Pilot and Feasibility Project to Establish a Childhood Nutrition and Health Clinic Managing Weight and Obesity Complications in a Primary Care Pediatric Practice
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Childhood
- Sponsor
- Oregon Health and Science University
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Change in body height
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jonathan Purnell
Professor
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- •Children with obesity (BMI \> 30 kg/m2 or \> 95th percentile) or in need of weight management of unwanted weight gain.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in body height
Time Frame: Baseline to follow-up (1-3 years)
Body height in meters
Impact on fatty liver
Time Frame: Baseline to follow-up (1-3 years)
Levels of liver enzymes ALT, AST
Impact on glucose control
Time Frame: Baseline to follow-up (1-3 years)
Hemoglobin A1c levels
Impact on lipid levels
Time Frame: Baseline to follow-up (1-3 years)
Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.
Change in body weight
Time Frame: Baseline to follow-up (1-3 years)
Body weight in kg
Change in BMI
Time Frame: 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
Secondary Outcomes
- Patient follow-up metrics(Baseline to follow-up (1-3 years))