Type 2 DiabetesNCT07219667
South Asians With Type 2 Diabetes at Risk for Depression
A study testing CHW-led T2D Intervention in people with Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will adapt a community health worker (CHW)-led Type 2 diabetes (T2D) intervention to include mental health and digital components using a trauma informed care approach, and test the feasibility and acceptability of this intervention to support South Asians with T2D at risk for depression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CHW-led T2D Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2027to 1 Jun 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aim 1 (Qualitative Component):
- South Asian ethnicity based on self-report information
- 18 years of age or older
- Residing in NYC
- Willingness and capacity to provide consent
- Aim 3: Pilot Intervention:
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- South Asian ethnicity based on patient demographic information
- 18 to 75 years of age
- Appointment for routine non-emergent primary care in the past 12 months
- Diagnosis of Type 2 diabetes
- Patient Health Questionnaire-9 (PHQ-9) score of ≥5 (mild to severe depression)
- Residing in NYC
- Willingness and capacity to provide consent
Who cannot join
- Aim 1 (Qualitative Component):
- Diagnosed cognitive deficits or limited decision-making capacity
- Aim 3: Pilot Intervention:
- Pregnant at the time of screening
- Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency)
- Malignancy or life-threatening illness with a life expectancy of <5 years
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- Inability to perform unsupervised physical activity
- Diagnosed cognitive deficits or limited decision-making capacity
- Currently taking anti-depressant medication or receiving counseling services.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Community-Engaged Approach to Supporting South Asians With Type 2 Diabetes at Risk for Depression
This study will adapt a community health worker (CHW)-led Type 2 diabetes (T2D) intervention to include mental health and digital components using a trauma informed care approach, and test the feasibility and acceptability of this intervention to support South Asians with T2D at risk for depression.
Read the detailed description
Specific Aim 1: Examine factors associated with distress, poor mental health, and comorbid T2D and depression among South Asians to inform pilot study structure and content.
Specific Aim 2: Adapt CHW-led T2D intervention to include mental health and digital components using a trauma-informed care approach and the ecological validity model.
Specific Aim 3: Evaluate the feasibility and acceptability of a pilot CHW-led intervention to support participants with T2D who are at risk for depression.
- Conditions
- Type 2 Diabetes
- Being tested
- CHW-led T2D 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.
CHW-led T2D InterventionBehavioural
CHW-led T2D intervention that includes mental health and digital health components.
| Study group | Role | What they receive |
|---|---|---|
| Adult South Asian patients in the New York City (NYC) region | Experimental | In Aim 3, CHWs will provide culturally and linguistically tailored health education to South Asian participants on the management of T2D and depressive symptoms. Receives: Behavioral: CHW-led T2D Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c Levels
Change in glycated hemoglobin (HbA1c).
Measured: Baseline, Month 3
Change in Diabetes Distress Scale (DDS) Score
The Diabetes Distress Scale (DDS) is a 17-item psychological questionnaire designed to assess the emotional and psychological distress experienced by individuals with diabetes. Each item is rated on a scale of 0 to 6. The total score is calculated by summing up the scores of all 17 items and ranges from 0-102; higher scores indicate greater distress.
Measured: Baseline, Month 3
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 is a 9-item questionnaire to assess depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. Higher scores indicate greater severity of depression.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start1 Aug 2027 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naheed Ahmed, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219667
- Sponsor's protocol ID
- 25-00438
- Other IDs
- 1K01DK140613-01A1
- Status last verified
- May 2026
- First submitted
- 21 Oct 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, will be shared with researchers who provide a methodologically sound proposals, provided the requesting researcher executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Study data will be deposited into the repository at the time of an associated study publication or end of performance period, whichever comes first. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Engaged Approach to Supporting South Asians With Type 2 Diabetes at Risk for Depression
- ClinicalTrials.gov ID
- NCT07219667
- Acronym / sponsor ID
- 25-00438
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 22 Oct 2025 (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 will adapt a community health worker (CHW)-led Type 2 diabetes (T2D) intervention to include mental health and digital components using a trauma informed care approach, and test the feasibility and acceptability of this intervention to support South Asians with T2D at risk for depression.
Detailed description
Specific Aim 1: Examine factors associated with distress, poor mental health, and comorbid T2D and depression among South Asians to inform pilot study structure and content.
Specific Aim 2: Adapt CHW-led T2D intervention to include mental health and digital components using a trauma-informed care approach and the ecological validity model.
Specific Aim 3: Evaluate the feasibility and acceptability of a pilot CHW-led intervention to support participants with T2D who are at risk for depression.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult South Asian patients in the New York City (NYC) region | Experimental | Behavioral: CHW-led T2D InterventionIn Aim 3, CHWs will provide culturally and linguistically tailored health education to South Asian participants on the management of T2D and depressive symptoms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- South Asian ethnicity based on self-report information
- 18 years of age or older
- Residing in NYC
- Willingness and capacity to provide consent
- South Asian ethnicity based on patient demographic information
Key exclusion criteria (9 listed)
- Diagnosed cognitive deficits or limited decision-making capacity
- Pregnant at the time of screening
- Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency)
- Malignancy or life-threatening illness with a life expectancy of <5 years
- Inability to perform unsupervised physical activity
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 |
|---|---|---|
| CHW-led T2D InterventionCHW-led T2D intervention that includes mental health and digital health components. | Behavioural | Adult South Asian patients in the New York City (NYC) region |
Primary outcome
Change in HbA1c Levels
Time frame: Baseline, Month 3
Change in glycated hemoglobin (HbA1c).
Change in Diabetes Distress Scale (DDS) Score
Time frame: Baseline, Month 3
The Diabetes Distress Scale (DDS) is a 17-item psychological questionnaire designed to assess the emotional and psychological distress experienced by individuals with diabetes. Each item is rated on a scale of 0 to 6. The total score is calculated by summing up the scores of all 17 items and ranges from 0-102; higher scores indicate greater distress.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, Month 3
The PHQ-9 is a 9-item questionnaire to assess depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27. Higher scores indicate greater severity of depression.
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 19 May 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, will be shared with researchers who provide a methodologically sound proposals, provided the requesting researcher executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Study data will be deposited into the repository at the time of an associated study publication or end of performance period, whichever comes first. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Naheed Ahmed, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW-led T2D Intervention in people with Type 2 Diabetes, run by NYU Langone Health 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 13 inclusion and 9 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: opening soon, as of the sponsor's last update on 19 May 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 Naheed Ahmed, PhD (646-501-3751, Naheed.Ahmed@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c Levels (time frame: Baseline, Month 3). The study lists 3 primary outcomes in all. 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 19 May 2026.