Family Model DSME in FBOs in the RMI

Sponsor
University of Arkansas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05502016
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
288
1
2
51
5.6

Study Details

Study Description

Brief Summary

Health disparities in the Republic of the Marshall Islands are striking, with extremely high rates of type 2 diabetes. Documented prevalence of type 2 diabetes in the Marshall Islands ranges from 20%-50%.This is significantly higher than the global (8.5%) and United States (11%) prevalence. Diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. Diabetes self-management education and support is critical for persons with diabetes. This study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in Marshallese by trained community health workers. The study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. The primary study outcome will be glycemic control as measured by HbA1c. Secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. Survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. The control arm of the study will have two pre-intervention data collections before beginning the intervention. Data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family Model Diabetes Self-Management Education and Support
  • Behavioral: Family Model Diabetes Self-Management Education and Support (Wait-list)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Family model diabetes self-management education and support

Behavioral: Family Model Diabetes Self-Management Education and Support
Participants assigned to this arm receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.

Active Comparator: Wait-list Control

Family model diabetes self-management education and support

Behavioral: Family Model Diabetes Self-Management Education and Support (Wait-list)
Participants assigned to this arm will wait approximately 12 weeks to receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.

Outcome Measures

Primary Outcome Measures

  1. Glycemic control, measured by change in mean HbA1c (%) from baseline [Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention]

    Point of care tests will be utilized to calculate HbA1c levels for each participant. The primary outcome measure is change in mean HbA1c (%) from baseline to immediate post-intervention, 4 months post-intervention, and 12 months post-intervention. Analyses will be adjusted for baseline HbA1c, sex, age, education, marital status, employment status, use of diabetes medications, and clustering of participants within churches.

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 type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)

  • have at least one family member willing to take part in the study

Exclusion Criteria:
  • has received diabetes self-management education 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

Site City State Country Postal Code
1 UAMS Community Health and Research Springdale Arkansas United States 72764

Sponsors and Collaborators

  • University of Arkansas
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Pearl McElfish, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT05502016
Other Study ID Numbers:
  • 263202
First Posted:
Aug 16, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022