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NCT Number: NCT06319716

LINK-IT: Leveraging vIdeos and commuNity Health worKers to Improve Diabetes OuTcomes

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Hemoglobin A1c (HbA1c) Levels

    Time frame: Baseline

  2. Hemoglobin A1c (HbA1c) Levels

    Time frame: Month 6

  3. Hemoglobin A1c (HbA1c) Levels

    Time frame: Month 12

Secondary outcomes

  1. 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 is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.

  2. 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 is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.

  3. 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 is the average of all scores and ranges from 1-10; where higher scores indicate greater self-efficacy.

  4. 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 more dietary behaviors that are consistent with health.

  5. 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 more dietary behaviors that are consistent with health.

  6. 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 more dietary behaviors that are consistent with health.

  7. 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.

  8. 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.

  9. 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.

  10. 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 12 to 48, with higher scores indicating more problems with medication adherence.

  11. Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

    Time frame: Month 6

    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.

  12. Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

    Time frame: Month 12

    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.

  13. Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

    Time frame: Baseline

    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.

  14. Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

    Time frame: Month 6

    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.

  15. Emotional Support Subscale from the NIH Toolbox Adult Social Relationship Scales

    Time frame: Month 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Hu, PhD

CONTACT

[email protected]

646-501-3438

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: LINK-IT

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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