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Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

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ClinicalTrials.gov Identifier: NCT04082702
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
University of North Texas Health Science Center
Information provided by (Responsible Party):
Baylor Research Institute

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE September 9, 2019
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE February 22, 2013
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
  • Body weight [ Time Frame: Baseline ]
    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).
  • Body weight [ Time Frame: 4-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).
  • Body weight [ Time Frame: 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).
  • Waist circumference: Number of participants above the recommended level [ Time Frame: Baseline ]
    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.
  • Waist circumference: Number of participants above the recommended level [ Time Frame: 4-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.
  • Waist circumference: Number of participants above the recommended level [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
  • Fasting glucose [ Time Frame: Baseline ]
    Fasting glucose was measured with the Cholestech LDX system
  • Fasting glucose [ Time Frame: 4-month ]
    Fasting glucose was measured with the Cholestech LDX system
  • Glycated Hemoglobin A1c [ Time Frame: Baseline ]
    Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
  • Glycated Hemoglobin A1c [ Time Frame: 4-month ]
    Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
  • Low-density lipoprotein cholesterol (LDL) [ Time Frame: Baseline ]
    LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
  • Low-density lipoprotein cholesterol (LDL) [ Time Frame: 4-month ]
    LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
  • High-density lipoprotein cholesterol (HDL) [ Time Frame: Baseline ]
    HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
  • High-density lipoprotein cholesterol (HDL) [ Time Frame: 4-month ]
    HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
  • Blood pressure [ Time Frame: Baseline ]
    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.
  • Blood pressure [ Time Frame: 4-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.
  • Blood pressure [ Time Frame: 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.
  • Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day [ Time Frame: Baseline ]
    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.
  • Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day [ Time Frame: 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.
  • Physical activity: Total number of active minutes per week [ Time Frame: Baseline ]
    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.
  • Physical activity: Total number of active minutes per week [ Time Frame: 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.
  • Physical activity [ Time Frame: 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) [ Time Frame: Baseline ]
    Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
  • Estradiol (pg/mL) [ Time Frame: 4-month ]
    Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
  • Cortisol (ng/mL) [ Time Frame: Baseline ]
    Fasting morning saliva sent to a laboratory to assay
  • Cortisol (ng/mL) [ Time Frame: 4-month ]
    Fasting morning saliva sent to a laboratory to assay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
Official Title  ICMJE Reducing Obesity in African American Women Through Lifestyle Enhancement
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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)
Masking Description:
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.
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Pre-diabetes
Intervention  ICMJE
  • Behavioral: 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Faith-enhanced diabetes prevention program
  • Active Comparator: 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.
    Intervention: Behavioral: Standard diabetes prevention program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2019)
221
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2017
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only female participants were eligible to enroll in this study due to their higher risk for obesity and diabetes.
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04082702
Other Study ID Numbers  ICMJE P20MD006882-2
P20MD006882 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Contact site contact person
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Baylor Research Institute
Study Sponsor  ICMJE Baylor Research Institute
Collaborators  ICMJE University of North Texas Health Science Center
Investigators  ICMJE Not Provided
PRS Account Baylor Research Institute
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP