Health Professionals Follow-up Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eric B. Rimm, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00005182
First received: May 25, 2000
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

To test the hypothesis that increased risk of coronary heart disease, stroke, peripheral vascular disease, and cancer is related to diets high in saturated fat, animal protein, and hydrogenated vegetable oil, and low in polyunsaturated fat, fiber, vitamins A, C, and E, calcium, selenium, and chromium.


Condition
Cardiovascular Diseases
Cerebrovascular Accident
Coronary Disease
Peripheral Vascular Diseases
Heart Diseases
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Incident CVD [ Time Frame: Renewed every 5 years since 1986 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma, RBC, WBC


Enrollment: 50000
Study Start Date: December 1985
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

The diet-heart hypothesis, that high dietary saturated fat and cholesterol intake increase the risk and high polyunsaturated fat reduces the risk of coronary heart disease in man is supported by ecologic studies, by experiments in rodents and non-human primates, by voluminous literature relating dietary factors to serum lipids, by several secondary prevention trials, and by the Lipid Research Clinics Trial demonstrating a reduction in coronary heart disease among participants assigned to cholestyramine.

Despite the substantial scientific interest and the obvious public health implications of the diet and heart disease issue, relatively few observational cohort or case-control investigations had been published prior to 1985. Although these observational studies were not entirely consistent, taken collectively, they tended to provide important general support for the diet-heart hypothesis. However, due to study design, limited numbers of endpoints, or methods of analysis, many central questions remained unanswered. The most important issue was the quantitative relationship between specific dietary factors and risk of coronary heart disease.

DESIGN NARRATIVE:

In this prospective cohort study, participants completed a mailed general medical and health questionnaire at baseline and an intensively validated semiquantitative food frequency questionnaire (SFFQ). At one year, tissue specimens were collected and catalogued for future nested case-control analyses of coronary heart disease risk in relation to levels of calcium, selenium, and chromium. Follow-up questionnaires to update exposure information and ascertain non-fatal endpoints were mailed at two-year intervals. All reported cases of non-fatal myocardial infarction, stroke, and cancer were documented with hospital records and/or pathology reports. Fatal events were ascertained with the National Death Index and documented. To standardize SFFQ nutrient scores against measurements of absolute intake, two one-week diet records were obtained from a random sample of 150 Boston-area participants.

The study was renewed in 1991, 1997, and in 2003 to continue the follow-up of 51,529 male health professionals. The cohort is followed by questionnaires mailed at two-year intervals to update exposure information and ascertain nonfatal events. Complete dietary assessments are included every four years.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male Health Professionals

Criteria

Recruited through their professional organizations or occupation from mailing house lists.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005182

Sponsors and Collaborators
Harvard School of Public Health
Investigators
Principal Investigator: Eric Rimm Harvard School of Public Health
  More Information

Publications:
Goldberg IJ: To drink or not to drink? N Engl J Med, 348(2):163-164, 2003. Editorial. No abstract available.

Responsible Party: Eric B. Rimm, Associate Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00005182     History of Changes
Other Study ID Numbers: 1060, R00HL088372
Study First Received: May 25, 2000
Last Updated: March 19, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Infarction
Myocardial Infarction
Cerebral Infarction
Stroke
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atherosclerosis

ClinicalTrials.gov processed this record on July 31, 2014