NCT04974476

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 24, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2021

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

July 14, 2021

Last Update Submit

November 9, 2021

Conditions

Overweight and Obesity

Keywords

Exercise Program

Outcome Measures

Primary Outcomes (6)

  • Pulse Wave Velocity (PWV)

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

    Up to 12 weeks

  • Pulse Wave Analysis Augmentation Index (AIx)

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

    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

    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

    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

    Up to 12 weeks

  • Aerobic Fitness

    Aerobic Fitness level as measured by the 20 meter shuttle run

    Up to 12 weeks

Study Arms (2)

In-person exercise training group

EXPERIMENTAL

participants in this group will receive in person exercise HIIT training 3 days a week for 12 weeks

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

Other: HIIT Exercise Training

Interventions

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.

In-person exercise training groupVirtual exercise training group

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arlette C Perry

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 23, 2021

Study Start

July 24, 2021

Primary Completion

November 8, 2021

Study Completion

November 8, 2021

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)