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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COMPLETED
PHASE2
900 participants
INTERVENTIONAL
1998-04-30
2001-03-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Interventions
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diet, physical activity, reduced sedentary behavior
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
0 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Stanford University
OTHER
Principal Investigators
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Thomas N. Robinson, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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References
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