Clinical trial NCT04082702: Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
Official title: Reducing Obesity in African American Women Through Lifestyle Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pre-diabetes
Keywords: CBPR
DPP
African-American
Women
Obesity
Pre-diabetes
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: University of North Texas Health Science Center
First posted: 2019-09-09
Enrollment: 221
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: Baseline
measure: Body weight
timeFrame: 4-month
measure: Body weight
timeFrame: 10-month
measure: Waist circumference: Number of participants above the recommended level
timeFrame: Baseline
measure: Waist circumference: Number of participants above the recommended level
timeFrame: 4-month
measure: Waist circumference: Number of participants above the recommended level
timeFrame: 10-month
Secondary outcomes:
measure: Fasting glucose
timeFrame: Baseline
measure: Fasting glucose
timeFrame: 4-month
measure: Glycated Hemoglobin A1c
timeFrame: Baseline
measure: Glycated Hemoglobin A1c
timeFrame: 4-month
measure: Low-density lipoprotein cholesterol (LDL)
timeFrame: Baseline
measure: Low-density lipoprotein cholesterol (LDL)
timeFrame: 4-month
measure: High-density lipoprotein cholesterol (HDL)
timeFrame: Baseline
measure: High-density lipoprotein cholesterol (HDL)
timeFrame: 4-month
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: 4-month
measure: Blood pressure
timeFrame: 10-month
measure: Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day
timeFrame: Baseline
measure: Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day
timeFrame: 4-month
measure: Physical activity: Total number of active minutes per week
timeFrame: Baseline
measure: Physical activity: Total number of active minutes per week
timeFrame: 4-month
measure: Physical activity
timeFrame: 10-month
measure: Estradiol (pg/mL)
timeFrame: Baseline
measure: Estradiol (pg/mL)
timeFrame: 4-month
measure: Cortisol (ng/mL)
timeFrame: Baseline
measure: Cortisol (ng/mL)
timeFrame: 4-month
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: UNT Health Science Center
state: Texas
Study officials:
affiliation: Baylor Scott and White Health
name: Heather Kitzman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.