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

Harvard School of Public Health (HSPH)0 sites116,671 target enrollmentNovember 1, 2017

ConditionsCardiovascular Diseases Cerebrovascular Disorders Metabolic Disease Neoplasms Endocrine System Diseases Neurologic Symptoms Skeletal Anomalies Diabetes Mellitus Pregnancy Complications

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: Harvard School of Public Health (HSPH)
Enrollment: 116671
Primary Endpoint: Myocardial infarction
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2017

End Date

April 2018

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Harvard School of Public Health (HSPH)

Responsible Party

Principal Investigator

Walter C. Willett

NHS II Principal Investigator; Professor of Epidemiology and Nutrition

Harvard School of Public Health (HSPH)

Eligibility Criteria

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)