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
1 other identifier
observational
400
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
CompletedJuly 19, 2023
July 1, 2023
4 years
July 11, 2023
July 17, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (1)
Patient follow-up metrics
Baseline to follow-up (1-3 years)
Study Arms (2)
Intervention
Pediatric patients with obesity or in need of weight management for unwanted weight gain.
Controls
Historic controls matched to the Intervention group on age, sex, and BMI percentile.
Interventions
Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management.
Eligibility Criteria
Patients in a general pediatrician's office internally in Portland, Oregon.
You may qualify if:
- Children with obesity (BMI \> 30 kg/m2 or \> 95th percentile) or in need of weight management of unwanted weight gain.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- William H. Hurt Foundationcollaborator
Study Sites (2)
The Children's Clinic
Portland, Oregon, 97225, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 11, 2023
First Posted
July 18, 2023
Study Start
July 1, 2022
Primary Completion
June 30, 2026
Study Completion
June 30, 2026
Last Updated
July 19, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
This study uses anonymized data. No IPD will be generated.