Efficacy of a School-based Obesity Prevention Program in Mexican Schoolchildren: Cluster Randomized Controlled Trial
NCT ID: NCT05461703
Last Updated: 2023-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2022-12-05
2024-11-30
Brief Summary
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Detailed Description
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To perform the protocol of the study, the SPIRIT 2013 guide was followed. The study was approved by the Research Ethics Committee of the University of Sonora Department of Nursing (EPD-007-2022).
Fifteen public schools (300 to 450 students) from Hermosillo, Sonora, Mexico will be conveniently invited to participate in the pilot study. The sample size was determined based on the capacity of providing the program and on finding possible positive effects on the variables of interest . The calculation of the sample size is not essential in a pilot study, where its main objective is to know the feasibility of the intervention and information regarding the response variables to later carry out the sample size calculation for a future definitive trial (Eldridge, 2016).
Once the informed consent and assent have been signed by the parents and children (respectively), the baseline measurements will be made over 4 weeks. The schools and participants that meet the inclusion/exclusion criteria will be randomly assigned to one of the three arms. 1). Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students (studying the last semesters of the degree or who have completed subjects but do not have the degree), 2). PNP implemented by school teachers and 3). a control group. An independent person from the recruitment and the intervention will perform the random allocation of the schools. This will be stratified by socioeconomic level. The random number sequence will be generated using the software "Research Randomizer" https://randomizer.org/.
The baseline characteristics will be analyzed among groups, and an ANOVA analysis will be used for the quantitative variables, and a chi-square test for the categorical outcomes in order to assure that groups are similar in all variables. If there are significant differences among groups at baseline, an adjustment will be made in the analysis. To evaluate the differences between groups in the change of the BMI Z-score, body fat, and the other secondary variables at the beginning and at the end of the intervention, a mixed model will be used to consider the effect between groups and within groups. All analyzes will be performed by the intention to treat. If data is not obtained for any reason or subjects were excluded due to a protocol violation, they will be replaced by their baseline measurement. The R studio software will be used to perform the analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students
The PNP consists of:
Nutrition education sessions: Nutrition advanced students of the University of Sonora will provide 1 face-to-face group class of one hour per week. The PNP handbook will be used to bring the different topics and dynamics to reinforce learning. The program will be focused on establishing some health-related goals.
Physical activity sessions: Three classes of 1 hour per week will be implemented by physical activity advanced students of the University of Sonora, independent of the school's curricular physical activity classes. A physical activity handbook designed by the study team will be used. Children will work on developing different skills.
Parents participation: They will receive one printed brochure with nutrition topics weekly. Also, they will be asked for their Facebook user (to create a private group) or the email to upload the information of the brochure and other didactic materials. Nutrition students will be in charge of providing the information.
Planet Nutrition Program
It is a 6-month school-based obesity prevention program that includes: nutrition education sessions, physical activity and family participation.
Planet Nutrition (PNP) implemented by school teachers
The PNP consists of:
Nutrition education sessions: Fourth grade school teachers will provide 1 face-to-face group class of one hour per week. The PNP handbook will be used to bring the different topics and dynamics to reinforce learning. The program will be focused on establishing some health-related goals.
Physical activity sessions: Three classes of 1 hour per week will be implemented by physical activity advanced students of the University of Sonora, independent of the school's curricular physical activity classes. A physical activity handbook designed by the study team will be used. Children will work on developing different skills.
Parents participation: They will receive one printed brochure with nutrition topics weekly. Also, they will be asked for their Facebook user (to create a private group) or the email and upload the information of the brochure and other didactic materials. School teachers will be in charge of providing the information.
Planet Nutrition Program
It is a 6-month school-based obesity prevention program that includes: nutrition education sessions, physical activity and family participation.
Control Group
Scholars of this group will continue with their normal school nutrition and physical activity classes. At the end of the study they will have access to the program materials through a web page.
No interventions assigned to this group
Interventions
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Planet Nutrition Program
It is a 6-month school-based obesity prevention program that includes: nutrition education sessions, physical activity and family participation.
Eligibility Criteria
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Inclusion Criteria
* school directors and teachers wish to participate.
* availability of space for physical activity classes.
* the school has at least 20 children per 4th-grade group.
* Schoolchildren:
-be a 4th grade student (9 to 11 years old).
* Implemeters:
* receive 80% of the program training.
* respond satisfactorily to a questionnaire that tests knowledge of the program
Exclusion Criteria
* Schoolchildren: Having a personal condition that prevents physical activity or a condition that parents consider should not involve the child.
9 Years
11 Years
ALL
Yes
Sponsors
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Centro de Investigación en Alimentación y Desarrollo A.C.
OTHER
Instituto Nacional de Geriatria, Mexico
OTHER_GOV
Universidad de León
OTHER
Universidad de Sonora
OTHER
Responsible Party
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Rolando Giovanni Díaz Zavala
Full-time professor and researcher
Principal Investigators
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Rolando G Díaz Zavala, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Sonora
Locations
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Public Schools
Hermosillo, Sonora, Mexico
Countries
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Central Contacts
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References
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Other Identifiers
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PNP02
Identifier Type: -
Identifier Source: org_study_id
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