Diabetes MellitusNCT04205617
Living Hungry Healthy Foods Prescription Program
A study testing produce prescription and nutrition education in people with Diabetes Mellitus, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- produce prescription and nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2019to 13 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- produce prescription and nutrition education
- Keywords
- Produce prescription, Food insecurity, Nutrition education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
produce prescription and nutrition educationOther
Also called medically tailored food
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Food Prescription | Experimental | Participants receive services through the Living Hungry program for food insecure diabetic patients. Receives: Other: produce prescription and nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
will be measured by blood draws at first and last program event
Measured: 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
will be measured through surveys and data from electronic medical records
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start14 Dec 2019
- Primary completion25 Jul 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/post quasi experimental
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Care District of Palm Beach County, South Florida Hunger Coalition, Jupiter Medical Center, MyClinic, Inc, FoundCare Inc., Living Hungry, Inc.
- Responsible party
- Principal investigator, Dariush Mozaffarian, Tufts University
- Investigators
- Dariush Mozaffarian, MD, DrPH, Principal investigator, Tufts University Friedman School of Nutrition Science and Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205617
- Sponsor's protocol ID
- 13491
- Status last verified
- Oct 2020
- First submitted
- 16 Dec 2019
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Hungry Healthy Foods Prescription Program
- ClinicalTrials.gov ID
- NCT04205617
- Acronym / sponsor ID
- 13491
- Conditions
- Diabetes Mellitus
- Keywords
- Produce prescription, Food insecurity, Nutrition education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Health Care District of Palm Beach County, South Florida Hunger Coalition, Jupiter Medical Center, MyClinic, Inc, FoundCare Inc., Living Hungry, Inc.
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/post quasi experimental
| Arm | Type | Receives |
|---|---|---|
| Healthy Food Prescription | Experimental | Other: produce prescription and nutrition educationParticipants receive services through the Living Hungry program for food insecure diabetic patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| produce prescription and nutrition educationAlso: medically tailored foodParticipants 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 | Healthy Food Prescription |
Primary outcome
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
13 secondary outcomes
Change in frequency of hospitalizations
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dariush Mozaffarian, MD, DrPH principal investigator
Tufts University Friedman School of Nutrition Science and Policy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing produce prescription and nutrition education in people with Diabetes Mellitus, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: pre/post change in HbA1c in participants from baseline to completion of the program at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.