LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in BMI z score
研究概览
简要总结
The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.
H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 years 0 months to 5 years 11 months of age
- •at or above the 95th percentile BMI for age and sex
- •have at least one parent with a BMI at or greater than 25
- •medical clearance from pediatrician
排除标准
- •non-English speaking
- •living greater than 50 miles from medical center
- •a disability or illness that would preclude engagement in moderate activity
- •medical condition/medication associated with weight
- •enrolled in another weight management program
研究组 & 干预措施
Clinic Only Behavioral Intervention
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
干预措施: Clinic Only Behavioral Intervention (Behavioral)
Pediatrician Counseling
A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.
干预措施: Pediatrician Counseling (Other)
Clinic + Home Behavioral Intervention
A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.
干预措施: Clinic + Home Behavioral Intervention (Behavioral)
结局指标
主要结局
Change in BMI z score
时间窗: Change from Baseline to 6 months
Body mass index z score
次要结局
- Change in Parent weight loss(Change from baseline to 6 months)
- Change in Child caloric intake(Change from baseline to 6 months)
- Change in Home food and activity environment(Change from baseline to 6 months)
- Change in Child physical activity(Change from baseline to 6 months)
- Change in Parent-child mealtime interactions(Change from baseline to 6 months)
- Change in Health related quality of life(Change from baseline to 6 months)