group: physical education schoolteachers and physical activity students.Experimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 6 months ( from baseline to the end of the study).

Secondary outcomes

1

Mean difference in BMI Z-score

Will be calculated using the weight, height, sex, and date of birth of the children, using the "Anthro Plus" v.1.0.4 software, which uses the WHO reference tables.

Time frame
At 6 months ( from baseline to the end of the study).
2

Mean difference in waist circumference

The measurement will be taken at the umbilical scar level (under the skin), with the participant standing, using a metallic anthropometric tape (Lufkin Executive Thineline W606PMM). Participants will be asked to indicate their umbilical scar location and to inhale and exhale prior to the measurement.

Time frame
At 6 months ( from baseline to the end of the study).
3

Difference in food consumption

Some questions from the semi-quantitative food frequency questionnaire (FFQ) from the National Health and Nutrition Survey (ENSANUT) will be used. Participants will be asked about the frequency of consumption of ultra-processed foods (sweet beverages, fried foods, cakes, and cookies) and healthy foods (fruits, vegetables, and water) in the previous 7 days. For each food, the size of the portion consumed was asked, considering an average portion established in the FFQ. Parents will answer the children's questionnaires.

Time frame
At 6 months ( from baseline to the end of the study).
4

Mean difference in physical activity and sedentary behavior

The questions on physical activity and sedentary lifestyle will be used from "The Health Behavior in School-Age Children" (HBSC) questionnaire. The questionnaire includes questions about the days and time (intensity, duration, and frequency) dedicated to physical activity in the last 7 days. In addition, the questionnaire includes a section on time dedicated to sedentary activities during the week and on the weekend.

Time frame
At 6 months ( from baseline to the end of the study).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Sonora

Lead sponsor

Centro de Investigación en Alimentación y Desarrollo A.C.

Collaborator

Instituto Nacional de Geriatria, Mexico

Collaborator

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