Obesity Prevention for Pre-Adolescents

Study Overview
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Brief Summary
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To develop and evaluate, in a randomized controlled trial, a comprehensive obesity prevention program for third, fourth and fifth grade students. The intervention includes activities in THE SCHOOL, THE HOME, and a clinically oriented component for HIGH-RISK CHILDREN. In addition, the intervention will be delivered over a 3 year period, with age and grade-appropriate components for 3rd, 4th and 5th graders and their families. The primary outcome is body mass index. PRIMARY OBJECTIVE: To significantly reduce body mass index, compared to controls, at the end of the three year intervention.

Detailed Description
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To develop and evaluate, in a randomized, controlled trial, a comprehensive obesity prevention program for third, fourth and fifth grade students. Late childhood and early adolescence appears to be an important period in the development of obesity. Physiologic changes associated with puberty may increase the risk of acquiring clinically significant obesity. Onset of obesity in early adolescence appears to be associated with increased risks of tracking of obesity into adulthood, obesity-associated morbidity and mortality in adulthood, and obesity-associated psychosocial morbidity. However, (1) we have a limited ability to accurately identify those children who will become obese adults and those who will suffer obesity-related morbidities, (2) most existing treatments for overweight children and adolescents have yielded modest, unsustained effects, and (3) single-component preventive interventions have been relatively ineffective. Acknowledging these observations, the consensus at the recent NHLBI Strategy Development Workshop for Public Education on Weight and Obesity was that population-based primary and secondary prevention efforts, targeting pre-adolescents, may hold the greatest promise for addressing the problem of obesity. Therefore, we propose an integrated, multiple-component, school and family-based, primary and secondary prevention program targeting third, fourth and fifth graders. Our proposed intervention model is derived directly from principles of Bandura's social cognitive theory. The intervention includes activities in THE SCHOOL, THE HOME, and a clinically oriented component for HIGH-RISK CHILDREN. In addition, the intervention will be delivered over a 3 year period, with age and grade-appropriate components for 3rd, 4th and 5th graders and their families. We will evaluate the efficacy of our comprehensive intervention in a cohort of third graders, in ethnically diverse elementary schools. Schools will be randomly assigned to the comprehensive intervention or an attention-placebo curriculum, to minimize the potential for compensatory rivalry or resentful demoralization. Assessments of children's height, weight, triceps skinfold thickness, waist and hip circumferences, food preferences, cardio-respiratory fitness, and self-reported behavior, attitudes, and knowledge will occur every 6 months, and 6-months following the end of the intervention. The primary outcome is body mass index. PRIMARY OBJECTIVE: To significantly reduce body mass index, compared to controls, at the end of the three year intervention.

Official Title
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School- and Family-Based Obesity Prevention for Children

Conditions
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Cardiovascular Diseases, Heart Diseases, Obesity

Intervention / Treatment
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* Behavioral: diet, physical activity, reduced sedentary behavior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all third graders in the participating elementary schools at baseline Exclusion Criteria: unable to complete the study procedures

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, physical activity, reduced sedentary behavior|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence/incidence of obesity |  |  | 
| prevalence of obesity among high risk children |  |  | 
| resting heart rate |  |  | 
| moderate to vigorous physical activity |  |  | 
| hours of television viewing |  |  | 
| fat intake |  |  | 
| preferences for low fat, high fiber foods |  |  | 
| weight concerns |  |  | 
| knowledge and attitudes |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity prevention, preadolescents, schools