Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Obesity and Mortality

This study has been completed.
Information provided by (Responsible Party):
David Allison, Phd, University of Alabama at Birmingham Identifier:
First received: June 20, 2013
Last updated: August 21, 2014
Last verified: August 2014

Previous analyses of the National Health and Nutrition Examination Survey have suggested that the mortality rate associated with obesity has decreased over calendar time in the U.S. population, potentially due to improvements in the medical care of obesity and its associated diseases. The primary aim of this project is to evaluate whether this reduction in the detrimental association of obesity with mortality rate over calendar time is supported by other data from U.S. prospective studies.

Obesity and Overweight

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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in Years of Life Lost Associated with Standard BMI categories Over Calendar Time [ Time Frame: Between 1960 and 2000 (up to 40 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Adjusted Hazard Ratio Over Calendar Time for Standard BMI Categories [ Time Frame: Between 1960 and 2000 (up to 40 years) ] [ Designated as safety issue: No ]

Enrollment: 311982
Study Start Date: January 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

U.S. based prospective cohorts of adults


Inclusion Criteria:

  • U.S. based studies with at least 1500 subjects
  • At least 5 years of mortality follow-up
  • BMI measured or self-reported available at 2 or more separate calendar time
  • Subjects varied in age at baseline

Exclusion Criteria:

  • Any study that does not meet the inclusion criteria was excluded
  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 identifier: NCT01889225

Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: David B Allison, Ph.D. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: David Allison, Phd, Principal Investigator, University of Alabama at Birmingham Identifier: NCT01889225     History of Changes
Other Study ID Numbers: R01-DK076771-Aim1A, R01DK076771
Study First Received: June 20, 2013
Last Updated: August 21, 2014
Health Authority: United States: National Institute of Health
United States: UAB Institutional Review Board processed this record on March 03, 2015