Chocolate Intake and Heart Disease and Stroke in the Women's Health Initiative: a Prospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83,310
- 主要终点
- incidence of heart disease
研究概览
简要总结
The investigators will conduct an epidemiological analysis of data from the Women's Health Initiative to investigate the prospective association between chocolate intake and the risk of heart disease and stroke.
详细描述
BACKGROUND: Three recent meta-analyses found significant prospective inverse associations between chocolate intake and cardiovascular disease risk. Evidence from these meta-analyses suggests that such inverse associations may only apply to elderly individuals or those with preexisting major chronic disease.
OBJECTIVE
The investigators will assess the association between habitual chocolate intake and subsequent incident coronary heart disease (CHD) and stroke, and the potential effect of modification by age.
DESIGN: The investigators will conduct multivariable Cox regression analyses using data from 83,310 postmenopausal women free of baseline preexisting major chronic disease in the prospective Women's Health Initiative cohort. Chocolate intake was assessed using a food frequency questionnaire. Physician adjudicated events or deaths were ascertained up to September 30, 2013.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women
- •age between 50 and 79 years
- •enrolled in the Women's Health Initiative (WHI) Observational Study, or in the control arm of one or more overlapping WHI clinical trials.
排除标准
- •implausible energy intakes, defined as <600 kcal/d or >5,000 kcal/d;
- •implausible body mass indices (BMI) (<15 or >50 kg/m2)
- •implausible height<122 cm (4 ft.)
- •self-reported preexisting serious chronic disease at baseline, including diabetes, angina, myocardial infarction (MI), stroke, heart failure, coronary artery bypass graft, percutaneous coronary intervention or cancer.
- •missing data on preexisting major chronic disease or any exposure, outcome or confounder variables.
结局指标
主要结局
incidence of heart disease
时间窗: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
physician adjudicated first occurrence of, or death due to, heart disease
change in BMI
时间窗: time between the baseline and year 3, average 3 years
change in BMI between visit 1 and 3
incidence of stroke
时间窗: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
physician adjudicated first occurrence of, or death due to, stroke
incidence of heart disease or stroke
时间窗: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
physician adjudicated first occurrence of, or death due to, heart disease or stroke
change in chocolate intake
时间窗: time between the baseline and visit 3, average 3 years
change in chocolate intake between visit 1 and 3
change in dietary energy intake
时间窗: time between the baseline and year 3, average 3 years
change in dietary energy intake between visit 1 and 3
change in dietary fat intake
时间窗: time between the baseline and year 3, average 3 years
change in dietary fat intake between visit 1 and 3
次要结局
未报告次要终点
研究者
James Greenberg
Associate Professor
Brooklyn College of the City University of New York