Diabetes Mellitus, Type 2FIRSTNCT06329375
Food Insecurity Reduction & Strategy Team
A study testing Nutrition program in people with Diabetes Mellitus, Type 2 and Food Insecurity, run by Stanford University at 1 site in United States.
Trial summary
This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Food Insecurity, Diabetes Mellitus, Type 1
- What is being tested?
- Nutrition program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 or Type 2 Diabetes Mellitus
- Admitted to Stanford Healthcare inpatient unit
- Residence in California at time of enrollment
- Positive Screening for Food Insecurity
- On a Healthcare Plan covered by Mom's Meals.
Who cannot join
- Plans to be discharged to a skilled nursing facility.
- Patients who prefer a language for which a short-form consent is not available.
- No Home Address
- Pregnant Participants.
- No access to refrigerator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Medicine
Palo Alto, California, 94304
Neera Ahuja, MD, 650-725-3515, nahuja@stanfordhealthcare.org
About this study
This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:
- To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.
- To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.
- To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program.
- Being tested
- Nutrition program
- Keywords
- inpatient
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition programOther
Nutrition program with twice daily meal delivery up to 90 days post-discharge and food and diet education at discharge.
| Study group | Role | What they receive |
|---|---|---|
| SoC group | No intervention | Standard of care (SOC) |
| Nutrition program (Intervention) | Experimental | Patients in the intervention group will be provided the following two resources in addition to SOC:
1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge).
2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options. Receives: Other: Nutrition program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food insecurity at 60 -days post initial discharge
Primary outcome is whether the participant had food insecurity in the past 30 days, measured at 60-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire.
- Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical)
- Never true, Sometimes true, Often true, Patient refused
- Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical)
- Never true, Sometimes true, Often true, Patient refused
Measured: 60 days from discharge
Secondary outcomes (5)
Food insecurity at 30- and 90- days post post initial discharge
The secondary outcome is whether the participant had food insecurity in the past 30 days, measured at 30-days and 90-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire:
- Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical)
- Never true, Sometimes true, Often true, Patient refused
- Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical)
- Never true, Sometimes true, Often true, Patient refused
Measured: 30-, and 90- days from discharge
Measures of diabetes stress
Feeling overwhelmed by the demands of living with Diabetes measured using ordinal scale with range 1-6.
Measured: 30-,60-, and 90- days from discharge
Measures of hypoglycemia
Whether ever having a low blood sugar (low glucose or hypoglycemic) reaction in the past 4 weeks and number of times having a low blood sugar (low glucose or hypoglycemic) reaction in the past 4 weeks. (ordinal scale: 0, 1-3, 4-7, 8+)
Measured: 30-,60-, and 90- days from discharge
Measures of medication adherence
Proportion of participants who missed their recommended diabetes medication in the past 7 days at least once and the mean number of days that the medication was missed in the past 7 days, measured using measured by participant self-report during survey response collection at 30-,60-, and 90-days post-discharge.
Measured: 30-,60-, and 90- days from discharge
Hospitalization
Proportion of participants having overnight hospitalizations in the past 30 days and mean number of nights with overnight hospitalizations in the past 30 days measured by participant self-report during survey response collection at 30-,60-, and 90-days post-discharge.
Measured: 30-,60-, and 90- days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start7 Oct 2024
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be prospectively randomized into either a nutrition program (intervention), or receiving state-of-the-art standard of care (SOC) in a 4:1 ratio. Patients in the intervention group will be provided the following two resources in addition to SOC: 1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge), 2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neera Ahuja, Stanford University
- Investigators
- Neera Ahuja, MD, Principal investigator, Stanford UniversityChristine Santiago, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329375
- Sponsor's protocol ID
- 72967
- Acronym
- FIRST
- Status last verified
- Apr 2026
- First submitted
- 29 Feb 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Insecurity Reduction & Strategy Team
- ClinicalTrials.gov ID
- NCT06329375
- Acronym / sponsor ID
- FIRST / 72967
- Keywords
- inpatient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 25 Mar 2024 (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 seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:
- To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.
- To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.
- To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be prospectively randomized into either a nutrition program (intervention), or receiving state-of-the-art standard of care (SOC) in a 4:1 ratio. Patients in the intervention group will be provided the following two resources in addition to SOC: 1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge), 2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options
| Arm | Type | Receives |
|---|---|---|
| SoC group | No intervention | –Standard of care (SOC) |
| Nutrition program (Intervention) | Experimental | Other: Nutrition programPatients in the intervention group will be provided the following two resources in addition to SOC: 1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge). 2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Admitted to Stanford Healthcare inpatient unit
- Residence in California at time of enrollment
- Positive Screening for Food Insecurity
- On a Healthcare Plan covered by Mom's Meals.
Key exclusion criteria (5 listed)
- Plans to be discharged to a skilled nursing facility.
- Patients who prefer a language for which a short-form consent is not available.
- No Home Address
- Pregnant Participants.
- No access to refrigerator.
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 |
|---|---|---|
| Nutrition programNutrition program with twice daily meal delivery up to 90 days post-discharge and food and diet education at discharge. | Other | Nutrition program (Intervention) |
Primary outcome
Food insecurity at 60 -days post initial discharge
Time frame: 60 days from discharge
Primary outcome is whether the participant had food insecurity in the past 30 days, measured at 60-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire. 1. Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical) a. Never true, Sometimes true, Often true, Patient refused 2. Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical) 1. Never true, Sometimes true, Often true, Patient refused
5 secondary outcomes
Food insecurity at 30- and 90- days post post initial discharge
Time frame: 30-, and 90- days from discharge
Measures of diabetes stress
Time frame: 30-,60-, and 90- days from discharge
Measures of hypoglycemia
Time frame: 30-,60-, and 90- days from discharge
Measures of medication adherence
Time frame: 30-,60-, and 90- days from discharge
Hospitalization
Time frame: 30-,60-, and 90- days from discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
Neera Ahuja, MD principal investigator
Stanford University
Christine Santiago, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition program in people with Diabetes Mellitus, Type 2 and Food Insecurity, run by Stanford 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 5 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: looking for participants now, as of the sponsor's last update on 11 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Santiago, MD ((650) 725-5071, csantia2@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food insecurity at 60 -days post initial discharge (time frame: 60 days from discharge). 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 11 Aug 2026.