Diabetes Mellitus, Type 2FAME-DNCT04828785
Food As MedicinE for Diabetes
A study testing MTM and Food Subsidy in people with Diabetes Mellitus, Type 2, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- MTM and Food Subsidy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of Type 2 Diabetes Mellitus
- Hemoglobin A1c ≥ 7.0% and ≤ 12.0% in last 12 months
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- BMI ≥25 kg/m^2 (≥ 23 kg/m^2 if self-report Asian ancestry)
- No plans to move from the area for at least 1 year
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
Who cannot join
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
- Lack of safe, stable residence and ability to store meals
- Lack of telephone
- Pregnancy/breastfeeding or intended pregnancy in the next year
Show all 11Show fewer
- History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured > 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded.
- Advanced kidney disease (estimated creatinine clearance < 30 mL/min)
- Known drug or alcohol misuse in the past 2 years
- Known psychosis or major psychiatric illness that prevents participation with study activities
- Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals With Type 2 Diabetes Mellitus and Food Insecurity
The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.
Read the detailed description
Food insecurity, "lack of access to enough food for an active, healthy life", affects over 20% of the 30 million Americans with diabetes. Food insecurity is more common in racial/ethnic minorities and those with lower socioeconomic status. Moreover, food insecurity is associated with worse diabetes control and increased complications, even after adjusting for other risk factors. Food insecurity is a major contributor to disparities in diabetes outcomes.
Medically tailored meal (MTM) delivery programs are a promising intervention for individuals with diabetes and food insecurity. MTM programs deliver fully prepared food, tailored by a registered dietitian nutritionist to the specific medical needs of the individual, and provide education to help optimize disease self-management. Food insecurity is typically addressed with food subsidies-offering additional financial resources that can be spent on food. While both food subsidies and MTM can increase healthy food access, MTM can help overcome other barriers to diabetes management including lack of time, ability, knowledge, and skills needed to prepare appropriate meals. The use of these programs is often called 'food as medicine', as the purpose is to provide exactly the foods needed to help prevent diabetes complications. MTM are receiving increasing public attention, but there are, as of yet, no full-scale trials to test its effects on diabetes outcomes when compared with other food insecurity interventions.
Our research team has developed a medically tailored meal intervention that combines provision of healthy food, tailored to the specific nutrition needs of the individual, with an evidence-based lifestyle intervention that uses the period of meal delivery as springboard to improve diabetes self-management, both while receiving meals and after meal delivery is completed.
This study is an explanatory-focused randomized trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants referred for medically tailored meals. Adults with type 2 diabetes, Hemoglobin A1c between 7.0% and 12.0%, and BMI ≥ 25 kg/m2 (≥ 23 kg/m2 for those with Asian ancestry) will be enrolled and randomly assigned to intervention or usual care + food subsidy. The intervention group will receive meal delivery and its attendant lifestyle intervention for 6 months, while the usual care + food subsidy group will receive a $40/month food subsidy, along with usual diabetes care.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- MTM, Food Subsidy
- Keywords
- Food Insecurity, Socioeconomic Factors, Lifestyle Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTMOther
weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
Food SubsidyOther
$40/month food subsidy
| Study group | Role | What they receive |
|---|---|---|
| Medically Tailored Meal (MTM) | Experimental | The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention. Receives: Other: MTM |
| Food Subsidy | Active comparator | As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy. Receives: Other: Food Subsidy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c at Month 6
Hemoglobin A1c Level
Measured: 6 months
Secondary outcomes (13)
Hemoglobin A1c at Month 12
Hemoglobin A1c Level
Measured: 12 months
Food Insecurity Score at Month 6
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Measured: 6 months
Food Insecurity Score at Month 12
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.
Measured: 12 months
Health-Related Quality of Life Score as Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. These scores are then used to calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Measured: 6 months
Health-Related Quality of Life Score as Assessed by PROMIS-29 at Month 12
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. These scores are then used to calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Measured: 12 months
Diabetes Distress Score as Assessed by PAID (Problem Areas in Diabetes)-11 at Month 6
Score ranges from 0-44 with higher scores indicating greater diabetes distress
Measured: 6 months
Diabetes Distress Score as Assessed by PAID-11 at Month 12
Score ranges from 0-44 with higher scores indicating greater diabetes distress
Measured: 12 months
Depressive Symptom Score at Month 6
Depressive Symptoms as assessed by PROMIS SF (Short Form) v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms.
Measured: 6 months
Depressive Symptom Score at Month 12
Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms.
Measured: 12 months
Number of Participants With Self-reported Hypoglycemia at Month 6
Reported hypoglycemia between 0 and 6 months after randomization
Measured: 6 months
Number of Participants With Self-reported Hypoglycemia at Month 12
Reported hypoglycemia between 6 and 12 months after randomization
Measured: 12 months
Number of Participants With Self-reported Severe Hypoglycemia at Month 6
Reported severe hypoglycemia between 0 and 6 months after randomization
Measured: 6 months
Number of Participants With Self-reported Severe Hypoglycemia at Month 12
Reported severe hypoglycemia between 6 and 12 months after randomization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start2 Jul 2021
- Primary completion11 Sep 2025
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned in 1:1 ratio to one of two intervention arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Community Servings, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Seth Berkowitz, MD, Principal investigator, UNC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828785
- Sponsor's protocol ID
- 20-2847
- Other IDs
- R01DK125831
- Acronym
- FAME-D
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2021
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that can be deidentified without risk of confidentiality breach will shared upon written request made to study investigators. In addition, all NIH policies regarding data sharing will be followed. Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Berkowitz SA, Kruse GR, Ball Ricks KA, Burch J, Ouimet E, Kitzis B, Forrest C, Terranova J, Stewart PW, Buse JB, Keyserling TC, Wexler DJ, Delahanty LM. Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial. Contemp Clin Trials. 2023 Jan;124:107039. doi: 10.1016/j.cct.2022.107039. Epub 2022 Dec 5.
PubMed 36470556
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals With Type 2 Diabetes Mellitus and Food Insecurity
- ClinicalTrials.gov ID
- NCT04828785
- Acronym / sponsor ID
- FAME-D / 20-2847
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Food Insecurity, Socioeconomic Factors, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Community Servings, Massachusetts General Hospital
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.
Detailed description
Food insecurity, "lack of access to enough food for an active, healthy life", affects over 20% of the 30 million Americans with diabetes. Food insecurity is more common in racial/ethnic minorities and those with lower socioeconomic status. Moreover, food insecurity is associated with worse diabetes control and increased complications, even after adjusting for other risk factors. Food insecurity is a major contributor to disparities in diabetes outcomes.
Medically tailored meal (MTM) delivery programs are a promising intervention for individuals with diabetes and food insecurity. MTM programs deliver fully prepared food, tailored by a registered dietitian nutritionist to the specific medical needs of the individual, and provide education to help optimize disease self-management. Food insecurity is typically addressed with food subsidies-offering additional financial resources that can be spent on food. While both food subsidies and MTM can increase healthy food access, MTM can help overcome other barriers to diabetes management including lack of time, ability, knowledge, and skills needed to prepare appropriate meals. The use of these programs is often called 'food as medicine', as the purpose is to provide exactly the foods needed to help prevent diabetes complications. MTM are receiving increasing public attention, but there are, as of yet, no full-scale trials to test its effects on diabetes outcomes when compared with other food insecurity interventions.
Our research team has developed a medically tailored meal intervention that combines provision of healthy food, tailored to the specific nutrition needs of the individual, with an evidence-based lifestyle intervention that uses the period of meal delivery as springboard to improve diabetes self-management, both while receiving meals and after meal delivery is completed.
This study is an explanatory-focused randomized trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants referred for medically tailored meals. Adults with type 2 diabetes, Hemoglobin A1c between 7.0% and 12.0%, and BMI ≥ 25 kg/m2 (≥ 23 kg/m2 for those with Asian ancestry) will be enrolled and randomly assigned to intervention or usual care + food subsidy. The intervention group will receive meal delivery and its attendant lifestyle intervention for 6 months, while the usual care + food subsidy group will receive a $40/month food subsidy, along with usual diabetes care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned in 1:1 ratio to one of two intervention arms
| Arm | Type | Receives |
|---|---|---|
| Medically Tailored Meal (MTM) | Experimental | Other: MTMThe Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention. |
| Food Subsidy | Active comparator | Other: Food SubsidyAs a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of Type 2 Diabetes Mellitus
- Hemoglobin A1c ≥ 7.0% and ≤ 12.0% in last 12 months
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- BMI ≥25 kg/m^2 (≥ 23 kg/m^2 if self-report Asian ancestry)
Key exclusion criteria (11 listed)
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
- Lack of safe, stable residence and ability to store meals
- Lack of telephone
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 |
|---|---|---|
| MTMweekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention. | Other | Medically Tailored Meal (MTM) |
| Food Subsidy$40/month food subsidy | Other | Food Subsidy |
Primary outcome
Hemoglobin A1c at Month 6
Time frame: 6 months
Hemoglobin A1c Level
13 secondary outcomes
Hemoglobin A1c at Month 12
Time frame: 12 months
Food Insecurity Score at Month 6
Time frame: 6 months
Food Insecurity Score at Month 12
Time frame: 12 months
Health-Related Quality of Life Score as Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6
Time frame: 6 months
Health-Related Quality of Life Score as Assessed by PROMIS-29 at Month 12
Time frame: 12 months
Diabetes Distress Score as Assessed by PAID (Problem Areas in Diabetes)-11 at Month 6
Time frame: 6 months
Diabetes Distress Score as Assessed by PAID-11 at Month 12
Time frame: 12 months
Depressive Symptom Score at Month 6
Time frame: 6 months
Depressive Symptom Score at Month 12
Time frame: 12 months
Number of Participants With Self-reported Hypoglycemia at Month 6
Time frame: 6 months
Number of Participants With Self-reported Hypoglycemia at Month 12
Time frame: 12 months
Number of Participants With Self-reported Severe Hypoglycemia at Month 6
Time frame: 6 months
Number of Participants With Self-reported Severe Hypoglycemia at Month 12
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36470556Berkowitz SA, Kruse GR, Ball Ricks KA, Burch J, Ouimet E, Kitzis B, Forrest C, Terranova J, Stewart PW, Buse JB, Keyserling TC, Wexler DJ, Delahanty LM. Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial. Contemp Clin Trials. 2023 Jan;124:107039. doi: 10.1016/j.cct.2022.107039. Epub 2022 Dec 5.
- Individual participant dataSharing planned: Yes. Individual participant data that can be deidentified without risk of confidentiality breach will shared upon written request made to study investigators. In addition, all NIH policies regarding data sharing will be followed. Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Seth Berkowitz, MD principal investigator
UNC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTM and Food Subsidy in people with Diabetes Mellitus, Type 2, run by University of North Carolina, Chapel Hill 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 8 inclusion and 11 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 3 Nov 2026. 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?
Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin A1c at Month 6 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828785, which also lists 1 linked publication.
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 3 Nov 2026.