Living Hungry Healthy Foods Prescription Program

Diabetes Mellitus Clinical Trial

Official title:

Living Hungry Healthy Foods Prescription Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205617
• Other study ID #: 13491
• Status: Completed
• Phase: N/A
• Start date: December 14, 2019
• Est. completion date: October 13, 2020

Study information

• Verified date: October 2020
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 13, 2020
• Est. primary completion date: July 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Diabetic with A1C over 8.0

3. Adults 18 years of age or older

4. Food-insecure

Exclusion Criteria:

1. Referred patients with HbA1c levels below 8.0 mmol/mol

2. Minors

3. Adults with severe mental illness who cannot provide informed consent, unless they have present a lawful caregiver or power of attorney.

4. Anyone who does not plan on staying in West Palm Beach for the next 4 months.

5. Pregnant women (can still receive services through the program but will not be included in the analysis)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• produce prescription and nutrition education
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.

Locations

Country	Name	City	State
United States	Living Hungry	West Palm Beach	Florida

Sponsors (7)

Lead Sponsor	Collaborator
Tufts University	FoundCare Inc., Health Care District of Palm Beach County, Jupiter Medical Center, Living Hungry, Inc., MyClinic, Inc, South Florida Hunger Coalition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c	will be measured by blood draws at first and last program event	pre/post change in HbA1c in participants from baseline to completion of the program at 4 months
Secondary	Change in frequency of hospitalizations	will be measured through surveys and data from electronic medical records	pre/post change in hospitalizations in participants from baseline to one month after completion of the program
Secondary	Change in frequency of emergency department admissions	will be measured through surveys and data from electronic medical records	pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
Secondary	Change in total health care costs	will be measured through data from hospital records	pre/post change in total health care costs in participants from baseline to one month after completion of the program
Secondary	Change in food insecurity	Food insecurity will be measured using the USDA 9-question food insecurity screener	pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
Secondary	Change in daily servings of fruits and vegetables	Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool	pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
Secondary	Change in daily servings of whole grains	Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool	pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
Secondary	Change in daily servings of lean proteins	Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool and includes: nuts, seeds, legumes, poultry, and fish.	pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
Secondary	Change in daily servings of sugary snacks and drinks	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	pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months
Secondary	Change in medication adherence	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.	pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
Secondary	Change in adhering to recommended diabetes management plan	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.	pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
Secondary	Change in blood LDL level	measured at first and last program event through a blood draw	pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
Secondary	Change in systolic blood pressure	measured at first and last program event	pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
Secondary	Change in diastolic blood pressure	measured at first and last program event	pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months