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Pediatric Healthy Weight Clinic (CORD)

Primary Purpose

Pediatric Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Weight Clinic
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clinically Based: Healthy Weight Clinic

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2021
Last Updated
October 20, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention, American Academy of Pediatrics
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1. Study Identification

Unique Protocol Identification Number
NCT05020314
Brief Title
Pediatric Healthy Weight Clinic
Acronym
CORD
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention, American Academy of Pediatrics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinically Based: Healthy Weight Clinic
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Healthy Weight Clinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Child BMI at 12 months
Description
Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.
Time Frame
0-12 months
Title
Change in Child BMI percent of the 95th percentile at 12 months
Description
Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire
Time Frame
0-12 months
Title
Change in Child Binge Eating at 12 months based on Questionnaire
Time Frame
0-12 months
Title
Change in Child Parental Stress at 12 months based on Questionnaire
Time Frame
0-12 months
Title
Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire
Time Frame
0-12 months
Title
Change in Child Nutrition at 12 months based on Questionnaire
Time Frame
0-12 months
Title
Change in Child Physical Activity at 12 months based on Questionnaire
Time Frame
0-12 months
Title
Change in Child Sleep at 12 months based on Questionnaire
Time Frame
0-12 months
Title
Change in Child Screen Time at 12 months based on Questionnaire
Time Frame
0-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, IRB approval has been obtained, and all necessary data sharing agreements have been executed.
IPD Sharing Time Frame
Data can be requested by emailing the PI or Project Manager.
IPD Sharing Access Criteria
An analysis plan is prepared and approved by the PI/Co-Is, IRB approval has been obtained, and All necessary data sharing agreements have been executed.
Citations:
PubMed Identifier
34569842
Citation
Fiechtner L, Sierra Velez D, Ayala SG, Castro I, Lindros J, Perkins M, Baker A, Salmon J, Biggs V, Cannon-Smith G, Smith JD, Simione M, Gortmaker SL, Taveras EM. Planned Evaluation of the Healthy Weight Clinic Pediatric Weight Management and Implementation: Massachusetts-CORD 3.0. Child Obes. 2021 Sep;17(S1):S55-S61. doi: 10.1089/chi.2021.0178.
Results Reference
background
PubMed Identifier
34569841
Citation
Fiechtner L, Castro I, Ayala SG, Velez DS, Lindros J, Perkins M, Baker A, Salmon J, Biggs V, Cannon-Smith G, Smith JD, Simione M, Gortmaker SL, Taveras EM. Design and Approach of the Healthy Weight Clinic Pediatric Weight Management Intervention Package and Implementation: Massachusetts-CORD 3.0. Child Obes. 2021 Sep;17(S1):S48-S54. doi: 10.1089/chi.2021.0177.
Results Reference
background

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Pediatric Healthy Weight Clinic

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