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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05950620
Enrollment
400
Registered
2023-07-18
Start date
2022-07-01
Completion date
2026-06-30
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

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.

Interventions

OTHERMedical 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.

Sponsors

William H. Hurt Foundation
CollaboratorUNKNOWN
Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 21 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in BMIBaseline 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
Change in body weightBaseline to follow-up (1-3 years)Body weight in kg
Change in body heightBaseline to follow-up (1-3 years)Body height in meters
Impact on lipid levelsBaseline to follow-up (1-3 years)Levels of total, LDL, HDL, and non-HDL cholesterol. Triglycerides.
Impact on glucose controlBaseline to follow-up (1-3 years)Hemoglobin A1c levels
Impact on fatty liverBaseline to follow-up (1-3 years)Levels of liver enzymes ALT, AST

Secondary

MeasureTime frameDescription
Patient follow-up metricsBaseline to follow-up (1-3 years)Patient clinical follow-up rate, medication adherence, and retention

Countries

United States

Contacts

Primary ContactJonathan Q Purnell, MD
purnellj@ohsu.edu503-494-1056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026