Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT06319716

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Video-Based Diabetes Self-Management Education and Support (DSMES)

Community Health Worker (CHW) Support

Study Details

Brief summary:

The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese immigrants with uncontrolled Type 2 diabetes in NYC.

Conditions

Type 2 Diabetes

Study ID

NCT06319716

Start date

Dec 29, 2024

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • self-identify as Chinese American;
  • be above 18 years old;
  • have a diagnosis of Type 2 diabetes (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 of at least 7%;
  • 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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: VIDEO

Participants assigned to the VIDEO arm will receive one brief Diabetes Self-Management Education and Support (DSMES) video per week for 24 weeks. The videos will be delivered via text message.

experimental: VIDEO+CHW

Participants assigned to the VIDEO+CHW arm will receive one brief DSMES video per week, in addition to bi-weekly support calls from a community health worker (CHW), for 24 weeks. The DSMES videos will be delivered via text message.

no intervention: CONTROL

Participants assigned to the CONTROL group will continue to receive usual care.

Interventions

Video-Based Diabetes Self-Management Education and Support (DSMES)

The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.

Community Health Worker (CHW) Support

CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.

Primary outcome measure

  • Hemoglobin A1c (HbA1c) Levels [ Time Frame: Baseline ]
  • Hemoglobin A1c (HbA1c) Levels [ Time Frame: Month 6 ]
  • Hemoglobin A1c (HbA1c) Levels [ Time Frame: 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

May 7, 2026

Last verified

May, 2026

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 2026-05-07.