OverweightNCT04860349
Is High Intensity Interval Training Effective to Reduce the Waist Circumference and Fat Percentage at Trunk Region
A study testing High Intensity Interval Training in people with Overweight and Physically Inactive, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial summary
Overweight is a risk factor for a number of non-communicable diseases, and this risk doubles, if an individual is physically inactive. Various exercise interventional protocols in the past have been reported on treating overweight and obesity which helps to decrease the different anthropometric variables. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Physically Inactive, Adults
- What is being tested?
- High Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 14 May 2021to 9 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Either gender
- Aged 18-25 years
- Physically Inactive
Who cannot join
- Any medical condition that restrict the participants to participate in physical exercise
- Blood pressure of more than 140/90 mmHg
- Participants taking any medication that causes drowsiness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Intensity Interval Training on Waist Circumference and Fat Percentage at Trunk Region Among Physically Inactive Overweight Young Adults
Overweight is a risk factor for a number of non-communicable diseases, and this risk doubles, if an individual is physically inactive. Various exercise interventional protocols in the past have been reported on treating overweight and obesity which helps to decrease the different anthropometric variables. Despite all these protocols, obese and overweight do not seem to benefit greatly by these exercise training programs, as lack of time is thought to the main reason for not engaging in healthful physical exercise. Research evidence has proven that people with a body mass index of more than 30 kg/m2 and waist circumference of more than 102 cm have 2-fold higher risk of waking fewer steps daily. Although physical exercise is thought to be very helpful in regulating the body weight, it is very important to identify the type of physical activity to effectively manage overweight and obesity. Aerobic exercise namely high intensity interval training have been reported to reduce the body mass, fat%, and waist circumference. Investigators believe that high intensity interval training would help in controlling the various anthropometric variables namely the body mass index, waist circumference, and fat% in trunk region in physically inactive overweight adults.
- Conditions
- Overweight, Physically Inactive, Adults
- Being tested
- High Intensity Interval Training
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
4-weeks of high intensity interval training, 3 sessions/week on alternate days. each session for 20 minutes, excluding the warm-up and cool-down.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | 20 minutes of High Intensity Interval Training for experimental group. Receives: Other: High Intensity Interval Training |
| Control | No intervention | No intervention for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: Change from Baseline Body Mass Index at 4 weeks
Waist Circumference
Measured: Change from Baseline Waist Circumference at 4 weeks
Fat Percentage at Trunk Region
Measured: Change from Baseline Fat Percentage at Trunk Region at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start14 May 2021
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imtiyaz Ali Mir, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860349
- Sponsor's protocol ID
- U/SERC/92/2021
- Status last verified
- Dec 2021
- First submitted
- 16 Apr 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Interval Training on Waist Circumference and Fat Percentage at Trunk Region Among Physically Inactive Overweight Young Adults
- ClinicalTrials.gov ID
- NCT04860349
- Acronym / sponsor ID
- U/SERC/92/2021
- Conditions
- Overweight, Physically Inactive, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 26 Apr 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.
Overweight is a risk factor for a number of non-communicable diseases, and this risk doubles, if an individual is physically inactive. Various exercise interventional protocols in the past have been reported on treating overweight and obesity which helps to decrease the different anthropometric variables. Despite all these protocols, obese and overweight do not seem to benefit greatly by these exercise training programs, as lack of time is thought to the main reason for not engaging in healthful physical exercise. Research evidence has proven that people with a body mass index of more than 30 kg/m2 and waist circumference of more than 102 cm have 2-fold higher risk of waking fewer steps daily. Although physical exercise is thought to be very helpful in regulating the body weight, it is very important to identify the type of physical activity to effectively manage overweight and obesity. Aerobic exercise namely high intensity interval training have been reported to reduce the body mass, fat%, and waist circumference. Investigators believe that high intensity interval training would help in controlling the various anthropometric variables namely the body mass index, waist circumference, and fat% in trunk region in physically inactive overweight adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Other: High Intensity Interval Training20 minutes of High Intensity Interval Training for experimental group. |
| Control | No intervention | –No intervention for the control group. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Either gender
- Aged 18-25 years
- Physically Inactive
Key exclusion criteria (3 listed)
- Any medical condition that restrict the participants to participate in physical exercise
- Blood pressure of more than 140/90 mmHg
- Participants taking any medication that causes drowsiness
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 |
|---|---|---|
| High Intensity Interval Training4-weeks of high intensity interval training, 3 sessions/week on alternate days. each session for 20 minutes, excluding the warm-up and cool-down. | Other | High Intensity Interval Training |
Primary outcome
Body Mass Index
Time frame: Change from Baseline Body Mass Index at 4 weeks
Waist Circumference
Time frame: Change from Baseline Waist Circumference at 4 weeks
Fat Percentage at Trunk Region
Time frame: Change from Baseline Fat Percentage at Trunk Region at 4 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 20 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training in people with Overweight and Physically Inactive, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
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 3 inclusion and 3 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 20 Dec 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 Malaysia. 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 Mass Index (time frame: Change from Baseline Body Mass Index at 4 weeks). The study lists 3 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 20 Dec 2021.