An interventional study of CHW-enabled CCL and Mobile health (mHealth) diabetes self-management education and support (DSMES) videos in Type2 Diabetes Mellitus, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Other
The purpose of this study is to evaluate a multi-level approach to improve diabetes control via access to social service supports and online, culturally-tailored diabetes self-management education and support (DSMES) videos among a community of primarily Chinese and Latino/a immigrants. The study aims to assess patient uptake, provider adoption, and INSPIRE program acceptability, appropriateness, feasibility, fidelity, penetration/reach, and maintenance.
In stage 1, the 8 family health center (FHC) clinics will be randomized 1:1 into Experimental Cohort A, which will receive the Community Health Worker (CHW)-enabled community-clinic linkage model (CCL) or Control Cohort B, with FHCs that will not receive the CHW-enabled CCL. Then, in stage 2, patients in clinics that received the CHW-enabled CCL will be randomized in a 1:1 ratio to Arm A who will receive text-based mhealth diabetes education videos or Arm B who will not receive mhealth.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 480 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be eligible to participate in this study, the patient participant must meet all the following criteria:
For patient participants randomized to the mHealth cohort, they must meet the below inclusion criteria
1. Willing to receive text messages with brief videos regarding T2DM management
Exclusion Criteria:
For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will receive 24 culturally tailored diabetes education videos via text message.
Behavioral: CHW-enabled CCL · Behavioral: Mobile health (mHealth) diabetes self-management education and support (DSMES) videos
For the first 6 months participants will receive CHW-enabled services from their clinic. Over the next 6 months participants will continue to receive standard of care (SOC).
Behavioral: CHW-enabled CCL
For 12 months participants will be followed as they receive SOC from their clinic.
The FHCs has access to the CHW-enabled CCL. With this intervention, participants will be screened for social determinants of health (SDoH) and be referred to care and social services that address any identified needs.
Participants will receive 24 culturally tailored DSMES videos through text message.
Change in HbA1c levels
Time frame: Baseline, Month 6
Level of satisfaction with community-clinic linkage (CCL) and mHealth
Participants are asked to rate satisfaction on a scale of 1 (not satisfied at all) to 10 (very satisfied).
Time frame: Month 12
Percentage of patients accepting Community Health Worker (CHW) support
Time frame: Month 12
Percentage of patients accepting mHealth
Time frame: Month 12
Percent completion of social service referrals
Time frame: Month 6
Percent mhealth videos watched
Time frame: Month 12
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator 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). Requests should be directed to: Brita.Roy@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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