Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

Obesity Clinical Trial

Official title:

Reducing Obesity in African American Women Through Lifestyle Enhancement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082702
• Other study ID #: P20MD006882-2
• Secondary ID: P20MD006882
• Status: Completed
• Phase: N/A
• Start date: February 22, 2013
• Est. completion date: May 31, 2017

Study information

• Verified date: August 2019
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: May 31, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity
• Pre-diabetes
• Prediabetic State

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UNT Health Science Center	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	University of North Texas Health Science Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Primary	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).	4-month
Primary	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).	10-month
Primary	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.	Baseline
Primary	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.	4-month
Primary	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.	10-month
Secondary	Fasting glucose	Fasting glucose was measured with the Cholestech LDX system	Baseline
Secondary	Fasting glucose	Fasting glucose was measured with the Cholestech LDX system	4-month
Secondary	Glycated Hemoglobin A1c	Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.	Baseline
Secondary	Glycated Hemoglobin A1c	Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.	4-month
Secondary	Low-density lipoprotein cholesterol (LDL)	LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system	Baseline
Secondary	Low-density lipoprotein cholesterol (LDL)	LDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system	4-month
Secondary	High-density lipoprotein cholesterol (HDL)	HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.	Baseline
Secondary	High-density lipoprotein cholesterol (HDL)	HDL was measured with a fasting blood sample obtained by finger stick with the Cholestech LDX system.	4-month
Secondary	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.	Baseline
Secondary	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.	4-month
Secondary	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.	10-month
Secondary	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.	Baseline
Secondary	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.	4-month
Secondary	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.	Baseline
Secondary	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.	4-month
Secondary	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.	10-month
Secondary	Estradiol (pg/mL)	Saliva collected in 4 consecutive weeks and sent to a laboratory to assay	Baseline
Secondary	Estradiol (pg/mL)	Saliva collected in 4 consecutive weeks and sent to a laboratory to assay	4-month
Secondary	Cortisol (ng/mL)	Fasting morning saliva sent to a laboratory to assay	Baseline
Secondary	Cortisol (ng/mL)	Fasting morning saliva sent to a laboratory to assay	4-month