Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Participants will be randomized with equal allocation to one of the 3 groups. The VIDEO group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The VIDEO+CHW group will receive the same DSMES videos plus bi-weekly support calls from a CHW for 24 weeks. The CHW will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIDEO | Experimental | 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. |
|
| VIDEO+CHW | Experimental | 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. |
|
| CONTROL | No Intervention | Participants assigned to the CONTROL group will continue to receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video-Based Diabetes Self-Management Education and Support (DSMES) | Behavioral | The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) Levels | Baseline | |
| Hemoglobin A1c (HbA1c) Levels | Month 6 | |
| Hemoglobin A1c (HbA1c) Levels | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 total score is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy. | Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Hu, PhD | Contact | 646-501-3438 | Lu.hu@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Lu Hu, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41628090 | Derived | Hu L, Liu J, Yang X, Teng C, Li H, Zhao Y, Levy N, Zhu K, Vang S, Kwon SC, Feldman N, Lau J, Jiang Y, Trinh-Shevrin C, Islam N. Leveraging videos and community health workers to address social determinants of health in immigrants (LINK-IT): Protocol for a randomized controlled trial. PLoS One. 2026 Feb 2;21(2):e0341217. doi: 10.1371/journal.pone.0341217. eCollection 2026. |
Not provided
Not provided
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Lu.hu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Community Health Worker (CHW) Support | Behavioral | CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community. |
|
| 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 total score is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy. | 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 total score is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy. | Month 12 |
| Starting the Conversation (STC) Diet Scale Score | 8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health. | Baseline |
| Starting the Conversation (STC) Diet Scale Score | 8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health. | Month 6 |
| Starting the Conversation (STC) Diet Scale Score | 8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate more dietary behaviors that are consistent with health. | 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 MET scores indicate higher weekly levels of physical activity. | 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 MET scores indicate higher weekly levels of physical activity. | 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 MET scores indicate higher weekly levels of physical activity. | Month 12 |
| Adherence to Refills and Medications Scale for Diabetes (ARMS-D) | ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 12 to 48, with higher scores indicating more problems with medication adherence. | Baseline |
| Adherence to Refills and Medications Scale for Diabetes (ARMS-D) | ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 12 to 48, with higher scores indicating more problems with medication adherence. | Month 6 |
| Adherence to Refills and Medications Scale for Diabetes (ARMS-D) | ARMS-D is an 11-item questionnaire used to assess medication-taking adherence at baseline, 6 months, and 12 months. Responses range from 1 ("none of the time") to 4 ("all of the time"). Item scores are summed to produce an overall adherence score ranging from 12 to 48, with higher scores indicating more problems with medication adherence. | Month 12 |
| Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales | 8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months. Total scores range from 8 to 40, with higher scores indicating greater perceived emotional support. | Baseline |
| Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales | 8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months. Total scores range from 8 to 40, with higher scores indicating greater perceived emotional support. | Month 6 |
| Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales | 8-item subscale to assess individuals' perceptions of empathy and understanding received from others in their social network at baseline, 6 months, and 12 months. Total scores range from 8 to 40, with higher scores indicating greater perceived emotional support. | Month 12 |
| D004700 | Endocrine System Diseases |
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |