An interventional study of Planet Nutrition Program in Childhood Obesity Pevention, sponsored by Universidad de Sonora. Not yet recruiting. Open to participants aged 9 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by Universidad de Sonora · Not applicable, Interventional, and Prevention
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).
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 240 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Universidad de Sonora is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will implement the Planet Nutrition program. Advanced nutrition students will deliver one 1-hour nutrition lesson per week during school hours and will also provide nutrition and health information to parents. Additionally, advanced physical activity students will lead two 1-hour exercise sessions per week at school.
Behavioral: Planet Nutrition Program
This group will implement the Planet Nutrition program. Advanced nutrition students will deliver one 1-hour nutrition lesson per week during school hours and will also provide nutrition and health information to parents. Additionally, advanced physical activity students will lead two 1-hour exercise sessions per week at school.
Behavioral: Planet Nutrition Program
The schoolchildren in this group will continue with their regular nutrition and physical activity classes. At the end of the study, they will receive a printed handbook with nutrition recommendations and gain access to the materials from the Planet Nutrition program via a website.
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.
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).
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).
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).
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).
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).
Mean difference in quality of Life scores
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).
Mean difference in nutrition knowledge
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).
Feasibility of the intervention
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.
Time frame: At 6 months ( from baseline to the end of the study).
No study locations are listed for this record.
Plan to share: No — Participant data (without sensitive information) may only be shared at the discretion of the principal investigator and for research purposes.
Start is estimated for Jan 2025; primary completion for Jun 2025, 4 months later.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 4 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Universidad de Sonora