ObesityNCT03980860
Effect of Two Exercise Programs on Obese Patients
A study testing Exercise Type in people with Obesity and Hypertension, run by Rowan University at 1 site in United States.
Trial summary
The purpose of the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Exercise Type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 1 Oct 2019
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anyone with a BMI of 25 and above
Who cannot join
- Those that cannot exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Rowan SOM Family Medicine
Stratford, New Jersey, 08084
About this study
Official title: Effect of HIIT vs Low Intensity Training on Fat Loss in Obese Patients
The purpose of the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. What the investigators are proposing is that HIIT is less effective because it will most likely decrease lean body mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.
- Conditions
- Obesity, Hypertension
- Being tested
- Exercise Type
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TypeOther
The implementation of 2 types of exercise programs to reduce body fat
| Study group | Role | What they receive |
|---|---|---|
| HIIT (High Intensity Interval Training) | Active comparator | Subjects are undergoing high intensity interval training Receives: Other: Exercise Type |
| Low intensity training long duration | Active comparator | Subjects are undergoing a lower intensity training program for a long duration Receives: Other: Exercise Type |
| Control | No intervention | No exercise program intervention (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat
Reduction in body fat
Measured: 6 weeks
Lean body mass
Retention of lean body mass
Measured: 6 weeks
Secondary outcomes (1)
Blood pressure
Reduction of blood pressure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start5 Jun 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a case/control study comparing overweight/obese patients of three different groups (control, HIIT, LIT). The goal of a case/control is to show whether exposure to HIIT, two times a week for 6 weeks will decrease lean body mass versus control and LIT. If it turns out that lean body mass does decrease, then HIIT is not an effective exercise modality for overweight/obese patients, and in fact LIT or control may be a better option.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adarsh Gupta, DO, MS, FACOFP, Rowan University
- Investigators
- Adarsh Gupta, DO, Principal investigator, Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980860
- Sponsor's protocol ID
- Pro2019000482
- Status last verified
- Oct 2019
- First submitted
- 6 Jun 2019
- Last updated
- 25 Oct 2019
- 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 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HIIT vs Low Intensity Training on Fat Loss in Obese Patients
- ClinicalTrials.gov ID
- NCT03980860
- Acronym / sponsor ID
- Pro2019000482
- Conditions
- Obesity, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 10 Jun 2019 (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 the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. What the investigators are proposing is that HIIT is less effective because it will most likely decrease lean body mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a case/control study comparing overweight/obese patients of three different groups (control, HIIT, LIT). The goal of a case/control is to show whether exposure to HIIT, two times a week for 6 weeks will decrease lean body mass versus control and LIT. If it turns out that lean body mass does decrease, then HIIT is not an effective exercise modality for overweight/obese patients, and in fact LIT or control may be a better option.
| Arm | Type | Receives |
|---|---|---|
| HIIT (High Intensity Interval Training) | Active comparator | Other: Exercise TypeSubjects are undergoing high intensity interval training |
| Low intensity training long duration | Active comparator | Other: Exercise TypeSubjects are undergoing a lower intensity training program for a long duration |
| Control | No intervention | –No exercise program intervention (usual care) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anyone with a BMI of 25 and above
Key exclusion criteria (1 listed)
- Those that cannot 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 |
|---|---|---|
| Exercise TypeThe implementation of 2 types of exercise programs to reduce body fat | Other | HIIT (High Intensity Interval Training), Low intensity training long duration |
Primary outcome
Body fat
Time frame: 6 weeks
Reduction in body fat
Lean body mass
Time frame: 6 weeks
Retention of lean body mass
1 secondary outcome
Blood pressure
Time frame: 6 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 25 Oct 2019.
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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.
Adarsh Gupta, DO principal investigator
Rowan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Type in people with Obesity and Hypertension, run by Rowan University 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 1 inclusion and 1 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 25 Oct 2019. 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?
Body fat (time frame: 6 weeks). The study lists 2 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 25 Oct 2019; AzTrials last refreshed its copy on 2 Nov 2026.