Lifestyle, Adiposity, and Cardiovascular Health in Youth

NCT03397407 | Completed

• 1 other identifier: AugustaU
• Study Type: observational
• Target: 796
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lifestyle; Adiposity; Cardiovascular Diseases; Adolescent

Outcome Measures

Primary Outcomes (3)

• Fatness

  Percentage of body fat (%)

  Through study completion, an average of 4 years

• Fitness

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

  Through study completion, an average of 4 years

• Insulin resistance

  Fasting insulin (pmol/L)

  Through study completion, an average of 4 years

Secondary Outcomes (2)

• Fat distribution

  Through study completion, an average of 4 years

• Cardiovascular risk factor

  Through study completion, an average of 4 years

Interventions

No intervention OTHER

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• European or African American and age 14-18 years

You may not qualify if:

• Taking medications or had any chronic medical conditions that might affect growth, maturation, physical activity, nutritional status, or metabolism.

Sponsors & Collaborators

• Augusta University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Buffy coat

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 12, 2018
• Study Start: August 1, 2001
• Primary Completion: July 31, 2004
• Study Completion: January 1, 2005
• Last Updated: January 12, 2018

Record last verified: 2018-01