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Completed

NCT Number: NCT05020314

Pediatric Healthy Weight Clinic

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Weight Clinic

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire

    Time frame: 0-12 months

  2. Change in Child Binge Eating at 12 months based on Questionnaire

    Time frame: 0-12 months

  3. Change in Child Parental Stress at 12 months based on Questionnaire

    Time frame: 0-12 months

  4. Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire

    Time frame: 0-12 months

  5. Change in Child Nutrition at 12 months based on Questionnaire

    Time frame: 0-12 months

  6. Change in Child Physical Activity at 12 months based on Questionnaire

    Time frame: 0-12 months

  7. Change in Child Sleep at 12 months based on Questionnaire

    Time frame: 0-12 months

  8. Change in Child Screen Time at 12 months based on Questionnaire

    Time frame: 0-12 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Academy of Pediatrics
  • Centers for Disease Control and Prevention

Registry information

Official study 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

Acronym: CORD

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2021
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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