Bringing Weight Management Into the Primary Care Pediatric Practice

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Other: Medical obesity management.

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Jonathan Q Purnell, MD; Phone Number: 503-494-1056; Email: purnellj@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Active, not recruiting
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97225
      • Recruiting
      • The Children's Clinic
      • Contact: Susanne Purnell; Phone Number: 503-297-3371; Email: spurnell@childrens-clinic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients in a general pediatrician's office internally in Portland, Oregon.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; Pediatric patients with obesity or in need of weight management for unwanted weight gain.	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.
Controls; Historic controls matched to the Intervention group on age, sex, and BMI percentile.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Body weight in kg	Baseline to follow-up (1-3 years)
Change in body height	Body height in meters	Baseline to follow-up (1-3 years)
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)
Impact on glucose control	Hemoglobin A1c levels	Baseline to follow-up (1-3 years)
Impact on fatty liver	Levels of liver enzymes ALT, AST	Baseline to follow-up (1-3 years)
Impact on lipid levels	Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.	Baseline to follow-up (1-3 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient follow-up metrics	Patient clinical follow-up rate, medication adherence, and retention	Baseline to follow-up (1-3 years)

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: William H. Hurt Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: IRB 24927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study uses anonymized data. No IPD will be generated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No