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Weekly Family Food Packages: Food is Medicine

Primary Purpose

Food Insecurity, Overweight, Obesity

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Weekly Family Food Packages

Family Health Group Sessions

About this trial

This is an interventional treatment trial for Food Insecurity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

MGH Revere HealthCare Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Weekly Family Food Packages

Family Health Group Sessions

Arm Description

Outcomes

Primary Outcome Measures

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

Change in Food Insecurity Status at 3 months

Food insecurity status assessed by the Hunger Vital Signs questionnaire

Change in Diet Quality at 3 months

Diet quality assessed by an abbreviated food frequency questionnaire

Secondary Outcome Measures

Change in Binge Eating Symptoms at 3 months

Binge eating symptoms assessed by questionnaire

Change in Blood Pressure at 6 months

Blood pressure as reported in the electronic health record

Change in Sleep at 3 months

Sleep duration as reported by questionnaire

Change in Physical Activity at 3 months

Physical activity as reported by questionnaire

Change in Screen Time at 3 months

Screen time as reported by questionnaire

Full Information

NCT ID

NCT05640414

First Posted

November 23, 2022

Last Updated

October 20, 2023

Sponsor

Massachusetts General Hospital

Collaborators

American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05640414

Brief Title

Weekly Family Food Packages: Food is Medicine

Official Title

Healthy Families Clinic and Teaching Kitchen Program

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The specific aims and objectives of this proposal are to: Evaluate a food pantry's weekly food distribution impact on behavioral, social and health outcomes in families. 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: Weekly family food packages from the Revere Food Pantry 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Insecurity, Overweight, Obesity, Cardiometabolic Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Weekly Family Food Packages

Arm Type

Experimental

Arm Title

Family Health Group Sessions

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Weekly Family Food Packages

Intervention Description

Families receive weekly family food packages for 6 months

Intervention Type

Behavioral

Intervention Name(s)

Family Health Group Sessions

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in BMI at 6 months

Description

Weight in kg and height in meters will be combined to report BMI in kg/m^2, as reported in the electronic health record

Time Frame

0-6 months

Title

Change in Food Insecurity Status at 3 months

Description

Food insecurity status assessed by the Hunger Vital Signs questionnaire

Time Frame

0-3 months

Title

Change in Diet Quality at 3 months

Description

Diet quality assessed by an abbreviated food frequency questionnaire

Time Frame

0-3 months

Secondary Outcome Measure Information:

Title

Change in Binge Eating Symptoms at 3 months

Description

Binge eating symptoms assessed by questionnaire

Time Frame

0-3 months

Title

Change in Blood Pressure at 6 months

Description

Blood pressure as reported in the electronic health record

Time Frame

0-6 months

Title

Change in Sleep at 3 months

Description

Sleep duration as reported by questionnaire

Time Frame

0-3 months

Title

Change in Physical Activity at 3 months

Description

Physical activity as reported by questionnaire

Time Frame

0-3 months

Title

Change in Screen Time at 3 months

Description

Screen time as reported by questionnaire

Time Frame

0-3 months

Other Pre-specified Outcome Measures:

Title

Change in abnormal lipid lab values at 6 months

Description

Lab values as reported in the electronic health record

Time Frame

0-6 months

Title

Change in abnormal glucose lab value at 6 months

Description

Lab values as reported in the electronic health record

Time Frame

0-6 months

Title

Change in abnormal ALT/AST lab values at 6 months

Description

Lab values as reported in the electronic health record

Time Frame

0-6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

MGH Revere HealthCare Center

City

Revere

State/Province

Massachusetts

ZIP/Postal Code

02151

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Weekly Family Food Packages: Food is Medicine

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