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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Loma Linda University | OTHER |
| Brenda Davis Nutrition Consultation Services | UNKNOWN |
| Canvasback Missions, Inc. |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Diabetes Care | Active Comparator | Standard of diabetes care in the Marshall Islands |
|
| Lifestyle Intervention | Experimental | Plant-based, whole foods diet with moderate exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol (total, HDL, LDL) and triglycerides | mg/dl | Change from Week 0 to Week 24 |
| Blood pressure | mm Hg | Change from Week 0 to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John H Kelly, M.D. | Loma Linda University; Black Hills Lifestyle Medicine Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39305340 | Derived | 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. | |
| 31231656 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| UNKNOWN |
Parallel-arm study, although the control group was allowed to crossover after completing the control condition.
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|
| 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. |
|
| Heart rate | beats/min | Change from Week 0 to Week 24 |
| High-sensitivity C-reactive protein | mg/l | Change from Week 0 to Week 24 |
| Body weight | kg | Change from Week 0 to Week 24 |
| Body mass index (BMI) | kg/m^2 | Change from Week 0 to Week 24 |
| Waist circumference | cm | Change from Week 0 to Week 24 |
| 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. |
| D004700 | Endocrine System Diseases |