Reducing Obesity in African American Women Through Lifestyle Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Waist circumference: Number of participants above the recommended level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Identify as African-American
- •18 years of age or older
- •Parishioner at enrolled church
- •Overweight or obese
- •Willingness to participate in a 10-month study.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Faith-enhanced diabetes prevention program (Behavioral)
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.
干预措施: Standard diabetes prevention program (Behavioral)
结局指标
主要结局
Waist circumference: Number of participants above the recommended level
时间窗: 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.
Body weight
时间窗: 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).
Body weight
时间窗: 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
时间窗: 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).
Waist circumference: Number of participants above the recommended level
时间窗: 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
时间窗: 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.
次要结局
- Low-density lipoprotein cholesterol (LDL)(4-month)
- Physical activity(10-month)
- Estradiol (pg/mL)(4-month)
- Cortisol (ng/mL)(4-month)
- Fasting glucose(4-month)
- Glycated Hemoglobin A1c(4-month)
- Physical activity: Total number of active minutes per week(4-month)
- Blood pressure(10-month)
- High-density lipoprotein cholesterol (HDL)(4-month)
- Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day(4-month)
- Fasting glucose(Baseline)
- Glycated Hemoglobin A1c(Baseline)
- Low-density lipoprotein cholesterol (LDL)(Baseline)
- High-density lipoprotein cholesterol (HDL)(Baseline)
- Blood pressure(Baseline)
- Blood pressure(4-month)
- Dietary patterns: Total energy (Kcal), total fat (gram), total sodium (milligram) intake on a typical day(Baseline)
- Physical activity: Total number of active minutes per week(Baseline)
- Estradiol (pg/mL)(Baseline)
- Cortisol (ng/mL)(Baseline)