Implementing an Effective Diabetes Intervention Among Low-Income Immigrants

Type 2 Diabetes Clinical Trial

— IDEAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319703
• Other study ID #: 22-00634
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Lu Hu, PhD
• Phone: 646-501-3438
• Email: Lu.hu[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: March 31, 2028
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Diabetes Self-Management Education and Support (DSMES) Videos
Text message-delivered video-based DSMES intervention.
• Community Health Worker Support (CHW)
Assess participants' SDOH barriers to Type 2 diabetes care and link them to available resources in the community.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1C (HbA1c) Test Scores	Scores 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.	Baseline, Month 6
Primary	Change in Hemoglobin A1C (HbA1c) Test Scores	Scores 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.	Baseline, Month 12
Secondary	Stanford Self-Efficacy for Diabetes Scale Score	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 score is the mean of the 8 items (Range: 1-10); higher scores indicate greater self-efficacy.	Baseline
Secondary	Stanford Self-Efficacy for Diabetes Scale Score	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 score is the mean of the 8 items (Range: 1-10); higher scores indicate greater self-efficacy.	Month 6
Secondary	Stanford Self-Efficacy for Diabetes Scale Score	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 score is the mean of the 8 items (Range: 1-10); higher scores indicate greater self-efficacy.	Month 12
Secondary	Summary of Diabetes Self-Care Activities (SDSCA) Score	11-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.	Baseline
Secondary	Summary of Diabetes Self-Care Activities (SDSCA) Score	11-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.	Month 6
Secondary	Summary of Diabetes Self-Care Activities (SDSCA) Score	11-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.	Month 12
Secondary	Starting the Conversation (STC) Diet Scale Score	8-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.	Baseline
Secondary	Starting the Conversation (STC) Diet Scale Score	8-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.	Month 6
Secondary	Starting the Conversation (STC) Diet Scale Score	8-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.	Month 12
Secondary	National Cancer Institute Dietary Screener Questionnaire Score	27-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.	Baseline
Secondary	National Cancer Institute Dietary Screener Questionnaire Score	27-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.	Month 6
Secondary	National Cancer Institute Dietary Screener Questionnaire Score	27-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.	Month 12
Secondary	International Physical Activity Questionnaire (IPAQ) Short-Version Score	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 scores indicate higher weekly levels of physical activity.	Baseline
Secondary	International Physical Activity Questionnaire (IPAQ) Short-Version Score	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 scores indicate higher weekly levels of physical activity.	Month 6
Secondary	International Physical Activity Questionnaire (IPAQ) Short-Version Score	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 scores indicate higher weekly levels of physical activity.	Month 12