LifestyleNCT03397407
Lifestyle, Adiposity, and Cardiovascular Health in Youth
An observational study of Lifestyle and Adiposity, run by Augusta University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle, Adiposity, Cardiovascular Diseases
- How many people
- 796 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2001to 1 Jan 2005
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Recruit 800 14 to 18 year olds, 200 in each ethnicity (European or African American) and gender subgroup.
Who may be able to join
- European or African American and age 14-18 years
Who cannot join
- Taking medications or had any chronic medical conditions that might affect growth, maturation, physical activity, nutritional status, or metabolism.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lifestyle, Adiposity, Cardiovascular Diseases, Adolescent
- Being tested
- No intervention
- Medical subject headings
- Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatness
Percentage of body fat (%)
Measured: Through study completion, an average of 4 years
Fitness
Maximal oxygen consumption (VO2, mL/kg/min)
Measured: Through study completion, an average of 4 years
Insulin resistance
Fasting insulin (pmol/L)
Measured: Through study completion, an average of 4 years
Secondary outcomes (2)
Fat distribution
Visceral adipose tissue volume (cm^3)
Measured: Through study completion, an average of 4 years
Cardiovascular risk factor
Triglyceride (TG, mmol/L) and high density lipoprotein cholesterol (HDLC, mmol/L) will be combined to report TG/HDLC ratio
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Aug 2001
- Primary completion31 Jul 2004
- Study completion1 Jan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LifestyleStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397407
- Sponsor's protocol ID
- AugustaU
- Status last verified
- Jan 2018
- First submitted
- 18 Dec 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle, Adiposity, and Cardiovascular Health in Youth Study
- ClinicalTrials.gov ID
- NCT03397407
- Acronym / sponsor ID
- AugustaU
- Conditions
- Lifestyle, Adiposity, Cardiovascular Diseases, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2001 (actual)
- Primary completion
- 31 Jul 2004 (actual)
- Study completion
- 1 Jan 2005 (actual)
- First posted
- 12 Jan 2018 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Recruit 800 14 to 18 year olds, 200 in each ethnicity (European or African American) and gender subgroup.
Key inclusion criteria (1 listed)
- European or African American and age 14-18 years
Key exclusion criteria (1 listed)
- Taking medications or had any chronic medical conditions that might affect growth, maturation, physical activity, nutritional status, or metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Fatness
Time frame: Through study completion, an average of 4 years
Percentage of body fat (%)
Fitness
Time frame: Through study completion, an average of 4 years
Maximal oxygen consumption (VO2, mL/kg/min)
Insulin resistance
Time frame: Through study completion, an average of 4 years
Fasting insulin (pmol/L)
2 secondary outcomes
Fat distribution
Time frame: Through study completion, an average of 4 years
Cardiovascular risk factor
Time frame: Through study completion, an average of 4 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 12 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lifestyle and Adiposity, run by Augusta University.
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 1 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 12 Jan 2018. 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?
Fatness (time frame: Through study completion, an average of 4 years). The study lists 3 primary outcomes in all. 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 12 Jan 2018.