Obesity and OverweightNCT01889225
Obesity and Mortality
An observational study of Obesity and Overweight, run by University of Alabama at Birmingham.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- How many people
- 311,982 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: U.S. based prospective cohorts of adults
Who may be able to join
- 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
Who cannot join
- Any study that does not meet the inclusion criteria was excluded
About this study
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.
- Conditions
- Obesity and Overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Risk Factor Intervention Trial - Usual Group | Not described | |
| Multiple Risk Factor Intervention Trial - Referred Group | Not described | |
| Framingham Heart study | Not described | |
| Framingham Offspring cohort | Not described | |
| Atherosclerosis Risk In Communities | Not described | |
| Charleston Heart study | Not described | |
| Cardiovascular Health study | Not described | |
| Rancho Bernardo study | Not described | |
| Nurses' Health I study | Not described | |
| Panel Study Income Dynamics | Not described | |
| MRFIT Referred Care | Not described | |
| HDFP Referral Care | Not described | |
| Alameda County Health and Ways of Living Study | Not described | |
| Nurses' Health II study | Not described | |
| Tecumseh County Health study | Not described | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Years of Life Lost Associated with Standard BMI categories Over Calendar Time
Measured: Between 1960 and 2000 (up to 40 years)
Secondary outcomes (1)
Change in Adjusted Hazard Ratio Over Calendar Time for Standard BMI Categories
Measured: Between 1960 and 2000 (up to 40 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 311,982 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Allison, Phd, University of Alabama at Birmingham
- Investigators
- David B Allison, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889225
- Sponsor's protocol ID
- R01-DK076771-Aim1A
- Other IDs
- R01DK076771
- Status last verified
- Aug 2014
- First submitted
- 20 Jun 2013
- Last updated
- 25 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Mortality
- ClinicalTrials.gov ID
- NCT01889225
- Acronym / sponsor ID
- R01-DK076771-Aim1A
- Conditions
- Obesity and Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311,982 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- U.S. based prospective cohorts of adults
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any study that does not meet the inclusion criteria was excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Years of Life Lost Associated with Standard BMI categories Over Calendar Time
Time frame: Between 1960 and 2000 (up to 40 years)
1 secondary outcome
Change in Adjusted Hazard Ratio Over Calendar Time for Standard BMI Categories
Time frame: Between 1960 and 2000 (up to 40 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B Allison, Ph.D. principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Years of Life Lost Associated with Standard BMI categories Over Calendar Time (time frame: Between 1960 and 2000 (up to 40 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014; AzTrials last refreshed its copy on 4 Nov 2026.