Bringing Weight Management Into the Primary Care Pediatric Practice
- Conditions
- Obesity, Childhood
- Interventions
- Other: Medical obesity management.
- Registration Number
- NCT05950620
- Lead Sponsor
- Oregon Health and Science University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
Children with obesity (BMI > 30 kg/m2 or > 95th percentile) or in need of weight management of unwanted weight gain.
None.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention Medical obesity management. Pediatric patients with obesity or in need of weight management for unwanted weight gain.
- Primary Outcome Measures
Name Time Method Impact on fatty liver Baseline to follow-up (1-3 years) Levels of liver enzymes ALT, AST
Impact on glucose control Baseline to follow-up (1-3 years) Hemoglobin A1c levels
Impact on lipid levels Baseline to follow-up (1-3 years) Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.
Change in body weight Baseline to follow-up (1-3 years) Body weight in kg
Change in body height Baseline to follow-up (1-3 years) Body height in meters
Change in BMI 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 Outcome Measures
Name Time Method Patient follow-up metrics Baseline to follow-up (1-3 years) Patient clinical follow-up rate, medication adherence, and retention
Trial Locations
- Locations (2)
The Children's Clinic
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States