Android Obesity, Metabolic Parameters and Adipose Tissue (AT) Gene ExpressionNCT01913171
Effect of Hula Hooping as Compared to Walking on Adipose Tissue Distribution, Metabolic Parameters and Adipose Tissue Gene Expression
A study testing Exercise in people with Android Obesity, Metabolic Parameters and Adipose Tissue (AT) Gene Expression, run by University of Helsinki at 1 site in Finland.
Trial summary
o determine effects of hula-hooping on android obesity, metabolic parameters and adipose tissue (AT) gene expression. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Android Obesity, Metabolic Parameters and Adipose Tissue (AT) Gene Expression
- What is being tested?
- Exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2011to Mar 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 70 years
- central adiposity as measured by the waist circumference (>80 cm in females and >94 cm in males) (9)
- ability to hula-hoop for a minimum of 2 minutes and to have the necessary space available for this activity either at home or at work
- ability to communicate meaningfully with the investigator and legal competence to provide written informed consent
Who cannot join
- clinical or biochemical evidence of disease other than obesity as judged by history, physical examination and standard laboratory tests
- excessive use of alcohol, i.e., over 20 g/day
- use of medications known to affect glucose or lipid metabolism and
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Medicine, University of Helsinki
Helsinki, FI-00290
About this study
- determine effects of hula-hooping on android obesity, metabolic parameters and adipose tissue (AT) gene expression.
- Being tested
- Exercise
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Walking | Active comparator | WALK. The participants were instructed to walk daily, at first week 12minutes/day, week II 16mins/day, week III 20mins/day, week IV 24 mins/day, week V 28mins/day, week VI 32mins/day at a pace that would moderately increase heart rate and result in sweating Receives: Other: Exercise |
| Hula-hooping | Active comparator | HULA. The participants were instructed to hula hoop daily, at first week 6minutes/day, week II 8mins/day, week III 10mins/day, week IV 12 mins/day, week V 14mins/day, week VI 16mins/day Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Android obesity
The primary objective was to evaluate the change in the % fat in the android region as measured by DEXA during 6 weeks of HULA as compared to WALK
Measured: 6weeks
Secondary outcomes (1)
metabolic parameters
The secondary objectives included the comparison of differences in waist circumference (cm), relative and absolute trunk and limb muscle mass as measured by DEXA (% and kg), fasting plasma glucose (mmol/l), fasting serum insulin (mU/l), liver enzymes (U/l), fasting plasma LDL and HDL cholesterol and triglycerides (mmol/l). Gene expression was analyzed in adipose tissue biopsies collected before and after each exercise intervention.
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
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 Android Obesity, Metabolic Parameters and Adipose Tissue (AT) Gene ExpressionStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanja Sadevirta, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913171
- Sponsor's protocol ID
- HULA 233401
- Other IDs
- HULA233401
- Status last verified
- Jul 2013
- First submitted
- 18 Jun 2013
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lahelma M, Sadevirta S, Lallukka-Bruck S, Sevastianova K, Mustelin L, Gylling H, Rockette-Wagner B, Kriska AM, Yki-Jarvinen H. Effects of Weighted Hula-Hooping Compared to Walking on Abdominal Fat, Trunk Muscularity, and Metabolic Parameters in Overweight Subjects: A Randomized Controlled Study. Obes Facts. 2019;12(4):385-396. doi: 10.1159/000500572. Epub 2019 Jun 19.
PubMed 31216547
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hula Hooping as Compared to Walking on Adipose Tissue Distribution, Metabolic Parameters and Adipose Tissue Gene Expression
- ClinicalTrials.gov ID
- NCT01913171
- Acronym / sponsor ID
- HULA 233401
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 31 Jul 2013 (estimated)
- 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.
- determine effects of hula-hooping on android obesity, metabolic parameters and adipose tissue (AT) gene expression.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking | Active comparator | Other: ExerciseWALK. The participants were instructed to walk daily, at first week 12minutes/day, week II 16mins/day, week III 20mins/day, week IV 24 mins/day, week V 28mins/day, week VI 32mins/day at a pace that would moderately increase heart rate and result in sweating |
| Hula-hooping | Active comparator | Other: ExerciseHULA. The participants were instructed to hula hoop daily, at first week 6minutes/day, week II 8mins/day, week III 10mins/day, week IV 12 mins/day, week V 14mins/day, week VI 16mins/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 70 years
- central adiposity as measured by the waist circumference (>80 cm in females and >94 cm in males) (9)
- ability to hula-hoop for a minimum of 2 minutes and to have the necessary space available for this activity either at home or at work
- ability to communicate meaningfully with the investigator and legal competence to provide written informed consent
Key exclusion criteria (4 listed)
- clinical or biochemical evidence of disease other than obesity as judged by history, physical examination and standard laboratory tests
- excessive use of alcohol, i.e., over 20 g/day
- use of medications known to affect glucose or lipid metabolism and
- pregnancy or lactation
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 | Other | Hula-hooping, Walking |
Primary outcome
Android obesity
Time frame: 6weeks
The primary objective was to evaluate the change in the % fat in the android region as measured by DEXA during 6 weeks of HULA as compared to WALK
1 secondary outcome
metabolic parameters
Time frame: 6weeks
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 31 Jul 2013.
- Derived from this study: PubMed 31216547Lahelma M, Sadevirta S, Lallukka-Bruck S, Sevastianova K, Mustelin L, Gylling H, Rockette-Wagner B, Kriska AM, Yki-Jarvinen H. Effects of Weighted Hula-Hooping Compared to Walking on Abdominal Fat, Trunk Muscularity, and Metabolic Parameters in Overweight Subjects: A Randomized Controlled Study. Obes Facts. 2019;12(4):385-396. doi: 10.1159/000500572. Epub 2019 Jun 19.
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 Android Obesity, Metabolic Parameters and Adipose Tissue (AT) Gene Expression, run by University of Helsinki at 1 site in Finland.
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 4 inclusion and 4 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 31 Jul 2013. 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 Finland. 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?
Android obesity (time frame: 6weeks). 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 NCT01913171, 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 31 Jul 2013.