Clinical trial NCT03270436: Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
Official title: Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-09-01
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of two diabetes prevention program curricula in the Marshallese population.
Primary purpose: PREVENTION

Brief summary: The investigators will conduct a comparative effectiveness cluster-randomized controlled trial (cRCT) of two Diabetes Prevention Program (DPP) lifestyle interventions: a faith-based intervention (Wholeness, Oneness, Righteousness, Deliverance \[WORD\] DPP); and a Pacific Islander adapted intervention (Partnership for Improving Lifestyle Interventions \[PILI\] DPP. Each intervention lasted 24 weeks and focused on the importance of healthy eating, being physically active, and maintaining a healthy weight. Eligible participants included overweight and obese Marshallese adults living in Arkansas and Oklahoma. The unit of randomization is at the church level. The primary outcome measure is body weight loss (from baseline weight). As selected by stakeholders, HbA1c, blood pressure, physical activity, and dietary intake will be evaluated as secondary outcome measures. Data collection will take place at baseline (pre-intervention), immediate post-intervention (6 months post-initiation of the intervention), and 6 months post-intervention (12 months post-initiation of the intervention).

Detailed description: Background and Rationale

Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific Islanders.

The Marshallese are a Pacific Islander population experiencing significant health disparities, with some of the highest documented rates of type 2 diabetes of any population group in the world. Our review of local, national, and international data sources found estimates of diabetes in the Marshallese population (those living in the US and in the Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8.3% for the US population and 4% worldwide. While national prevalence data are limited, 23.7% of Pacific Islanders surveyed by the Centers for Disease Control and Prevention (CDC) in 2010 reported a diagnosis of type 2 diabetes, more than all other racial/ethnic groups. Our pilot research, which includes health screenings with the Marshallese community in northwest Arkansas (n=398), documented extremely high incidence of diabetes (38.4%) and pre-diabetes (32.6%). Our pilot data also revealed similar disparities in one of the strongest risk factors for diabetes-obesity-with 90% of Marshallese participants classified as overweight or obese. Thirty-two percent of those who had pre-diabetes were also overweight or obese. Further compounding these significant disparities in diabetes prevalence and related risk factors, research indicates that Pacific Islanders living in the US are less likely than other racial/ethnic groups to receive preventative or diagnostic treatment, or diabetes education.

Reducing disparities by reducing weight. Overweight/obesity is considered the strongest modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) can be clinically meaningful.

Specific aim. Our aim is to compare the effectiveness of achieving weight loss between two Diabetes Prevention Program (DPP) Lifestyle Interventions - the faith-based Wholeness, Oneness, Righteousness, Deliverance (WORD) DPP, and the Pacific Islander culturally-adapted Partnership for Improving Lifestyle Interventions (PILI) DPP - in the Marshallese population using a cluster randomized controlled trial (cRCT).

Study design. The study design is a comparative effectiveness cRCT conducted in church settings or other community setting convenient to the participant group. Churches were selected as the primary setting based on Marshallese stakeholder input.

Randomized participant assignment. Randomization will occur at the church cluster level, with 1:1 assignment of churches to each arm. Churches and community based participant groups will be blocked (i.e., grouped into similar units) according to geographic region and approximate number of adult church members. Randomization will be conducted by a biostatistician or designated investigator, who will have no interactions with potential participants and has no supervisory role with study staff responsible for recruiting, consent, and intervention process.

Recruitment and Consent

Church-based recruitment is specified by stakeholders as culturally appropriate and the community's preferred recruitment method. During recruitment, Marshallese study staff will give presentations and distribute study information in English and Marshallese. Those who express interest will complete an eligibility screener, to determine eligibility. All study information and consent materials will be provided in English and/or Marshallese based upon the participants' preferences. Eligible participants will be provided a copy of the consent to review, and participants will have the opportunity to ask questions, consent, and enroll in the study. The consent process will include providing information to the potential participants and the opportunity to have bilingual Marshallese staff answer questions regarding study participation. The consent document will be given to the participant, and the informed consent process will be documented in the participant's research record.

Eligibility criteria: Inclusion Criteria:

* Self reported Marshallese
* 18 years of age or older
* BMI greater than or equal to 25

Exclusion Criteria:

* A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.)
* Currently pregnant or breastfeeding an infant who is 6 months old or younger
* Have any condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, plans to move out of the area within 6 months, an inability to finish the intervention, etc.

Primary outcomes:
measure: Change in Mean Body Weight (kg)
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention
Secondary outcomes:
measure: Change in Mean HbA1c (%)
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention
measure: Change in Mean Systolic Blood Pressure (mmHg)
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention
measure: Change in Mean Diastolic Blood Pressure (mmHg)
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention
measure: Change in Sugar-sweetened Beverage Consumption
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention
measure: Change in Fruit and Vegetable Consumption
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention
measure: Change in Proportion of Participants Engaging in Sufficient Levels of Physical Activity
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention
Other outcomes:
measure: Change in Eating Habits Self-efficacy Score
timeFrame: Baseline, Immediate post-intervention, 6 months post-intervention
measure: Change in Physical Activity Self-efficacy
timeFrame: Baseline, Immediate post-intervention, 6 months post-intervention
measure: Change in Perceived Family Support for Exercise and Dietary Habits
timeFrame: Baseline, Immediate post-intervention, 6 months post-intervention
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Pearl McElfish, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McElfish PA, Long CR, Kaholokula JK, Aitaoto N, Bursac Z, Capelle L, Laelan M, Bing WI, Riklon S, Rowland B, Ayers BL, Wilmoth RO, Langston KN, Schootman M, Selig JP, Yeary KHK. Design of a comparative effectiveness randomized controlled trial testing a faith-based Diabetes Prevention Program (WORD DPP) vs. a Pacific culturally adapted Diabetes Prevention Program (PILI DPP) for Marshallese in the United States. Medicine (Baltimore). 2018 May;97(19):e0677. doi: 10.1097/MD.0000000000010677.