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Completed

NCT Number: NCT03246997

Project Powerfood: Promoting Food Security, Equity, and Health

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)

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Key information

Conditions

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

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Autumn Group

Other

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

Other names: Fresh fruit and vegetable subsidy

Spring Group

Other

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

Other names: Fresh fruit and vegetable subsidy

Primary outcomes

  1. Number of farm shares picked-up

    Time frame: up to 12 months

    Number of farm shares picked-up

  2. Overall satisfaction score

    Time frame: up to 12 months

    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

Secondary outcomes

  1. 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

  2. BMI

    Time frame: up to 12 months

    The child participant's body mass index

  3. 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.

  4. Hemoglobin A1c level

    Time frame: up to 12 months

    The adult participant's glycemic control (as measured by hemoglobin A1c)

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Corbin Hill Food Project
  • New York Common Pantry
  • Wholesome Wave

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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