- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03397407
Lifestyle, Adiposity, and Cardiovascular Health in Youth
January 10, 2018 updated by: Augusta University
Lifestyle, Adiposity, and Cardiovascular Health in Youth Study
Adiposity is a key link between lifestyle factors (like diet and exercise) and cardiovascular (CV) disease.
However, little is known about the link during the juvenile years, when the processes leading to CV disease are at an early stage of development.
The specific aims are as follow: (1) to determine the relations of free-living diet and exercise to total body percent fat ( percentBF), visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status.
(2) to determine the relations of fatness and fitness to different CV disease risk factors.
Design and methods: (1) Recruit 800 14 to 18 year olds, 200 in each ethnicity and gender subgroup.
(2) Assess diet with seven 24-hour recalls, and exercise with two seven-day recalls and heart rate monitoring.
(3) Measure percent body fat with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test.
(4) Measure major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen).
(5) Conduct multivariate and univariate analyses to determine relationships.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adult studies have shown that adiposity, especially visceral adipose tissue, and cardiovascular (CV) fitness are key links between lifestyle factors like diet and exercise on one hand, and CV disease on the other.
However, very little is known about these links during the juvenile years, when the processes leading to CV disease are at an early stage of development.
The specific aims are as follow: (1) to determine the relations of free-living diet and exercise to total body percent fat ( percent BF), visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status.
(2) to determine the relations of fatness and fitness to different CV risk factors.
Design and methods: (1) Recruit 800 14 to 18 year olds, 200 in each ethnicity and gender subgroup.
(2) Assess diet with seven 24-hour recalls, and exercise with two seven-day recalls and Actigraph monitors.
(3) Measure percent body fat with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test.
(4) Measure major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen).
(5) Conduct multivariate and univariate analyses to determine relationships.
Health relatedness: The provided by this project will assist in the formulation of effective lifestyle interventions targeted to specific demographic groups for primary prevention of CV disease, starting early in life when the foundations for adult disease are being laid.
Study Type
Observational
Enrollment (Actual)
796
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
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Recruit 800 14 to 18 year olds, 200 in each ethnicity (European or African American) and gender subgroup.
Description
Inclusion Criteria:
- European or African American and age 14-18 years
Exclusion Criteria:
- Taking medications or had any chronic medical conditions that might affect growth, maturation, physical activity, nutritional status, or metabolism.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatness
Time Frame: Through study completion, an average of 4 years
|
Percentage of body fat (%)
|
Through study completion, an average of 4 years
|
Fitness
Time Frame: Through study completion, an average of 4 years
|
Maximal oxygen consumption (VO2, mL/kg/min)
|
Through study completion, an average of 4 years
|
Insulin resistance
Time Frame: Through study completion, an average of 4 years
|
Fasting insulin (pmol/L)
|
Through study completion, an average of 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat distribution
Time Frame: Through study completion, an average of 4 years
|
Visceral adipose tissue volume (cm^3)
|
Through study completion, an average of 4 years
|
Cardiovascular risk factor
Time Frame: Through study completion, an average of 4 years
|
Triglyceride (TG, mmol/L) and high density lipoprotein cholesterol (HDLC, mmol/L) will be combined to report TG/HDLC ratio
|
Through study completion, an average of 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
August 1, 2001
Primary Completion (Actual)
July 31, 2004
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
January 10, 2018
First Posted (Actual)
January 12, 2018
Study Record Updates
Last Update Posted (Actual)
January 12, 2018
Last Update Submitted That Met QC Criteria
January 10, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AugustaU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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