Clinical trial NCT03328546: Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)
Official title: Dietary Patterns and Health Outcomes (Cardiovascular, Metabolic, Endocrine, Neurological, Skeletal Muscular, Cancer)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Cerebrovascular Disorders
Metabolic Disease
Neoplasms
Endocrine System Diseases
Neurologic Symptoms
Skeletal Anomalies
Diabetes Mellitus
Pregnancy Complications
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2017-11-01
Enrollment: 116671
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Myocardial infarction
timeFrame: 1989-2017
measure: Coronary heart disease
timeFrame: 1989-2017
measure: Stroke
timeFrame: 1989-2017
measure: Diabetes Mellitus (type 2)
timeFrame: 1989-2017
measure: Gestational Diabetes Mellitus
timeFrame: 1989-2017
measure: Hypertensive disorders
timeFrame: 1989-2017
measure: Hypertensive disorders of pregnancy
timeFrame: 1989-2001
measure: Colon cancer
timeFrame: 1989-2017
measure: Breast cancer
timeFrame: 1989-2017
measure: Fractures
timeFrame: 1989-2017
measure: Physical functioning
timeFrame: 1989-2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Walter C. Willett, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.