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Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

NCT ID: NCT04082702

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-22

Study Completion Date

2017-05-31

Brief Summary

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This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the diabetes prevention program (DPP) for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data. The faith components were specifically linked to weekly DPP learning objectives to strategically emphasize behavioral skills with religious principles. Using a CBPR approach, the Better Me Within trial was able to enroll 12 churches, screen 333 AA women, and randomize 221 after collection of objective eligibility measures. A prospective, randomized, nested by church, design was used to evaluate the faith-enhanced DPP as compared to a standard DPP on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up.

Detailed Description

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Reducing obesity positively impacts diabetes and cardiovascular risk; however, evidence-based lifestyle programs, such as the diabetes prevention program (DPP), show reduced effectiveness in African American (AA) women. In addition to an attenuated response to lifestyle programs, AA women also demonstrate high rates of obesity, diabetes, and cardiovascular disease. To address these disparities, enhancements to evidence-based lifestyle programs for AA women need to be developed and evaluated with culturally relevant and rigorous study designs. This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the DPP for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data (N=64 AA adults) integrating five components: a brief pastor led sermon, memory verse, in class or take-home faith activity, promises to remember, and scripture and prayer integrated into participant curriculum and facilitator materials. The faith components were specifically linked to weekly DPP learning objectives to strategically emphasize behavioral skills with religious principles. Using a CBPR approach, the Better Me Within trial was able to enroll 12 churches, screen 333 AA women, and randomize 221 (Mean age =48.8 ±11.2; Mean BMI =36.7 ±8.4; 52% technical or high school) after collection of objective eligibility measures. A prospective, randomized, nested by church, design was used to evaluate the faith-enhanced DPP as compared to a standard DPP on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up. This study provides essential data to guide enhancements to evidence-based lifestyle programs for AA women who are at high risk for chronic disease.

Conditions

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Obesity Pre-diabetes

Keywords

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CBPR DPP African-American Women Obesity Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a prospective, 2-group, randomized nested (by church) design with eleven congregations, comparing a healthy weight management program with a pastor/church leader component (Intervention) to a healthy weight management program without a pastor/church component (Control). Focus groups were conducted with a sample of 64 participants for understanding needs, perspectives and barriers to healthy weight management. A total of 221 overweight and obese female participants from about 11 churches (approximately 25-30 individuals per church) were recruited and participated in this study following the protocols. The DPP Curriculum includes an intervention phase (approximately weekly for 4 months) and maintenance phase (once or twice a month for 6 months). Faith components (handouts and mini-sermon) are only used by the treatment (intervention) group through both the intervention and maintenance phase.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Research personnel involved in delivering interventions were not allowed to facilitate the outcome measures. Project coordinator, key personnel, and trained volunteers (which included graduate students) collected all the data elements. Statisticians and data coordinators were blinded of intervention group assignments of the participants until the end of the study.

Study Groups

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Faith-enhanced DPP

A total of six churches were randomized to this arm that included 119 participants and received 10-month DPP with faith components.

Group Type EXPERIMENTAL

Faith-enhanced diabetes prevention program

Intervention Type BEHAVIORAL

The faith-enhanced curriculum was faith-based and developed using CBPR approaches. The Faith-DPP condition included delivery of the DPP. The group intervention was delivered by one to two trained peers from the church and consisted of 16 weekly group meetings followed by 6 bi-monthly or monthly maintenance sessions. The faith enhanced curriculum included five strategies: 1) a mini sermon (\~15 min in length) delivered by a pastor (head pastors were required to deliver at least one per month), first lady, or church leader (pastor associate, deacon, elder, etc.), 2) a memory verse, 3) in class or take-home faith activity (application of faith principles), 4) promises to remember, and 5) scripture and prayer integrated into participant curriculum and facilitator materials. These five faith enhancements were developed by the CAB to enhance the DPP's weekly learning objectives, which resulted in faith components specifically linked to each week of DPP content.

Standard DPP

A total of five churches were randomized to this arm that included 102 participants who received the standard DPP on the church settings.

Group Type ACTIVE_COMPARATOR

Standard diabetes prevention program

Intervention Type BEHAVIORAL

The S-DPP condition was faith-placed, a secular program (the DPP) held at an faith-based organization. This condition received the same diabetes prevention program (DPP) as the Faith-DPP, but did not receive any faith enhancements or pastor involvement.

Interventions

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Faith-enhanced diabetes prevention program

The faith-enhanced curriculum was faith-based and developed using CBPR approaches. The Faith-DPP condition included delivery of the DPP. The group intervention was delivered by one to two trained peers from the church and consisted of 16 weekly group meetings followed by 6 bi-monthly or monthly maintenance sessions. The faith enhanced curriculum included five strategies: 1) a mini sermon (\~15 min in length) delivered by a pastor (head pastors were required to deliver at least one per month), first lady, or church leader (pastor associate, deacon, elder, etc.), 2) a memory verse, 3) in class or take-home faith activity (application of faith principles), 4) promises to remember, and 5) scripture and prayer integrated into participant curriculum and facilitator materials. These five faith enhancements were developed by the CAB to enhance the DPP's weekly learning objectives, which resulted in faith components specifically linked to each week of DPP content.

Intervention Type BEHAVIORAL

Standard diabetes prevention program

The S-DPP condition was faith-placed, a secular program (the DPP) held at an faith-based organization. This condition received the same diabetes prevention program (DPP) as the Faith-DPP, but did not receive any faith enhancements or pastor involvement.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Identify as African-American
* Female
* 18 years of age or older
* Parishioner at enrolled church
* Overweight or obese
* Willingness to participate in a 10-month study.

Exclusion Criteria

* Currently attending a weight loss program
* Diagnosed with diabetes
* Medical condition that interfered with physical activity or dietary changes
* Plans to move in the next 10 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of North Texas Health Science Center

OTHER

Sponsor Role collaborator

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Kitzman, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Health

Locations

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UNT Health Science Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

References

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Kitzman H, Dodgen L, Mamun A, Slater JL, King G, Slater D, King A, Mandapati S, DeHaven M. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial. Contemp Clin Trials. 2017 Nov;62:77-90. doi: 10.1016/j.cct.2017.08.003. Epub 2017 Aug 12.

Reference Type BACKGROUND
PMID: 28807739 (View on PubMed)

Tan M, Mamun A, Kitzman H, Mandapati SR, Dodgen L. Neighborhood Disadvantage and Allostatic Load in African American Women at Risk for Obesity-Related Diseases. Prev Chronic Dis. 2017 Nov 22;14:E119. doi: 10.5888/pcd14.170143.

Reference Type BACKGROUND
PMID: 29166248 (View on PubMed)

Kitzman H, Mamun A, Dodgen L, Slater D, King G, King A, Slater JL, DeHaven M. Better Me Within Randomized Trial: Faith-Based Diabetes Prevention Program for Weight Loss in African American Women. Am J Health Promot. 2021 Feb;35(2):202-213. doi: 10.1177/0890117120958545. Epub 2020 Sep 18.

Reference Type DERIVED
PMID: 32945175 (View on PubMed)

Mamun A, Kitzman H, Dodgen L. Reducing metabolic syndrome through a community-based lifestyle intervention in African American women. Nutr Metab Cardiovasc Dis. 2020 Sep 24;30(10):1785-1794. doi: 10.1016/j.numecd.2020.06.005. Epub 2020 Jun 12.

Reference Type DERIVED
PMID: 32605881 (View on PubMed)

Other Identifiers

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P20MD006882

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P20MD006882-2

Identifier Type: -

Identifier Source: org_study_id