Clinical trial NCT03246997: Project Powerfood: Promoting Food Security, Equity, and Health
Official title: Project Powerfood: Promoting Food Security, Equity, and Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Keywords: Food Insecure
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: New York Common Pantry
name: Corbin Hill Food Project
name: Wholesome Wave
First posted: 2017-08-11
Enrollment: 95
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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)


Eligibility criteria: 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)

Primary outcomes:
measure: Number of farm shares picked-up
timeFrame: up to 12 months
measure: Overall satisfaction score
timeFrame: up to 12 months
Secondary outcomes:
measure: Health Eating Index
timeFrame: up to 12 months
measure: BMI
timeFrame: up to 12 months
measure: USDA US Household Food Security Survey
timeFrame: up to 12 months
measure: Hemoglobin A1c level
timeFrame: up to 12 months
measure: The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale
timeFrame: up to 12 months
measure: Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky
timeFrame: up to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Victoria Mayer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: