NCT06802302Not yet recruiting
Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children
Effectiveness of a School-based Obesity Prevention Program on Body Fat At 6 Months of Mexican Children: a Cluster Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 20 Jan 2025
- Start date
- 30 Jan 2025
- Primary completion date
- 13 Jun 2025
- Lead sponsor
- Universidad de Sonora
- Diseases
- Obesity
- NCT number
- NCT06802302
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 30 Jan 2025 to the primary completion date, 13 Jun 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating.
- Implementers
Other
- Participating in a similar study.
- Children
Who the study is looking for
- 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.
Criteria the registry did not label
- Schools
Age in the registry: 9 years to 12 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.