NCT00081692

Brief Summary

To relate cardiac structure and blood pressure (BP) elevation in adults to childhood BP and body size and composition.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
715

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

3.9 years

First QC Date

April 19, 2004

Last Update Submit

August 5, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Established and validated the echocardiographic protocol that was used to generate the serial data on cardiac structure and function in 723 adults in the FLS population .

    Investigators are currently finishing an investigation of racial divergence in cardiac structure, cardiac function and blood pressure in relationship to child growth from 9 to 18 years in 700 women who were participants in the National Growth and Health Study participants. Preliminary results show that women who were overweight during childhood (25 ≤ BMI \< 30 kg/m2) had a significantly larger LVM and elevated systolic blood pressure (SBP) at age 22 years than women who were not overweight during childhood. Women who had elevated SBP during childhood had a significantly larger LVM and elevated SBP at age 22 years than women who did not have elevated SBP values during childhood.

    1929-2009

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Echocardiographic measurements were made in 437 male and 492 female adults in the Fels Longitudinal Study who had serial measurements of body composition made and recorded as children. The selection criteria include participants who have at least 10 serial anthropometric visits between 2 and 20 years of age. The anthropometric measurements include weight and height for computation of BMI and blood pressure. Approximately one-half of the sample is 50 years and older.

No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Sabo RT, Lu Z, Daniels S, Sun SS. Serial childhood BMI and associations with adult hypertension and obesity: the Fels Longitudinal Study. Obesity (Silver Spring). 2012 Aug;20(8):1741-3. doi: 10.1038/oby.2012.58. Epub 2012 Mar 8.

  • Sabo RT, Lu Z, Daniels S, Sun SS. Relationships between serial childhood adiposity measures and adult blood pressure: The Fels longitudinal study. Am J Hum Biol. 2010 Nov-Dec;22(6):830-5. doi: 10.1002/ajhb.21091.

Biospecimen

Retention: NONE RETAINED

Only receiving data

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Shumei Sun, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2004

First Posted

April 21, 2004

Study Start

January 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 7, 2013

Record last verified: 2013-08