Pilot and Feasibility Project to Establish a Childhood Nutrition and Health Clinic Managing Weight and Obesity Complications in a Primary Care Pediatric Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in body height
研究概览
简要总结
This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.
详细描述
The goal of this project is to create a sustainable clinical model in the primary care setting that improves nutritional health, lessens obesity, and addresses weight-related complications of children and adolescents to reduce risk for metabolic disease in later life. The primary objectives include tracking changes in BMI (both absolute and percentile) and levels of hemoglobin A1c, liver enzymes (AST, ALT levels), and lipids in patients seen in a primary care setting by a general pediatrician board-certified in obesity medicine. Secondary objectives include tracking patient adherence, follow-up, and retention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with obesity (BMI > 30 kg/m2 or > 95th percentile) or in need of weight management of unwanted weight gain.
排除标准
- 未提供
结局指标
主要结局
Change in body height
时间窗: Baseline to follow-up (1-3 years)
Body height in meters
Impact on fatty liver
时间窗: Baseline to follow-up (1-3 years)
Levels of liver enzymes ALT, AST
Impact on glucose control
时间窗: Baseline to follow-up (1-3 years)
Hemoglobin A1c levels
Impact on lipid levels
时间窗: Baseline to follow-up (1-3 years)
Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.
Change in body weight
时间窗: Baseline to follow-up (1-3 years)
Body weight in kg
Change in BMI
时间窗: Baseline to follow-up (1-3 years)
BMI will be calculated using the formula: kg weight / m2 height. Will be in both absolute and percentile for age
次要结局
- Patient follow-up metrics(Baseline to follow-up (1-3 years))
研究者
Jonathan Purnell
Professor
Oregon Health and Science University