Type 2 DiabetesIDEALNCT06319703
Implementing an Effective Diabetes Intervention Among Low-Income Immigrants
A study testing Diabetes Self-Management Education and Support (DSMES) Videos and Community Health Worker Support (CHW) in people with Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diabetes Self-Management Education and Support (DSMES) Videos and Community Health Worker Support (CHW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2024to 30 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must:
- self-identify as a Chinese immigrant;
- be between 18-70 years old,
- have a diagnosis of T2D in the medical record;
- have had an appointment with a physician for routine T2D care within the past 12 months;
- have a most recent HbA1c > or = 8%;
- be willing to receive brief videos regarding T2D management, and
- possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.
Who cannot join
- unable or unwilling to provide informed consent;
- unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
- unwilling to accept randomization assignment;
- is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study, or
- is breastfeeding (e.g., they may have potential dietary restrictions).
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
NYU Langone Health
New York, New York, 10016
About this study
Official title: IDEAL: Implementing an Effective Diabetes intervEntion Among Low-income Immigrants
The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos.
- Conditions
- Type 2 Diabetes
- Being tested
- Diabetes Self-Management Education and Support (DSMES) Videos, Community Health Worker Support (CHW)
- Keywords
- Mobile Health, mHealth
- 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.
Diabetes Self-Management Education and Support (DSMES) VideosBehavioural
Text message-delivered video-based DSMES intervention.
Community Health Worker Support (CHW)Behavioural
Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community.
| Study group | Role | What they receive |
|---|---|---|
| DSMES+CHW (IDEAL) | Experimental | Participants in this group will receive brief pre-recorded DSMES videos, which include both educational and Social Cognitive Theory-based behavioral content. Participants will receive 1 DSMES video via text message each week for a total of 24 weeks with each video lasting about 5 minutes in duration. In addition, they will also receive brief phone calls from CHWs every 2 weeks during the 24 weeks video program. During these calls, CHWs will assess whether participants need assistance on social determinants of health (SDOH) barriers. If needed, CHWs will link participants to available services within the community. CHWs will also provide assistance on navigating the complex health care systems and serve as an advocate for patients during doctor visits if needed. Receives: Behavioral: Diabetes Self-Management Education and Support (DSMES) Videos; Behavioral: Community Health Worker Support (CHW) |
| Wait-list control group (CONTROL) | No intervention | Participants in this group will continue to receive the standard of usual care for their T2D at their doctor's office during the course of our study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C (HbA1c) Test Scores
Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin.
Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.
Measured: Baseline, Month 6
Change in Hemoglobin A1C (HbA1c) Test Scores
Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin.
Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.
Measured: Baseline, Month 12
Secondary outcomes (15)
Stanford Self-Efficacy for Diabetes Scale Score
8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident).
The score is the mean of the 8 items (Range: 1-10); higher scores indicate greater self-efficacy.
Measured: Baseline
Stanford Self-Efficacy for Diabetes Scale Score
8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident).
The score is the mean of the 8 items (Range: 1-10); higher scores indicate greater self-efficacy.
Measured: Month 6
Stanford Self-Efficacy for Diabetes Scale Score
8-item self-assessment of participants' confidence level in performing specific self-management behaviors. Items are ranked on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident).
The score is the mean of the 8 items (Range: 1-10); higher scores indicate greater self-efficacy.
Measured: Month 12
Summary of Diabetes Self-Care Activities (SDSCA) Score
11-item self-report questionnaire assessing participants' adherence to diabetes self-management behaviors. Participants select the number of days (0 to 7) in the past week they have performed the behavior.
The result is an average score between 0 and 7; higher scores indicate better diabetes self-management behavior.
Measured: Baseline
Summary of Diabetes Self-Care Activities (SDSCA) Score
11-item self-report questionnaire assessing participants' adherence to diabetes self-management behaviors. Participants select the number of days (0 to 7) in the past week they have performed the behavior.
The result is an average score between 0 and 7; higher scores indicate better diabetes self-management behavior.
Measured: Month 6
Summary of Diabetes Self-Care Activities (SDSCA) Score
11-item self-report questionnaire assessing participants' adherence to diabetes self-management behaviors. Participants select the number of days (0 to 7) in the past week they have performed the behavior.
The result is an average score between 0 and 7; higher scores indicate better diabetes self-management behavior.
Measured: Month 12
Starting the Conversation (STC) Diet Scale Score
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; higher scores indicate more dietary behaviors that are not consistent with health.
Measured: Baseline
Starting the Conversation (STC) Diet Scale Score
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; higher scores indicate more dietary behaviors that are not consistent with health.
Measured: Month 6
Starting the Conversation (STC) Diet Scale Score
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; higher scores indicate more dietary behaviors that are not consistent with health.
Measured: Month 12
National Cancer Institute Dietary Screener Questionnaire Score
27-item self-assessment of frequency of consumption of selected foods and drinks over the past month.
The scoring procedure converts responses to estimates of individual dietary intake for: Fruits and Vegetables (cup equivalents); Dairy (cup equivalents); Added Sugars (teaspoon equivalents); Whole Grains (ounce equivalents); Fiber (grams); and Calcium (milligrams). Higher scores indicate higher consumption of the food item.
Measured: Baseline
National Cancer Institute Dietary Screener Questionnaire Score
27-item self-assessment of frequency of consumption of selected foods and drinks over the past month.
The scoring procedure converts responses to estimates of individual dietary intake for: Fruits and Vegetables (cup equivalents); Dairy (cup equivalents); Added Sugars (teaspoon equivalents); Whole Grains (ounce equivalents); Fiber (grams); and Calcium (milligrams). Higher scores indicate higher consumption of the food item.
Measured: Month 6
National Cancer Institute Dietary Screener Questionnaire Score
27-item self-assessment of frequency of consumption of selected foods and drinks over the past month.
The scoring procedure converts responses to estimates of individual dietary intake for: Fruits and Vegetables (cup equivalents); Dairy (cup equivalents); Added Sugars (teaspoon equivalents); Whole Grains (ounce equivalents); Fiber (grams); and Calcium (milligrams). Higher scores indicate higher consumption of the food item.
Measured: Month 12
International Physical Activity Questionnaire (IPAQ) Short-Version Score
Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity.
Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity.
The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.
Higher scores indicate higher weekly levels of physical activity.
Measured: Baseline
International Physical Activity Questionnaire (IPAQ) Short-Version Score
Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity.
Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity.
The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.
Higher scores indicate higher weekly levels of physical activity.
Measured: Month 6
International Physical Activity Questionnaire (IPAQ) Short-Version Score
Self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity.
Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity.
The formula for calculating MET is as follows: 8(vigorous activity)(minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes) = MET.
Higher scores indicate higher weekly levels of physical activity.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start29 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Lu Hu, PhD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319703
- Sponsor's protocol ID
- 22-00634
- Acronym
- IDEAL
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Lu.hu@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDEAL: Implementing an Effective Diabetes intervEntion Among Low-income Immigrants
- ClinicalTrials.gov ID
- NCT06319703
- Acronym / sponsor ID
- IDEAL / 22-00634
- Conditions
- Type 2 Diabetes
- Keywords
- Mobile Health, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 29 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 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.
The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSMES+CHW (IDEAL) | Experimental | Behavioral: Diabetes Self-Management Education and Support (DSMES) Videos, Behavioral: Community Health Worker Support (CHW)Participants in this group will receive brief pre-recorded DSMES videos, which include both educational and Social Cognitive Theory-based behavioral content. Participants will receive 1 DSMES video via text message each week for a total of 24 weeks with each video lasting about 5 minutes in duration. In addition, they will also receive brief phone calls from CHWs every 2 weeks during the 24 weeks video program. During these calls, CHWs will assess whether participants need assistance on social determinants of health (SDOH) barriers. If needed, CHWs will link participants to available services within the community. CHWs will also provide assistance on navigating the complex health care systems and serve as an advocate for patients during doctor visits if needed. |
| Wait-list control group (CONTROL) | No intervention | –Participants in this group will continue to receive the standard of usual care for their T2D at their doctor's office during the course of our study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- self-identify as a Chinese immigrant;
- be between 18-70 years old,
- have a diagnosis of T2D in the medical record;
- have had an appointment with a physician for routine T2D care within the past 12 months;
- have a most recent HbA1c > or = 8%;
Key exclusion criteria (5 listed)
- unable or unwilling to provide informed consent;
- unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
- unwilling to accept randomization assignment;
- is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study, or
- is breastfeeding (e.g., they may have potential dietary restrictions).
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 |
|---|---|---|
| Diabetes Self-Management Education and Support (DSMES) VideosText message-delivered video-based DSMES intervention. | Behavioural | DSMES+CHW (IDEAL) |
| Community Health Worker Support (CHW)Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community. | Behavioural | DSMES+CHW (IDEAL) |
Primary outcome
Change in Hemoglobin A1C (HbA1c) Test Scores
Time frame: Baseline, Month 6
Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin. Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.
Change in Hemoglobin A1C (HbA1c) Test Scores
Time frame: Baseline, Month 12
Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin. Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.
15 secondary outcomes
Stanford Self-Efficacy for Diabetes Scale Score
Time frame: Baseline
Stanford Self-Efficacy for Diabetes Scale Score
Time frame: Month 6
Stanford Self-Efficacy for Diabetes Scale Score
Time frame: Month 12
Summary of Diabetes Self-Care Activities (SDSCA) Score
Time frame: Baseline
Summary of Diabetes Self-Care Activities (SDSCA) Score
Time frame: Month 6
Summary of Diabetes Self-Care Activities (SDSCA) Score
Time frame: Month 12
Starting the Conversation (STC) Diet Scale Score
Time frame: Baseline
Starting the Conversation (STC) Diet Scale Score
Time frame: Month 6
Starting the Conversation (STC) Diet Scale Score
Time frame: Month 12
National Cancer Institute Dietary Screener Questionnaire Score
Time frame: Baseline
National Cancer Institute Dietary Screener Questionnaire Score
Time frame: Month 6
National Cancer Institute Dietary Screener Questionnaire Score
Time frame: Month 12
International Physical Activity Questionnaire (IPAQ) Short-Version Score
Time frame: Baseline
International Physical Activity Questionnaire (IPAQ) Short-Version Score
Time frame: Month 6
International Physical Activity Questionnaire (IPAQ) Short-Version Score
Time frame: Month 12
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 9 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Lu.hu@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Lu Hu, PhD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self-Management Education and Support (DSMES) Videos and Community Health Worker Support (CHW) 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 8 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 9 Mar 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 Lu Hu, PhD (646-501-3438, Lu.hu@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1C (HbA1c) Test Scores (time frame: Baseline, Month 6). 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?
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 9 Mar 2026.