Clinical trial NCT03397407: Lifestyle, Adiposity, and Cardiovascular Health in Youth
Official title: Lifestyle, Adiposity, and Cardiovascular Health in Youth Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lifestyle
Adiposity
Cardiovascular Diseases
Adolescent
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 796
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatness
timeFrame: Through study completion, an average of 4 years
measure: Fitness
timeFrame: Through study completion, an average of 4 years
measure: Insulin resistance
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Fat distribution
timeFrame: Through study completion, an average of 4 years
measure: Cardiovascular risk factor
timeFrame: Through study completion, an average of 4 years
Other outcomes:
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