Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

Reducing Obesity in African American Women Through Lifestyle Enhancement

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Pre-diabetes
• Intervention / Treatment: Behavioral: Faith-enhanced diabetes prevention program; Behavioral: Standard diabetes prevention program

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: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76107
      • UNT Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: University of North Texas Health Science Center
• Investigators: Principal Investigator: Heather Kitzman, PhD, Baylor Scott and White Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2013
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Women; African-American; Pre-diabetes; DPP; CBPR
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperglycemia; Obesity; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: P20MD006882-2; P20MD006882 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Contact site contact person
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No