Behavioral Rx & Nutrition in Pediatric Chronic Disease (LAUNCH)
LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
The objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is:
H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 months post-treatment.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Ohio
-
Cincinnati、Ohio、美国、45229
- Cincinnati Children's Hospital Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- child age between 2- 5 years;
- child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
- medical clearance from pediatrician; and
- at least one parent with a BMI > 25. -
Exclusion Criteria:
- non-English speaking;
- living more than 50 miles from the medical center;
- a disability/illness that would preclude engagement in at least moderate physical activity;
- medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Clinic and Home Behavioral Intervention
|
A 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions.
Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity.
|
|
有源比较器：Pediatrician Counseling
|
A one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
BMI z score
大体时间：Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Parent weight loss
大体时间：baseline, 24 weeks, 48 weeks
|
baseline, 24 weeks, 48 weeks
|
|
Child caloric intake
大体时间：baseline, 6 months, 12 months
|
baseline, 6 months, 12 months
|
|
Home food and activity environment
大体时间：baseline, 6 months, 12 months
|
baseline, 6 months, 12 months
|
|
Child physical activity
大体时间：baseline, 6 motnhs, 12 months
|
baseline, 6 motnhs, 12 months
|
|
Parent-child mealtime interactions
大体时间：baseline, 6 months, 12 months
|
baseline, 6 months, 12 months
|
合作者和调查者
合作者
调查人员
- 首席研究员：Lori J Stark, Ph.D.、Children's Hospital Medical Center, Cincinnati
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.