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OpenTrials
Completed

NCT Number: NCT03328546

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

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).

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Key information

Conditions

Cardiovascular Diseases Brain Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Disease Metabolic Diseases Neoplasms Nervous System Diseases Neurologic Manifestations Neurologic Symptoms Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Skeletal Anomalies Urogenital Diseases Vascular Diseases

Age range

24 year–44 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary intake

Other

Dietary intake converted into dietary pattern scores.

Primary outcomes

  1. Myocardial infarction

    Time frame: 1989-2017

    Necrosis of heart muscle secondary to prolonged ischemia.

  2. Coronary heart disease

    Time frame: 1989-2017

    Atherosclerosis

  3. Stroke

    Time frame: 1989-2017

    Sudden death of brain cells due to lack of oxygen

  4. Diabetes Mellitus (type 2)

    Time frame: 1989-2017

    Insulin resistance

  5. Gestational Diabetes Mellitus

    Time frame: 1989-2017

    Glucose intolerance with onset/first recognition during pregnancy

  6. Hypertensive disorders

    Time frame: 1989-2017

    Chronic hypertension

  7. Hypertensive disorders of pregnancy

    Time frame: 1989-2001

    Pregnancy induced hypertension, toxemia/preeclampsia

  8. Colon cancer

    Time frame: 1989-2017

    Malignant tumor in the colon

  9. Breast cancer

    Time frame: 1989-2017

    Malignant tumor of breast cells

  10. Fractures

    Time frame: 1989-2017

    Fragility fractures of common sites such as hip and wrist.

  11. Physical functioning

    Time frame: 1989-2017

    Physical function such as falls, walking, and self care

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

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

Registry information

Important dates

Study start
1989
Primary completion
2017
Study completion
2018
First posted
Nov 1, 2017
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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