NCT04949568

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: New York University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetes Mellitus, Type 2
• Patient Engagement
• Patient Education

Interventions

Type	Name	Description
BEHAVIORAL	Diabetes Self-Management Behaviors	The intervention is to be delivered by an interventionist.

Timeline

• Start date: 2023-08-12
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-07-02
• Last updated: 2025-07-22

Locations

1 site across 1 country: United States