Fat BurnNCT04696614
Testing the Effect of Exercise Intervention Using a SMART Design.
A study testing exercise in people with Fat Burn, run by National Taiwan University at 1 site in Taiwan.
Trial summary
Exercise is the most effective way on reducing visceral adipose tissue (VAT), which is strongly linked with obesity to hypertension, cardiovascular disease, and insulin resistance. However, the current exercise dosage for reducing VAT cannot be accurately quantified. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Burn
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Nov 2020to 31 Jul 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 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Community residents (a) who are 40-65 years old without diet control, (b) body fat ≧ 30% measured by body composition analyzer, and (c) can communicate in Mandarin or Taiwanese will be included.
Who cannot join
- This study will exclude residents with (a) recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP > 200 mmHg, or diastolic BP >110 mmHg; and (b) those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Testing the Effect of Exercise Intervention Using a SMART Design on Reducing Visceral Adipose Tissue in Community Residents: A Mixed-Method, Longitudinal Study.
Exercise is the most effective way on reducing visceral adipose tissue (VAT), which is strongly linked with obesity to hypertension, cardiovascular disease, and insulin resistance. However, the current exercise dosage for reducing VAT cannot be accurately quantified. The aims of this study are to develop and test the optimal exercise dosage and sequence for reducing VAT in overweight and obese community residents. Purposive sampling will be used to enroll at least 206 participants aged 40-65 years and body fat more than 30% without diet control from 2 community centers in southern Taiwan. The project will use the sequential multiple assignment randomized trial (SMART) design to conduct a 16-week 2-stage (each for 8-weeks) adaptive exercise intervention for community residents. In the first stage, participants will be randomized into groups performing 8 weeks either moderate intensity of aerobic exercise or interval training 3 times per week. Participants whose VAT does not decrease by over 3%, measured using a body composition analyzer, compared with the baseline will be 1:1 rerandomized into groups with aerobic exercise combined with resistance exercise or received the exchange of first stage treatment (interval training or aerobic exercise) in the second stage. Those with substantial response to the first-stage intervention (VAT reduction of more than 3%) will continue to receive the same exercise treatment until 16 weeks. Linear mixed model, weighted and replicated regression will be used to identify the optimal sequence of exercises for the greatest reduction in VAT. The findings can assist clinical health workers to develop exercise prescriptions for effectively reducing VAT, and help community residents reduce VAT through exercise to achieve the health promotion.
- Conditions
- Fat Burn
- Being tested
- exercise
- Keywords
- sequential multiple assignment randomized trial, exercise, visceral adipose tissue
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
intervention groups provided different sequential modality of exercise
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise to aerobic exercise | Experimental | first 8-week: aerobic exercise second 8-week: aerobic exercise Receives: Behavioral: exercise |
| aerobic exercise to interval training | Experimental | first 8-week: aerobic exercise second 8-week: interval training Receives: Behavioral: exercise |
| aerobic exercise to aerobic exercise +resistance exercise | Experimental | first 8-week: aerobic exercise second 8-week: aerobic exercise +resistance exercise Receives: Behavioral: exercise |
| interval training to interval training | Experimental | first 8-week: interval training second 8-week: interval training Receives: Behavioral: exercise |
| interval training to aerobic exercise | Experimental | first 8-week: interval training second 8-week: aerobic exercise Receives: Behavioral: exercise |
| interval training to aerobic exercise+resistance exercise | Experimental | first 8-week: interval training second 8-week: aerobic exercise +resistance exercise Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
visceral adipose tissue
measured using body composition analyzer
Measured: three times (baseline, change visceral adipose tissue from Baseline to 8 week, change visceral adipose tissue from Baseline to 16 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start10 Nov 2020
- Primary completion4 Jan 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fat BurnStudies 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
- Sequential
- Model description
- Participants will be randomized with 1:1 equal allocation at baseline to one of two first-stage interventions (8 weeks aerobic exercise (AE) or interval training). Those who exhibit early signs of nonresponse determined by a tailoring variable (reduced (visceral adipose tissue (VAT) \< 3%) will then be rerandomized to one of two second-stage interventions (AE + RE (resistance exercise) vs interval training or AE), also with 1:1 equal allocation, whereas those who have a significant response to the first-stage intervention will continue to receive the same exercise treatment until 16 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hsuan Chang, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696614
- Sponsor's protocol ID
- 108466
- Status last verified
- Apr 2022
- First submitted
- 4 Jan 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang YH, Lee YH, Wu KL, Hsu WL, Hung H, Shun SC. Exercise Strategy for Reducing Visceral Adipose Tissue in Community Residents With Obesity: A Sequential Multiple Assignment Randomized Trial. J Nurs Res. 2025 Apr 1;33(2):e385. doi: 10.1097/jnr.0000000000000662.
PubMed 40019278
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing the Effect of Exercise Intervention Using a SMART Design on Reducing Visceral Adipose Tissue in Community Residents: A Mixed-Method, Longitudinal Study.
- ClinicalTrials.gov ID
- NCT04696614
- Acronym / sponsor ID
- 108466
- Conditions
- Fat Burn
- Keywords
- sequential multiple assignment randomized trial, exercise, visceral adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 4 Jan 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 6 Jan 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.
Exercise is the most effective way on reducing visceral adipose tissue (VAT), which is strongly linked with obesity to hypertension, cardiovascular disease, and insulin resistance. However, the current exercise dosage for reducing VAT cannot be accurately quantified. The aims of this study are to develop and test the optimal exercise dosage and sequence for reducing VAT in overweight and obese community residents. Purposive sampling will be used to enroll at least 206 participants aged 40-65 years and body fat more than 30% without diet control from 2 community centers in southern Taiwan. The project will use the sequential multiple assignment randomized trial (SMART) design to conduct a 16-week 2-stage (each for 8-weeks) adaptive exercise intervention for community residents. In the first stage, participants will be randomized into groups performing 8 weeks either moderate intensity of aerobic exercise or interval training 3 times per week. Participants whose VAT does not decrease by over 3%, measured using a body composition analyzer, compared with the baseline will be 1:1 rerandomized into groups with aerobic exercise combined with resistance exercise or received the exchange of first stage treatment (interval training or aerobic exercise) in the second stage. Those with substantial response to the first-stage intervention (VAT reduction of more than 3%) will continue to receive the same exercise treatment until 16 weeks. Linear mixed model, weighted and replicated regression will be used to identify the optimal sequence of exercises for the greatest reduction in VAT. The findings can assist clinical health workers to develop exercise prescriptions for effectively reducing VAT, and help community residents reduce VAT through exercise to achieve the health promotion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Participants will be randomized with 1:1 equal allocation at baseline to one of two first-stage interventions (8 weeks aerobic exercise (AE) or interval training). Those who exhibit early signs of nonresponse determined by a tailoring variable (reduced (visceral adipose tissue (VAT) < 3%) will then be rerandomized to one of two second-stage interventions (AE + RE (resistance exercise) vs interval training or AE), also with 1:1 equal allocation, whereas those who have a significant response to the first-stage intervention will continue to receive the same exercise treatment until 16 weeks.
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise to aerobic exercise | Experimental | Behavioral: exercisefirst 8-week: aerobic exercise second 8-week: aerobic exercise |
| aerobic exercise to interval training | Experimental | Behavioral: exercisefirst 8-week: aerobic exercise second 8-week: interval training |
| aerobic exercise to aerobic exercise +resistance exercise | Experimental | Behavioral: exercisefirst 8-week: aerobic exercise second 8-week: aerobic exercise +resistance exercise |
| interval training to interval training | Experimental | Behavioral: exercisefirst 8-week: interval training second 8-week: interval training |
| interval training to aerobic exercise | Experimental | Behavioral: exercisefirst 8-week: interval training second 8-week: aerobic exercise |
| interval training to aerobic exercise+resistance exercise | Experimental | Behavioral: exercisefirst 8-week: interval training second 8-week: aerobic exercise +resistance exercise |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Community residents (a) who are 40-65 years old without diet control, (b) body fat ≧ 30% measured by body composition analyzer, and (c) can communicate in Mandarin or Taiwanese will be included.
Key exclusion criteria (1 listed)
- This study will exclude residents with (a) recent unstable condition involving stroke or those with heart disease, handicap, pregnancy, mental disorders, systolic BP > 200 mmHg, or diastolic BP >110 mmHg; and (b) those with contraindications in body composition analyzer measurement including people with pacemakers, artificial metal joints, amputated hands or feet, and those who cannot be cooperated with standing during testing.
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 |
|---|---|---|
| exerciseintervention groups provided different sequential modality of exercise | Behavioural | aerobic exercise to aerobic exercise, aerobic exercise to aerobic exercise +resistance exercise, aerobic exercise to interval training, interval training to aerobic exercise, interval training to aerobic exercise+resistance exercise, interval training to interval training |
Primary outcome
visceral adipose tissue
Time frame: three times (baseline, change visceral adipose tissue from Baseline to 8 week, change visceral adipose tissue from Baseline to 16 week)
measured using body composition analyzer
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 7 Apr 2022.
- Derived from this study: PubMed 40019278Chang YH, Lee YH, Wu KL, Hsu WL, Hung H, Shun SC. Exercise Strategy for Reducing Visceral Adipose Tissue in Community Residents With Obesity: A Sequential Multiple Assignment Randomized Trial. J Nurs Res. 2025 Apr 1;33(2):e385. doi: 10.1097/jnr.0000000000000662.
- Individual participant dataSharing planned: No
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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 exercise in people with Fat Burn, run by National Taiwan University at 1 site in Taiwan.
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 7 Apr 2022. 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 Taiwan. 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?
visceral adipose tissue (time frame: three times (baseline, change visceral adipose tissue from Baseline to 8 week, change visceral adipose tissue from Baseline to 16 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696614, which also lists 1 linked publication.
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 7 Apr 2022.