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

NCT03328546 | Completed

• 4 other identifiers: NHS2/DPS-GENUM1CA176726K99ES026648K01DK103720-01
• Study Type: observational
• Target: 116,671
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Outcome Measures

Primary Outcomes (11)

• Myocardial infarction

  Necrosis of heart muscle secondary to prolonged ischemia.

  1989-2017

• Coronary heart disease

  Atherosclerosis

  1989-2017

• Stroke

  Sudden death of brain cells due to lack of oxygen

  1989-2017

• Diabetes Mellitus (type 2)

  Insulin resistance

  1989-2017

• Gestational Diabetes Mellitus

  Glucose intolerance with onset/first recognition during pregnancy

  1989-2017

• Hypertensive disorders

  Chronic hypertension

  1989-2017

• Hypertensive disorders of pregnancy

  Pregnancy induced hypertension, toxemia/preeclampsia

  1989-2001

• Colon cancer

  Malignant tumor in the colon

  1989-2017

• Breast cancer

  Malignant tumor of breast cells

  1989-2017

• Fractures

  Fragility fractures of common sites such as hip and wrist.

  1989-2017

• Physical functioning

  Physical function such as falls, walking, and self care

  1989-2017

Interventions

Dietary intake OTHER

Dietary intake converted into dietary pattern scores.

Eligibility Criteria

• Age: 24 Years - 44 Years
• Gender Eligibility Details: Our analysis was based on a cohort of female registered nurses.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Related Publications (10)

• 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.

  PMID: 25398889 BACKGROUND

• 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.

  PMID: 22513989 BACKGROUND

• 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.

  PMID: 22207512 BACKGROUND

• 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.

  PMID: 22760563 RESULT

• 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.

  PMID: 25240079 RESULT

• 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.

  PMID: 24493161 RESULT

• 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.

  PMID: 22074723 RESULT

• 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.

  PMID: 23297654 RESULT

• 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.

  PMID: 16155283 RESULT

• 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.

  PMID: 27459449 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and buffy coat

MeSH Terms

Conditions

Cardiovascular Diseases; Cerebrovascular Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Neurologic Manifestations; Diabetes Mellitus; Pregnancy Complications

Interventions

Eating

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Walter C. Willett, MD, DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NHS II Principal Investigator; Professor of Epidemiology and Nutrition

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 1, 2017
• Study Start: January 1, 1989
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share