Vidas Activas, famiLias saludablEs (Active Lives, Healthy Families) (VALÉ)
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Change from Baseline Blood Pressure at 3 months and 6 months
研究概览
简要总结
This proposal aims to test the initial feasibility and efficacy of a 10-week multidisciplinary pediatric weight management program among low-income Latino children, aged 5 to 11 years, from the Woodbridge, VA area. The following specific aims will be tested:
详细描述
Specific Aim 1: To test the acceptability of a multidisciplinary group intervention targeted towards low-income Latino families with a child who is obese.
Specific Aim 2: To test the effectiveness of the intervention by determining differences in behavioral changes (i.e. nutrition and physical activity habits), anthropometric (BMI-for-age, body fat) and clinical health outcomes (i.e. blood pressure, blood biomarkers) between children exposed to the intervention program vs. control children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pre-pubertal (girls must not have started menses)
- •Of Latino/Hispanic descent (parent self-identified)
- •BMI for age >85th percentile (based on CDC growth reference)
- •Child between 5-11 years old
- •Healthy (no known chronic diseases or regular medication)
- •Parent/adult caregivers willing to participate in all study visits
排除标准
- •Not of Latino/Hispanic descent
- •<5 years old or >11 years old
- •BMI for age <85th percentile
- •Not pre-pubertal (girls have experienced their first menses)
- •Child has learning deficits or acute/chronic medical condition
- •Parent/guardian has no transportation or unable to participate in sessions
结局指标
主要结局
Change from Baseline Blood Pressure at 3 months and 6 months
时间窗: Baseline, 3 and 6 months
Systolic \& Diastolic Blood Pressure
Change from Baseline BMI at 3 months and 6 months
时间窗: Baseline, 3 and 6 months
body weight (kg)/height(m\^2)
Change from Baseline HbA1c at 3 months and 6 months
时间窗: Baseline, 3 and 6 months
HbA1c (%)
Change from Baseline Body Fat Percentage at 3 months and 6 months
时间窗: Baseline, 3 and 6 months
% via bioelectric impedance
Change from Baseline Blood Lipids at 3 months and 6 months
时间窗: Baseline, 3 and 6 months
LDL, HDL, TRG, TC (mg/dL)
Change from Baseline Waist Circumference at 3 months and 6 months
时间窗: Baseline, 3 and 6 months
cm
Change from Baseline Glucose at 3 months and 6 months
时间窗: Baseline, 3 and 6 months
Glucose (mg/dL)
次要结局
未报告次要终点