Weekly Family Food Packages: Food is Medicine

Healthy Families Clinic and Teaching Kitchen Program

The specific aims and objectives of this proposal are to:

1. Evaluate a food pantry's weekly food distribution impact on behavioral, social and health outcomes in families.

2. In a subset of families with a child aged 6-17 years, test a pilot intervention offering the following components, with a goal of improving family behavioral, social and health outcomes:

   1. Weekly family food packages from the Revere Food Pantry
   2. 6-Monthly group sessions that include information on healthy behaviors, chronic disease management and teaching families how to prepare simple recipes based on the food they receive that week from the food pantry.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Food Insecurity; Cardiometabolic Syndrome
• Intervention / Treatment: Other: Weekly Family Food Packages; Behavioral: Family Health Group Sessions

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Revere, Massachusetts, United States, 02151
      • MGH Revere HealthCare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekly Family Food Packages	Other: Weekly Family Food Packages; Families receive weekly family food packages for 6 months
Experimental: Family Health Group Sessions	Other: Weekly Family Food Packages; Families receive weekly family food packages for 6 months; Behavioral: Family Health Group Sessions; Families with children aged 6-17 years attend 6 monthly group sessions with cooking demonstrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-6 months
Change in Food Insecurity Status at 3 months	Food insecurity status assessed by the Hunger Vital Signs questionnaire	0-3 months
Change in Diet Quality at 3 months	Diet quality assessed by an abbreviated food frequency questionnaire	0-3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Binge Eating Symptoms at 3 months	Binge eating symptoms assessed by questionnaire	0-3 months
Change in Blood Pressure at 6 months	Blood pressure as reported in the electronic health record	0-6 months
Change in Sleep at 3 months	Sleep duration as reported by questionnaire	0-3 months
Change in Physical Activity at 3 months	Physical activity as reported by questionnaire	0-3 months
Change in Screen Time at 3 months	Screen time as reported by questionnaire	0-3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in abnormal lipid lab values at 6 months	Lab values as reported in the electronic health record	0-6 months
Change in abnormal glucose lab value at 6 months	Lab values as reported in the electronic health record	0-6 months
Change in abnormal ALT/AST lab values at 6 months	Lab values as reported in the electronic health record	0-6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Vitamix Foundation; American Academy of Pediatrics; Ardmore Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): March 3, 2025
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 3, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Overweight; Metabolic Syndrome
• Other Study ID Numbers: 2022P002892

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: 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 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