跳至主要内容
临床试验/NCT00851201
NCT00851201已完成不适用

Comprehensive Approach to Family Weight Management

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2009年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
2
主要终点
BMI percentile for age and sex, biomarkers e.g, glucose, insulin, lipids

研究概览

简要总结

The purpose of this study is to address the Healthy People 2010 obesity prevention objective. This study will test the effects of a comprehensive family weight management program on the BMI z-score of 7-12 year-old children with a BMI > 85th percentile who receive primary care in a large municipal Bronx hospital. The intervention framework will draw on social marketing theory and the transtheoretical model of behavioral change to incorporate successful obesity prevention strategies. A two-arm randomized controlled clinical trial (RCT), which will enroll (n =506) 7-12 year old children with a > 85th BMI percentile, will compare the Experimental Intensive Intervention to a Standard (Control) Intervention. The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2)quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will add: 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) Tailored support using a "toolbox" approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) monthly after-core follow-up groups. The study will determine if children randomized to the Experimental Intensive Intervention will have greater improvement in BMI change (z-scores) than those randomized to the Control Standard Intervention. The study will also evaluate the effects on the Experimental Intervention on lifestyle variables and assess intervention costs. The RE-AIM evaluation will address: Reach: How many of the eligible children/ families were referred and how many of those referred actually enrolled? We will use BMI data in the computerized medical records to evaluate the proportion and the appropriateness of the referrals. Efficacy/Effectiveness: How did the Experimental intervention affect BMI (changes in z-score), and key biomarkers when followed as planned? Adoption: How acceptable were the intervention(s) to the primary care medical team and the children/families in the pediatric clinics etc? (from process measures and post intervention surveys) Implementation: How many of the intervention activities were provided as planned? Quality control measures will be used to evaluate the integrity of the intervention(s). Maintenance: How much of the intervention effect is sustainable? Individual effects will be evaluated based on the 24 month follow data. Institutional effects evaluation will include the potential to maintain services using third-party coverage.

研究设计

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

入排标准

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

入选标准

  • BMI greater than 85th percentile for sex, age 7-12 years

排除标准

  • health or condition that would interfere with study participation, unwilling or inability to provide parent/guardian consent or child ascent, intention to move from area

研究组 & 干预措施

Standard Intervention

Active Comparator

干预措施: Standard intervention (Behavioral)

Intensive lifestyle

Experimental

干预措施: Intensive lifestyle (Behavioral)

结局指标

主要结局

BMI percentile for age and sex, biomarkers e.g, glucose, insulin, lipids

时间窗: 12 months after randomization

次要结局

  • dietary intake, and physical activity measures(12 months after randomization)

研究者

研究点 (2)

Loading locations...

相似试验