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Completed

NCT Number: NCT04082702

Better Me Within Trial to Improve Lifestyle Behaviors in African Americans

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.

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Key information

Conditions

Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-diabetes Signs and Symptoms

Age range

18 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNT Health Science Center

Fort Worth, Texas, 76107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Faith-enhanced diabetes prevention program

Behavioral

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

Behavioral

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 outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Fasting glucose

    Time frame: Baseline

    Fasting glucose was measured with the Cholestech LDX system

  2. Fasting glucose

    Time frame: 4-month

    Fasting glucose was measured with the Cholestech LDX system

  3. Glycated Hemoglobin A1c

    Time frame: Baseline

    Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.

  4. Glycated Hemoglobin A1c

    Time frame: 4-month

    Glycated hemoglobin A1C was measured with Bayer A1c Now + Multi-Test A1c System.

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Estradiol (pg/mL)

    Time frame: Baseline

    Saliva collected in 4 consecutive weeks and sent to a laboratory to assay

  18. Estradiol (pg/mL)

    Time frame: 4-month

    Saliva collected in 4 consecutive weeks and sent to a laboratory to assay

  19. Cortisol (ng/mL)

    Time frame: Baseline

    Fasting morning saliva sent to a laboratory to assay

  20. Cortisol (ng/mL)

    Time frame: 4-month

    Fasting morning saliva sent to a laboratory to assay

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • University of North Texas Health Science Center

Registry information

Official study title

Reducing Obesity in African American Women Through Lifestyle Enhancement

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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