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Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

Baylor Scott and White Health (BSWH) logo

Baylor Scott and White Health (BSWH)

Status

Completed

Conditions

Pre-diabetes
Obesity

Treatments

Behavioral: Faith-enhanced diabetes prevention program
Behavioral: Standard diabetes prevention program

Study type

Interventional

Funder types

Other

Identifiers

NCT04082702
P20MD006882 (U.S. NIH Grant/Contract)
P20MD006882-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment

221 patients

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

221 participants in 2 patient groups

Faith-enhanced DPP
Experimental group
Description:
A total of six churches were randomized to this arm that included 119 participants and received 10-month DPP with faith components.
Treatment:
Behavioral: Faith-enhanced diabetes prevention program
Standard DPP
Active Comparator group
Description:
A total of five churches were randomized to this arm that included 102 participants who received the standard DPP on the church settings.
Treatment:
Behavioral: Standard diabetes prevention program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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