Lifestyle Intervention to Treat Diabetes in the Marshall Islands

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Standard of diabetes care; Behavioral: Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Diabetes Care; Standard of diabetes care in the Marshall Islands	Behavioral: Standard of diabetes care; 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.
Experimental: Lifestyle Intervention; Plant-based, whole foods diet with moderate exercise	Behavioral: Lifestyle Intervention; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: United States Department of Defense; Loma Linda University; Brenda Davis Nutrition Consultation Services; Canvasback Missions, Inc.
• Investigators: Principal Investigator: John H Kelly, M.D., Loma Linda University; Black Hills Lifestyle Medicine Center

Publications and helpful links

General Publications

• Davis BC, Jamshed H, Peterson CM, Sabate J, Harris RD, Koratkar R, Spence JW, Kelly JH Jr. An Intensive Lifestyle Intervention to Treat Type 2 Diabetes in the Republic of the Marshall Islands: Protocol for a Randomized Controlled Trial. Front Nutr. 2019 Jun 5;6:79. doi: 10.3389/fnut.2019.00079. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2006
• Primary Completion (Actual): July 31, 2008
• Study Completion: July 31, 2008

Study Registration Dates

• First Submitted: March 3, 2019
• First Submitted That Met QC Criteria: March 3, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB-170414009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No