Overweight and ObesityNCT04974476
Onsite vs. Virtual Group Fitness in Overweight/Obese Women
A study testing HIIT Exercise Training in people with Overweight and Obesity, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- HIIT Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2021to 8 Nov 2021
- Phase
- Interventional
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Overweight and Obesity
- Being tested
- HIIT Exercise Training
- Keywords
- Exercise Program
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT Exercise TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| In-person exercise training group | Experimental | participants in this group will receive in person exercise HIIT training 3 days a week for 12 weeks Receives: Other: HIIT Exercise Training |
| Virtual exercise training group | Experimental | participants in this group will receive virtual exercise HIIT training 3 days a week for 12 weeks Receives: Other: HIIT Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity (PWV)
vascular marker of cardiac risk will be reported as PWV (m/s) as measured using SphygmoCor
Measured: Up to 12 weeks
Pulse Wave Analysis Augmentation Index (AIx)
vascular marker of cardiac risk will be reported as AIx (%) as measured using SphygmoCor
Measured: Up to 12 weeks
Pulse Wave Analysis Mean Arterial Pressure (MAP)
vascular marker of cardiac risk will be reported as MAP (mmHg) as measured using SphygmoCor
Measured: Up to 12 weeks
Visceral Adipose Tissue (VAT) content
Anthropometric measure will be reported as VAT content as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer
Measured: Up to 12 weeks
Total Adiposity
Anthropometric measure will be reported as Total Adiposity as measured by noninvasive direct segmental multi-frequency bioelectrical impedance body composition analyzer
Measured: Up to 12 weeks
Aerobic Fitness
Aerobic Fitness level as measured by the 20 meter shuttle run
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start24 Jul 2021
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arlette Perry, University of Miami
- Investigators
- Arlette C Perry, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974476
- Sponsor's protocol ID
- 20210038
- Status last verified
- Nov 2021
- First submitted
- 14 Jul 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04974476
- Acronym / sponsor ID
- 20210038
- Conditions
- Overweight and Obesity
- Keywords
- Exercise Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 24 Jul 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 23 Jul 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person exercise training group | Experimental | Other: HIIT Exercise Trainingparticipants in this group will receive in person exercise HIIT training 3 days a week for 12 weeks |
| Virtual exercise training group | Experimental | Other: HIIT Exercise Trainingparticipants in this group will receive virtual exercise HIIT training 3 days a week for 12 weeks |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| HIIT Exercise TrainingThe 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. | Other | In-person exercise training group, Virtual exercise training group |
Primary outcome
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
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
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
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
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
Aerobic Fitness
Time frame: Up to 12 weeks
Aerobic Fitness level as measured by the 20 meter shuttle run
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 10 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Arlette C Perry principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT Exercise Training in people with Overweight and Obesity, run by University of Miami at 1 site in United States.
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 4 inclusion and 8 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pulse Wave Velocity (PWV) (time frame: Up to 12 weeks). The study lists 6 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 10 Nov 2021.