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NCT Number: NCT06319703

Implementing an Effective Diabetes Intervention Among Low-Income Immigrants

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participants must:

  • self-identify as a Chinese immigrant;
  • be between 18-70 years old,
  • have a diagnosis of 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 > or = 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).

Treatment and study plan

Diabetes Self-Management Education and Support (DSMES) Videos

Behavioral

Text message-delivered video-based DSMES intervention.

Community Health Worker Support (CHW)

Behavioral

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

Primary outcomes

  1. Change in Hemoglobin A1C (HbA1c) Test Scores

    Time frame: Baseline, Month 6

    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.

  2. Change in Hemoglobin A1C (HbA1c) Test Scores

    Time frame: Baseline, Month 12

    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.

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 score is the mean of the 8 items (Range: 1-10); 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 score is the mean of the 8 items (Range: 1-10); 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 score is the mean of the 8 items (Range: 1-10); higher scores indicate greater self-efficacy.

  4. Summary of Diabetes Self-Care Activities (SDSCA) Score

    Time frame: Baseline

    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.

  5. Summary of Diabetes Self-Care Activities (SDSCA) Score

    Time frame: Month 6

    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.

  6. Summary of Diabetes Self-Care Activities (SDSCA) Score

    Time frame: Month 12

    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.

  7. Starting the Conversation (STC) Diet Scale Score

    Time frame: Baseline

    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.

  8. 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; higher scores indicate more dietary behaviors that are not consistent with health.

  9. 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; higher scores indicate more dietary behaviors that are not consistent with health.

  10. National Cancer Institute Dietary Screener Questionnaire Score

    Time frame: Baseline

    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.

  11. National Cancer Institute Dietary Screener Questionnaire Score

    Time frame: Month 6

    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.

  12. National Cancer Institute Dietary Screener Questionnaire Score

    Time frame: Month 12

    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.

  13. 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 scores indicate higher weekly levels of physical activity.

  14. 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 scores indicate higher weekly levels of physical activity.

  15. 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 scores indicate higher weekly levels of physical activity.

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

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: IDEAL

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2024
Registry last updated
Mar 9, 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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