Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
Primary Purpose
Obesity, Pre-diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Faith-enhanced diabetes prevention program
Standard diabetes prevention program
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring CBPR, DPP, African-American, Women, Obesity, Pre-diabetes
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.
Sites / Locations
- UNT Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Faith-enhanced DPP
Standard DPP
Arm Description
A total of six churches were randomized to this arm that included 119 participants and received 10-month DPP with faith components.
A total of five churches were randomized to this arm that included 102 participants who received the standard DPP on the church settings.
Outcomes
Primary Outcome Measures
Body weight
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
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
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
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
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
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.
Secondary Outcome Measures
Fasting glucose
Fasting glucose was measured with the Cholestech LDX system
Fasting glucose
Fasting glucose was measured with the Cholestech LDX system
Glycated Hemoglobin A1c
Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
Glycated Hemoglobin A1c
Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
Low-density lipoprotein cholesterol (LDL)
LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
Low-density lipoprotein cholesterol (LDL)
LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
High-density lipoprotein cholesterol (HDL)
HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
High-density lipoprotein cholesterol (HDL)
HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
Blood pressure
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
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
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
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
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
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
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
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)
Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
Estradiol (pg/mL)
Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
Cortisol (ng/mL)
Fasting morning saliva sent to a laboratory to assay
Cortisol (ng/mL)
Fasting morning saliva sent to a laboratory to assay
Full Information
NCT ID
NCT04082702
First Posted
August 29, 2019
Last Updated
December 9, 2019
Sponsor
Baylor Research Institute
Collaborators
University of North Texas Health Science Center
1. Study Identification
Unique Protocol Identification Number
NCT04082702
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 22, 2013 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
University of North Texas Health Science Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre-diabetes
Keywords
CBPR, DPP, African-American, Women, Obesity, Pre-diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Faith-enhanced DPP
Arm Type
Experimental
Arm Description
A total of six churches were randomized to this arm that included 119 participants and received 10-month DPP with faith components.
Arm Title
Standard DPP
Arm Type
Active Comparator
Arm Description
A total of five churches were randomized to this arm that included 102 participants who received the standard DPP on the church settings.
Intervention Type
Behavioral
Intervention Name(s)
Faith-enhanced diabetes prevention program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard diabetes prevention program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight
Description
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).
Time Frame
Baseline
Title
Body weight
Description
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).
Time Frame
4-month
Title
Body weight
Description
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).
Time Frame
10-month
Title
Waist circumference: Number of participants above the recommended level
Description
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.
Time Frame
Baseline
Title
Waist circumference: Number of participants above the recommended level
Description
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.
Time Frame
4-month
Title
Waist circumference: Number of participants above the recommended level
Description
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.
Time Frame
10-month
Secondary Outcome Measure Information:
Title
Fasting glucose
Description
Fasting glucose was measured with the Cholestech LDX system
Time Frame
Baseline
Title
Fasting glucose
Description
Fasting glucose was measured with the Cholestech LDX system
Time Frame
4-month
Title
Glycated Hemoglobin A1c
Description
Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
Time Frame
Baseline
Title
Glycated Hemoglobin A1c
Description
Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.
Time Frame
4-month
Title
Low-density lipoprotein cholesterol (LDL)
Description
LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
Time Frame
Baseline
Title
Low-density lipoprotein cholesterol (LDL)
Description
LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system
Time Frame
4-month
Title
High-density lipoprotein cholesterol (HDL)
Description
HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
Time Frame
Baseline
Title
High-density lipoprotein cholesterol (HDL)
Description
HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.
Time Frame
4-month
Title
Blood pressure
Description
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.
Time Frame
Baseline
Title
Blood pressure
Description
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.
Time Frame
4-month
Title
Blood pressure
Description
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.
Time Frame
10-month
Title
Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day
Description
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.
Time Frame
Baseline
Title
Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day
Description
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.
Time Frame
4-month
Title
Physical activity: Total number of active minutes per week
Description
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.
Time Frame
Baseline
Title
Physical activity: Total number of active minutes per week
Description
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.
Time Frame
4-month
Title
Physical activity
Description
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.
Time Frame
10-month
Title
Estradiol (pg/mL)
Description
Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
Time Frame
Baseline
Title
Estradiol (pg/mL)
Description
Saliva collected in 4 consecutive weeks and sent to a laboratory to assay
Time Frame
4-month
Title
Cortisol (ng/mL)
Description
Fasting morning saliva sent to a laboratory to assay
Time Frame
Baseline
Title
Cortisol (ng/mL)
Description
Fasting morning saliva sent to a laboratory to assay
Time Frame
4-month
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female participants were eligible to enroll in this study due to their higher risk for obesity and diabetes.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Kitzman, PhD
Organizational Affiliation
Baylor Scott and White Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNT Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Contact site contact person
Citations:
PubMed Identifier
28807739
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.
Results Reference
background
PubMed Identifier
29166248
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.
Results Reference
background
PubMed Identifier
32945175
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.
Results Reference
derived
PubMed Identifier
32605881
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.
Results Reference
derived
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Better Me Within Trial to Improve Lifestyle Behaviors in African Americans
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