NCT Number: NCT06802302
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.
Trial opening soon.
Get Notified9 year–12 year
All sexes
Interventional
Not applicable
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Schools
Inclusion criteria
Exclusion criteria
Children
Inclusion criteria
Exclusion criteria
Implementers
Inclusion criteria
-Received 80% of the program training. Satisfactory response to a questionnaire that assessed their knowledge of the program following the training.
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.
Time frame: At 6 months ( from baseline to the end of the study).
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).
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).
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).
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).
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).
The PedsQL™ questionnaire (Pediatric Quality of Life Inventory) will used to evaluate aspects of quality of life. This generic health status instrument assesses the frequency of problems experienced in the past month in the following aspects: physical, emotional, social, and school functioning. Responses are on a 5-point Likert scale (never = 0 to always = 4). The score for each item was inverted and converted to a linear scale from 0 to 100, with a higher score indicating a better quality of life.
Time frame: At 6 months ( from baseline to the end of the study).
A questionnaire designed by the study team will be used to assess knowledge on nutrition issues. It consists of 19 questions about nutrition and health. Knowledge was evaluated on a scale from 0 to 10, with the more correct answers, the higher the score.
Time frame: At 6 months ( from baseline to the end of the study).
The feasibility of the implementation of the program will be evaluated with retention, acceptability, adherence and fidelity.
Retention: number of schools and participants that completed the final measurements.
Acceptability: A questionnaire will be applied to children, parents, and implementers to evaluate the acceptability of the program and materials on a scale from 0 to 10.
Adherence: number of nutrition and phisical activity classes attended by children.
Fidelity: number of classes delivered by implementers.
Contact information is provided by the study sponsor or research team.
Universidad de Sonora
Other
Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children: a Cluster Randomized Controlled Trial
Acronym: PPN
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.
Published trials that share one or more normalized conditions with this study.
NCT07389421
Behavior, Behavior, Animal
View Trial DetailsNCT07616232
Body Weight, Childhood Obesity Pevention
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07160530
Behavior, Behavior, Animal
Lincoln, Nebraska, United States
View Trial DetailsNCT07184281
Behavior, Body Weight
Suzhou, Jiangsu, China
View Trial Details