Lifestyle Intervention to Treat Diabetes in the Marshall Islands

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

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.

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Loma Linda University

  collaborator OTHER

• Brenda Davis Nutrition Consultation Services

  collaborator UNKNOWN

• Canvasback Missions, Inc.

  collaborator UNKNOWN

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• John H Kelly, M.D. · Loma Linda University; Black Hills Lifestyle Medicine Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-01

Primary Completion

2008-07-31

Completion

2008-07-31