[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577746":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":21,"responsibleParty":39,"collaborators":42,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":21,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":76,"whyStopped":21,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":21},{"fullName":5,"class":6},"Universidad de Sonora","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Planet Nutrition Program",{"label":15,"type":10,"description":11,"interventionNames":16},"PEST-PA group: physical education schoolteachers and physical activity students.",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"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.",null,[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":21},"BEHAVIORAL","Planet Nutrition Program","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.",[9,15],[29],{"name":30,"affiliation":5,"role":31},"Rolando G Díaz Zavala","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Teresita Martínez Contreras, MSc","CONTACT","52 662 289 3793","4630","teresitamartinez@unison.mx",{"type":31,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Rolando Giovanni Díaz Zavala","Full-time professor",[43,45],{"name":44,"class":6},"Centro de Investigación en Alimentación y Desarrollo A.C.",{"name":46,"class":47},"Instituto Nacional de Geriatria, Mexico","OTHER_GOV","100577746","effectiveness-of-a-school-based-obesity-prevention-program-on-body-fat-at-6-months-of-mexican-children-100577746",false,"NCT06802302","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","PPN","Schools\n\nInclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Participating in a similar study.\n\nChildren\n\nInclusion Criteria:\n\n* 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).\n\nExclusion Criteria:\n\n* A personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating.\n\nImplementers\n\nInclusion Criteria:\n\n-Received 80% of the program training. Satisfactory response to a questionnaire that assessed their knowledge of the program following the training.",true,"ALL","9 Years","12 Years",{"count":61,"type":62},240,"ESTIMATED","INTERVENTIONAL",[65],"NA","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.",[68],"Childhood Obesity Pevention",[70,71,72,73,74,75],"Intervention","Nutrition","Physical activity","Randomized controlled trial","Body fat","School","NOT_YET_RECRUITING","2025-01-29",{"date":79,"type":80},"2025-01-31","ACTUAL",{"date":82,"type":62},"2025-01-30",{"date":84,"type":62},"2025-06-13",{"name":5,"class":6}]