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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
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    January 8, 2016
    Sponsor
    Stanford University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    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
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    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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