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Completed

NCT Number: NCT03397407

Lifestyle, Adiposity, and Cardiovascular Health in Youth

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Fatness

    Time frame: Through study completion, an average of 4 years

    Percentage of body fat (%)

  2. Fitness

    Time frame: Through study completion, an average of 4 years

    Maximal oxygen consumption (VO2, mL/kg/min)

  3. Insulin resistance

    Time frame: Through study completion, an average of 4 years

    Fasting insulin (pmol/L)

Secondary outcomes

  1. Fat distribution

    Time frame: Through study completion, an average of 4 years

    Visceral adipose tissue volume (cm^3)

  2. 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

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

Lifestyle, Adiposity, and Cardiovascular Health in Youth Study

Important dates

Study start
2001
Primary completion
2004
Study completion
2005
First posted
Jan 12, 2018
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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