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Implementing an Effective Diabetes Intervention Among Low-Income Immigrants

IDEAL: Implementing an Effective Diabetes intervEntion Among Low-income Immigrants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06319703
Acronym
IDEAL
Enrollment
270
Registered
2024-03-20
Start date
2024-12-29
Completion date
2028-06-30
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Mobile Health, mHealth

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.

Interventions

BEHAVIORALDiabetes Self-Management Education and Support (DSMES) Videos

Text message-delivered video-based DSMES intervention.

Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community.

Sponsors

NYU Langone Health
Lead SponsorOTHER
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Hemoglobin A1C (HbA1c) Test ScoresBaseline, Month 6Scores expressed as a percentage of red blood cells that have sugar-coated hemoglobin. Patients with Type 2 Diabetes receive a HbA1c blood test at their doctors' office every 3-6 months as part of usual care; testing results will be abstracted from the medical record at the participant's health care facility to minimize participant burden.

Secondary

MeasureTime frameDescription
Stanford Self-Efficacy for Diabetes Scale ScoreBaseline8-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 score is the mean of the 8 items (Range: 1-10); higher scores indicate greater self-efficacy.
Summary of Diabetes Self-Care Activities (SDSCA) ScoreBaseline11-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 result is an average score between 0 and 7; higher scores indicate better diabetes self-management behavior.
Starting the Conversation (STC) Diet Scale ScoreBaseline8-item self-report questionnaire measuring dietary behaviors. Scores range from 0 to 16; higher scores indicate more dietary behaviors that are not consistent with health.
National Cancer Institute Dietary Screener Questionnaire ScoreBaseline27-item self-assessment of frequency of consumption of selected foods and drinks over the past month. The scoring procedure converts responses to estimates of individual dietary intake for: Fruits and Vegetables (cup equivalents); Dairy (cup equivalents); Added Sugars (teaspoon equivalents); Whole Grains (ounce equivalents); Fiber (grams); and Calcium (milligrams). Higher scores indicate higher consumption of the food item.
International Physical Activity Questionnaire (IPAQ) Short-Version ScoreBaselineSelf-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 scores indicate higher weekly levels of physical activity.

Countries

United States

Contacts

CONTACTLu Hu, PhD
Lu.hu@nyulangone.org646-501-3438
PRINCIPAL_INVESTIGATORLu Hu, PhD

NYU School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026