Preparing a Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control in Black Women with Hypertension and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of participants who complete the 12 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
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 BMI ≥ 30
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 12 week intervention
时间窗: Up to 12 weeks
Completion will be measured by class attendance
Acceptability of the intervention
时间窗: Up to 12 weeks
Assessed via participant feedback
dietary intake during intervention
时间窗: Baseline to 12 weeks
Dietary intake at baseline and 12 weeks
Number of participants recruited
时间窗: Up to 12 weeks
Patients recruited, screened, eligible and consented to participate in the study
Number of participants who complete data collection visits
时间窗: Baseline to 4 months
Completion measured by participants completing surveys, blood pressure measurements, and those who provide blood biospecimens
Change in mean blood pressures (mmHg) during intervention
时间窗: Baseline to 12 weeks
Change will be measured by comparing blood pressures from baseline to 12 weeks
次要结局
- Change in body weight during intervention(Up to 12 weeks)
- Change in body weight at 6 months(12 weeks to 24 weeks)
- Change in blood pressure at 6 months(12 weeks to 24 weeks)
- Dietary intake during post-intervention(12 weeks to 24 weeks)
研究者
Saria Lofton
Assistant Professor
University of Illinois at Chicago