Weekly Family Food Packages: Food is Medicine

NCT05640414 | Completed

• 1 other identifier: 2022P002892
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims and objectives of this proposal are to:

1. 1.Evaluate a food pantry's weekly food distribution impact on behavioral, social and health outcomes in families.
2. 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:
3. 3.Weekly family food packages from the Revere Food Pantry
4. 4.6-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.

Conditions

Food Insecurity; Overweight; Obesity; Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in Binge Eating Symptoms at 3 months

  0-3 months

• Change in Blood Pressure at 6 months

  0-6 months

• Change in Sleep at 3 months

  0-3 months

• Change in Physical Activity at 3 months

  0-3 months

• Change in Screen Time at 3 months

  0-3 months

Study Arms (2)

Weekly Family Food Packages

EXPERIMENTAL

Other: Weekly Family Food Packages

Family Health Group Sessions

EXPERIMENTAL

Other: Weekly Family Food Packages; Behavioral: Family Health Group Sessions

Interventions

Weekly Family Food Packages OTHER

Families receive weekly family food packages for 6 months

Family Health Group Sessions; Weekly Family Food Packages

Family Health Group Sessions BEHAVIORAL

Families with children aged 6-17 years attend 6 monthly group sessions with cooking demonstrations

Family Health Group Sessions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Referral to the food pantry
• \- Family has a child aged 6-17 years

You may not qualify if:

• \- Not able to speak English or Spanish

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Academy of Pediatrics: collaborator
• Ardmore Foundation: collaborator
• Vitamix Foundation: collaborator

Study Sites (1)

MGH Revere HealthCare Center

Revere, Massachusetts, 02151, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 7, 2022
• Study Start: February 1, 2023
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data can be requested by emailing the PI or Project Manager.
• 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.

Locations

US (1)