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

Completed

• Conditions: Endocrine System Diseases; Cerebrovascular Disorders; Neurologic Symptoms; Neoplasms; Diabetes Mellitus; Cardiovascular Diseases; Metabolic Disease; Skeletal Anomalies; Pregnancy Complications

• Registration Number: NCT03328546
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Study Timeline

• Study Start: 1989-01-01
• Primary Completion: 2017-04
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-29
• Study First Posted: 2017-11-01
• Study Completion: 2018-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116671

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary heart disease	1989-2017	Atherosclerosis
Hypertensive disorders	1989-2017	Chronic hypertension
Myocardial infarction	1989-2017	Necrosis of heart muscle secondary to prolonged ischemia.
Stroke	1989-2017	Sudden death of brain cells due to lack of oxygen
Diabetes Mellitus (type 2)	1989-2017	Insulin resistance
Physical functioning	1989-2017	Physical function such as falls, walking, and self care
Fractures	1989-2017	Fragility fractures of common sites such as hip and wrist.
Gestational Diabetes Mellitus	1989-2017	Glucose intolerance with onset/first recognition during pregnancy
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