Clinical trial NCT04205617: Living Hungry Healthy Foods Prescription Program
Official title: Living Hungry Healthy Foods Prescription Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Produce prescription
Food insecurity
Nutrition education
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Health Care District of Palm Beach County
name: South Florida Hunger Coalition
name: Jupiter Medical Center
name: MyClinic, Inc
name: FoundCare Inc.
name: Living Hungry, Inc.
First posted: 2019-12-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre/post quasi experimental
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: pre/post change in HbA1c in participants from baseline to completion of the program at 4 months
Secondary outcomes:
measure: Change in frequency of hospitalizations
timeFrame: pre/post change in hospitalizations in participants from baseline to one month after completion of the program
measure: Change in frequency of emergency department admissions
timeFrame: pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
measure: Change in total health care costs
timeFrame: pre/post change in total health care costs in participants from baseline to one month after completion of the program
measure: Change in food insecurity
timeFrame: pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
measure: Change in daily servings of fruits and vegetables
timeFrame: pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
measure: Change in daily servings of whole grains
timeFrame: pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
measure: Change in daily servings of lean proteins
timeFrame: pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
measure: Change in daily servings of sugary snacks and drinks
timeFrame: pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months
measure: Change in medication adherence
timeFrame: pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
measure: Change in adhering to recommended diabetes management plan
timeFrame: pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
measure: Change in blood LDL level
timeFrame: pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
measure: Change in systolic blood pressure
timeFrame: pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
measure: Change in diastolic blood pressure
timeFrame: pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Living Hungry
state: Florida
Study officials:
affiliation: Tufts University Friedman School of Nutrition Science and Policy
name: Dariush Mozaffarian, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References: