A Lifestyle Change Program for Managing Diabetes

NCT07049679 | Withdrawn

• 1 other identifier: 298932
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Occupational Resilience Measure (ORM 1.0)

  a 20-item self-report assessment designed to evaluate occupational resilience, which is the capacity to persist in an occupation despite adversity

  At time of enrollment and week 15

• Diabetes-related quality of Life (RV-DQOL)

  The 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.

  At time of enrollment and week 15

• A1C lab measure

  is 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.

  screening and week 15

Study Arms (2)

Standard of Care - Group B

NO INTERVENTION

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.

ActiveHeal Diabetes (AHD) Program - Group A

EXPERIMENTAL

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

Behavioral: ActiveHeal Diabetes (AHD) Program

Interventions

ActiveHeal Diabetes (AHD) Program BEHAVIORAL

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

ActiveHeal Diabetes (AHD) Program - Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Comorbidities that limit participation in the specified activities (i.e., stepper exercises, dieting, and dancing).

Sponsors & Collaborators

• University of Arkansas: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: August 6, 2025
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share