CORD: Pediatric Healthy Weight Clinic

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05020314

Collaborator

Centers for Disease Control and Prevention (U.S. Fed), American Academy of Pediatrics (Other)

200

Enrollment

Location

Arm

22.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity	Behavioral: Healthy Weight Clinic	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Children receiving care at the two 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.Children receiving care at the two 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)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 7, 2021

Anticipated Primary Completion Date :

Aug 15, 2023

Anticipated Study Completion Date :

Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clinically Based: Healthy Weight Clinic	Behavioral: Healthy Weight Clinic 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.

Arm

Intervention/Treatment

Experimental: Clinically Based: Healthy Weight Clinic

Behavioral: Healthy Weight Clinic

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital
Centers for Disease Control and Prevention
American Academy of Pediatrics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lauren G. Fiechtner, M.D., Director of Nutrition, Division of Gastroenterology and Pediatric Health Outcomes Research, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05020314

Other Study ID Numbers:

2021P000258

First Posted:

Aug 25, 2021

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of Jul 19, 2022