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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328546
• Other study ID #: NHS2/DPS-GEN
• Secondary ID: UM1CA176726K99ES
• Status: Completed
• Start date: January 1, 1989
• Est. completion date: April 2018

Study information

• Verified date: April 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116671
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• Dietary intake
Dietary intake converted into dietary pattern scores.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH)

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. d — View 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. — View 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 — View 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. — View 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarction	Necrosis of heart muscle secondary to prolonged ischemia.	1989-2017
Primary	Coronary heart disease	Atherosclerosis	1989-2017
Primary	Stroke	Sudden death of brain cells due to lack of oxygen	1989-2017
Primary	Diabetes Mellitus (type 2)	Insulin resistance	1989-2017
Primary	Gestational Diabetes Mellitus	Glucose intolerance with onset/first recognition during pregnancy	1989-2017
Primary	Hypertensive disorders	Chronic hypertension	1989-2017
Primary	Hypertensive disorders of pregnancy	Pregnancy induced hypertension, toxemia/preeclampsia	1989-2001
Primary	Colon cancer	Malignant tumor in the colon	1989-2017
Primary	Breast cancer	Malignant tumor of breast cells	1989-2017
Primary	Fractures	Fragility fractures of common sites such as hip and wrist.	1989-2017
Primary	Physical functioning	Physical function such as falls, walking, and self care	1989-2017