An interventional study of produce prescription and nutrition education in Diabetes Mellitus, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by Tufts University · Not applicable, Interventional, and Supportive care
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.
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.
Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive services through the Living Hungry program for food insecure diabetic patients.
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.
Also known as: medically tailored food
Change in Hemoglobin A1c
will be measured by blood draws at first and last program event
Time frame: pre/post change in HbA1c in participants from baseline to completion of the program at 4 months
Change in frequency of hospitalizations
will be measured through surveys and data from electronic medical records
Time frame: pre/post change in hospitalizations in participants from baseline to one month after completion of the program
Change in frequency of emergency department admissions
will be measured through surveys and data from electronic medical records
Time frame: 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
will be measured through data from hospital records
Time frame: pre/post change in total health care costs in participants from baseline to one month after completion of the program
Change in food insecurity
Food insecurity will be measured using the USDA 9-question food insecurity screener
Time frame: 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
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool
Time frame: pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
Change in daily servings of whole grains
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool
Time frame: pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
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.
Time frame: pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
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
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
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.
Time frame: pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
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.
Time frame: pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
Change in blood LDL level
measured at first and last program event through a blood draw
Time frame: pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
Change in systolic blood pressure
measured at first and last program event
Time frame: pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
Change in diastolic blood pressure
measured at first and last program event
Time frame: pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
Plan to share: No
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