Pediatric Healthy Weight Clinic (CORD)

April 11, 2025 updated by: Lauren G. Fiechtner, M.D., Massachusetts General Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
191

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Child BMI at 12 months
Time Frame: 0-12 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
Time Frame: 0-12 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 z-score at 12 months
Time Frame: 0-12 months
Weight and height will be combined to report BMI z-score based on CDC growth curves
0-12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire
Time Frame: 0-12 months
0-12 months
Change in Child Binge Eating at 12 months based on Questionnaire
Time Frame: 0-12 months
0-12 months
Change in Child Parental Stress at 12 months based on Questionnaire
Time Frame: 0-12 months
0-12 months
Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire
Time Frame: 0-12 months
0-12 months
Change in Child Nutrition at 12 months based on Questionnaire
Time Frame: 0-12 months
0-12 months
Change in Child Physical Activity at 12 months based on Questionnaire
Time Frame: 0-12 months
0-12 months
Change in Child Sleep at 12 months based on Questionnaire
Time Frame: 0-12 months
0-12 months
Change in Child Screen Time at 12 months based on Questionnaire
Time Frame: 0-12 months
0-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention
American Academy of Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021P000258; 2023P003302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

  1. An analysis plan is prepared and approved by the PI/Co-Is,
  2. IRB approval has been obtained, and
  3. All necessary data sharing agreements have been executed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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