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A Lifestyle Change Program for Managing Diabetes

A Lifestyle Change Program for Managing Diabetes Among the Marshallese in Northwest Arkansas: A Pilot Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07049679
Enrollment
0
Registered
2025-07-03
Start date
2025-08-06
Completion date
2025-08-06
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

The proposed study aims to fill the gap by adapting an evidence-based intervention and conducting a pilot trial to determine the new program's estimated effect sizes on occupational resilience, A1c, and diabetes-related quality of life. Developing and adapting Lifestyle Redesign (LR) for Marshallese diabetes management is significant because it would reduce health disparities in a community that is disproportionately affected by the disease, and a large number of Marshallese (currently approximately 15,000) have resided in the northwest Arkansas region since the 1980s.

Detailed description

To pilot-test AHD Program, a lifestyle change intervention for diabetes management, and obtain estimates of effect sizes on occupational resilience, A1C, and diabetes-related quality of life. It is hypothesized that occupational resilience, diabetes-related quality of life, and A1C will be improved by the end of the program.

Interventions

BEHAVIORALActiveHeal Diabetes (AHD) Program

Biweekly phone/Zoom calls to support physical activity and dietary behavior change, focused on history, experience, benefits and adaptation

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Marshallese Adults * type 2 diabetes and test results (within 30 days) showing A1C greater than 6.4% or Estimated Average Glucose greater than 137 mg/dL. * Able (and willing) to participate in exercise, diet management, and group dancing.

Exclusion criteria

* Marshallese who otherwise meet inclusion criteria but are not willing to commit to active participation in a lifestyle change intervention. * Comorbidities that limit participation in the specified activities (i.e., stepper exercises, dieting, and dancing).

Design outcomes

Primary

MeasureTime frameDescription
Occupational Resilience Measure (ORM 1.0)At time of enrollment and week 15a 20-item self-report assessment designed to evaluate occupational resilience, which is the capacity to persist in an occupation despite adversity
Diabetes-related quality of Life (RV-DQOL)At time of enrollment and week 15The primary objective of the RV-DQoL is to measure various aspects of quality of life affected by diabetes, including: Satisfaction: Assessing patient satisfaction with different aspects of their life, including time spent managing diabetes and receiving checkups, current treatment, knowledge about diabetes, body appearance, and overall life satisfaction. Impact: Evaluating the extent to which diabetes impacts daily life, including feelings of physical illness or pain related to treatment, embarrassment related to managing diabetes in public, and interference with family life. Worry: Assessing the degree of worry related to diabetes, such as passing out due to low blood sugar, changes in body appearance, and the potential for developing complications.
A1C lab measurescreening and week 15is a blood test that measures your average blood sugar (glucose) levels over the past two to three months. It works by measuring the amount of glucose attached to hemoglobin, a protein in your red blood cells responsible for carrying oxygen.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026