School and Family-Based Obesity Prevention for Children
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Obesity
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005750
First Posted
May 25, 2000
Last Updated
January 8, 2016
Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005750
Brief Title
School and Family-Based Obesity Prevention for Children
Study Type
Observational
2. Study Status
Record Verification Date
July 2001
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To conduct an integrated, multiple-component, school- and community-based intervention targeting both primary and secondary prevention of obesity among third-fourth-and fifth-graders ("School- and Family-Based Obesity Prevention for Children").
Detailed Description
BACKGROUND:
An estimated 25-40 percent of United States pre-adolescents and adolescents are obese. Higher rates have been noted among minority youth. Onset of obesity in late childhood and early adolescence is associated with increased risks of "tracking" of obesity into adulthood, subsequent obesity-related morbidity and mortality, and obesity- related psychosocial morbidity. However, there is limited ability to accurately identify those children who will become obese adults and those who will suffer obesity-related morbidities, Existing treatments for child and adolescent obesity have yielded modest, unsustained effects, and single-component prevention interventions have been relatively ineffective.
DESIGN NARRATIVE:
The intervention model was derived from principles of Bandura's social cognitive theory, and included activities in the school, and the home, and a clinically oriented component for high-risk children. The school component included: a computer-based classroom curriculum; a physical education curriculum; and a school lunch intervention. The home component included correspondence materials and a videotape for parents. Children identified as "high risk" were eligible to enroll in an intensive intervention. In addition, several innovative approaches were included: interventions to influence food preferences and television viewing, interventions promoting health advocacy, and computer-assisted instruction.
An "efficacy trial" evaluated the three-year intervention in a cohort of approximately 1200 3rd graders, in 14 ethnically diverse elementary schools, with follow-up in the 6th grade. 7 schools were randomly assigned to the comprehensive intervention, and 7 schools received an attention-placebo classroom curriculum. Anthropometric measures and assessments of food preferences, cardio-respiratory fitness and self-reported behavior, attitudes and knowledge occurred every six months. Parent interviews occurred annually. Although a careful assessment of effects on parents and the schools was conducted, the crucial question was whether the overall intervention had an impact on student adiposity and behaviors.
The primary objective was to significantly reduce the prevalence of obesity, compared to controls, at the end of the three year intervention. Secondary objectives included maintenance of effects at 6-month follow-up, reducing obesity among high-risk children, improving cardio-respiratory fitness, increasing physical activity, decreasing sedentary activity, reducing the prevalence of unhealthful weight control methods, and improving knowledge, attitudes and perceived self-efficacy regarding the adoption of healthful behaviors. In addition, the investigators identified personal, behavioral and environmental (including family) factors prospectively associated with development of obesity, maintenance of normal weight, weight reduction among overweight children and obesity-related behaviors. Finally, they examined longitudinal changes in height, weight, body mass index (BMI), triceps skin fold thickness, and waist and hip circumferences in girls and boys 8 - 12 years of age, with respect to stages of pubertal development.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Obesity
7. Study Design
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
10546696
Citation
Robinson TN. Reducing children's television viewing to prevent obesity: a randomized controlled trial. JAMA. 1999 Oct 27;282(16):1561-7. doi: 10.1001/jama.282.16.1561.
Results Reference
background
PubMed Identifier
10340806
Citation
Robinson TN. Behavioural treatment of childhood and adolescent obesity. Int J Obes Relat Metab Disord. 1999 Mar;23 Suppl 2:S52-7. doi: 10.1038/sj.ijo.0800860.
Results Reference
background
PubMed Identifier
9544774
Citation
Robinson TN. Does television cause childhood obesity? JAMA. 1998 Mar 25;279(12):959-60. doi: 10.1001/jama.279.12.959. No abstract available.
Results Reference
background
PubMed Identifier
11437193
Citation
Robinson TN, Saphir MN, Kraemer HC, Varady A, Haydel KF. Effects of reducing television viewing on children's requests for toys: a randomized controlled trial. J Dev Behav Pediatr. 2001 Jun;22(3):179-84. doi: 10.1097/00004703-200106000-00005.
Results Reference
background
PubMed Identifier
11346672
Citation
Robinson TN, Kiernan M, Matheson DM, Haydel KF. Is parental control over children's eating associated with childhood obesity? Results from a population-based sample of third graders. Obes Res. 2001 May;9(5):306-12. doi: 10.1038/oby.2000.38.
Results Reference
background
PubMed Identifier
11177057
Citation
Robinson TN, Wilde ML, Navracruz LC, Haydel KF, Varady A. Effects of reducing children's television and video game use on aggressive behavior: a randomized controlled trial. Arch Pediatr Adolesc Med. 2001 Jan;155(1):17-23. doi: 10.1001/archpedi.155.1.17.
Results Reference
background
PubMed Identifier
11174614
Citation
Robinson TN, Chang JY, Haydel KF, Killen JD. Overweight concerns and body dissatisfaction among third-grade children: the impacts of ethnicity and socioeconomic status. J Pediatr. 2001 Feb;138(2):181-7. doi: 10.1067/mpd.2001.110526.
Results Reference
background
PubMed Identifier
11017963
Citation
Robinson TN. The epidemic of pediatric obesity. West J Med. 2000 Oct;173(4):220-1. doi: 10.1136/ewjm.173.4.220. No abstract available.
Results Reference
background
PubMed Identifier
10980798
Citation
Erickson SJ, Robinson TN, Haydel KF, Killen JD. Are overweight children unhappy?: Body mass index, depressive symptoms, and overweight concerns in elementary school children. Arch Pediatr Adolesc Med. 2000 Sep;154(9):931-5. doi: 10.1001/archpedi.154.9.931.
Results Reference
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School and Family-Based Obesity Prevention for Children
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