Clinical trial NCT06319703: Implementing an Effective Diabetes Intervention Among Low-Income Immigrants
Official title: IDEAL: Implementing an Effective Diabetes intervEntion Among Low-income Immigrants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Mobile Health
mHealth
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-03-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D 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.


Eligibility criteria: Inclusion Criteria:

Participants must:

1. self-identify as a Chinese immigrant;
2. be between 18-70 years old,
3. have a diagnosis of T2D in the medical record;
4. have had an appointment with a physician for routine T2D care within the past 12 months;
5. have a most recent HbA1c \> or = 8%;
6. be willing to receive brief videos regarding T2D management, and
7. possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.

Exclusion Criteria:

1. unable or unwilling to provide informed consent;
2. unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
3. unwilling to accept randomization assignment;
4. is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study, or
5. is breastfeeding (e.g., they may have potential dietary restrictions).

Primary outcomes:
measure: Change in Hemoglobin A1C (HbA1c) Test Scores
timeFrame: Baseline, Month 6
measure: Change in Hemoglobin A1C (HbA1c) Test Scores
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Stanford Self-Efficacy for Diabetes Scale Score
timeFrame: Baseline
measure: Stanford Self-Efficacy for Diabetes Scale Score
timeFrame: Month 6
measure: Stanford Self-Efficacy for Diabetes Scale Score
timeFrame: Month 12
measure: Summary of Diabetes Self-Care Activities (SDSCA) Score
timeFrame: Baseline
measure: Summary of Diabetes Self-Care Activities (SDSCA) Score
timeFrame: Month 6
measure: Summary of Diabetes Self-Care Activities (SDSCA) Score
timeFrame: Month 12
measure: Starting the Conversation (STC) Diet Scale Score
timeFrame: Baseline
measure: Starting the Conversation (STC) Diet Scale Score
timeFrame: Month 6
measure: Starting the Conversation (STC) Diet Scale Score
timeFrame: Month 12
measure: National Cancer Institute Dietary Screener Questionnaire Score
timeFrame: Baseline
measure: National Cancer Institute Dietary Screener Questionnaire Score
timeFrame: Month 6
measure: National Cancer Institute Dietary Screener Questionnaire Score
timeFrame: Month 12
measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score
timeFrame: Month 6
measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score
timeFrame: Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Lu Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References: