FDSMEFBO: Family Model Diabetes Self-Management Education in Faith Based Organizations

Sponsor
University of Arkansas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04256486
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
576
Enrollment
2
Arms
39
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Family Model Diabetes Self-Management Education and Support
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
576 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Family Model Diabetes Self-Management Education in Faith Based Organizations
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Family DSMES

Behavioral: Family Model Diabetes Self-Management Education and Support
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.

Experimental: Wait List

Behavioral: Family Model Diabetes Self-Management Education and Support
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.

Outcome Measures

Primary Outcome Measures

  1. Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points [Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention]

    Measured by Change in Adjusted Mean HbA1c(%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, and 24 Months Post-intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • self-reported Marshallese

  • 18 years of age or older

  • have T2D (defined as having an HbA1c equal to or greater than 6.5)

  • have at least one family member willing to take part

Exclusion Criteria:
  • has received DSME in the past five years

  • has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder

  • plans to move out of the geographic region

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Arkansas
  • National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Pearl McElfish, Phd, MDA, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT04256486
Other Study ID Numbers:
  • 229034
  • 1R01MD013852-01
First Posted:
Feb 5, 2020
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Arkansas
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2022