Living Hungry Healthy Foods Prescription Program

NCT04205617 | Completed

• 1 other identifier: 13491
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Produce prescription; Food insecurity; Nutrition education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in frequency of hospitalizations

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

• Change in frequency of emergency department admissions

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

• Change in total health care costs

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

• Change in food insecurity

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

• Change in daily servings of fruits and vegetables

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

Study Arms (1)

Healthy Food Prescription

EXPERIMENTAL

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

Other: produce prescription and nutrition education

Interventions

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.

Also known as: medically tailored food

Healthy Food Prescription

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Living Hungry

West Palm Beach, Florida, 33401, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Dariush Mozaffarian, MD, DrPH

  Tufts University Friedman School of Nutrition Science and Policy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean - Friedman School

Model Details: Pre/post quasi experimental

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 19, 2019
• Study Start: December 14, 2019
• Primary Completion: July 25, 2020
• Study Completion: October 13, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)