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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2; Patient Engagement; Patient Education
• Intervention / Treatment: Behavioral: Diabetes Self-Management Behaviors

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • New York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Diabetes Self-Management Behaviors; The intervention is to be delivered by an interventionist.
No Intervention: Usual Type 2 Diabetes Care; The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Diabetes of Self-Care Activities Scale (11- item)	Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)	(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)	(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)	(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)	(T0) baseline through (T3) 90 days post-intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Cherlie Magny-Normilus, PhD, FNP-BC, FAAN, New York University

Publications and helpful links

General Publications

• Magny-Normilus C, Whittemore R, Wexler DJ, Schnipper JL, Nunez-Smith M, Fu MR. Barriers to Type 2 Diabetes Management Among Older Adult Haitian Immigrants. Sci Diabetes Self Manag Care. 2021 Oct;47(5):382-390. doi: 10.1177/26350106211040435.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, Type 2; Metabolic Diseases; Immigrant Health; Self-Management Behaviors; Haitian Americans
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2024-9103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No