NCT04949568

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 12, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 22, 2025

Status Verified

October 1, 2024

Enrollment Period

2.4 years

First QC Date

June 25, 2021

Last Update Submit

July 21, 2025

Conditions

Diabetes Mellitus, Type 2Patient EngagementPatient Education

Keywords

Immigrant HealthDiabetes Mellitus, Type 2Metabolic DiseasesSelf-Management BehaviorsHaitian Americans

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

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

    (T0) baseline through (T3) 90 days post-intervention

Study Arms (2)

Diabetes Self-Management Behaviors

EXPERIMENTAL

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

Usual Type 2 Diabetes Care

NO INTERVENTION

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.

Interventions

Diabetes Self-Management BehaviorsBEHAVIORAL

The intervention is to be delivered by an interventionist.

Diabetes Self-Management Behaviors

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University

New York, New York, 10010, United States

Location

Related Publications (1)

  • 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.

    PMID: 34610761BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Patient ParticipationMetabolic Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Cherlie Magny-Normilus, PhD, FNP-BC, FAAN

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Behavioral: Diabetes Self-management behaviors
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 2, 2021

Study Start

August 12, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 22, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)