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Recruiting NCT06319703

Implementing an Effective Diabetes Intervention Among Low-Income Immigrants

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diabetes Self-Management Education and Support (DSMES) Videos, Community Health Worker Support (CHW).
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Change in Hemoglobin A1C (HbA1c) Test Scores [Time frame: Baseline, Month 6]
  • Change in Hemoglobin A1C (HbA1c) Test Scores [Time frame: Baseline, Month 12]
Secondary outcome measures (12)
  • Stanford Self-Efficacy for Diabetes Scale Score [Time frame: Baseline]
  • Stanford Self-Efficacy for Diabetes Scale Score [Time frame: Month 6]
  • Stanford Self-Efficacy for Diabetes Scale Score [Time frame: Month 12]
  • Summary of Diabetes Self-Care Activities (SDSCA) Score [Time frame: Baseline]
  • Summary of Diabetes Self-Care Activities (SDSCA) Score [Time frame: Month 6]
  • Summary of Diabetes Self-Care Activities (SDSCA) Score [Time frame: Month 12]
  • Starting the Conversation (STC) Diet Scale Score [Time frame: Baseline]
  • Starting the Conversation (STC) Diet Scale Score [Time frame: Month 6]
  • Starting the Conversation (STC) Diet Scale Score [Time frame: Month 12]
  • National Cancer Institute Dietary Screener Questionnaire Score [Time frame: Baseline]
  • National Cancer Institute Dietary Screener Questionnaire Score [Time frame: Month 6]
  • National Cancer Institute Dietary Screener Questionnaire Score [Time frame: Month 12]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06319703 · 22-00634

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗