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Lifestyle Intervention to Treat Diabetes in the Marshall Islands

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Behavioral: Lifestyle Intervention
Behavioral: Standard of diabetes care

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03862963
IRB-170414009

Details and patient eligibility

About

The Republic of the Marshall Islands has the highest prevalence of type 2 diabetes (T2D) in the world. This clinical trial tested whether a community-based, intensive, plant-rich lifestyle intervention with exercise is more effective for treating and managing T2D in the Republic of the Marshall Islands than the standard of diabetes care. The intensive lifestyle intervention consisted of a plant-rich diet and moderate exercise. It centered around a 12-week program of counseling and instruction on healthy eating, exercise, and stress management, as well as hands-on cooking classes and prepared meals. Cardiometabolic outcomes were assessed throughout the intervention and at 24 weeks. The present study is the first randomized clinical trial ever conducted in the Republic of the Marshall Islands and the first lifestyle intervention trial conducted in Micronesia.

Enrollment

138 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Resident of the Republic of Marshall Islands
  • Aged 18 - 75 years
  • HbA1c ≥ 8.0% or diagnosed with T2D and taking diabetes medication
  • Medical clearance to participate from Diabetes Wellness Center (DWC) physicians.

Exclusion criteria

  • Recent (≤3 months) change in a diabetes-related medication dosage
  • A physical or medical condition that would impede participation in the lifestyle intervention (e.g., wheel-chair bound, unstable angina)
  • Evidence of significant coronary heart disease
  • Previous participation in an intensive lifestyle intervention

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

138 participants in 2 patient groups

Standard of Diabetes Care
Active Comparator group
Description:
Standard of diabetes care in the Marshall Islands
Treatment:
Behavioral: Standard of diabetes care
Lifestyle Intervention
Experimental group
Description:
Plant-based, whole foods diet with moderate exercise
Treatment:
Behavioral: Lifestyle Intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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