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Project Powerfood: Promoting Food Security, Equity, and Health

This study is currently recruiting participants.
Verified August 2017 by Icahn School of Medicine at Mount Sinai
Sponsor:
ClinicalTrials.gov Identifier:
NCT03246997
First Posted: August 11, 2017
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
New York Common Pantry
Corbin Hill Food Project
Wholesome Wave
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  Purpose

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)

Condition Intervention
Diabetes Obesity Other: Autumn Group Other: Spring Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Project Powerfood: Promoting Food Security, Equity, and Health

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Number of farm shares picked-up [ Time Frame: up to 12 months ]
    Number of farm shares picked-up

  • Overall satisfaction score [ Time Frame: up to 12 months ]
    overall satisfaction with the program measured on a 5 point likert scale 1=very dissatisfied, 2=dissatisfied, 3=either satisfied or dissatisfied, 4= satisfied, or 5=very satisfied


Secondary Outcome Measures:
  • Health Eating Index [ Time Frame: up to 12 months ]
    Diet quality, defined by the Health Eating Index which will be derived from the completion of 2 24-hour dietary recalls

  • BMI [ Time Frame: up to 12 months ]
    The child participant's body mass index

  • USDA US Household Food Security Survey [ Time Frame: up to 12 months ]
    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.

  • Hemogloblin A1c level [ Time Frame: up to 12 months ]
    The adult participant's glycemic control (as measured by hemoglobin A1c)

  • The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale [ Time Frame: up to 12 months ]
    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).

  • Self Efficacy for Eating/Cooking Fruit and Vegetables by Condrasky [ Time Frame: up to 12 months ]
    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.


Estimated Enrollment: 100
Actual Study Start Date: June 21, 2017
Estimated Study Completion Date: June 21, 2018
Estimated Primary Completion Date: June 21, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Autumn Group
Intervention Group
Other: Autumn Group
The intervention is participating in a fruit and vegetable farm share for 6 months.
Other Name: Fresh fruit and vegetable subsidy
Spring Group
Delayed Intervention
Other: Spring Group
The intervention is participating in a fruit and vegetable farm share for 6 months.
Other Name: Fresh fruit and vegetable subsidy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246997


Contacts
Contact: Victoria Mayer, MD, MS 212-659-9194 victoria.mayer@moutsinai.org
Contact: Emily Hanlen, MPH, M.Ed. 212-659-9594 emily.hanlen@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Victoria Mayer, MD, MS    212-659-9194    victoria.mayer@mountsinai.org   
Principal Investigator: Victoria Mayer, MD, MS         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
New York Common Pantry
Corbin Hill Food Project
Wholesome Wave
Investigators
Principal Investigator: Victoria Mayer, MD, MS Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03246997     History of Changes
Other Study ID Numbers: GCO 16-0031
First Submitted: August 8, 2017
First Posted: August 11, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Food Insecure