Lifestyle Intervention to Treat Diabetes in the Marshall Islands

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Lifestyle Intervention; Behavioral: Standard of diabetes care

• Registration Number: NCT03862963
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-01
• Primary Completion: 2008-07-31
• Study Completion: 2008-07-31
• Study First Submitted: 2019-03-03
• Study First Submitted QC: 2019-03-03
• Study First Posted: 2019-03-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Lifestyle Intervention	Plant-based, whole foods diet with moderate exercise
Standard of Diabetes Care	Standard of diabetes care	Standard of diabetes care in the Marshall Islands

Primary Outcome Measures

Name	Time	Method
Fasting glucose	Change from Week 0 to Week 24	mg/dl
HOMA-IR	Change from Week 0 to Week 24	Insulin resistance as measured by HOMA-IR
HbA1c	Change from Week 0 to Week 24	Percent
Fasting insulin	Change from Week 0 to Week 24	mU/l
Usage of diabetes medications	Change from Week 0 to Week 24	Number as measured by the medication effect score

Secondary Outcome Measures

Name	Time	Method
High-sensitivity C-reactive protein	Change from Week 0 to Week 24	mg/l
Body weight	Change from Week 0 to Week 24	kg
Cholesterol (total, HDL, LDL) and triglycerides	Change from Week 0 to Week 24	mg/dl
Blood pressure	Change from Week 0 to Week 24	mm Hg
Heart rate	Change from Week 0 to Week 24	beats/min
Waist circumference	Change from Week 0 to Week 24	cm
Body mass index (BMI)	Change from Week 0 to Week 24	kg/m\^2