Obesity Prevention for Pre-Adolescents

September 12, 2005 updated by: Stanford University

School- and Family-Based Obesity Prevention for Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

900

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all third graders in the participating elementary schools at baseline

Exclusion Criteria:

  • unable to complete the study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
body mass index

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Thomas N. Robinson, MD, MPH, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Robinson TN, Killen JD. Obesity prevention for children and adolescents. In: Thompson, J.K., & Smolak, L. (Eds.) Body Image, Eating Disorders, and Obesity in Youth: Assessment, Prevention, and Treatment. Washington, DC: American Psychological Association, 2001, pp. 261-292.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Study Completion

March 1, 2001

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 16, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL054102 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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