Project Powerfood: Promoting Food Security, Equity, and Health

NCT03246997 | Completed

• 1 other identifier: GCO 16-0031
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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. 1.Implement screening for food insecurity in adult and pediatric primary care practices at Mount Sinai.
2. 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. 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:
4. 4.Feasibility of program in a busy primary care practice
5. 5.Outcomes before and after the intervention (at baseline, 6 and 12 months), including diet, diabetes control, and body mass index (BMI)
6. 6.Outcomes in a comparison group (that will receive the food prescriptions beginning at 6 months)

Conditions

Diabetes; Obesity

Keywords

Food Insecure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Health Eating Index

  up to 12 months

• BMI

  up to 12 months

• USDA US Household Food Security Survey

  up to 12 months

• Hemoglobin A1c level

  up to 12 months

• The Stanford Patient Education Research Center Diabetes Self-Efficacy Scale

  up to 12 months

Study Arms (2)

Autumn Group

OTHER

Intervention Group

Other: Autumn Group

Spring Group

OTHER

Delayed Intervention

Other: Spring Group

Interventions

Autumn Group OTHER

The intervention is participating in a fruit and vegetable farm share for 6 months.

Also known as: Fresh fruit and vegetable subsidy

Autumn Group

Spring Group OTHER

The intervention is participating in a fruit and vegetable farm share for 6 months.

Also known as: Fresh fruit and vegetable subsidy

Spring Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• New York Common Pantry: collaborator
• Corbin Hill Food Project: collaborator
• Wholesome Wave: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Victoria Mayer, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: June 21, 2017
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)