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

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2; Patient Education; Patient Engagement
• Interventions: Behavioral: Diabetes Self-Management Behaviors

• Registration Number: NCT04949568
• Lead Sponsor: New York University

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-02
• Study Start: 2023-08-12
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Self-Management Behaviors	Diabetes Self-Management Behaviors	Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks.

Primary Outcome Measures

Name	Time	Method
Stanford Diabetes Self-Efficacy Scale (8- item)	(T0) baseline through (T3) 90 days post-intervention	Change in general self-efficacy 1-10, higher scores indicate improvement)
Wrist-worn actigraphy (ActiGraph) to be worn while awake	(T0) baseline through (T3) 90 days post-intervention	Change in physical activity (Frequent physical activity indicates improvement)
Summary of Diabetes of Self-Care Activities Scale (11- item)	(T0) baseline through (T3) 90 days post-intervention	Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)
Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro	(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 Outcome Measures

Name	Time	Method
Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6	(T0) baseline through (T3) 90 days post-intervention	Change in diabetes distress ( 0-6, lower scores indicates improvement)

Trial Locations

Locations (1)

New York University; 🇺🇸 New York, New York, United States