Body Weight ChangesNCT03524521
Body Weight-Based Interval Training in Sedentary Overweight and Obese Adults
A study testing Interval Training in people with Body Weight Changes and Overweight and Obesity, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Overweight and Obesity, Physical Activity
- What is being tested?
- Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 8 Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Interval Training Using Body Weight on Body Composition in Sedentary Overweight and Obese Adults
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.
Read the 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.
- Being tested
- Interval Training, Standard of Care
- Medical subject headings
- Body Weight Changes, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval TrainingBehavioural
Interval training is prescribed 3 days per week using 5 body weight exercises in a progressive fashion.
Standard of CareBehavioural
Walking prescribed to meet current exercise guidelines; 150 minutes per week.
| Study group | Role | What they receive |
|---|---|---|
| Standard Walking | Active comparator | This arm is prescribed standard of care exercise prescription; 30 minutes of moderate intensity walking, 5 days/week. Receives: Behavioral: Standard of Care |
| Interval Training | Experimental | This arm is prescribed body-weight based interval training 3 days per week with progressive increase in exercise intervals and sets. Receives: Behavioral: Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body fat percent
DEXA derived body fat %
Measured: 12 weeks
Secondary outcomes (4)
Change in Weight
Weight in kilograms
Measured: 12 weeks
Change in peak VO2
Peak VO2 in ml/kg/min
Measured: 12 weeks
Visceral adipose tissue area
cm^2
Measured: 12 weeks
Thigh adipose tissue area
cm^2
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start6 Nov 2018
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda R. Bonikowske, Mayo Clinic
- Investigators
- Amanda R Bonikowske, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524521
- Sponsor's protocol ID
- 17-010163
- Status last verified
- Jan 2021
- First submitted
- 30 Apr 2018
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interval Training Using Body Weight on Body Composition in Sedentary Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT03524521
- Acronym / sponsor ID
- 17-010163
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 14 May 2018 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Walking | Active comparator | Behavioral: Standard of CareThis arm is prescribed standard of care exercise prescription; 30 minutes of moderate intensity walking, 5 days/week. |
| Interval Training | Experimental | Behavioral: Interval TrainingThis arm is prescribed body-weight based interval training 3 days per week with progressive increase in exercise intervals and sets. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Interval TrainingInterval training is prescribed 3 days per week using 5 body weight exercises in a progressive fashion. | Behavioural | Interval Training |
| Standard of CareWalking prescribed to meet current exercise guidelines; 150 minutes per week. | Behavioural | Standard Walking |
Primary outcome
Change in Body fat percent
Time frame: 12 weeks
DEXA derived body fat %
4 secondary outcomes
Change in Weight
Time frame: 12 weeks
Change in peak VO2
Time frame: 12 weeks
Visceral adipose tissue area
Time frame: 12 weeks
Thigh adipose tissue area
Time frame: 12 weeks
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 11 Jan 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Amanda R Bonikowske principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval Training in people with Body Weight Changes and Overweight and Obesity, run by Mayo Clinic 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 6 inclusion and 6 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 11 Jan 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?
Change in Body fat percent (time frame: 12 weeks). 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 11 Jan 2021.