Community-Based Strategies to Reduce Cardiometabolic Disease in the Deep South
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 273
- 试验地点
- 4
- 主要终点
- Weight
研究概览
简要总结
The purpose of this study is to promote healthy weight loss among African American women, age 30 or older, who are pre-diabetic and/or have high blood pressure and who live, work, or worship in select rural communities throughout Alabama and Mississippi. The goal of the study is to help reduce the burden of obesity, diabetes, and high blood pressure for these women and to collect information on the reach, effectiveness, adoption, implementation, maintenance, and cost effectiveness of our two evidence-base weight loss programs.
详细描述
This study leverages two evidence-based interventions (EBIs) that have been culturally-adapted for the target population and have previously achieved clinically-relevant weight loss and other clinical outcomes (educational group weight loss intervention) along with improvements in diet and physical activity (home gardening intervention). Combining these EBIs addresses multiple domains (behavioral, personal environment, sociocultural) and levels (individual, interpersonal, community) of influence on risk factors for obesity and other cardiometabolic diseases prevalent in the Deep South. These interventions, delivered by local lay staff and non-academic partners, have a high potential for sustainability; however, there is a need to further evaluate the external validity and implementation-related barriers and facilitators to maximize reach, adoption and implementation. The investigators will employ a pragmatic, multilevel, cluster-randomized, type 1 hybrid effectiveness-implementation trial. A total of 264 Black women (age ≥ 30 years) with overweight or obesity and pre-diabetic or hypertensive from 12 rural counties (6 Alabama, 6 Mississippi) will receive either the combined educational group weight loss intervention plus a home gardening intervention or the educational group weight loss classes alone. The specific aims are to compare interventions on: (1) primary outcomes related to implementation effectiveness (reach, adoption, maintenance of health behaviors), (2) secondary outcomes on clinical effectiveness, and (3) cost effectiveness. Findings will inform discussions with coalition partners to achieve our long-term goal of widely disseminating and sustaining multi-level interventions to reduce the multiple chronic disease burden and health disparities in the Deep South.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •self-identifies as Black and/or African American
- •≥ 30 years old
- •a measured BMI >25 kg/m2 and at least one other cardiometabolic risk factor (physician diagnosis of pre-diabetes and/or hypertension within past 2 years)
- •lives, works, or worships in one of the 12 intervention communities and expresses no intentions to move outside of that community in the 18 months following enrollment
- •a willingness to participate in the study for the 18-months duration.
排除标准
- •being or planning to become pregnant during the 18-month study duration
- •a baseline blood pressure and/or glucose that is outside of the normal range and a medical provider does not provide clearance to participate
- •medical contraindications
结局指标
主要结局
Weight
时间窗: 0, 6, and 12 months
Changes in Weight, measured in pounds
Dietary Intake
时间窗: 0, 6, and 12 months
Changes in diet, measured using a questionnaire
BMI
时间窗: 0, 6, and 12 months
Changes in BMI, calculated as a person's weight in kilograms divided by the square of height in meters
Waist Circumference
时间窗: 0, 6, and 12 months
Changes in waist circumference, measured in centimeters
次要结局
- Cholesterol Levels(0, 6, and 12 months)
- Diastolic and Systolic Blood Pressure(0, 6, and 12 months)
- Fasting Glucose(0, 6, and 12 months)
- Perceived Quality of Life(0, 6, and 12 months)
- Physical Activity(0, 6, and 12 months)
研究者
Monica L Baskin
Adjunct Professor
University of Alabama at Birmingham
