ClinicalTrials.gg
CompletedNCT03328546Updated Apr 14, 2023

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

An observational study in Cardiovascular Diseases, Cerebrovascular Disorders and Metabolic Disease, sponsored by Harvard School of Public Health (HSPH). Completed. Open to female participants aged 24 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-14.

Primary conditionCerebrovascular DisordersRegistry: Cardiovascular DiseasesReclassifiedWhy we changed it
Registry
Cardiovascular Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cerebrovascular Disorders
Why
  1. The study's listed conditions name Cerebrovascular Disorders, a narrower term within Cardiovascular Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Harvard School of Public Health (HSPH) · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
116,671
Ages
24 Years to 44 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Cerebrovascular Disorders
  • Metabolic Disease
  • Neoplasms
  • Endocrine System Diseases
  • Neurologic Symptoms
  • Skeletal Anomalies
  • Diabetes Mellitus
  • Pregnancy Complications
03

In context

Cerebrovascular Disorders Reclassified

449 studies on the registry are indexed under Cerebrovascular Disorders; 127 are open to participants now.

This study's enrollment of 116,671 is above the median of 450 across 145 observational studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Compared within Cerebrovascular Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
24 Years to 44 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
116,671 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherDietary intake

    Dietary intake converted into dietary pattern scores.

06

What researchers measure

Primary outcomes

  1. Myocardial infarction

    Necrosis of heart muscle secondary to prolonged ischemia.

    Time frame: 1989-2017

  2. Coronary heart disease

    Atherosclerosis

    Time frame: 1989-2017

  3. Stroke

    Sudden death of brain cells due to lack of oxygen

    Time frame: 1989-2017

  4. Diabetes Mellitus (type 2)

    Insulin resistance

    Time frame: 1989-2017

  5. Gestational Diabetes Mellitus

    Glucose intolerance with onset/first recognition during pregnancy

    Time frame: 1989-2017

  6. Hypertensive disorders

    Chronic hypertension

    Time frame: 1989-2017

  7. Hypertensive disorders of pregnancy

    Pregnancy induced hypertension, toxemia/preeclampsia

    Time frame: 1989-2001

  8. Colon cancer

    Malignant tumor in the colon

    Time frame: 1989-2017

  9. Breast cancer

    Malignant tumor of breast cells

    Time frame: 1989-2017

  10. Fractures

    Fragility fractures of common sites such as hip and wrist.

    Time frame: 1989-2017

  11. Physical functioning

    Physical function such as falls, walking, and self care

    Time frame: 1989-2017

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No — Data are de-identified

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 1989 to primary completion in Apr 2017, 339 months.

Of 75 non-industry observational studies under Cerebrovascular Disorders, half reached primary completion within 103 months of starting (the median), counting those still running; a quarter within 59 and three quarters within 339. This study's 339 months is above that.

Counting every sponsor, half of 79 studies reached it within 103 months; a quarter within 46 and three quarters within 339.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2017
First posted
Nov 1, 2017
StartActual
Jan 1, 1989
Primary completionActual
Apr 2017
CompletionActual
Apr 2018
Last update
Apr 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03328546
Responsible party
Walter C. Willett (NHS II Principal Investigator; Professor of Epidemiology and Nutrition, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
Nov 1, 2017
Start date
Jan 1, 1989
Primary completion
Apr 2017
Completion
Apr 2018
Last update
Apr 14, 2023

Study contacts

Walter C. Willett, MD, DrPH
principal investigator · Harvard School of Public Health (HSPH)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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