Lifestyle Intervention to Treat Diabetes in the Marshall Islands

• ClinicalTrials.gov Identifier: NCT03862963
• Recruitment Status: Completed
• First Posted: March 5, 2019
• Last Update Posted: March 5, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborators: United States Department of Defense; Loma Linda University; Brenda Davis Nutrition Consultation Services; Canvasback Missions, Inc.
• Information provided by (Responsible Party): Courtney M Peterson, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Standard of diabetes care; Behavioral: Lifestyle Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel-arm study, although the control group was allowed to crossover after completing the control condition.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lifestyle Intervention Trial to Treat Type 2 Diabetes in the Republic of the Marshall Islands
• Actual Study Start Date: June 1, 2006
• Actual Primary Completion Date: July 31, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Fasting glucose [ Time Frame: Change from Week 0 to Week 24 ]
   mg/dl
2. HbA1c [ Time Frame: Change from Week 0 to Week 24 ]
   Percent
3. Fasting insulin [ Time Frame: Change from Week 0 to Week 24 ]
   mU/l
4. HOMA-IR [ Time Frame: Change from Week 0 to Week 24 ]
   Insulin resistance as measured by HOMA-IR
5. Usage of diabetes medications [ Time Frame: Change from Week 0 to Week 24 ]
   Number as measured by the medication effect score

Secondary Outcome Measures :

1. Cholesterol (total, HDL, LDL) and triglycerides [ Time Frame: Change from Week 0 to Week 24 ]
   mg/dl
2. Blood pressure [ Time Frame: Change from Week 0 to Week 24 ]
   mm Hg
3. Heart rate [ Time Frame: Change from Week 0 to Week 24 ]
   beats/min
4. High-sensitivity C-reactive protein [ Time Frame: Change from Week 0 to Week 24 ]
   mg/l
5. Body weight [ Time Frame: Change from Week 0 to Week 24 ]
   kg
6. Body mass index (BMI) [ Time Frame: Change from Week 0 to Week 24 ]
   kg/m^2
7. Waist circumference [ Time Frame: Change from Week 0 to Week 24 ]
   cm

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Alabama at Birmingham

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davis BC, Jamshed H, Peterson CM, Sabaté 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.

• Responsible Party: Courtney M Peterson, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03862963
• Other Study ID Numbers: IRB-170414009
• First Posted: March 5, 2019
• Last Update Posted: March 5, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases