Bringing Weight Management Into the Primary Care Pediatric Practice

Sponsor

Oregon Health and Science University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05950620

Collaborator

William H. Hurt Foundation (Other)

400

Enrollment

Locations

Anticipated Duration (Months)

200

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Childhood	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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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
Impact on glucose control [Baseline to follow-up (1-3 years)]
Hemoglobin A1c levels
Impact on fatty liver [Baseline to follow-up (1-3 years)]
Levels of liver enzymes ALT, AST
Impact on lipid levels [Baseline to follow-up (1-3 years)]
Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.

Secondary Outcome Measures

Patient follow-up metrics [Baseline to follow-up (1-3 years)]
Patient clinical follow-up rate, medication adherence, and retention

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 21 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Clinic	Portland	Oregon	United States	97225
2	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University
William H. Hurt Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan Purnell, Professor, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT05950620

Other Study ID Numbers:

IRB 24927

First Posted:

Jul 18, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of Jul 19, 2023