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临床试验/NCT00177229
NCT00177229已完成不适用

Family-Based Treatment of Severe Pediatric Obesity

University of Pittsburgh0 个研究点目标入组 192 人开始时间: 2001年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
192
主要终点
BMI and cardiovascular risk factors

研究概览

简要总结

The purpose of this study is to determine if a family based diet and exercise program is helpful for extremely overweight children aged 8-12, and to compare this approach to standard medical management of severe pediatric obesity.

详细描述

The prevalence of pediatric obesity has increased significantly, and approximately 11% of American children and adolescents are obese. Of particular concern, the greatest increase in prevalence has occured among the heaviest children. Severe pediatric obesity (defined as > 150% of ideal body weight for height) is associated with higher rates of medical and psychosocial morbidity than milder obesity is. Moreover, severely obese children are likelier than less severely obese children are to become obese adults and suffer the long-term health consequences of obesity. Although the efficacy of family-based behavioral weight control programs in the treatment of moderate pediatric obesity is well established, few studies have focused on the treatment of severe obesity. Thus in this application, we propose a randomized controlled trial to evaluate the efficacy of a family-based behavioral weight control program in the management of severe pediatric obesity.

Two hundred children aged 8-12 will be randomized to a six-month family-based program or usual care, and will complete assessments at pre- and post- treatment and 6-month and 12-month follow-ups. We hypothesized that: 1) Children who participate in the family-based program, when compared to children who receive usual care, will show favorable changes in body mass index, body composition, food intake, activity level, and cardiovascular risk factors. 2) Children who participate in the family-based program, when compared to children who receive usual care, will report higher levels of self-esteem, social competence and health-related quality of life, and report fewer psychiatric symptoms. A secondary aim of the the proposed investigation is to examine the relationships among gender, race, compliance to diet and exercise. level of parent adherence and treatment outcome. The proposed investigation is significant as the first effort to systematically evaluate a treatment program for severely obese children. It will provide data about a serious public health problem and establish a foundation for programmatic research to develop effective treatments for an underserved population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Be >150% of ideal body weight for height and age based on norms of the World Health Organization.
  • Have at least one parent or guardian who will participate in the treatment program with child.

排除标准

  • Mental retardation, pervasive developmental disorder or psychosis, psychiatric symptomatology sufficiently severe to require immediate treatment.
  • Genetic obesity syndrome as determined by the study physician.
  • Currently receiving obesity treatment and/or participating in a weight management program.
  • Inability to engage in moderate exercise defined as 30 minutes of vigorous activity on most days of the week.
  • Acute or severe medical conditions that require aggressive weight management intervention (e.g., diabetes pseudotumor cerebri, or hypoventilation).
  • Regular use of a medication that affects body weight such as oral steroids or antipsychotic medications.
  • Taking stimulant or antidepressant medication for a period < four months.

结局指标

主要结局

BMI and cardiovascular risk factors

时间窗: 0,6,12,18

次要结局

  • Eating, activity, and psychosocial functioning(0,6,12,18)

研究者

申办方类型
Other

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