Living Hungry Healthy Foods Prescription Program

NCT ID: NCT04205617

Last Updated: 2020-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-14
• Study Completion Date: 2020-10-13

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Healthy Food Prescription

Participants receive services through the Living Hungry program for food insecure diabetic patients.

Group Type: EXPERIMENTAL

produce prescription and nutrition education

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

medically tailored food

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Care District of Palm Beach County

UNKNOWN

Sponsor Role: collaborator

South Florida Hunger Coalition

UNKNOWN

Sponsor Role: collaborator

Jupiter Medical Center

OTHER

Sponsor Role: collaborator

MyClinic, Inc

UNKNOWN

Sponsor Role: collaborator

FoundCare Inc.

UNKNOWN

Sponsor Role: collaborator

Living Hungry, Inc.

UNKNOWN

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Dariush Mozaffarian

Dean - Friedman School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dariush Mozaffarian, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

Tufts University Friedman School of Nutrition Science and Policy

Locations

Living Hungry

West Palm Beach, Florida, United States

Countries

United States

Other Identifiers

13491

Identifier Type: -

Identifier Source: org_study_id