Clinical & Community Approaches to Weight Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-09-30

Brief Summary

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This project seeks to build on innovative strategies to optimize the care of low-income children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement a new clinical-community intervention, theoretically grounded in the Integrated Clinical and Community Systems of Care Model, to address obesity through optimized screening and management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy Weight and Your Child weight management program (originally known as MEND). The study will examine outcomes for children that matter most to a broad group of stakeholders including parents, clinicians, and public health practitioners as well as inform the care of \>7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.

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Detailed Description

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This is a 2-arm RCT. Enrolled patients are randomized to a pediatric weight management intervention (PWMI): 1)a Healthy Weight Clinic based at a federally-qualified health center (FQHC), or 2) a modified Healthy Weight and Your Child intervention delivered in YMCAs. A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Children were randomized to either: 1) federally qualified health center-based Healthy Weight Clinic, or 2) YMCA community-based Healthy Weight and Your Child Program.

A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clinically Based: Healthy Weight Clinic

All families referred to the Healthy Weight Clinic intervention arm will be scheduled for a 30-45 minute orientation clinic visit to orient the child and family to the program. During this visit, the family will meet with the community health worker who will provide a schedule of clinic visits and dietitian contacts. The community health worker will assess the child's social and environmental context to allow treatment tailoring. For the first 6 months, each family will be asked to attend two clinic visits per month and complete weekly 20-30 minute contacts with the dietitian via telephone. The program aims to deliver approximately 30 contact hours in the 6-month period. This will be followed by monthly visits to the Healthy Weight Clinic and monthly calls with their dietitian.

Group Type EXPERIMENTAL

Healthy Weight Clinic

Intervention Type BEHAVIORAL

Community Based: Healthy Weight & Your Child

All families referred to the Healthy Weight and Your Child intervention arm will be scheduled for a 60-minute family information session to orient the child and family to the program. During this visit, the family will receive information about the program and logistics such as program schedule and format and attendance. The program is delivered over 12 months, which includes 16 weekly sessions, followed by 4 sessions delivered every other week and concluding with 5 monthly sessions. Most sessions are 2 hours in length and include a group of about 8-15 children and their caregivers. The first hour is delivered in a classroom setting and the second hour in an additional area conducive for physical activity.

Group Type EXPERIMENTAL

Healthy Weight and Your Child

Intervention Type BEHAVIORAL

Interventions

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Healthy Weight Clinic

Intervention Type BEHAVIORAL

Healthy Weight and Your Child

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* child is age 6.0 through 12.9 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 and Spanish

Exclusion Criteria

* children who do not have at least one parent who is able to follow study procedures for 1 year
* families who plan to leave their primary care health center within the study time frame
* families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties
* children who were taking medications that substantially interfere with growth
* children who have a sibling enrolled in the study.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No