Bringing Weight Management Into the Primary Care Pediatric Practice

Recruiting

• 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.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-19
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Children with obesity (BMI > 30 kg/m2 or > 95th percentile) or in need of weight management of unwanted weight gain.

Exclusion Criteria

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