Trials / Completed
CompletedNCT03328546
Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 116,671 (actual)
- Sponsor
- Harvard School of Public Health (HSPH) · Academic / Other
- Sex
- Female
- Age
- 24 Years – 44 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Cardiovascular Diseases
- Cerebrovascular Disorders
- Metabolic Disease
- Neoplasms
- Endocrine System Diseases
- Neurologic Symptoms
- Skeletal Anomalies
- Diabetes Mellitus
- Pregnancy Complications
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Dietary intake | Dietary intake converted into dietary pattern scores. |
Timeline
- Start date
- 1989-01-01
- Primary completion
- 2017-04-01
- Completion
- 2018-04-01
- First posted
- 2017-11-01
- Last updated
- 2023-04-14
Source: ClinicalTrials.gov record NCT03328546. Inclusion in this directory is not an endorsement.