Developing FIM-BCS: A Lifestyle Modification for African-American Breast Cancer Survivors With Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of participants who complete the 8 week intervention
研究概览
简要总结
Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention
- grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.
详细描述
The objective of this study is to conduct the RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) for 12 weeks among Black women who are obese and hypertensive living Chicago. We propose to 1) Pilot the RN-CHEFRx intervention and measures that will be used to assess blood pressure, BMI status, and sodium intake with 20 Black women diagnosed with hypertension and BMI ≥ 30. We will assess the efficacy of the evaluation tools to be used in a future clinical trial at three-time points (baseline, 12 weeks, and 6 months); and 2) Assess the feasibility and acceptability of the RN-CHeFRx intervention using interviews, surveys, and documentary analysis. Findings from this study will inform a larger efficacy trial of RN-CHeFRx to improve dietary behaviors and blood pressure control among Black women with hypertension and obesity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •self-identified as Black or of African descent
- •≥ 18 years old
- •baseline blood pressure ≥130/85 or diagnosed with hypertension and/or BMI ≥ 25
排除标准
- •inability to cook in their homes
- •cognitive deficits impeding the ability to participate or provide informed consent
- •current treatment for cancer
- •liver or renal disease
- •pregnancy
- •lack of English language proficiency
结局指标
主要结局
Number of participants who complete the 8 week intervention
时间窗: [Time Frame: Up to 8 weeks]
Completion will be measured by class attendance
次要结局
未报告次要终点