Cardiovascular Diseases, Cerebrovascular Disorders, Diabetes Mellitus, Endocrine System Diseases, Metabolic Disease, Neoplasms, Neurologic Symptoms, Pregnancy Complications, Skeletal Anomalies
Conditions
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).
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.
Interventions
OTHERDietary intake
Dietary intake converted into dietary pattern scores.
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
National Institute of Environmental Health Sciences (NIEHS)
Harvard School of Public Health (HSPH)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 44 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed