- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04205617
Living Hungry Healthy Foods Prescription Program
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
West Palm Beach, Florida, United States, 33401
- Living Hungry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Food Prescription
Participants receive services through the Living Hungry program for food insecure diabetic patients.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hemoglobin A1c
Time Frame: pre/post change in HbA1c in participants from baseline to completion of the program at 4 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in frequency of hospitalizations
Time Frame: pre/post change in hospitalizations in participants from baseline to one month after completion of the program
|
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
|
Change in frequency of emergency department admissions
Time Frame: pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
|
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
|
Change in total health care costs
Time Frame: pre/post change in total health care costs in participants from baseline to one month after completion of the program
|
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
|
Change in food insecurity
Time Frame: pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
|
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
|
Change in daily servings of fruits and vegetables
Time Frame: pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
|
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
|
Change in daily servings of whole grains
Time Frame: pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
|
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
|
Change in daily servings of lean proteins
Time Frame: pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
|
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
|
Change in daily servings of sugary snacks and drinks
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
|
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
|
Change in medication adherence
Time Frame: pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
|
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
|
Change in adhering to recommended diabetes management plan
Time Frame: pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
|
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
|
Change in blood LDL level
Time Frame: pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
|
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
|
Change in systolic blood pressure
Time Frame: pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
|
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
|
Change in diastolic blood pressure
Time Frame: pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dariush Mozaffarian, MD, DrPH, Tufts University Friedman School of Nutrition Science and Policy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13491
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownType2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
Meir Medical CenterCompletedDiabetes Mellitus Type 2 | Diabetes Mellitus, Non-insulin Dependant | Diabetes Mellitus, on Oral Hypoglycemic Treatment | Adult Type Diabetes MellitusIsrael
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Active, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
Clinical Trials on produce prescription and nutrition education
-
Kaiser PermanenteActive, not recruiting
-
Gretchen Swanson Center for NutritionUniversity of Colorado, Denver; University of California, San Francisco; Children... and other collaboratorsEnrolling by invitation
-
University at BuffaloNot yet recruitingFood Preferences | Food Habits
-
Griffin HospitalGriffin Faculty Physicians; About FreshNot yet recruitingDiabetes Mellitus, Type 2 | Pre Diabetes
-
Brown UniversityPeter G. Peterson FoundationRecruitingFood InsecurityUnited States
-
The University of Texas Health Science Center,...American Heart AssociationNot yet recruitingNutritional Deficiency in PregnancyUnited States
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; United States Department of Agriculture... and other collaboratorsCompleted
-
Mid-Ohio Food CollectiveWeight Watchers InternationalCompletedFood Insecurity | Overweight and Obesity | Weight Change, Body | Produce PrescriptionUnited States
-
Milton S. Hershey Medical CenterCompleted
-
McGill UniversityInternational Development Research Centre, CanadaCompletedImproving Young Child NutritionGhana