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Lifestyle Intervention to Treat Diabetes in the Marshall Islands

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03862963
Recruitment Status : Completed
First Posted : March 5, 2019
Last Update Posted : May 24, 2022
Sponsor:
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

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

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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
Study Completion Date : July 31, 2008

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862963


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
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Principal Investigator: John H Kelly, M.D. Loma Linda University; Black Hills Lifestyle Medicine Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases