Pediatric Healthy Weight Clinic

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to increase access to and adoption of the Healthy Weight Clinic package in primary care settings serving low income families in the United States who have a disproportionately high prevalence of childhood obesity. Two federally-qualified health centers in Mississippi and two health centers in Massachusetts will be implementing a Healthy Weight Clinic Program. The Healthy Weight Clinic is staffed by a medical provider, a Dietitian/Nutritionist, and a Community Healthy Worker. Patients attend individual medical visits (once per month for 12 months) with the multidisciplinary team, group visits led by a member of the team (once per month for 6 months), and phone follow-up between visits. All patients who receive care at the pilot implementation sites will be exposed to the systems-level intervention. A subset of patients will be invited to participate in a research evaluation of the program.

Official Title
-----------------
Healthy Weight Clinic: Packaging and Spreading Proven Pediatric Weight Management Interventions for Use by Low-Income Families, Childhood Obesity Research Demonstration Project (CORD) 3.0

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Behavioral: Healthy Weight Clinic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child is age 2 through 18 years at referral child's BMI meets or exceeds the 85th percentile for age and sex parent can read and respond to interviews and questionnaires in English or Spanish received care at one of the participating pilot sites Exclusion Criteria: children who do not have at least one parent who can report on their child's daily activities for 1 year families who plan to leave their pediatric health center in the next year children who have conditions or take medications that substantially interfere with growth, physical activity, or dietary recommendations

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Children receiving care at the implementation sites, and who are referred to and attend the Healthy Weight Clinic will receive the intervention as described. A sample of demographically matched children who did not receive the intervention will serve as a comparison group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinically Based: Healthy Weight Clinic<br> | Behavioral: Healthy Weight Clinic<br>* Patients meet with a multi-disciplinary team over a 12 month period. In addition to the clinical visits, group visits, and phone calls, patients will also receive education materials, community resources, and an optional text messaging/social media library of messages.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child BMI at 12 months | Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves. | 0-12 months | 
| Change in Child BMI percent of the 95th percentile at 12 months | Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves. | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire |  | 0-12 months | 
| Change in Child Binge Eating at 12 months based on Questionnaire |  | 0-12 months | 
| Change in Child Parental Stress at 12 months based on Questionnaire |  | 0-12 months | 
| Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire |  | 0-12 months | 
| Change in Child Nutrition at 12 months based on Questionnaire |  | 0-12 months | 
| Change in Child Physical Activity at 12 months based on Questionnaire |  | 0-12 months | 
| Change in Child Sleep at 12 months based on Questionnaire |  | 0-12 months | 
| Change in Child Screen Time at 12 months based on Questionnaire |  | 0-12 months |