Obesity Clinical Trial
Official title:
Project Powerfood: Promoting Food Security, Equity, and Health
Verified date | July 2019 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
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) |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Corbin Hill Food Project, New York Common Pantry, Wholesome Wave |
United States,
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 |
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