Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116,671
- 主要终点
- Myocardial infarction
研究概览
简要总结
To study, prospectively, the association between dietary patterns and risk of health outcomes (cardiovascular, metabolic, endocrine, neurological, skeletal muscular, cancer) in cohort study of 116,671 women age 24 to 44 years at baseline in 1989 (the Nurses' Health Study II; NHS II).
详细描述
Health status and lifestyle information was self-reported on a questionnaire at baseline, and on questionnaires distributed to participants biennially thereafter. Dietary intake data was collected in form of a comprehensive, 131-item food frequency questionnaire (FFQ), distributed among participants every four years. The response rate remained over 90%. Dietary data was validated using biomarkers, health status data using medical records.
Dietary pattern scores were derived from FFQs using cumulative average whenever possible from years preceding the outcomes.
Multivariable Cox proportional hazards models were used to evaluate associations between dietary pattern scores and health outcomes, except in case of pregnancy complications (such as gestational diabetes mellitus/GDM and hypertensive disorders of pregnancy/HDPs) where multivariable logistic regression models with generalized estimating equations, with an exchangeable working correlation structure to account for correlated outcomes between pregnancies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women without history of chronic disease and/or primary outcome at the time of recruitment. Women contribute person-time until a first diagnosis of the primary outcome or until the end of follow-up.
- •All women who reported a singleton pregnancy between 1991-2001 (data on pregnancy outcomes was collected on biennial questionnaires until 2001, since majority of women exited the reproductive age by then) (only for maternal outcomes)
排除标准
- •women with a history of chronic disease (type 2 diabetes, cardiovascular disease, or cancer) or other disease studied as the primary outcome
- •women with a missing or incomplete FFQ (more than 70 out of 131 items missing, or with caloric intake <800 kcal/day or >3500kcal/day) prior to endpoint.
- •women with missing data on the primary outcome on biennial questionnaire.
- •twin/multiple pregnancy (only for maternal outcomes)
结局指标
主要结局
Myocardial infarction
时间窗: 1989-2017
Necrosis of heart muscle secondary to prolonged ischemia.
Stroke
时间窗: 1989-2017
Sudden death of brain cells due to lack of oxygen
Diabetes Mellitus (type 2)
时间窗: 1989-2017
Insulin resistance
Physical functioning
时间窗: 1989-2017
Physical function such as falls, walking, and self care
Coronary heart disease
时间窗: 1989-2017
Atherosclerosis
Hypertensive disorders
时间窗: 1989-2017
Chronic hypertension
Fractures
时间窗: 1989-2017
Fragility fractures of common sites such as hip and wrist.
Gestational Diabetes Mellitus
时间窗: 1989-2017
Glucose intolerance with onset/first recognition during pregnancy
Hypertensive disorders of pregnancy
时间窗: 1989-2001
Pregnancy induced hypertension, toxemia/preeclampsia
Colon cancer
时间窗: 1989-2017
Malignant tumor in the colon
Breast cancer
时间窗: 1989-2017
Malignant tumor of breast cells
次要结局
未报告次要终点
研究者
Walter C. Willett
NHS II Principal Investigator; Professor of Epidemiology and Nutrition
Harvard School of Public Health (HSPH)