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

April 12, 2023 updated by: Walter C. Willett, Harvard School of Public Health (HSPH)
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

116671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The Nurses' Health Study II (NHS II) is a prospective cohort established in 1989 that includes 116,671 female registered U.S. nurses, aged 24-44 at baseline. Mailed questionnaires were administered biennially to collect data on medical and lifestyle factors, with a follow-up rate exceeding 90% for each 2-year cycle. Comprehensive food frequency questionnaires (FFQs) were distributed every four years to collect data on dietary intake.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1989

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

October 29, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHS2/DPS-GEN
  • UM1CA176726 (U.S. NIH Grant/Contract)
  • K99ES026648 (U.S. NIH Grant/Contract)
  • K01DK103720-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are de-identified

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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