Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
- Conditions
- ObesityPre-diabetes
- Interventions
- Behavioral: Standard diabetes prevention programBehavioral: Faith-enhanced diabetes prevention program
- Registration Number
- NCT04082702
- Lead Sponsor
- Baylor Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 221
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard DPP Standard diabetes prevention program A total of five churches were randomized to this arm that included 102 participants who received the standard DPP on the church settings. Faith-enhanced DPP Faith-enhanced diabetes prevention program A total of six churches were randomized to this arm that included 119 participants and received 10-month DPP with faith components.
- Primary Outcome Measures
Name Time Method Waist circumference: Number of participants above the recommended level 10-month Waist circumference was taken at the top of the pelvis (e.g., above the uppermost lateral border of the right ilium) with a measuring tape twice and averaged.
Body weight 10-month Weight (lbs) was collected with a digital scale in light clothing with shoes removed. Weight was collected twice and the average was computed. Height was also measured using the same protocol to calculate the BMI (body-mass index).
- Secondary Outcome Measures
Name Time Method Low-density lipoprotein cholesterol (LDL) 4-month LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
Physical activity 10-month Physical activity was measured by self-report with the Past Week Modifiable Physical Activity Questionnaire. A total of all physical activity minutes was calculated from the questionnaire.
Desired level of physical activity is defined as 150 minutes or more per week.Estradiol (pg/mL) 4-month Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
Cortisol (ng/mL) 4-month Fasting morning saliva sent to a laboratory to assay
Fasting glucose 4-month Fasting glucose was measured with the Cholestech LDX system
Glycated Hemoglobin A1c 4-month Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
Physical activity: Total number of active minutes per week 4-month Physical activity was measured by self-report with the Past Week Modifiable Physical Activity Questionnaire. A total of all physical activity minutes was calculated from the questionnaire.
Desired level of physical activity is defined as 150 minutes or more per week.Blood pressure 10-month Blood pressure was collected with an automated blood pressure device following a seated 5 min rest in a quiet area. Two measurements were taken following Eighth Joint National Committee protocols and averaged.
High-density lipoprotein cholesterol (HDL) 4-month HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day 4-month Diet was measured with the Lower Mississippi Delta Nutrition Intervention Research Initiative (Delta NIRI) food frequency questionnaire. Data is scanned and analyzed by Northeastern University's Dietary Assessment Center. Total energy, fat, sodium, and other dietary components were estimated from the questionnaire.
Desired total energy (Kcal) (range: 500 to 10,000) intake is defined as 2000 Kcal or less.
Desired fat (gram) (range: 10 to 500) intake is defined as 77 gram or less. Desired sodium (milligram) (range: 100 to 20,000) intake is defined as 2300 milligram or less.
Trial Locations
- Locations (1)
UNT Health Science Center
🇺🇸Fort Worth, Texas, United States