Obesity and Mortality | NCT01889225

Studies
Obesity and Mortality

NCT01889225

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Aug 25, 2014Estimated

Enrollment

311,982Actual

Phase

Not provided

Conditions

Obesity and Overweight

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DK076771	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 20, 2013

First Submission Date that Met QC Criteria

Jun 27, 2013

First Posted Date

Jun 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2014

Last Update Posted Date

Aug 25, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Allison, Phd, Principal Investigator, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

311,982Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Years of Life Lost Associated with Standard BMI categories Over Calendar Time		Between 1960 and 2000 (up to 40 years)

Secondary Outcomes

Measure	Description	Time Frame
Change in Adjusted Hazard Ratio Over Calendar Time for Standard BMI Categories		Between 1960 and 2000 (up to 40 years)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

U.S. based prospective cohorts of adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David B Allison, Ph.D.	University of Alabama at Birmingham	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided