Dietary Analyses in the Nurses' Health Study, Nurses' Health Study II, and Health Professionals Follow-Up Study

Stroke Clinical Trial

— Diet  

Official title:

Dietary Analyses in the Nurses' Health Studies and Health Professionals Follow-Up Study (Diabetes, Cardiovascular Disease, and Mortality)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366532
• Other study ID #: 2000-P-002221
• Status: Completed
• Phase: N/A
• First received: December 4, 2017
• Last updated: December 4, 2017
• Start date: August 1980
• Est. completion date: August 2012

Study information

• Verified date: December 2017
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the relationships of a variety of nutrients, foods, and dietary patterns with the subsequent risk of developing type 2 diabetes, cardiovascular disease, and mortality in US men and women.

Description:

The Nurses' Health Study (NHS) consisted of 121,700 female registered nurses aged 30 to 55 years from 11 US states who were enrolled in 1976. The NHSII was initiated in 1989 with the recruitment of 116,671 younger female registered nurses, 24 to 44 years of age, from 14 states. The Health Professionals Follow-up Study (HPFS) was established in 1986 and was comprised of 51,529 US male health professionals ranging in age from 40 to 75 years at enrollment from 50 states.

Study investigators sent follow-up questionnaires biennially to participants to update information on past medical history as well as lifestyle factors. Validated food frequency questionnaires (FFQs) were first sent in 1980 for the NHS, 1991 for the NHSII, and 1986 for the HPFS. Dietary assessments have been updated every 2-4 years since baseline. The FFQs collect information on average intake of each food item over the past year. It also specifies a common serving size for each item. Participants could select from one of nine intake frequency choices, ranging from less than once per month to six or more times per day. Participants also provided information on current use and dose of multivitamins and use of other vitamin supplements.

For these three cohorts, investigators repeatedly collected and updated information on several anthropometric and lifestyle factors such as weight, smoking status, alcohol use, coffee intake, and physical activity level. Information was also collected on several major risk factors.

Study subjects reported new diagnoses biennially. After obtaining permission from participants, their medical and pathological records were acquired. Study physicians blinded to questionnaire information reviewed these records to confirm diagnoses of coronary heart disease and stroke. Self-reported diabetes diagnoses are confirmed using a validated supplementary questionnaire on symptoms, blood glucose levels, and medication use. Deaths are identified through reports from next of kin, postal authorities, or by searching the National Death Index.

All investigations regarding dietary factors in relation to type 2 diabetes, cardiovascular disease, and mortality have been approved by the institutional review boards of both Brigham and Women's Hospital and Harvard T.H Chan School of Public Health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289900
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Returned baseline food frequency questionnaires (FFQs).

Exclusion Criteria:

• Participants who had died or reported a diagnosis of diabetes (including type 1 diabetes, type 2 diabetes, and gestational diabetes for women), cardiovascular disease (CVD) or cancer at and before the baseline for the dietary analyses.

• Participants who left more than 70 of the 131 food items blank on the baseline FFQ, reported unusual total energy intake levels (<3,347 or >17,573 kJ/day for men, and <2,092 or >14,644 kJ/day for women), or had missing baseline dietary information.

• Participants who only completed the baseline questionnaire.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Morality
• Myocardial Ischemia
• Stroke
• Type2 Diabetes

Intervention

Other:
• Dietary assessments
We use food frequency questionnaires to collect and update intake of foods and nutrients in observational studies. No intervention is involved.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Harvard Medical School

References & Publications (2)

Belanger CF, Hennekens CH, Rosner B, Speizer FE. The nurses' health study. Am J Nurs. 1978 Jun;78(6):1039-40. — View Citation

Rimm EB, Giovannucci EL, Willett WC, Colditz GA, Ascherio A, Rosner B, Stampfer MJ. Prospective study of alcohol consumption and risk of coronary disease in men. Lancet. 1991 Aug 24;338(8765):464-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 2 diabetes	Type 2 diabetes	Since 1976, with active follow-up
Primary	Cardiovascular disease	Coronary heart disease and stroke	Since 1976, with active follow-up
Primary	Mortality	Deaths due to various causes	Since 1976, with active follow-up

External Links

•   Health Professionals Follow-up Study
•   Nurses' Health Studies