Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Cerebrovascular Disorders Metabolic Disease Neoplasms Endocrine System Diseases Neurologic Symptoms Skeletal Anomalies Diabetes Mellitus Pregnancy Complications	Other: Dietary intake

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

116671 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)

Actual Study Start Date :

Jan 1, 1989

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2028

Outcome Measures

Primary Outcome Measures

Myocardial infarction [1989-2017]
Necrosis of heart muscle secondary to prolonged ischemia.
Coronary heart disease [1989-2017]
Atherosclerosis
Stroke [1989-2017]
Sudden death of brain cells due to lack of oxygen
Diabetes Mellitus (type 2) [1989-2017]
Insulin resistance
Gestational Diabetes Mellitus [1989-2017]
Glucose intolerance with onset/first recognition during pregnancy
Hypertensive disorders [1989-2017]
Chronic hypertension
Hypertensive disorders of pregnancy [1989-2001]
Pregnancy induced hypertension, toxemia/preeclampsia
Colon cancer [1989-2017]
Malignant tumor in the colon
Breast cancer [1989-2017]
Malignant tumor of breast cells
Fractures [1989-2017]
Fragility fractures of common sites such as hip and wrist.
Physical functioning [1989-2017]
Physical function such as falls, walking, and self care

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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)

Exclusion Criteria:

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)