Bringing Weight Management Into the Primary Care Pediatric Practice

Obesity, Childhood Clinical Trial

Official title:

Pilot and Feasibility Project to Establish a Childhood Nutrition and Health Clinic Managing Weight and Obesity Complications in a Primary Care Pediatric Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950620
• Other study ID #: IRB 24927
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: Oregon Health and Science University
• Contact: Jonathan Q Purnell, MD
• Phone: 503-494-1056
• Email: purnellj[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Gender: All
• Age group: 1 Month to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Other:
• Medical obesity management.
Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	The Children's Clinic	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	William H. Hurt Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Body weight in kg	Baseline to follow-up (1-3 years)
Primary	Change in body height	Body height in meters	Baseline to follow-up (1-3 years)
Primary	Change in BMI	BMI will be calculated using the formula: kg weight / m2 height. Will be in both absolute and percentile for age	Baseline to follow-up (1-3 years)
Primary	Impact on glucose control	Hemoglobin A1c levels	Baseline to follow-up (1-3 years)
Primary	Impact on fatty liver	Levels of liver enzymes ALT, AST	Baseline to follow-up (1-3 years)
Primary	Impact on lipid levels	Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.	Baseline to follow-up (1-3 years)
Secondary	Patient follow-up metrics	Patient clinical follow-up rate, medication adherence, and retention	Baseline to follow-up (1-3 years)