Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 2
- 主要终点
- Child adiposity
研究概览
简要总结
Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. This randomized trial will directly test whether delivering family-based behavioral interventions for pediatric overweight/obesity in the home setting improves weight loss outcomes in low-income children relative to medical center-based treatment. The trial will also quantify the cost-effectiveness of home visitation, and explore the mechanisms accounting for observed treatment effects
详细描述
The goal of this project is to systematically evaluate the incremental weight loss benefit and cost-effectiveness of delivering standard family-based treatment for pediatric overweight/obesity in the home setting vs. traditional medical settings. In a randomized controlled trial involving low-income households, 266 children ages 6-12 years will be allocated to 12 months of family-based treatment delivered either in their home or at an urban academic medical center. Both arms will receive the same intervention content and dosage, and differ only in the location of in-person treatment sessions. Aim 1 is to test the hypothesis that home-based treatment produces a greater reduction in child adiposity, reflected in 12-month change in BMI z-score. Aim 2 is to compare the cost-effectiveness of home-based treatment to medical center-based treatment, and calculate the added cost of the incremental weight loss benefit associated with home visitation. These data will inform efforts to disseminate home-based interventions for low-income populations by public health agencies and third-party payers. Aim 3 is to explore specific mechanisms through which home visitation may improve weight loss outcomes.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcomes assessors, PI, and some co-investigators will be blinded to group assignment.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Family includes at least one child who is 6 to 12 years old, and is overweight or obese (has a body mass index at or above the 85th percentile for age and sex)
- •Child's household has an income-to-poverty ratio ≤ 2.0
排除标准
- •Child or caregiver(s) are not fluent in English
- •Unwilling to attend and complete either home-based or clinic-based treatment, or to complete any aspect of the study assessment battery
- •Medical contraindication or barrier to weight loss treatment
- •Caregiver has a major medical or psychiatric condition likely to interfere with treatment
- •Plans to relocate outside the Chicago area in the next 12 months, or living in temporary or group housing with other families
- •Resides more than 15 miles from the Illinois Medical District (study site)
- •Conditions in or around the home that jeopardize staff/interventionist safety
结局指标
主要结局
Child adiposity
时间窗: 12 months
Change from baseline in child body mass index z-score (zBMI)
次要结局
- Cost-effectiveness(12 months)
- Clinically significant weight loss(12 months)