Weekly Family Food Packages: Food is Medicine

Obesity Clinical Trial

Official title:

Healthy Families Clinic and Teaching Kitchen Program

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05640414
• Other study ID #: 2022P002892
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 125
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Food Insecurity
• Metabolic Syndrome
• Obesity
• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	MGH Revere HealthCare Center	Revere	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in abnormal lipid lab values at 6 months	Lab values as reported in the electronic health record	0-6 months
Other	Change in abnormal glucose lab value at 6 months	Lab values as reported in the electronic health record	0-6 months
Other	Change in abnormal ALT/AST lab values at 6 months	Lab values as reported in the electronic health record	0-6 months
Primary	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
Primary	Change in Food Insecurity Status at 3 months	Food insecurity status assessed by the Hunger Vital Signs questionnaire	0-3 months
Primary	Change in Diet Quality at 3 months	Diet quality assessed by an abbreviated food frequency questionnaire	0-3 months
Secondary	Change in Binge Eating Symptoms at 3 months	Binge eating symptoms assessed by questionnaire	0-3 months
Secondary	Change in Blood Pressure at 6 months	Blood pressure as reported in the electronic health record	0-6 months
Secondary	Change in Sleep at 3 months	Sleep duration as reported by questionnaire	0-3 months
Secondary	Change in Physical Activity at 3 months	Physical activity as reported by questionnaire	0-3 months
Secondary	Change in Screen Time at 3 months	Screen time as reported by questionnaire	0-3 months