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Completed

NCT Number: NCT04974476

Onsite vs. Virtual Group Fitness in Overweight/Obese Women

The purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study of overweight and obese women.

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Key information

Conditions

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

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Premenopausal adult females over the age of 18 and under the age of 45 with a BMI greater than or equal to 25 and a waist circumference greater than or equal to 35 inches.
  • No medical contraindications to participation in an exercise program including major medical illnesses (i.e. cardiovascular disease, stroke, cancer, etc.)
  • Ability to provide informed consent
  • Willingness and ability to participate in an interval training in-person group fitness exercise program 3x/week for 12 weeks

Exclusion criteria

  • Adults unable to consent or mini-mental score less than 18.
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Post-menopausal women
  • Do not speak English
  • Prisoners
  • Subjects on medicines (serum glucose, insulin, weight loss medicines, beta-blockers) and having any medical pre-conditions that would interfere with one's capacity to exercise.
  • Answer "Yes" to any of the questions on the Pre-Activity Screening Questionnaire (PASQ)

Treatment and study plan

HIIT Exercise Training

Other

The HIIT total session duration will be approximately 30 minutes and will be composed of 10 sets of 60 seconds of high-intensity exercises, >80% of maximum heart rate (MHR), interspersed with a recovery period of 60 seconds of low-intensity exercise at 60% of MHR.

Primary outcomes

  1. Pulse Wave Velocity (PWV)

    Time frame: Up to 12 weeks

    vascular marker of cardiac risk will be reported as PWV (m/s) as measured using SphygmoCor

  2. Pulse Wave Analysis Augmentation Index (AIx)

    Time frame: Up to 12 weeks

    vascular marker of cardiac risk will be reported as AIx (%) as measured using SphygmoCor

  3. Pulse Wave Analysis Mean Arterial Pressure (MAP)

    Time frame: Up to 12 weeks

    vascular marker of cardiac risk will be reported as MAP (mmHg) as measured using SphygmoCor

  4. Visceral Adipose Tissue (VAT) content

    Time frame: Up to 12 weeks

    Anthropometric measure will be reported as VAT content as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer

  5. Total Adiposity

    Time frame: Up to 12 weeks

    Anthropometric measure will be reported as Total Adiposity as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer

  6. Aerobic Fitness

    Time frame: Up to 12 weeks

    Aerobic Fitness level as measured by the 20 meter shuttle run

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

A Comparison of Onsite vs. Virtual Fitness Program on Anthropometric Measures, Aerobic Fitness, and Vascular Markers of Cardiac Risk Markers in Overweight/Obese Premenopausal Women

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2021
Registry last updated
Nov 10, 2021

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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