Lifestyle Intervention to Treat Diabetes in the Marshall Islands

NCT03862963 | Completed

• 1 other identifier: IRB-170414009
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Cholesterol (total, HDL, LDL) and triglycerides

  Change from Week 0 to Week 24

• Blood pressure

  Change from Week 0 to Week 24

• Heart rate

  Change from Week 0 to Week 24

• High-sensitivity C-reactive protein

  Change from Week 0 to Week 24

• Body weight

  Change from Week 0 to Week 24

Study Arms (2)

Standard of Diabetes Care

ACTIVE COMPARATOR

Standard of diabetes care in the Marshall Islands

Behavioral: Standard of diabetes care

Lifestyle Intervention

EXPERIMENTAL

Plant-based, whole foods diet with moderate exercise

Behavioral: Lifestyle Intervention

Interventions

Standard of diabetes care BEHAVIORAL

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.

Standard of Diabetes Care

Lifestyle Intervention BEHAVIORAL

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.

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• United States Department of Defense: collaborator
• Loma Linda University: collaborator
• Brenda Davis Nutrition Consultation Services: collaborator
• Canvasback Missions, Inc.: collaborator

Related Publications (2)

• Hanick CJ, Peterson CM, Davis BC, Sabate J, Kelly JH Jr. A whole-food, plant-based intensive lifestyle intervention improves glycaemic control and reduces medications in individuals with type 2 diabetes: a randomised controlled trial. Diabetologia. 2025 Feb;68(2):308-319. doi: 10.1007/s00125-024-06272-8. Epub 2024 Sep 21.

  PMID: 39305340 DERIVED

• 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.

  PMID: 31231656 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• John H Kelly, M.D.

  Loma Linda University; Black Hills Lifestyle Medicine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel-arm study, although the control group was allowed to crossover after completing the control condition.

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 5, 2019
• Study Start: June 1, 2006
• Primary Completion: July 31, 2008
• Study Completion: July 31, 2008
• Last Updated: May 16, 2023

Record last verified: 2023-05