Recruiting

Diabetes Intervention

Sponsor:

NYU Langone Health

Code:

NCT06319703

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Diabetes Self-Management Education and Support (DSMES) Videos

Community Health Worker Support (CHW)

Study Details

Brief 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 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

Study ID

NCT06319703

Start date

Dec 29, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants must:

1. self-identify as a Chinese immigrant;
2. be between 18-70 years old,
3. have a diagnosis of T2D in the medical record;
4. have had an appointment with a physician for routine T2D care within the past 12 months;
5. have a most recent HbA1c > or = 8%;
6. be willing to receive brief videos regarding T2D management, and
7. possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.

Exclusion Criteria:

1. unable or unwilling to provide informed consent;
2. unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
3. unwilling to accept randomization assignment;
4. is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study, or
5. is breastfeeding (e.g., they may have potential dietary restrictions).

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: DSMES+CHW (IDEAL)

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.

no intervention: Wait-list control group (CONTROL)

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.

Interventions

Diabetes Self-Management Education and Support (DSMES) Videos

Text message-delivered video-based DSMES intervention.

Community Health Worker Support (CHW)

Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community.

Primary outcome measure

  • Change in Hemoglobin A1C (HbA1c) Test Scores [ Time Frame: Baseline, Month 6 ]
  • Change in Hemoglobin A1C (HbA1c) Test Scores [ Time Frame: Baseline, Month 12 ]

Central Contacts and Locations

Central contacts

Lu Hu, PhD

646-501-3438Lu.hu@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • Mobile Health
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-09.