Skip to main content
OpenTrials
Completed

NCT Number: NCT04205617

Living Hungry Healthy Foods Prescription Program

This study is a pre/post, pilot evaluation of the 4-month, Living Hungry program for food-insecure patients with uncontrolled diabetes. The program provides free produce, whole grains and legumes to participants and their household every-other week, in addition, to nutrition education and glucose monitoring devices. The study is analyzing diabetes management indicators, including HbA1c, dietary quality, food insecurity, and medication adherence, plus health care utilization.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Living Hungry

West Palm Beach, Florida, 33401, United States

About this study

The Living Hungry Collaborative, in partnership with the South Florida Hunger Coalition, previously operated a pilot program, Fresh Food Farmacy, staged from June 1, 2018, to September 29, 2018. The program consisted of nine Eat Well Pop-Up Pantry events at the My Clinic in Jupiter, Florida, serving 104 patients and feeding approximately 300 people including their families. Each set of groceries contained two weeks' worth of "medically tailored" groceries for diabetic-friendly meals for food-insecure patients diagnosed with diabetes or prediabetes. All clients involved in the intervention were referred by staff at the same four clinics that will participate in this study: My Clinic, C.L. Brumback Clinic in Jupiter, Jupiter Medical Center, and FoundCare. The Living Hungry Collaborative has an ongoing program to further evolve and test the "Fresh Food Farmacy", renamed as the Healthy Food Prescription Program intervention in Palm Beach County, for food-insecure, diabetic patients.

In addition to receiving diabetic appropriate groceries at the former Fresh Food Farmacy events, clients will be engaged in diabetes education classes led by volunteer doctors and nurses, cooking demonstrations, shared meals, 1:1 and group coaching by nutritionists and dietitians on best choices from a menu for diabetics, and tasting new recipes with produce from the pop-up event. The pilot program allowed Living Hungry to fine-tune the patient referral process, distribution logistics, and establish strong partnerships required for the next phase of the program. However, gaps exist to understand the extent to which the program design is improving the health of the participating diabetic patients.

Living Hungry will partner with Tufts University to conduct an evaluation of this existing program on key health outcomes that concern the partner clinics, specifically: biomarkers including Hemoglobin A1C, BMI, blood pressure, lipid profile, health care utilization including medication use, hospitalizations, emergency department visits, and health care costs, plus dietary quality, food insecurity, medication use, and quality of life indicators. The study is a pilot evaluation, implementing a quasi-experimental, pre/post study design.

The Living Hungry Healthy Foods Prescription Program is a community-based program that will be available to individuals whether or not they participate in the evaluation by Tufts University. This program is using the same referral and data collections procedures as the pilot, which include having physicians at the partner clinics refer patients with HbA1C levels greater than 8.0 mmol/mol and who are food insecure to Living Hungry to participate in the program. In addition, Living Hungry will again collect data on HbA1c, BMI, blood pressure, lipid profiles, and distribute a survey to participants.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Referred patient from one of four medical partners: My Clinic, C.L. Brumback Clinic, FoundCare and Jupiter Medical Center and has been a patient for at least one-year.
  • Diabetic with A1C over 8.0
  • Adults 18 years of age or older
  • Food-insecure

Exclusion criteria

  • Referred patients with HbA1c levels below 8.0 mmol/mol
  • Minors
  • Adults with severe mental illness who cannot provide informed consent, unless they have present a lawful caregiver or power of attorney.
  • Anyone who does not plan on staying in West Palm Beach for the next 4 months.
  • Pregnant women (can still receive services through the program but will not be included in the analysis)

Treatment and study plan

produce prescription and nutrition education

Other

Participants will receive diabetic appropriate groceries, diabetes education classes led by volunteer doctors and nurses, cooking demonstrations, shared meals, 1:1 and group coaching by dietitians.

Other names: medically tailored food

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: pre/post change in HbA1c in participants from baseline to completion of the program at 4 months

    will be measured by blood draws at first and last program event

Secondary outcomes

  1. Change in frequency of hospitalizations

    Time frame: pre/post change in hospitalizations in participants from baseline to one month after completion of the program

    will be measured through surveys and data from electronic medical records

  2. Change in frequency of emergency department admissions

    Time frame: pre/post change in emergency department admissions in participants from baseline to one month after completion of the program

    will be measured through surveys and data from electronic medical records

  3. Change in total health care costs

    Time frame: pre/post change in total health care costs in participants from baseline to one month after completion of the program

    will be measured through data from hospital records

  4. Change in food insecurity

    Time frame: pre/post change in food insecurity in participants from baseline to completion of the program at 4 months

    Food insecurity will be measured using the USDA 9-question food insecurity screener

  5. Change in daily servings of fruits and vegetables

    Time frame: pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months

    Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool

  6. Change in daily servings of whole grains

    Time frame: pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months

    Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool

  7. Change in daily servings of lean proteins

    Time frame: pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months

    Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool and includes: nuts, seeds, legumes, poultry, and fish.

  8. Change in daily servings of sugary snacks and drinks

    Time frame: pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months

    Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool and includes: sugar sweetened beverages, pastries, cookies, cakes, candy, and other sweets

  9. Change in medication adherence

    Time frame: pre/post change in medication adherence in participants from baseline to completion of the program at 4 months

    Measured as a composite score that will be assessed through a survey. Components include: frequency of sacrificing medication purchases for other household needs (such as food, utilities) and change in medication use.

  10. Change in adhering to recommended diabetes management plan

    Time frame: pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months

    Measured as a composite scale that will be assessed through a survey. Components include frequency in which participants followed the recommendations of their physicians to manage their diabetes.

  11. Change in blood LDL level

    Time frame: pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months

    measured at first and last program event through a blood draw

  12. Change in systolic blood pressure

    Time frame: pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months

    measured at first and last program event

  13. Change in diastolic blood pressure

    Time frame: pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months

    measured at first and last program event

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • FoundCare Inc.
  • Health Care District of Palm Beach County
  • Jupiter Medical Center
  • Living Hungry, Inc.
  • MyClinic, Inc
  • South Florida Hunger Coalition

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2019
Registry last updated
Oct 28, 2020

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.

Published trials that share one or more normalized conditions with this study.