Project Powerfood: Promoting Food Security, Equity, and Health

Study Overview
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Brief Summary
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Project Powerfood is a pilot program aimed at addressing food insecurity and food access in primary care through the implementation of a food prescription program in collaboration with a number of community partners. The objectives of this project are: Implement screening for food insecurity in adult and pediatric primary care practices at Mount Sinai. Provide fresh fruit and vegetable prescriptions to be redeemed for farm shares from local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a fruit and vegetable box. Participants will have the option to purchase 2 boxes per month for 6 months. Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese children who are food insecure and/or receive SNAP and/or WIC benefits. Examine/evaluate: Feasibility of program in a busy primary care practice Outcomes before and after the intervention (at baseline, 6 and 12 months), including diet, diabetes control, and body mass index (BMI) Outcomes in a comparison group (that will receive the food prescriptions beginning at 6 months)

Official Title
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Project Powerfood: Promoting Food Security, Equity, and Health

Conditions
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Diabetes, Obesity

Intervention / Treatment
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* Other: Autumn Group
* Other: Spring Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Food insecure and/or receive SNAP and/or WIC Adult patients: poorly-controlled diabetes (hemoglobin A1c greater than 8.0%) Pediatric patients: obesity, ages 5-11 Speak English or Spanish Exclusion Criteria: Food secure and do not receive SNAP or WIC Adult Patients: do not have diabetes Pediatric Patients: not obese, under 5 years old or between 11 and 18 Speak neither English or Spanish Severe kidney disease (Chronic Kidney Disease (CKD Stage IV or V)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are enrolled in the study and randomly assigned to the immediate intervention or the delayed intervention group. Participants in the immediate intervention group will receive the intervention for 6 months with a 6-month and 12-month follow-up starting from day one of enrollment. Participants in the delayed intervention group will receive the intervention beginning 6 months after enrollment with a 6-month and 12-month follow-up starting from day one of enrollment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Autumn Group<br>Intervention Group | Other: Autumn Group<br>* The intervention is participating in a fruit and vegetable farm share for 6 months.<br>* Other names: Fresh fruit and vegetable subsidy;|
| Other: Spring Group<br>Delayed Intervention | Other: Spring Group<br>* The intervention is participating in a fruit and vegetable farm share for 6 months.<br>* Other names: Fresh fruit and vegetable subsidy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of farm shares picked-up | Number of farm shares picked-up | up to 12 months | 
| Overall satisfaction score | overall satisfaction with the program measured by likelihood of recommending the program to a friend on a 4 point scale 1 = not likely at all, 2 = somewhat likely, 3 = likely 4 = very likely | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Eating Index | Diet quality, defined by the Health Eating Index which will be derived from the completion of 2 24-hour dietary recalls | up to 12 months | 
| BMI | The child participant's body mass index | up to 12 months | 
| USDA US Household Food Security Survey | Food Insecurity as measured by an 18-item Self reported concern about being able to afford food or have access to food at the end of a given month. Responses to the questions in the food security survey module are combined into a scale using non-linear statistical methods based on the Rasch measurement model. | up to 12 months | 
| Hemoglobin A1c level | The adult participant's glycemic control (as measured by hemoglobin A1c) | up to 12 months | 
| The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale | Diabetes Self Efficacy as measured by Self reported feelings on one's ability to control and manage their diabetes. 8-item survey, total range from 8 (not at all confident) to 80 (totally confident). | up to 12 months | 
| Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky | Cooking attitudes as measured by self reported attitudes about cooking and the use of the provided fresh fruits and vegetables to provide food to themselves and or their families. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecure