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Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults

Primary Purpose

Body Weight Changes, Overweight and Obesity, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interval Training
Standard of Care
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Body Weight Changes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults 18-65 years of age
  • Willing and able to provide informed consent
  • Sedentary, overweight and obese adults (<90 minutes of moderate intensity exercise)
  • BMI 25≤35
  • Able to safely begin an exercise program
  • Have a smartphone, and willing and able to download and use the Fitbit app

Exclusion Criteria:

  • Unable to provide informed consent.
  • Known cardiovascular disease, or uncontrolled hypertension,
  • Diagnosed type 1 or 2 diabetes
  • Women who are pregnant or plan to become pregnant in the next 3-4 months
  • Orthopedic injury/limitation or any other contraindications to exercise.
  • Medications that cause weight gain (steroids, HIV-related medications, etc.), or glucose lowering medications

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Walking

Interval Training

Arm Description

This arm is prescribed standard of care exercise prescription; 30 minutes of moderate intensity walking, 5 days/week.

This arm is prescribed body-weight based interval training 3 days per week with progressive increase in exercise intervals and sets.

Outcomes

Primary Outcome Measures

Change in Body fat percent
DEXA derived body fat %

Secondary Outcome Measures

Change in Weight
Weight in kilograms
Change in peak VO2
Peak VO2 in ml/kg/min
Visceral adipose tissue area
cm^2
Thigh adipose tissue area
cm^2

Full Information

First Posted
April 30, 2018
Last Updated
January 8, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03524521
Brief Title
Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults
Official Title
The Effect of Interval Training Using Body Weight on Body Composition in Sedentary Overweight and Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Body-weight based interval training (IT) performed 3 times per week will lead to reductions in abdominal adiposity and reduce overall body fat percentage in overweight and obese sedentary adults more effectively than moderate intensity continuous training (MICT). Body-weight interval training will improve exercise capacity (peak VO2) in overweight/obese adults.
Detailed Description
Participants will be randomly assigned to one of the two home-based exercise groups. The MICT group is the standard care group and will be instructed to walk for 30 minutes, 5 days per week at a moderate intensity. The goal is to accumulate 150 minutes of continuous aerobic exercise each week. Participants will be instructed on the use of the Rating of Perceived Exertion (RPE) scale during baseline testing and will be instructed to reach an RPE of 12-16. A heart rate monitor will be worn to monitor exercise intensity. Heart rate should reach ~70% of maximal heart rate. The IT group will perform 5 body-weight exercises in three progressive phases. During the first 2 weeks the circuit will be completed twice, 30 second intervals, 90 seconds of rest. The exercises will be performed on 3 days of the week with at least one day of rest between exercise days (ideally Monday, Wednesday, Friday). The number of repetitions will increase to a maximum of 4 while the interval and rest periods increase to a maximum of 45 seconds each. The total time spent performing intervals by week 8 will be 15 minutes. A 2 minute warm up and 3 minute cool down will be performed, such as jumping jacks or simply walking. A heart rate monitor will be used to measure exercise intensity. Heart rate should reach approximately 90% of heart rate max during the intervals. Participants will be instructed on the use of the Rating of Perceived Exertion scale during baseline testing and will be instructed to reach an RPE of ≥17 during the high intensity intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Overweight and Obesity, Physical Activity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Walking
Arm Type
Active Comparator
Arm Description
This arm is prescribed standard of care exercise prescription; 30 minutes of moderate intensity walking, 5 days/week.
Arm Title
Interval Training
Arm Type
Experimental
Arm Description
This arm is prescribed body-weight based interval training 3 days per week with progressive increase in exercise intervals and sets.
Intervention Type
Behavioral
Intervention Name(s)
Interval Training
Intervention Description
Interval training is prescribed 3 days per week using 5 body weight exercises in a progressive fashion.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
Walking prescribed to meet current exercise guidelines; 150 minutes per week.
Primary Outcome Measure Information:
Title
Change in Body fat percent
Description
DEXA derived body fat %
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Weight
Description
Weight in kilograms
Time Frame
12 weeks
Title
Change in peak VO2
Description
Peak VO2 in ml/kg/min
Time Frame
12 weeks
Title
Visceral adipose tissue area
Description
cm^2
Time Frame
12 weeks
Title
Thigh adipose tissue area
Description
cm^2
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults 18-65 years of age Willing and able to provide informed consent Sedentary, overweight and obese adults (<90 minutes of moderate intensity exercise) BMI 25≤35 Able to safely begin an exercise program Have a smartphone, and willing and able to download and use the Fitbit app Exclusion Criteria: Unable to provide informed consent. Known cardiovascular disease, or uncontrolled hypertension, Diagnosed type 1 or 2 diabetes Women who are pregnant or plan to become pregnant in the next 3-4 months Orthopedic injury/limitation or any other contraindications to exercise. Medications that cause weight gain (steroids, HIV-related medications, etc.), or glucose lowering medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda R Bonikowske
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults

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