NCT01889225

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311,982

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

5.9 years

First QC Date

June 20, 2013

Last Update Submit

August 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Years of Life Lost Associated with Standard BMI categories Over Calendar Time

    Between 1960 and 2000 (up to 40 years)

Secondary Outcomes (1)

  • Change in Adjusted Hazard Ratio Over Calendar Time for Standard BMI Categories

    Between 1960 and 2000 (up to 40 years)

Study Arms (19)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

U.S. based prospective cohorts of adults

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David B Allison, Ph.D.

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 28, 2013

Study Start

January 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 25, 2014

Record last verified: 2014-08