Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
Condition: Obesity; Pre-diabetes
MeSH terms: Obesity; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Faith-enhanced diabetes prevention program; Standard diabetes prevention program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: CBPR; DPP; African-American; Women; Obesity; Pre-diabetes