Clinical trial NCT03862963: Lifestyle Intervention to Treat Diabetes in the Marshall Islands
Official title: Lifestyle Intervention Trial to Treat Type 2 Diabetes in the Republic of the Marshall Islands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Loma Linda University
name: Brenda Davis Nutrition Consultation Services
name: Canvasback Missions, Inc.
First posted: 2019-03-05
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm study, although the control group was allowed to crossover after completing the control condition.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Fasting glucose
timeFrame: Change from Week 0 to Week 24
measure: HbA1c
timeFrame: Change from Week 0 to Week 24
measure: Fasting insulin
timeFrame: Change from Week 0 to Week 24
measure: HOMA-IR
timeFrame: Change from Week 0 to Week 24
measure: Usage of diabetes medications
timeFrame: Change from Week 0 to Week 24
Secondary outcomes:
measure: Cholesterol (total, HDL, LDL) and triglycerides
timeFrame: Change from Week 0 to Week 24
measure: Blood pressure
timeFrame: Change from Week 0 to Week 24
measure: Heart rate
timeFrame: Change from Week 0 to Week 24
measure: High-sensitivity C-reactive protein
timeFrame: Change from Week 0 to Week 24
measure: Body weight
timeFrame: Change from Week 0 to Week 24
measure: Body mass index (BMI)
timeFrame: Change from Week 0 to Week 24
measure: Waist circumference
timeFrame: Change from Week 0 to Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University; Black Hills Lifestyle Medicine Center
name: John H Kelly, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.