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Completed

NCT Number: NCT03862963

Lifestyle Intervention to Treat Diabetes in the Marshall Islands

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Brenda Davis Nutrition Consultation Services
  • Canvasback Missions, Inc.
  • Loma Linda University
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 5, 2019
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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