Bringing Weight Management Into the Primary Care Pediatric Practice

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Other: Medical obesity management.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Pediatric patients with obesity or in need of weight management for unwanted weight gain. | Other: Medical obesity management.<br>* Dietician visits, education, anti-obesity medications, and/or referral for metabolic-bariatric surgery as indicated by American Academy of Pediatrics guidelines for obesity management.<br>|
| Controls<br>Historic controls matched to the Intervention group on age, sex, and BMI percentile. | |

What is the study measuring?
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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) |