Weekly Family Food Packages: Food is Medicine

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05640414
• Collaborator: American Academy of Pediatrics (Other), Ardmore Foundation (Other), Vitamix Foundation (Other)
• Enrollment: 125
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief Summary

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 50 families.

2. In a subset of 25 families with a child aged 6-17 years with overweight or obesity, test a pilot intervention offering the following components, with a goal of improving family behavioral, social and health outcomes:

3. Weekly family food packages from the Revere Food Pantry

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.

Condition or Disease	Intervention/Treatment	Phase
Food Insecurity; Overweight; Obesity; Cardiometabolic Syndrome	Other: Weekly Family Food Packages; Behavioral: Family Health Group Sessions	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Healthy Families Clinic and Teaching Kitchen Program
• Anticipated Study Start Date: Dec 15, 2022
• Anticipated Primary Completion Date: Dec 15, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

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 who have overweight or obesity attend 6 monthly group sessions with cooking demonstrations

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

Other Outcome Measures

1. Change in abnormal lipid lab values at 6 months [0-6 months]

   Lab values as reported in the electronic health record

2. Change in abnormal glucose lab value at 6 months [0-6 months]

   Lab values as reported in the electronic health record

3. Change in abnormal ALT/AST lab values at 6 months [0-6 months]

   Lab values as reported in the electronic health record

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

• Parent reports the child has had a diagnosis of overweight or obesity

Exclusion Criteria:

• Not able to speak English or Spanish

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Massachusetts General Hospital
• American Academy of Pediatrics
• Ardmore Foundation
• Vitamix Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lauren G. Fiechtner, M.D., Assistant Professor, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05640414
• Other Study ID Numbers: 2022P002892
• First Posted: Dec 7, 2022
• Last Update Posted: Dec 7, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Syndrome; Overweight

Study Results

No Results Posted as of Dec 7, 2022