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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
40
The intervention is to be delivered by an interventionist.
New York University
New York, New York, United States
Summary of Diabetes of Self-Care Activities Scale (11- item)
Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)
Time frame: (T0) baseline through (T3) 90 days post-intervention
Stanford Diabetes Self-Efficacy Scale (8- item)
Change in general self-efficacy 1-10, higher scores indicate improvement)
Time frame: (T0) baseline through (T3) 90 days post-intervention
Wrist-worn actigraphy (ActiGraph) to be worn while awake
Change in physical activity (Frequent physical activity indicates improvement)
Time frame: (T0) baseline through (T3) 90 days post-intervention
Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro
Time in range and glucose variability (More time in range and less glucose variability indicates improvement)
Time frame: (T0) baseline through (T3) 90 days post-intervention
Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6
Change in diabetes distress ( 0-6, lower scores indicates improvement)
Time frame: (T0) baseline through (T3) 90 days post-intervention
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