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OpenTrials
Completed

NCT Number: NCT05640414

Weekly Family Food Packages: Food is Medicine

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.

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Key information

Conditions

Food Insecurity Body Weight Cardiometabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MGH Revere HealthCare Center

Revere, Massachusetts, 02151, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Weekly Family Food Packages

Other

Families receive weekly family food packages for 6 months

Family Health Group Sessions

Behavioral

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

Primary outcomes

  1. Change in BMI at 6 months

    Time frame: 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

    Time frame: 0-3 months

    Food insecurity status assessed by the Hunger Vital Signs questionnaire

  3. Change in Diet Quality at 3 months

    Time frame: 0-3 months

    Diet quality assessed by an abbreviated food frequency questionnaire

Secondary outcomes

  1. Change in Binge Eating Symptoms at 3 months

    Time frame: 0-3 months

    Binge eating symptoms assessed by questionnaire

  2. Change in Blood Pressure at 6 months

    Time frame: 0-6 months

    Blood pressure as reported in the electronic health record

  3. Change in Sleep at 3 months

    Time frame: 0-3 months

    Sleep duration as reported by questionnaire

  4. Change in Physical Activity at 3 months

    Time frame: 0-3 months

    Physical activity as reported by questionnaire

  5. Change in Screen Time at 3 months

    Time frame: 0-3 months

    Screen time as reported by questionnaire

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Academy of Pediatrics
  • Ardmore Foundation
  • Vitamix Foundation

Registry information

Official study title

Healthy Families Clinic and Teaching Kitchen Program

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 7, 2022
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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