Lifestyle Intervention to Treat Diabetes in the Marshall Islands

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862963
• Other study ID #: IRB-170414009
• Status: Completed
• Phase: N/A
• Start date: June 1, 2006
• Est. completion date: July 31, 2008

Study information

• Verified date: May 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 31, 2008
• Est. primary completion date: July 31, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Brenda Davis Nutrition Consultation Services, Canvasback Missions, Inc., Loma Linda University, United States Department of Defense

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	mg/dl	Change from Week 0 to Week 24
Primary	HbA1c	Percent	Change from Week 0 to Week 24
Primary	Fasting insulin	mU/l	Change from Week 0 to Week 24
Primary	HOMA-IR	Insulin resistance as measured by HOMA-IR	Change from Week 0 to Week 24
Primary	Usage of diabetes medications	Number as measured by the medication effect score	Change from Week 0 to Week 24
Secondary	Cholesterol (total, HDL, LDL) and triglycerides	mg/dl	Change from Week 0 to Week 24
Secondary	Blood pressure	mm Hg	Change from Week 0 to Week 24
Secondary	Heart rate	beats/min	Change from Week 0 to Week 24
Secondary	High-sensitivity C-reactive protein	mg/l	Change from Week 0 to Week 24
Secondary	Body weight	kg	Change from Week 0 to Week 24
Secondary	Body mass index (BMI)	kg/m^2	Change from Week 0 to Week 24
Secondary	Waist circumference	cm	Change from Week 0 to Week 24