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Cardiovascular DiseasesNCT03328546

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

An observational study of Cardiovascular Diseases and Cerebrovascular Disorders, run by Harvard School of Public Health (HSPH).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 24 to 44 years, women onlyHealthy volunteers can take part
What is being tested?
Dietary intake
How many people
116,671 participants
Where
No sites listed yet
Study dates
1 Jan 1989to Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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)

About this study

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).

Read the 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.

Being tested
Dietary intake
Medical subject headings
Cardiovascular Diseases, Cerebrovascular Disorders, Metabolic Diseases, Neoplasms, Endocrine System Diseases, Neurologic Manifestations, Diabetes Mellitus, Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary intakeOther

    Dietary intake converted into dietary pattern scores.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial infarction

    Necrosis of heart muscle secondary to prolonged ischemia.

    Measured: 1989-2017

  2. Coronary heart disease

    Atherosclerosis

    Measured: 1989-2017

  3. Stroke

    Sudden death of brain cells due to lack of oxygen

    Measured: 1989-2017

  4. Diabetes Mellitus (type 2)

    Insulin resistance

    Measured: 1989-2017

  5. Gestational Diabetes Mellitus

    Glucose intolerance with onset/first recognition during pregnancy

    Measured: 1989-2017

  6. Hypertensive disorders

    Chronic hypertension

    Measured: 1989-2017

  7. Hypertensive disorders of pregnancy

    Pregnancy induced hypertension, toxemia/preeclampsia

    Measured: 1989-2001

  8. Colon cancer

    Malignant tumor in the colon

    Measured: 1989-2017

  9. Breast cancer

    Malignant tumor of breast cells

    Measured: 1989-2017

  10. Fractures

    Fragility fractures of common sites such as hip and wrist.

    Measured: 1989-2017

  11. Physical functioning

    Physical function such as falls, walking, and self care

    Measured: 1989-2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start1 Jan 1989
  3. Primary completionApr 2017
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
116,671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03328546
Sponsor's protocol ID
NHS2/DPS-GEN
Other IDs
UM1CA176726, K99ES026648, K01DK103720-01
Status last verified
Apr 2023
First submitted
23 Oct 2017
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data are de-identified

Publications

  • Chiuve SE, Cook NR, Shay CM, Rexrode KM, Albert CM, Manson JE, Willett WC, Rimm EB. Lifestyle-based prediction model for the prevention of CVD: the Healthy Heart Score. J Am Heart Assoc. 2014 Nov 14;3(6):e000954. doi: 10.1161/JAHA.114.000954.

    PubMed 25398889

  • Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, Stampfer MJ, Willett WC. Alternative dietary indices both strongly predict risk of chronic disease. J Nutr. 2012 Jun;142(6):1009-18. doi: 10.3945/jn.111.157222. Epub 2012 Apr 18.

    PubMed 22513989

  • Bernstein AM, Pan A, Rexrode KM, Stampfer M, Hu FB, Mozaffarian D, Willett WC. Dietary protein sources and the risk of stroke in men and women. Stroke. 2012 Mar;43(3):637-44. doi: 10.1161/STROKEAHA.111.633404. Epub 2011 Dec 29.

    PubMed 22207512

  • Tobias DK, Zhang C, Chavarro J, Bowers K, Rich-Edwards J, Rosner B, Mozaffarian D, Hu FB. Prepregnancy adherence to dietary patterns and lower risk of gestational diabetes mellitus. Am J Clin Nutr. 2012 Aug;96(2):289-95. doi: 10.3945/ajcn.111.028266. Epub 2012 Jul 3.

    PubMed 22760563

  • Gaskins AJ, Rich-Edwards JW, Hauser R, Williams PL, Gillman MW, Penzias A, Missmer SA, Chavarro JE. Prepregnancy dietary patterns and risk of pregnancy loss. Am J Clin Nutr. 2014 Oct;100(4):1166-72. doi: 10.3945/ajcn.114.083634. Epub 2014 Aug 13.

    PubMed 25240079

  • Nimptsch K, Malik VS, Fung TT, Pischon T, Hu FB, Willett WC, Fuchs CS, Ogino S, Chan AT, Giovannucci E, Wu K. Dietary patterns during high school and risk of colorectal adenoma in a cohort of middle-aged women. Int J Cancer. 2014 May 15;134(10):2458-67. doi: 10.1002/ijc.28578. Epub 2013 Nov 25.

    PubMed 24493161

  • Malik VS, Fung TT, van Dam RM, Rimm EB, Rosner B, Hu FB. Dietary patterns during adolescence and risk of type 2 diabetes in middle-aged women. Diabetes Care. 2012 Jan;35(1):12-8. doi: 10.2337/dc11-0386. Epub 2011 Nov 10.

    PubMed 22074723

  • Willett WC, Stampfer MJ. Current evidence on healthy eating. Annu Rev Public Health. 2013;34:77-95. doi: 10.1146/annurev-publhealth-031811-124646. Epub 2013 Jan 7.

    PubMed 23297654

  • Schulze MB, Hoffmann K, Manson JE, Willett WC, Meigs JB, Weikert C, Heidemann C, Colditz GA, Hu FB. Dietary pattern, inflammation, and incidence of type 2 diabetes in women. Am J Clin Nutr. 2005 Sep;82(3):675-84; quiz 714-5. doi: 10.1093/ajcn.82.3.675.

    PubMed 16155283

  • Yu E, Rimm E, Qi L, Rexrode K, Albert CM, Sun Q, Willett WC, Hu FB, Manson JE. Diet, Lifestyle, Biomarkers, Genetic Factors, and Risk of Cardiovascular Disease in the Nurses' Health Studies. Am J Public Health. 2016 Sep;106(9):1616-23. doi: 10.2105/AJPH.2016.303316. Epub 2016 Jul 26.

    PubMed 27459449

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Cerebrovascular Disorders, run by Harvard School of Public Health (HSPH).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial infarction (time frame: 1989-2017). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03328546, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

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