Weekly Family Food Packages: Food is Medicine

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified March 2025 by Massachusetts General Hospital
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 22, 2022
First Posted
December 6, 2022
Last Update Posted
April 14, 2025
Last Verified
March 2025

ClinicalTrials.gov processed this data on April 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Food InsecurityOverweightObesityCardiometabolic Syndrome
Other: Weekly Family Food PackagesOther: Weekly Family Food Packages

Study Design

Study TypeInterventional
Actual Enrollment132 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleHealthy Families Clinic and Teaching Kitchen Program
Study Start DateJanuary 31, 2023
Actual Primary Completion DateMarch 2, 2025
Actual Study Completion DateMarch 2, 2025

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

Outcome Measures

Primary Outcome Measures
  1. Change in BMI at 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
    Food insecurity status assessed by the Hunger Vital Signs questionnaire
  3. Change in Diet Quality at 3 months
    Diet quality assessed by an abbreviated food frequency questionnaire
Secondary Outcome Measures
  1. Change in Binge Eating Symptoms at 3 months
    Binge eating symptoms assessed by questionnaire
  2. Change in Blood Pressure at 6 months
    Blood pressure as reported in the electronic health record
  3. Change in Sleep at 3 months
    Sleep duration as reported by questionnaire
  4. Change in Physical Activity at 3 months
    Physical activity as reported by questionnaire
  5. Change in Screen Time at 3 months
    Screen time as reported by questionnaire

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 CollaboratorsMassachusetts General Hospital
Locations
MGH Revere HealthCare Center | Revere Massachusetts, United States, 02151