Project Powerfood: Promoting Food Security, Equity, and Health

Obesity Clinical Trial

Official title:

Project Powerfood: Promoting Food Security, Equity, and Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246997
• Other study ID #: GCO 16-0031
• Status: Completed
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: March 29, 2019

Study information

• Verified date: July 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 29, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Other:
• Autumn Group
The intervention is participating in a fruit and vegetable farm share for 6 months.
• Spring Group
The intervention is participating in a fruit and vegetable farm share for 6 months.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Corbin Hill Food Project, New York Common Pantry, Wholesome Wave

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of farm shares picked-up	Number of farm shares picked-up	up to 12 months
Primary	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	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
Secondary	BMI	The child participant's body mass index	up to 12 months
Secondary	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
Secondary	Hemoglobin A1c level	The adult participant's glycemic control (as measured by hemoglobin A1c)	up to 12 months
Secondary	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
Secondary	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