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Obesity Prevention for Pre-Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185978
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Stanford University
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases Heart Diseases Obesity Behavioral: diet, physical activity, reduced sedentary behavior Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: School- and Family-Based Obesity Prevention for Children

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • body mass index

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 900
Study Start Date: April 1998
Estimated Study Completion Date: March 2001
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all third graders in the participating elementary schools at baseline

Exclusion Criteria:

  • unable to complete the study procedures
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185978


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Thomas N. Robinson, MD, MPH Stanford University
  More Information

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.

ClinicalTrials.gov Identifier: NCT00185978     History of Changes
Other Study ID Numbers: R01HL054102 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Stanford University:
obesity prevention
preadolescents
schools

Additional relevant MeSH terms:
Obesity
Cardiovascular Diseases
Heart Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms