Type 2 Diabetes Mellitus
Conditions
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.
Interventions
BEHAVIORALStandard 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.
BEHAVIORALLifestyle 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
United States Department of Defense
Loma Linda University
Brenda Davis Nutrition Consultation Services
Canvasback Missions, Inc.
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel-arm study, although the control group was allowed to crossover after completing the control condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | Change from Week 0 to Week 24 | mg/dl |
| HbA1c | Change from Week 0 to Week 24 | Percent |
| Fasting insulin | Change from Week 0 to Week 24 | mU/l |
| HOMA-IR | Change from Week 0 to Week 24 | Insulin resistance as measured by HOMA-IR |
| Usage of diabetes medications | Change from Week 0 to Week 24 | Number as measured by the medication effect score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) | Change from Week 0 to Week 24 | kg/m\^2 |
| Cholesterol (total, HDL, LDL) and triglycerides | Change from Week 0 to Week 24 | mg/dl |
| Waist circumference | Change from Week 0 to Week 24 | cm |
| Blood pressure | Change from Week 0 to Week 24 | mm Hg |
| Heart rate | Change from Week 0 to Week 24 | beats/min |
| High-sensitivity C-reactive protein | Change from Week 0 to Week 24 | mg/l |
| Body weight | Change from Week 0 to Week 24 | kg |
Outcome results
None listed