- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889225
Obesity and Mortality
August 21, 2014 updated by: David Allison, Phd, University of Alabama at Birmingham
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
311982
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
U.S. based prospective cohorts of adults
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Multiple Risk Factor Intervention Trial - Usual Group
|
Multiple Risk Factor Intervention Trial - Referred Group
|
Framingham Heart study
|
Framingham Offspring cohort
|
Atherosclerosis Risk In Communities
|
Charleston Heart study
|
Cardiovascular Health study
|
Rancho Bernardo study
|
Nurses' Health I study
|
Panel Study Income Dynamics
|
MRFIT Referred Care
|
HDFP Referral Care
|
Alameda County Health and Ways of Living Study
|
Nurses' Health II study
|
Tecumseh County Health study
|
EPESE-East Boston
Established Populations for Epidemiologic Studies of the Elderly-East Boston
|
EPESE-Duke
Established Populations for Epidemiologic Studies of the Elderly-Duke
|
EPESE-Iowa
Established Populations for Epidemiologic Studies of the Elderly-Iowa
|
EPESE-New Haven
Established Populations for Epidemiologic Studies of the Elderly-New Haven
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Years of Life Lost Associated with Standard BMI categories Over Calendar Time
Time Frame: Between 1960 and 2000 (up to 40 years)
|
Between 1960 and 2000 (up to 40 years)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Adjusted Hazard Ratio Over Calendar Time for Standard BMI Categories
Time Frame: Between 1960 and 2000 (up to 40 years)
|
Between 1960 and 2000 (up to 40 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David B Allison, Ph.D., University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
June 27, 2013
First Posted (Estimate)
June 28, 2013
Study Record Updates
Last Update Posted (Estimate)
August 25, 2014
Last Update Submitted That Met QC Criteria
August 21, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01-DK076771-Aim1A
- R01DK076771 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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