Skip to content

Obesity Prevention for Pre-Adolescents

School- and Family-Based Obesity Prevention for Children

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00185978
Enrollment
900
Registered
2005-09-16
Start date
1998-04-30
Completion date
2001-03-31
Last updated
2005-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Obesity

Keywords

obesity prevention, preadolescents, schools

Brief summary

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

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.

Interventions

BEHAVIORALdiet, physical activity, reduced sedentary behavior

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* all third graders in the participating elementary schools at baseline

Exclusion criteria

* unable to complete the study procedures

Design outcomes

Primary

MeasureTime frame
body mass index

Secondary

MeasureTime frame
prevalence of obesity among high risk children
resting heart rate
moderate to vigorous physical activity
hours of television viewing
prevalence/incidence of obesity
preferences for low fat, high fiber foods
weight concerns
knowledge and attitudes
fat intake

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026