Project Powerfood: Promoting Food Security, Equity, and Health

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:

1. Implement screening for food insecurity in adult and pediatric primary care practices at Mount Sinai.
2. 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.

3. 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:

   1. Feasibility of program in a busy primary care practice
   2. Outcomes before and after the intervention (at baseline, 6 and 12 months), including diet, diabetes control, and body mass index (BMI)
   3. Outcomes in a comparison group (that will receive the food prescriptions beginning at 6 months)

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Other: Autumn Group; Other: Spring Group

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Autumn Group; Intervention Group	Other: Autumn Group; The intervention is participating in a fruit and vegetable farm share for 6 months.; Other Names: Fresh fruit and vegetable subsidy
Other: Spring Group; Delayed Intervention	Other: Spring Group; The intervention is participating in a fruit and vegetable farm share for 6 months.; Other Names: Fresh fruit and vegetable subsidy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: New York Common Pantry; Corbin Hill Food Project; Wholesome Wave
• Investigators: Principal Investigator: Victoria Mayer, MD, MS, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): March 29, 2019

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Food Insecure
• Other Study ID Numbers: GCO 16-0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No