NCT01018121已完成1 期
LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- BMI z score
研究概览
简要总结
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
- •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 >
排除标准
- •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.
结局指标
主要结局
BMI z score
时间窗: Baseline, 6 months, 12 months
次要结局
- Parent weight loss(baseline, 24 weeks, 48 weeks)
- Child caloric intake(baseline, 6 months, 12 months)
- Home food and activity environment(baseline, 6 months, 12 months)
- Child physical activity(baseline, 6 motnhs, 12 months)
- Parent-child mealtime interactions(baseline, 6 months, 12 months)
研究者
研究点 (2)
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