Childhood Obesity PeventionPPNNCT06802302
Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children
A study testing Planet Nutrition Program in people with Childhood Obesity Pevention, run by Universidad de Sonora.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity Pevention
- What is being tested?
- Planet Nutrition Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2025to 13 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- 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).
- -Received 80% of the program training. Satisfactory response to a questionnaire that assessed their knowledge of the program following the training.
Who cannot join
- Participating in a similar study.
- Children
- A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating.
- Implementers
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children: a Cluster Randomized Controlled 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.
Read the detailed description
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).
- Conditions
- Childhood Obesity Pevention
- Being tested
- Planet Nutrition Program
- Keywords
- Intervention, Nutrition, Physical activity, Randomized controlled trial, Body fat, School
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planet Nutrition ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| NUT-PA group: intervention delivered by advanced nutrition and physical activity students. | Experimental | 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. Receives: Behavioral: Planet Nutrition Program |
| PEST-PA group: physical education schoolteachers and physical activity students. | Experimental | 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. Receives: Behavioral: Planet Nutrition Program |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months ( from baseline to the end of the study).
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 months ( from baseline to the end of the study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion13 Jun 2025 (estimated)
- Study completion13 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Childhood Obesity PeventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Schools that meet the inclusion/exclusion criteria will be randomly assigned to one of three groups: 1) a program implemented by nutrition and physical activity students (NUT-PA group), 2) a program delivered by physical education teachers and physical activity students (PEST-PA group), or 3) a control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Sonora
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación en Alimentación y Desarrollo A.C., Instituto Nacional de Geriatria, Mexico
- Responsible party
- Principal investigator, Rolando Giovanni Díaz Zavala, Universidad de Sonora
- Investigators
- Rolando G Díaz Zavala, Principal investigator, Universidad de Sonora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802302
- Sponsor's protocol ID
- PPN2025
- Acronym
- PPN
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data (without sensitive information) may only be shared at the discretion of the principal investigator and for research purposes.
Publications
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Currie C, Inchley J, Molcho M, Lenzi M, Veselska Z, Wild F. Health Behaviour in School-Aged Children (HBSC) Study Protocol: Background , Methodology and Mandatory Items for the 2013/14 Survey.; 2014. http://www.hbsc.org
Shamah-Levy T, Vielma-Orozco E, Heredia-Hernández O, Romero-Martínez M, Mojica-Cuevas J CNL, Santaella-Castell JA RDJ. Encuesta Nacional de Salud y Nutrición 2018-19: Resultados Nacionales.; 2020. Accessed September 4, 2020. https://ensanut.insp.mx/encuestas/ensanut2018/informes.php
Marfell-Jones M, Olds T, Stewart A, Carter L. International Standards for Anthropometric Assessment. First edit. (ISAK, ed.).; 2006.
Ramirez E, Valencia ME, Bourges H, Espinosa T, Moya-Camarena SY, Salazar G, Aleman-Mateo H. Body composition prediction equations based on deuterium oxide dilution method in Mexican children: a national study. Eur J Clin Nutr. 2012 Oct;66(10):1099-103. doi: 10.1038/ejcn.2012.89. Epub 2012 Jul 18.
PubMed 22805494WHO. Growth Reference 5-19 years. BMI-for-age (5-19 years). 2007. https://www.who.int/growthref/en/
Ramírez Rivera DL, Martínez Contreras T, Villegas Valle RC, et al. Effectiveness of a school-based obesity prevention program on the BMI Z-score and body fat at 6 months in Mexican children: study protocol of a cluster randomized controlled trial. Biotecnia. 2023;25(3):71-78. doi:10.18633/biotecnia.v25i3.2074
Ramírez-Rivera DL, Martínez-Contreras Teresita, Henry-Mejia Gricelda, et al. Efecto de una intervención en línea de cambio en el estilo de vida sobre el puntaje zIMC de escolares mexicanos: protocolo de ensayo controlado aleatorizado piloto cegado a evaluadores
Ramirez-Rivera DL, Martinez-Contreras T, Villegas-Valle RC, Henry-Mejia G, Quizan-Plata T, Haby MM, Diaz-Zavala RG. Preliminary Results of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Single-School Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 18;18(2):790. doi: 10.3390/ijerph18020790.
PubMed 33477722Spiga F, Davies AL, Tomlinson E, Moore TH, Dawson S, Breheny K, Savovic J, Gao Y, Phillips SM, Hillier-Brown F, Hodder RK, Wolfenden L, Higgins JP, Summerbell CD. Interventions to prevent obesity in children aged 5 to 11 years old. Cochrane Database Syst Rev. 2024 May 20;5(5):CD015328. doi: 10.1002/14651858.CD015328.pub2.
PubMed 38763517Shamah-Levy T, Gaona-Pineda EB, Cuevas-Nasu L, Morales-Ruan C, Valenzuela-Bravo DG, Mendez-Gomez Humaran I, Avila-Arcos MA. Prevalencias de sobrepeso y obesidad en poblacion escolar y adolescente de Mexico. Ensanut Continua 2020-2022. Salud Publica Mex. 2023 Jun 14;65:s218-s224. doi: 10.21149/14762. Spanish.
PubMed 38060970NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 population-representative studies with 222 million children, adolescents, and adults. Lancet. 2024 Mar 16;403(10431):1027-1050. doi: 10.1016/S0140-6736(23)02750-2. Epub 2024 Feb 29.
PubMed 38432237