LINK-IT: Leveraging vIdeos and commuNity Health worKers to Improve Diabetes OuTcomes
ID: NCT06319716
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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 Americans with uncontrolled type 2 diabetes in NYC.
Read Full Scientific Objectives & Methods
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.
The DSMES videos provide important diabetes education to participants and empower them to become an activated patient on the individual level.
CHWs will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community.
Treatment Arms Description
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.
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.
Participants assigned to the CONTROL group will continue to receive usual care. At the end of the study, they will receive DSMES videos.
- self-identify as ethnically Chinese;
- be above 18 years old;
- have a diagnosis of Type 2 diabetes (T2D) in the medical record;
- have an HbA1c≥7% in the past 12 months
- be willing to participate in video-based interventions; and
- possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.
- 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).
Primary Outcome Measures
- Hemoglobin A1c (HbA1c) Levels — Time Frame: Baseline
- Hemoglobin A1c (HbA1c) Levels — Time Frame: Month 6
- Hemoglobin A1c (HbA1c) Levels — Time Frame: Month 12
View Secondary Outcome Measures (27)
- Stanford Self-Efficacy for Diabetes Scale Score — Time Frame: Baseline
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 can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
- Stanford Self-Efficacy for Diabetes Scale Score — Time Frame: Month 6
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 can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
- Stanford Self-Efficacy for Diabetes Scale Score — Time Frame: Month 12
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 can be calculated by summing the 8 item scores (range, 8-80), with higher scores indicating greater self-efficacy.
- Starting the Conversation (STC) Diet Scale Score — Time Frame: Baseline
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
- Starting the Conversation (STC) Diet Scale Score — Time Frame: Month 6
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
- Starting the Conversation (STC) Diet Scale Score — Time Frame: Month 12
8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; lower scores indicate healthier eating behaviors.
- International Physical Activity Questionnaire (IPAQ) Short-Version Score — Time Frame: Baseline
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.
- International Physical Activity Questionnaire (IPAQ) Short-Version Score — Time Frame: Month 6
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.
- International Physical Activity Questionnaire (IPAQ) Short-Version Score — Time Frame: Month 12
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.
- Adherence to Refills and Medications Scale for Diabetes (ARMS-D) — Time Frame: Baseline
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 11 to 44, with higher scores indicating more problems with medication adherence.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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- 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.PubMed ↗
View Official Medical/Scientific Title
LINK-IT: Leveraging vIdeos and commuNity Health worKers to Improve Diabetes OuTcomes