Lifestyle Intervention to Treat Diabetes in the Marshall Islands

Study Overview
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Brief Summary
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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.

Official Title
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Lifestyle Intervention Trial to Treat Type 2 Diabetes in the Republic of the Marshall Islands

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Standard of diabetes care
* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel-arm study, although the control group was allowed to crossover after completing the control condition.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Diabetes Care<br>Standard of diabetes care in the Marshall Islands | Behavioral: Standard of diabetes care<br>* The standard of diabetes care consisted of standard treatment protocols used by the MOH Diabetes Clinic. These included placing T2D patients on anti-hyperglycemic agents appropriate to their HbA1c levels (including sulfonylureas, metformin, and insulin) and providing oral and written information about the importance of maintaining a healthy weight, eating a healthy diet, and getting regular exercise. Participants in the control group were instructed not to make changes in their diet and activity levels during the study.<br>|
| Experimental: Lifestyle Intervention<br>Plant-based, whole foods diet with moderate exercise | Behavioral: Lifestyle Intervention<br>* The lifestyle intervention consisted of a high-fiber, low-fat, mostly plant-based diet and 30-60 minutes per day of culturally-relevant, moderate intensity exercise. Participants initially received 12 weeks of group educational classes and some prepared meals and then followed the lifestyle intervention on their own for the remaining 12 weeks. Group classes included informative sessions on healthy eating, exercise (both aerobic and strength training), and stress management, as well as hands-on cooking classes. Classes were delivered as a combination of PowerPoint presentations, practical workshops, dine-outs, shopping tours, and cooking classes with spouses.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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