Diabetes Prevention Program Lifestyle Intervention in the Marshallese Population

NCT03270436 | Completed Results DMC

• 1 other identifier: 207034
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Mean Body Weight (kg)

  Change in mean body weight (kg) from baseline to immediate post intervention and 6 months post-intervention. Participant weight (without shoes) was measured in light clothing using a calibrated digital scale at each time point.

  Baseline, immediate post-intervention, 6 months post-intervention

Secondary Outcomes (6)

• Change in Mean HbA1c (%)

  Baseline, immediate post-intervention, 6 months post-intervention

• Change in Mean Systolic Blood Pressure (mmHg)

  Baseline, immediate post-intervention, 6 months post-intervention

• Change in Mean Diastolic Blood Pressure (mmHg)

  Baseline, immediate post-intervention, 6 months post-intervention

• Change in Sugar-sweetened Beverage Consumption

  Baseline, immediate post-intervention, 6 months post-intervention

• Change in Fruit and Vegetable Consumption

  Baseline, immediate post-intervention, 6 months post-intervention

Other Outcomes (3)

• Change in Eating Habits Self-efficacy Score

  Baseline, Immediate post-intervention, 6 months post-intervention

• Change in Physical Activity Self-efficacy

  Baseline, Immediate post-intervention, 6 months post-intervention

• Change in Perceived Family Support for Exercise and Dietary Habits

  Baseline, Immediate post-intervention, 6 months post-intervention

Study Arms (2)

Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program

EXPERIMENTAL

The Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program (WORD DPP) is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. The first 8 modules are intended to be delivered weekly. The last 8 modules are intended to be delivered every other week. Participants in the WORD DPP will be encouraged to maintain a daily weight, nutrition, physical activity and prayer log.

Behavioral: Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program

Partnership for Improving Lifestyle Intervention Diabetes Prevention Program

EXPERIMENTAL

The Partnership for Improving Lifestyle Intervention Diabetes Prevention Program (PILI DPP) is a family and community based diabetes prevention curriculum that teaches participants to engage their social support (family and community) to have a healthy weight, eat healthy, and be physically active. The PILI DPP includes 14 modules that are intended to be delivered over a 24 week period and each module approximately 90 minutes in length. The first 4 modules are intended to be delivered weekly. The last 10 modules are intended to be delivered every other week. Participants will be encouraged to track their weight, physical activity, and their nutrition in a log on a daily basis.

Behavioral: Partnership for Improving Lifestyle Intervention Diabetes Prevention Program

Interventions

Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program BEHAVIORAL

Faith based diabetes curriculum that teaches participants to connect faith and health.

Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program

Partnership for Improving Lifestyle Intervention Diabetes Prevention Program BEHAVIORAL

Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.

Partnership for Improving Lifestyle Intervention Diabetes Prevention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, 72703, United States

Location

Related Publications (2)

• McElfish PA, Felix HC, Bursac Z, Rowland B, Yeary KHK, Long CR, Selig JP, Kaholokula JK, Riklon S. A Cluster Randomized Controlled Trial Comparing Diabetes Prevention Program Interventions for Overweight/Obese Marshallese Adults. Inquiry. 2023 Jan-Dec;60:469580231152051. doi: 10.1177/00469580231152051.

  PMID: 36799349 DERIVED

• 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.

  PMID: 29742712 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Pearl A. McElfish
• Organization: University of Arkansas for Medical Sciences

pamcelfish@uams.edu

479-713-8680

Study Officials

• Pearl McElfish, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of two diabetes prevention program curricula in the Marshallese population.

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 1, 2017
• Study Start: January 8, 2018
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)