Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Video-Based Diabetes Self-Management Education and Support (DSMES); Behavioral: Community Health Worker (CHW) Support

• Registration Number: NCT06319716
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Study Start: 2024-12-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• self-identify as a Chinese immigrant;
• be between 18-70 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 8%;
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIDEO+CHW	Video-Based Diabetes Self-Management Education and Support (DSMES)	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.
VIDEO+CHW	Community Health Worker (CHW) Support	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.
VIDEO	Video-Based Diabetes Self-Management Education and Support (DSMES)	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c) Levels	Month 12

Secondary Outcome Measures

Name	Time	Method
Stanford Self-Efficacy for Diabetes Scale Score	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.
Starting the Conversation (STC) Diet Scale Score	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.
International Physical Activity Questionnaire (IPAQ) Short-Version Score	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.
Summary of Diabetes Self-Care Activities (SDSCA) Score	Month 12	13-item self-report questionnaire assessing participants' adherence to diabetes self-management behaviors. Participants select the number of days (0 to 7) in the past week they have performed the behavior. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater self-care.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States