Healthy Families Clinic and Teaching Kitchen Program

ClinicalTrials.gov processed this data on October 20, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

ENROLLING BY INVITATION (See Contacts and Locations)
Verified October 2023 by Massachusetts General Hospital, American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation

Sponsor

Massachusetts General Hospital

Information Provided by (Responsible Party)

Lauren G. Fiechtner, M.D.

Clinicaltrials.gov Identifier

NCT05640414
Other Study ID Numbers: 2022P002892
First Submitted: November 23, 2022
First Posted: December 7, 2022
Last Update Posted: October 23, 2023
Last Verified: October 2023
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Food Insecurity
  • Overweight
  • Obesity
  • Cardiometabolic Syndrome
  • Other: Weekly Family Food Packages
  • Behavioral: Family Health Group Sessions

Study Design

Study TypeInterventional
Anticipated Enrollment125 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleHealthy Families Clinic and Teaching Kitchen Program
Study Start DateFebruary 1, 2023
Anticipated Primary Completion DateSeptember 30, 2024
Anticipated Study Completion DateSeptember 30, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Weekly Family Food Packages
  • Other: Weekly Family Food Packages
    • Families receive weekly family food packages for 6 months
  • Family Health Group Sessions
  • Other: Weekly Family Food Packages
    • Families receive weekly family food packages for 6 months
  • Behavioral: Family Health Group Sessions

    Outcome Measures

    Primary Outcome Measures

    1. Change in BMI at 6 months [0-6 months]
      Weight in kg and height in meters will be combined to report BMI in kg/m^2, as reported in the electronic health record
    2. Change in Food Insecurity Status at 3 months [0-3 months]
      Food insecurity status assessed by the Hunger Vital Signs questionnaire
    3. Change in Diet Quality at 3 months [0-3 months]
      Diet quality assessed by an abbreviated food frequency questionnaire

    Secondary Outcome Measures

    1. Change in Binge Eating Symptoms at 3 months [0-3 months]
      Binge eating symptoms assessed by questionnaire
    2. Change in Blood Pressure at 6 months [0-6 months]
      Blood pressure as reported in the electronic health record
    3. Change in Sleep at 3 months [0-3 months]
      Sleep duration as reported by questionnaire
    4. Change in Physical Activity at 3 months [0-3 months]
      Physical activity as reported by questionnaire
    5. Change in Screen Time at 3 months [0-3 months]
      Screen time as reported by questionnaire

    Eligibility Criteria

    Ages Eligible for Study (Child, Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • Referral to the food pantry
    • Additional inclusion criteria for Group Sessions:
    • Family has a child aged 6-17 years
    Exclusion Criteria
    • Not able to speak English or Spanish

    Contacts and Locations

    Sponsors and Collaborators Massachusetts General Hospital, American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation
    American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation
    Locations
    • MGH Revere HealthCare Center | Revere, Massachusetts, United States, 02151

    More Information

    Additional Relevant MeSH Terms

    • Overweight
    • Metabolic Syndrome
    • Overnutrition
    • Nutrition Disorders
    • Body Weight
    • Insulin Resistance
    • Hyperinsulinism
    • Glucose Metabolism Disorders
    • Metabolic Diseases