Healthy Body Healthy Souls in the Marshallese Population

NCT03377244 | Completed Results DMC

• 1 other identifier: 217566
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to pilot test a weight-loss intervention for Marshallese adults, referred to throughout as Healthy Bodies Healthy Souls (HBHS). The HBHS intervention includes the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) implemented at the individual level, with the additional enhancement of working with Marshallese churches to implement church-level changes to support the individual behavioral intervention of the WORD DPP. We will then compare changes in outcomes with participants in the churches who were exposed to the policy changes but did not participate in the WORD DPP, and with those enrolled in a separate DPP trial who participated in the WORD DPP but were not exposed to church-level policy changes.

Conditions

Weight Loss; Pre Diabetes; Overweight and Obesity

Keywords

Marshallese; Pacific Islanders

Outcome Measures

Primary Outcomes (1)

• Mean Percent Body Weight (Pounds) Change

  Mean percent body weight (pounds) change from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb using a calibrated digital scale.

  Baseline, 6 months post-intervention

Secondary Outcomes (9)

• Change in Mean HbA1c (%)

  Baseline, 6 months post-intervention

• Change in Mean Systolic Blood Pressure (mmHg)

  Baseline, 6 months post-intervention

• Change in Mean Diastolic Blood Pressure (mmHg)

  Baseline, 6 months post-intervention

• Change in Eating Habits Self-Efficacy

  Baseline, 6 months post-intervention

• Change in Physical Activity Self-Efficacy

  Baseline, 6 months post-intervention

Study Arms (3)

HBHS

EXPERIMENTAL

Participants in the Healthy Bodies Healthy Souls (HBHS) arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The 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. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.

Behavioral: HBHS

HBHS Policy

ACTIVE COMPARATOR

Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities.

Behavioral: HBHS Policy

WORD DPP

OTHER

Participants in the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The 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-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length.

Behavioral: WORD DPP

Interventions

HBHS BEHAVIORAL

Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.

HBHS

HBHS Policy BEHAVIORAL

Church-level policy changes that encourages participants to engage in healthy behaviors.

HBHS Policy

WORD DPP BEHAVIORAL

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

WORD DPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported Marshallese
• years of age or older
• To participate in the DPP-LI, have a body mass index (BMI) of ≥25 kg/m\^2

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, and inability to finish the intervention, etc.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, 72703, United States

Location

Related Publications (5)

• Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997 May;6(5):355-61.

  PMID: 9149896 BACKGROUND

• Gruber KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008 Fall;43(171):557-75.

  PMID: 19086670 BACKGROUND

• Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. J Consult Clin Psychol. 1991 Oct;59(5):739-44. doi: 10.1037//0022-006x.59.5.739.

  PMID: 1955608 BACKGROUND

• Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.

  PMID: 10882320 BACKGROUND

• Resnick B, Luisi D, Vogel A, Junaleepa P. Reliability and validity of the self-efficacy for exercise and outcome expectations for exercise scales with minority older adults. J Nurs Meas. 2004 Winter;12(3):235-47. doi: 10.1891/jnum.12.3.235.

  PMID: 16138727 BACKGROUND

Related Links

• DASH 2 Brief Physical Activity Questionnaire (p. 116)

MeSH Terms

Conditions

Weight Loss; Glucose Intolerance; Overweight; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders

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, MBA

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Our aim is to pilot test a multi-level weight-loss intervention in the Marshallese community. Changes in outcomes were examined from baseline to 6 months post-intervention (12 months post-initiation of the intervention).

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 19, 2017
• Study Start: September 30, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: January 29, 2021
• Results First Posted: December 31, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)