A Lifestyle Change Program for Managing Diabetes

NCT ID: NCT07049679

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-06

Study Completion Date

2025-08-06

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of Care - Group B

This group will not participate in the AHD Program. The group participants will continue their routine care but will be invited to all 6 sessions on managing a healthy diet run by the EFNEP team.

Group Type NO_INTERVENTION

No interventions assigned to this group

ActiveHeal Diabetes (AHD) Program - Group A

This group will continue routine care and participate in the AHD Program. AHD Program.

Group Type EXPERIMENTAL

ActiveHeal Diabetes (AHD) Program

Intervention Type BEHAVIORAL

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

Interventions

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ActiveHeal Diabetes (AHD) Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* Comorbidities that limit participation in the specified activities (i.e., stepper exercises, dieting, and dancing).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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298932

Identifier Type: -

Identifier Source: org_study_id

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