Type 2 DiabetesCHEFS-DMNCT04959487
Changing Health Through Food Support for Diabetes
A study testing Food support and Nutritional Counseling and education in people with Type 2 Diabetes and Food Insecurity, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a pragmatic randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). This pragmatic RCT will leverage Project Open Hand's (POH) real-world programs to test the impact of a six month medically tailored food support and nutrition intervention ("CHEFS-DM") on glycemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Food Insecurity
- What is being tested?
- Food support and Nutritional Counseling and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 12 Jun 2025
- 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
- Confirmed diagnosis of T2DM confirmed by medical or laboratory records. For T2DM, any of the following criteria will be considered (from the American Diabetes Association):
- glycated hemoglobin (HbA1c) ≥6.5%, or
- fasting plasma glucose of ≥126, or
- a 2-hour plasma glucose level of 200 or higher during a 75 g oral glucose tolerance test, or
- a random plasma glucose of 200 or higher in patients with symptoms of hyperglycemia
- Age ≥18 years.
Show all 10Show fewer
- Screening positive for food insecurity (at least one positive answer) in the previous 6 months assessed using the 6-item version of the US Household Food Security Survey Module (US Department of Agriculture), or has household income <200% of the federal poverty level.
- English or Spanish language fluency.
- Adequate cognitive and hearing capacity to consent and complete study measures.
- Reside in Alameda County or San Francisco County.
Who cannot join
- Type-1 diabetes mellitus
- Individuals with disorders known to affect the accuracy of the HbA1c measure (e.g., end stage renal disease and individuals with known hemoglobinopathies).
- Inability to attend the educational workshops.
- Inability to schedule baseline assessments and/or blood draw after repeated requests.
- Pregnant individuals, or individuals planning to get pregnant within 6 months, or are lactating, or are postpartum less than 6 months.
- Current POH clients, past POH clients who stopped services less than 6 months prior, or past or present participants in other POH medically tailored meals studies.
Show all 13Show fewer
- Does not have access to food storage, including a refrigerator and freezer to safely keep food.
- Does not have access to facilities to reheat and prepare meals using Project Open Hand food.
- Anticipates moving out of study area of Alameda and San Francisco Counties in the next 6 months.
- Receives more than 1 meal per day from a free food support resource or agency.
- Allergic to or will not eat eggs, soy, wheat, nuts, seeds or seed oils, or other foods commonly included among ingredients in POH meals.
- Allergic to dairy products, or unable to tolerate any dairy products including milk, yogurt and cheese.
- Individual does not eat any or all of POH's meat meal options and will not eat the vegetarian POH meal option.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health
This is a pragmatic randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). This pragmatic RCT will leverage Project Open Hand's (POH) real-world programs to test the impact of a six month medically tailored food support and nutrition intervention ("CHEFS-DM") on glycemic control and other cardiometabolic outcomes, investigate the paths through which CHEFS-DM may durably improve health, and assess the economic value of the intervention to society.
Read the detailed description
CHEFS-DM is a six-month intervention providing a diabetes-tailored diet meeting approximately 75% of daily energy requirements and designed based on American Diabetes Association (ADA) guidelines, together with diabetes nutritional education provided by registered dietitians. In this pragmatic RCT, investigators propose to rigorously evaluate the intervention among 440* low-income adults with Type 2 Diabetes Mellitus (T2DM) recruited from networks of safety net clinics in San Francisco and Alameda counties, California.
Participants will be randomized 1:1 to the intervention (n=220*) versus control (n=220*), using a parallel design. The study aims are as follows:
Aim 1: To determine the impact of CHEFS-DM on glycemic control and other cardiometabolic outcomes.
Aim 2: To determine the impact of CHEFS-DM on intermediate outcomes that may mediate any impact of CHEFS-DM on T2DM health.
Participant will be followed for 6 months (control arm) and 12 months (intervention arm) with structured interviews, anthropometric assessments, 24-hour dietary recalls, blood pressure measurements, blood draws, and semi structured interviews. Follow-up will be broken up into two phases. From baseline to six months, researchers will implement the CHEFS-DM intervention and follow both intervention and control arm participants (n=440*). After the end of the six-month follow-up, the intervention arm will transition to receiving standard POH services comprising 33% to 67% of daily energy requirements depending on health status, and will be followed for an additional six months, in order to assess the extent to which any health benefits are sustained at 12 months (n=220*). Hence, the control arm will be followed for six months and participate in two sets of assessments (baseline and at six months), and the intervention arm will be followed for 12 months and participate in three sets of assessments (baseline, six months, and twelve months).
*Update: Due to COVID-era challenges, NIH approved changes to the study in January 2024 including a reduced sample size (at least n=246) and reduced measures and procedures to ease participant burden (see updated SAP Version 2, Section 7, for details).
- Conditions
- Type 2 Diabetes, Food Insecurity
- Being tested
- Food support, Nutritional Counseling and education
- Keywords
- Food security, Diabetes Mellitus, Food assistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supportOther
- Diabetes-tailored food support. Project Open Hand will provide intervention participants six months of supplemental food support meeting on average 75% of their daily energy requirements. Food support will consist of a mix of meals tailored for T2DM, and T2DM-healthy groceries, consistent with American Diabetes Association (ADA) guidelines for diabetes healthy diets under the responsibility of a registered dietitian.
Nutritional Counseling and educationOther
- Nutritional counseling and education: The registered dietitian will provide individual nutritional counseling two times (at baseline and month 5-6) during the intervention. In addition, group-based DM nutrition education will be conducted over four 1-hour-long sessions. The nutrition education will be conducted by a POH dietitian, and the curriculum will be consistent with published diabetes self- management education principles, utilizing effective strategies in lower wealth, lower literacy populations.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | During the active trial period, control participants will receive standard of care as offered by clinical partners to all T2DM patients, meaning that they will receive the same care as if they were not enrolled in the study [no intervention]. This may include referral by their providers to nutritional counseling, T2DM support groups, local diabetes self-management programs, or locally available food support services, entirely independent of the study. At the end of 6 month follow up (after end of active comparison), the control arm will receive similar services from POH to what the intervention arm received during the intervention, regardless POH eligibility criteria (6 months of DM-tailored food support to meet 67% of their daily requirements, video recording of the 4 CHEFS-DM education classes, and access to a POH dietitian at their request). They will only receive this after their endline assessment period has ended. |
| Food support and nutrition education | Experimental | The intervention entails two components: 1) food support that consists of weekly medically tailored meals and healthy groceries that on average covers 75% of daily energy requirements from baseline to six months and 2) diabetes-tailored nutritional education that consists of two individual counseling sessions with a Registered dietitian and four group education sessions. Receives: Other: Food support; Other: Nutritional Counseling and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c From Baseline to Six Months by Study Arm
Change HbA1c levels (%) from baseline to six months by study arms.
Measured: Baseline and 6-months follow up
Change in Food Insecurity Severity From Baseline to Six Months by Study Arm
The US adult food security survey module from the US Department of Agriculture (USDA) will be used to assess the change in the food security scores from baseline to six months. The score ranges from 0 to 10. Higher score indicates higher severity of food insecurity
Measured: Baseline and 6-months follow-up
Secondary outcomes (13)
Change in the Percentage of Participants With Low and Very Low Food Security
Low and very low food security will be defined as 3 or more items answered affirmatively in the USDA's US adult food security survey module. Change in the percentage of participants with low or very low food security, from baseline to six months by intervention arms, is reported.
Measured: Baseline and 6-month follow-up
Change in Percentage of Participants With HbA1c <9% by Study Arm.
Change in percentage of participants with HbA1c < 9%, a threshold indicating poor diabetes control (higher indicates worse diabetes control), from baseline to six months by intervention, arms is reported.
Measured: Baseline and 6-month follow-up
Change in Systolic Blood Pressure From Baseline to Six Months
Changes in the average of three repeated measurements of systolic blood pressure (mm Hg) from baseline to six months by study arm.
Measured: Baseline and 6-month follow-up
Change in Oral Medication Adherence From Baseline to Six Months by Study Arm
A single-item Rating Visual Analogue Scale is used to evaluate oral diabetes medication adherence. Using the scale, participants self-report the adherence of medication ranging from 0% to 100%. The changes in diabetes medication adherence (percentage) from baseline to six months by study arms are reported.
Measured: Baseline and 6-month follow-up
Change in Percentage of Participants With Acute Health Care Utilization From Baseline to Six Month by Study Arm
Change in percentage of participants that used emergency health care (Emergency department or urgent care) during the 6 months of the study by study arm is reported.
Measured: Baseline and 6-month
Change in Percentage of Participants With a Least One Hospital Admission From Baseline to Six Months by Study Arm
Change in percentage of participants who were hospitalized at least once from baseline to six months of the study by study arms is reported.
Measured: Baseline to six months
Change in Percentage of Participants Missing at Least One Outpatient Visit From Baseline to Six Months by Study Arm
Change in percentage of participants that missed at least one outpatient visits from baseline to six months by study arms is reported.
Measured: Baseline to six months
Change in Health-related Quality of Life Scores From Baseline to Six Months by Study Arm
The quality of life will be measured using the standardized 12-item short form health survey (SF-12v2). The SF-12v2 provides a summary score for physical and mental health. The transformed T score has a mean=50 and Standard Deviation=10, in which higher values means better health. The change in SF-12 T scores from baseline to six months by study arm will be reported.
Measured: Baseline and 6-month follow-up
Change in Body Mass Index (BMI) From Baseline to Six Months by Study Arm
The average of three repeated measurements of weight and height will be obtained at baseline and at six months. The BMI will be calculated (weight (kg)/ (height (m)^2). Changes in in BMI values (kg/ m^2) from baseline to six months by study arm will be reported.
Measured: Baseline and six months
Change in Healthy Eating Index Score 2015 (HEI-2015) From Baseline to Six Months by Study Arm.
Dietary information using an automated self- administered 24-hour dietary recall instrument from the National Cancer Institute's (ASA24) will be collected. The HEI-2015 is a measure of diet quality which evaluates how well the food consumed aligns with the Dietary guidelines for American population. The HEI-2015 score ranges from 0-100 in which a higher score indicates better diet quality. The adequacy component of the HEI ranges from 0-60 and the moderation component ranges from 0-40 (both with higher score indicating better diet quality); here the overall score is reported. Changes in the HEI-2015 score from baseline to six months by study arm will be reported.
Measured: Baseline and 6-months follow-up
Change in Depressive Symptoms From Baseline to Six Months by Study Arm
The 9-item Patient Health Questionnaire (PHQ-9) will be used to evaluate depressive symptoms. The PHQ-9 score ranges from 0 to 27, with higher scores indicating higher levels of depression. The change in PHQ-9 scores from baseline to six months by study arm will be reported.
Measured: Baseline and six months
Change in Diabetes Distress Scale From Baseline to Six Months by Study Arm
The diabetes distress scale (DDS) has 17 items measuring frustration, anger, and discouragement associated with managing complex diabetes health-care directives. The DDS score ranges from 1 to 6, with higher scores indicating higher levels of distress. The change in diabetes distress scores from baseline to six months by study arms will be reported.
Measured: Baseline and 6-month follow-up
Change in Diabetes Self-efficacy From Baseline to Six Months by Study Arm
The 8-item Perceived Diabetes Self-Management (PDSM) scale will be used to assess confidence in one's ability to manage numerous self-care behaviors, including diet, and management of glucose. The PDSM scores ranges from 8 to 40, with higher scores indicating more confidence in self-managing their diabetes. The changes in the PDSM scores from baseline to six months by study arm will be reported.
Measured: Baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start23 Aug 2021
- Primary completion5 Feb 2025
- Study completion12 Jun 2025
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 (9)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 (n=440\*) will be randomized to the intervention (n=220\*) or control (n=220\*) arms, stratified by county (San Francisco vs. Alameda County) and poor diabetes control (A1c \< 9%, vs. ≥ 9%). The intervention consists of providing diabetes-tailored food support and nutritional education (two sessions of individual counseling and four session of in-group diabetes-tailored nutrition education sessions) over six months to patients with type 2 diabetes. \*Update: Due to COVID-era challenges, NIH approved changes to the study in January 2024 including a reduced sample size (at least n=246) and reduced measures and procedures to ease participant burden (see updated Protocol/SAP Version 2, Section 7, for details).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Project Open Hand
- Responsible party
- Sponsor
- Investigators
- Kartika Palar, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959487
- Sponsor's protocol ID
- R01DK124630
- Other IDs
- R01DK124630
- Acronym
- CHEFS-DM
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2021
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palar K, Napoles T, Hufstedler LL, Seligman H, Hecht FM, Madsen K, Ryle M, Pitchford S, Frongillo EA, Weiser SD. Comprehensive and Medically Appropriate Food Support Is Associated with Improved HIV and Diabetes Health. J Urban Health. 2017 Feb;94(1):87-99. doi: 10.1007/s11524-016-0129-7.
PubMed 28097614Seligman HK, Lyles C, Marshall MB, Prendergast K, Smith MC, Headings A, Bradshaw G, Rosenmoss S, Waxman E. A Pilot Food Bank Intervention Featuring Diabetes-Appropriate Food Improved Glycemic Control Among Clients In Three States. Health Aff (Millwood). 2015 Nov;34(11):1956-63. doi: 10.1377/hlthaff.2015.0641.
PubMed 26526255Seligman HK, Schillinger D. Hunger and socioeconomic disparities in chronic disease. N Engl J Med. 2010 Jul 1;363(1):6-9. doi: 10.1056/NEJMp1000072. No abstract available.
PubMed 20592297Gurvey J, Rand K, Daugherty S, Dinger C, Schmeling J, Laverty N. Examining health care costs among MANNA clients and a comparison group. J Prim Care Community Health. 2013 Oct;4(4):311-7. doi: 10.1177/2150131913490737. Epub 2013 Jun 3.
PubMed 23799677Berkowitz SA, Terranova J, Hill C, Ajayi T, Linsky T, Tishler LW, DeWalt DA. Meal Delivery Programs Reduce The Use Of Costly Health Care In Dually Eligible Medicare And Medicaid Beneficiaries. Health Aff (Millwood). 2018 Apr;37(4):535-542. doi: 10.1377/hlthaff.2017.0999.
PubMed 29608345Berkowitz SA, Terranova J, Randall L, Cranston K, Waters DB, Hsu J. Association Between Receipt of a Medically Tailored Meal Program and Health Care Use. JAMA Intern Med. 2019 Jun 1;179(6):786-793. doi: 10.1001/jamainternmed.2019.0198.
PubMed 31009050Seligman HK, Jacobs EA, Lopez A, Tschann J, Fernandez A. Food insecurity and glycemic control among low-income patients with type 2 diabetes. Diabetes Care. 2012 Feb;35(2):233-8. doi: 10.2337/dc11-1627. Epub 2011 Dec 30.
PubMed 22210570Seligman HK, Jacobs EA, Lopez A, Sarkar U, Tschann J, Fernandez A. Food insecurity and hypoglycemia among safety net patients with diabetes. Arch Intern Med. 2011 Jul 11;171(13):1204-6. doi: 10.1001/archinternmed.2011.287. No abstract available.
PubMed 21747017Marpadga S, Fernandez A, Leung J, Tang A, Seligman H, Murphy EJ. Challenges and Successes with Food Resource Referrals for Food-Insecure Patients with Diabetes. Perm J. 2019;23:18-097. doi: 10.7812/TPP/18-097.
PubMed 30939269
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health
- ClinicalTrials.gov ID
- NCT04959487
- Acronym / sponsor ID
- CHEFS-DM / R01DK124630
- Conditions
- Type 2 Diabetes, Food Insecurity
- Keywords
- Food security, Diabetes Mellitus, Food assistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Project Open Hand
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pragmatic randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). This pragmatic RCT will leverage Project Open Hand's (POH) real-world programs to test the impact of a six month medically tailored food support and nutrition intervention ("CHEFS-DM") on glycemic control and other cardiometabolic outcomes, investigate the paths through which CHEFS-DM may durably improve health, and assess the economic value of the intervention to society.
Detailed description
CHEFS-DM is a six-month intervention providing a diabetes-tailored diet meeting approximately 75% of daily energy requirements and designed based on American Diabetes Association (ADA) guidelines, together with diabetes nutritional education provided by registered dietitians. In this pragmatic RCT, investigators propose to rigorously evaluate the intervention among 440* low-income adults with Type 2 Diabetes Mellitus (T2DM) recruited from networks of safety net clinics in San Francisco and Alameda counties, California.
Participants will be randomized 1:1 to the intervention (n=220*) versus control (n=220*), using a parallel design. The study aims are as follows:
Aim 1: To determine the impact of CHEFS-DM on glycemic control and other cardiometabolic outcomes.
Aim 2: To determine the impact of CHEFS-DM on intermediate outcomes that may mediate any impact of CHEFS-DM on T2DM health.
Participant will be followed for 6 months (control arm) and 12 months (intervention arm) with structured interviews, anthropometric assessments, 24-hour dietary recalls, blood pressure measurements, blood draws, and semi structured interviews. Follow-up will be broken up into two phases. From baseline to six months, researchers will implement the CHEFS-DM intervention and follow both intervention and control arm participants (n=440*). After the end of the six-month follow-up, the intervention arm will transition to receiving standard POH services comprising 33% to 67% of daily energy requirements depending on health status, and will be followed for an additional six months, in order to assess the extent to which any health benefits are sustained at 12 months (n=220*). Hence, the control arm will be followed for six months and participate in two sets of assessments (baseline and at six months), and the intervention arm will be followed for 12 months and participate in three sets of assessments (baseline, six months, and twelve months).
*Update: Due to COVID-era challenges, NIH approved changes to the study in January 2024 including a reduced sample size (at least n=246) and reduced measures and procedures to ease participant burden (see updated SAP Version 2, Section 7, for details).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants (n=440*) will be randomized to the intervention (n=220*) or control (n=220*) arms, stratified by county (San Francisco vs. Alameda County) and poor diabetes control (A1c < 9%, vs. ≥ 9%). The intervention consists of providing diabetes-tailored food support and nutritional education (two sessions of individual counseling and four session of in-group diabetes-tailored nutrition education sessions) over six months to patients with type 2 diabetes. *Update: Due to COVID-era challenges, NIH approved changes to the study in January 2024 including a reduced sample size (at least n=246) and reduced measures and procedures to ease participant burden (see updated Protocol/SAP Version 2, Section 7, for details).
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –During the active trial period, control participants will receive standard of care as offered by clinical partners to all T2DM patients, meaning that they will receive the same care as if they were not enrolled in the study [no intervention]. This may include referral by their providers to nutritional counseling, T2DM support groups, local diabetes self-management programs, or locally available food support services, entirely independent of the study. At the end of 6 month follow up (after end of active comparison), the control arm will receive similar services from POH to what the intervention arm received during the intervention, regardless POH eligibility criteria (6 months of DM-tailored food support to meet 67% of their daily requirements, video recording of the 4 CHEFS-DM education classes, and access to a POH dietitian at their request). They will only receive this after their endline assessment period has ended. |
| Food support and nutrition education | Experimental | Other: Food support, Other: Nutritional Counseling and educationThe intervention entails two components: 1) food support that consists of weekly medically tailored meals and healthy groceries that on average covers 75% of daily energy requirements from baseline to six months and 2) diabetes-tailored nutritional education that consists of two individual counseling sessions with a Registered dietitian and four group education sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed diagnosis of T2DM confirmed by medical or laboratory records. For T2DM, any of the following criteria will be considered (from the American Diabetes Association):
- Age ≥18 years.
- Screening positive for food insecurity (at least one positive answer) in the previous 6 months assessed using the 6-item version of the US Household Food Security Survey Module (US Department of Agriculture), or has household income <200% of the federal poverty level.
- English or Spanish language fluency.
- Adequate cognitive and hearing capacity to consent and complete study measures.
Key exclusion criteria (13 listed)
- Type-1 diabetes mellitus
- Individuals with disorders known to affect the accuracy of the HbA1c measure (e.g., end stage renal disease and individuals with known hemoglobinopathies).
- Inability to attend the educational workshops.
- Inability to schedule baseline assessments and/or blood draw after repeated requests.
- Pregnant individuals, or individuals planning to get pregnant within 6 months, or are lactating, or are postpartum less than 6 months.
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 |
|---|---|---|
| Food support1. Diabetes-tailored food support. Project Open Hand will provide intervention participants six months of supplemental food support meeting on average 75% of their daily energy requirements. Food support will consist of a mix of meals tailored for T2DM, and T2DM-healthy groceries, consistent with American Diabetes Association (ADA) guidelines for diabetes healthy diets under the responsibility of a registered dietitian. | Other | Food support and nutrition education |
| Nutritional Counseling and education2. Nutritional counseling and education: The registered dietitian will provide individual nutritional counseling two times (at baseline and month 5-6) during the intervention. In addition, group-based DM nutrition education will be conducted over four 1-hour-long sessions. The nutrition education will be conducted by a POH dietitian, and the curriculum will be consistent with published diabetes self- management education principles, utilizing effective strategies in lower wealth, lower literacy populations. | Other | Food support and nutrition education |
Primary outcome
Change in Hemoglobin A1c From Baseline to Six Months by Study Arm
Time frame: Baseline and 6-months follow up
Change HbA1c levels (%) from baseline to six months by study arms.
Change in Food Insecurity Severity From Baseline to Six Months by Study Arm
Time frame: Baseline and 6-months follow-up
The US adult food security survey module from the US Department of Agriculture (USDA) will be used to assess the change in the food security scores from baseline to six months. The score ranges from 0 to 10. Higher score indicates higher severity of food insecurity
13 secondary outcomes
Change in the Percentage of Participants With Low and Very Low Food Security
Time frame: Baseline and 6-month follow-up
Change in Percentage of Participants With HbA1c <9% by Study Arm.
Time frame: Baseline and 6-month follow-up
Change in Systolic Blood Pressure From Baseline to Six Months
Time frame: Baseline and 6-month follow-up
Change in Oral Medication Adherence From Baseline to Six Months by Study Arm
Time frame: Baseline and 6-month follow-up
Change in Percentage of Participants With Acute Health Care Utilization From Baseline to Six Month by Study Arm
Time frame: Baseline and 6-month
Change in Percentage of Participants With a Least One Hospital Admission From Baseline to Six Months by Study Arm
Time frame: Baseline to six months
Change in Percentage of Participants Missing at Least One Outpatient Visit From Baseline to Six Months by Study Arm
Time frame: Baseline to six months
Change in Health-related Quality of Life Scores From Baseline to Six Months by Study Arm
Time frame: Baseline and 6-month follow-up
Change in Body Mass Index (BMI) From Baseline to Six Months by Study Arm
Time frame: Baseline and six months
Change in Healthy Eating Index Score 2015 (HEI-2015) From Baseline to Six Months by Study Arm.
Time frame: Baseline and 6-months follow-up
Change in Depressive Symptoms From Baseline to Six Months by Study Arm
Time frame: Baseline and six months
Change in Diabetes Distress Scale From Baseline to Six Months by Study Arm
Time frame: Baseline and 6-month follow-up
Change in Diabetes Self-efficacy From Baseline to Six Months by Study Arm
Time frame: Baseline and six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28097614Palar K, Napoles T, Hufstedler LL, Seligman H, Hecht FM, Madsen K, Ryle M, Pitchford S, Frongillo EA, Weiser SD. Comprehensive and Medically Appropriate Food Support Is Associated with Improved HIV and Diabetes Health. J Urban Health. 2017 Feb;94(1):87-99. doi: 10.1007/s11524-016-0129-7.
- Background: PubMed 26526255Seligman HK, Lyles C, Marshall MB, Prendergast K, Smith MC, Headings A, Bradshaw G, Rosenmoss S, Waxman E. A Pilot Food Bank Intervention Featuring Diabetes-Appropriate Food Improved Glycemic Control Among Clients In Three States. Health Aff (Millwood). 2015 Nov;34(11):1956-63. doi: 10.1377/hlthaff.2015.0641.
- Background: PubMed 20592297Seligman HK, Schillinger D. Hunger and socioeconomic disparities in chronic disease. N Engl J Med. 2010 Jul 1;363(1):6-9. doi: 10.1056/NEJMp1000072. No abstract available.
- Background: PubMed 23799677Gurvey J, Rand K, Daugherty S, Dinger C, Schmeling J, Laverty N. Examining health care costs among MANNA clients and a comparison group. J Prim Care Community Health. 2013 Oct;4(4):311-7. doi: 10.1177/2150131913490737. Epub 2013 Jun 3.
- Background: PubMed 29608345Berkowitz SA, Terranova J, Hill C, Ajayi T, Linsky T, Tishler LW, DeWalt DA. Meal Delivery Programs Reduce The Use Of Costly Health Care In Dually Eligible Medicare And Medicaid Beneficiaries. Health Aff (Millwood). 2018 Apr;37(4):535-542. doi: 10.1377/hlthaff.2017.0999.
- Background: PubMed 31009050Berkowitz SA, Terranova J, Randall L, Cranston K, Waters DB, Hsu J. Association Between Receipt of a Medically Tailored Meal Program and Health Care Use. JAMA Intern Med. 2019 Jun 1;179(6):786-793. doi: 10.1001/jamainternmed.2019.0198.
- Background: PubMed 22210570Seligman HK, Jacobs EA, Lopez A, Tschann J, Fernandez A. Food insecurity and glycemic control among low-income patients with type 2 diabetes. Diabetes Care. 2012 Feb;35(2):233-8. doi: 10.2337/dc11-1627. Epub 2011 Dec 30.
- Background: PubMed 21747017Seligman HK, Jacobs EA, Lopez A, Sarkar U, Tschann J, Fernandez A. Food insecurity and hypoglycemia among safety net patients with diabetes. Arch Intern Med. 2011 Jul 11;171(13):1204-6. doi: 10.1001/archinternmed.2011.287. No abstract available.
- Background: PubMed 30939269Marpadga S, Fernandez A, Leung J, Tang A, Seligman H, Murphy EJ. Challenges and Successes with Food Resource Referrals for Food-Insecure Patients with Diabetes. Perm J. 2019;23:18-097. doi: 10.7812/TPP/18-097.
- 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.
Kartika Palar, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food support and Nutritional Counseling and education in people with Type 2 Diabetes and Food Insecurity, run by University of California, San Francisco 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 10 inclusion and 13 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 29 Sep 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 29 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?
Change in Hemoglobin A1c From Baseline to Six Months by Study Arm (time frame: Baseline and 6-months follow up). The study lists 2 primary outcomes in all. 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 NCT04959487, which also lists 9 linked publications.
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 29 Sep 2026.