A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 6
- 主要终点
- Number of subjects enrolled versus number of subjects who meet min. participation criteria
研究概览
简要总结
The investigators propose a randomized controlled effectiveness trial to evaluate the integrated clinic-community model of child obesity treatment as compared with routine primary care.
详细描述
The purpose of this study is to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) affect children's health. The investigators will be looking at changes in child BMI, physical activity, nutrition, and overall health. The investigators also hope to better understand biological differences in metabolism and the microbiome (the bacteria that grows normally on and in the body) in children with high BMI who are making lifestyle changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child age 5-18 years
- •Child body mass index ≥ 95th %ile
- •Parent can speak and read in English or Spanish
- •Parent ownership of a device that is able to receive and send text messages
排除标准
- •Live farther than a 20-mile radius from the Healthy and Fit program site
- •Endogenous or genetic cause of obesity
- •Taking a medication that causes weight gain
- •Participation in a pediatric weight management program within 12 months
- •Parent or child significant health problem that would limit participation
- •Enrollment is above the max weekly enrollment of 60 participants/week)
- •Reported or planned pregnancy
- •Opt-out Criteria
- •Primary care physician opts patient out of study for reasons including: severe obesity, urgent co-morbidities, parental unwillingness to be contacted by a research assistant, or at physician clinical judgment.
结局指标
主要结局
Number of subjects enrolled versus number of subjects who meet min. participation criteria
时间窗: 12 months
As measured by enrollment logs
Change in z-BMI
时间窗: Baseline, 6 months
Change in molecular pathways dysregulated in pediatric obesity
时间窗: Baseline, 6 months
Stool and blood samples
Physical activity
时间窗: Up to 12 months
child physical activity; objectively tracked with fitness tracker
Change in child fitness
时间窗: baseline, 3 months, 12 months
3 minute bench stepping test
Change in Child Quality of Life
时间窗: baseline, 3 months, 12 months
Composite score of Sizing Me Up Questionnaires
Change in Body Appreciation
时间窗: baseline, 3 months, 12 months
Body appreciation scale 13-item questionnaire (1. Never, 2. Seldom, 3. Sometimes, 4. Often, 5. Always)
Change in heart rate
时间窗: baseline, 12 months
Change in FLASHE Food and Activity Screener Scores
时间窗: Baseline, 6 months, 12 months
Questionnaire about child and parent nutrition and activity habits
Change in fasting lipid profile
时间窗: Baseline, 6 months, 12 months
Change in fasting glucose
时间窗: Baseline, 6 months, 12 months
Change in alanine aminotransferase (A1)
时间窗: Baseline, 6 months, 12 months
Change in child quality of life (2)
时间窗: baseline, 3 months, 12 months
PROMIS Questionnaire (not composite score)
次要结局
未报告次要终点