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OpenTrials
Active, Not Recruiting

NCT Number: NCT04949568

Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes

The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Education Patient Engagement Patient Participation Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University

New York, 10010, United States

About this study

This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Self-described Haitian immigrant aged 21 and older
  • Known diagnosis of type 2 diabetes for at least one year
  • Have lived in the US for at least one year
  • Have an HbA1c of 7.5%
  • Willing and able to participate in an individual interview

Exclusion criteria

  • Having a diagnosis of type 1 diabetes
  • Unable to comprehend, consent and or fully participate in the study

Treatment and study plan

Diabetes Self-Management Behaviors

Behavioral

The intervention is to be delivered by an interventionist.

Primary outcomes

  1. Summary of Diabetes of Self-Care Activities Scale (11- item)

    Time frame: (T0) baseline through (T3) 90 days post-intervention

    Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)

  2. Stanford Diabetes Self-Efficacy Scale (8- item)

    Time frame: (T0) baseline through (T3) 90 days post-intervention

    Change in general self-efficacy 1-10, higher scores indicate improvement)

  3. Wrist-worn actigraphy (ActiGraph) to be worn while awake

    Time frame: (T0) baseline through (T3) 90 days post-intervention

    Change in physical activity (Frequent physical activity indicates improvement)

  4. Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro

    Time frame: (T0) baseline through (T3) 90 days post-intervention

    Time in range and glucose variability (More time in range and less glucose variability indicates improvement)

Secondary outcomes

  1. Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6

    Time frame: (T0) baseline through (T3) 90 days post-intervention

    Change in diabetes distress ( 0-6, lower scores indicates improvement)

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Official study title

Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2021
Registry last updated
Jul 22, 2025

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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