Weekly Family Food Packages: Food is Medicine

Study Overview
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Brief Summary
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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.

Official Title
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Healthy Families Clinic and Teaching Kitchen Program

Conditions
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Food Insecurity, Overweight, Obesity, Cardiometabolic Syndrome

Intervention / Treatment
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* Other: Weekly Family Food Packages
* Behavioral: Family Health Group Sessions


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly Family Food Packages<br> | Other: Weekly Family Food Packages<br>* Families receive weekly family food packages for 6 months<br>|
| Experimental: Family Health Group Sessions<br> | Other: Weekly Family Food Packages<br>* Families receive weekly family food packages for 6 months<br>Behavioral: Family Health Group Sessions<br>* Families with children aged 6-17 years attend 6 monthly group sessions with cooking demonstrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Binge Eating Symptoms at 3 months | Binge eating symptoms assessed by questionnaire | 0-3 months | 
| Change in Blood Pressure at 6 months | Blood pressure as reported in the electronic health record | 0-6 months | 
| Change in Sleep at 3 months | Sleep duration as reported by questionnaire | 0-3 months | 
| Change in Physical Activity at 3 months | Physical activity as reported by questionnaire | 0-3 months | 
| Change in Screen Time at 3 months | Screen time as reported by questionnaire | 0-3 months |