High Intensity Interval TrainingNCT03433690
The Effect of HIIT in Handling Obesity in Children
A study testing HIIT and Moderate training in people with High Intensity Interval Training and Child Obesity, run by Regionshospital Nordjylland.
Trial summary
In this study the investigators wish to investigate whether a short duration High-intensity Interval Training(HIT) is superior to a moderate activity training modus with regards to improving weight-loss, Blood pressure and sleep quality in severely obese children and adolescents also receiving a multidisciplinary… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- High Intensity Interval Training, Child Obesity
- What is being tested?
- HIIT and Moderate training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2015to 25 Jan 2018
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Iso-BMI > 30 according to the IOTF iso-BMI cut-off points
- Age 8-18 years of age
Who cannot join
- Weight below iso-BMI 30, according to the IOTF iso-BMI cut-off points
- Mental illness in the child or the parents that complicates attendance at activities.
- Physical limitations or illness that prevent the child from performing exercise
- If participant is not able to perform all 12 weeks of exercise for other reasons.
About this study
Official title: The Effect of High Intensity Interval Training in Handling Obesity in Children and Adolescents. A Randomized Controlled Trial.
In this study the investigators wish to investigate whether a short duration High-intensity Interval Training(HIT) is superior to a moderate activity training modus with regards to improving weight-loss, Blood pressure and sleep quality in severely obese children and adolescents also receiving a multidisciplinary treatment regime.
Read the detailed description
Prevalence of overweight and obesity among children and adolescents are rapidly rising worldwide. Despite the alarming situation, great confusion of how to tackle obesity persists for two main reasons: the condition is much more complex than initially thought, and many aspects regarding pathophysiology remain unrevealed, leading to an insufficient understanding of the disorder. Childhood obesity is, strongly associated with numerous disorders e.g. hypertension, insuline resistance, sleep apnea, depression and many more.
High intensity Interval Training has proven beneficial in treating obesity and comorbidities in adults. The investigators wish to investigate whether twelve weeks of High-intensity Interval Training(HIT) twice a week is superior to a moderate activity training modus for same period of time with regards to improving weight loss, blood pressure and sleep quality, in severely obese children and adolescents also receiving a multidisciplinary treatment regime. Participants are severely obese children and adolescents referred to the outpatient Clinic for treatment of obesity. Participants are randomizid to either moderate training or HIIT. Antropometric measures, blood pressure and sleep quality as measured by sensewear armbands, are done at baseline, after the twelve weeks of training and again one year after inclusion. Participants are monitored with pulse monitors during training sessions to register if training goals are obtained.
- Conditions
- High Intensity Interval Training, Child Obesity
- Being tested
- HIIT, Moderate training
- Keywords
- Child Obesity, Adolescents, High Intensity Interval Training, Moderate training
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
High Intensity Interval Training for twelve weeks
Moderate trainingBehavioural
Moderate training for twelve weeks
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | Twelve weeks of High Intensity Interval Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic. Receives: Behavioral: HIIT |
| Moderate training | Active comparator | Twelve weeks of Moderate Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic. Receives: Behavioral: Moderate training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction
In Kg
Measured: Twelve months
Secondary outcomes (2)
Blood pressure
24-hour blood pressure Measurements done by spacelaps 90217A
Measured: At baseline, after twelve weeks training and after twelve months
Sleep Quality
Measured by sensewear armbands which is worn for a week at a time
Measured: At baseline, after twelve weeks training and after twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start28 Jul 2015
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Interval TrainingStudies 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
- Model description
- Randomized Controlled trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tine Caroc Warner, Regionshospital Nordjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433690
- Sponsor's protocol ID
- RHN_TCW_01
- Status last verified
- Feb 2018
- First submitted
- 25 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Intensity Interval Training in Handling Obesity in Children and Adolescents. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03433690
- Acronym / sponsor ID
- RHN_TCW_01
- Conditions
- High Intensity Interval Training, Child Obesity
- Keywords
- Child Obesity, Adolescents, High Intensity Interval Training, Moderate training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 14 Feb 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.
In this study the investigators wish to investigate whether a short duration High-intensity Interval Training(HIT) is superior to a moderate activity training modus with regards to improving weight-loss, Blood pressure and sleep quality in severely obese children and adolescents also receiving a multidisciplinary treatment regime.
Detailed description
Prevalence of overweight and obesity among children and adolescents are rapidly rising worldwide. Despite the alarming situation, great confusion of how to tackle obesity persists for two main reasons: the condition is much more complex than initially thought, and many aspects regarding pathophysiology remain unrevealed, leading to an insufficient understanding of the disorder. Childhood obesity is, strongly associated with numerous disorders e.g. hypertension, insuline resistance, sleep apnea, depression and many more.
High intensity Interval Training has proven beneficial in treating obesity and comorbidities in adults. The investigators wish to investigate whether twelve weeks of High-intensity Interval Training(HIT) twice a week is superior to a moderate activity training modus for same period of time with regards to improving weight loss, blood pressure and sleep quality, in severely obese children and adolescents also receiving a multidisciplinary treatment regime. Participants are severely obese children and adolescents referred to the outpatient Clinic for treatment of obesity. Participants are randomizid to either moderate training or HIIT. Antropometric measures, blood pressure and sleep quality as measured by sensewear armbands, are done at baseline, after the twelve weeks of training and again one year after inclusion. Participants are monitored with pulse monitors during training sessions to register if training goals are obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled trial
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Behavioral: HIITTwelve weeks of High Intensity Interval Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic. |
| Moderate training | Active comparator | Behavioral: Moderate trainingTwelve weeks of Moderate Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Iso-BMI > 30 according to the IOTF iso-BMI cut-off points
- Age 8-18 years of age
Key exclusion criteria (4 listed)
- Weight below iso-BMI 30, according to the IOTF iso-BMI cut-off points
- Mental illness in the child or the parents that complicates attendance at activities.
- Physical limitations or illness that prevent the child from performing exercise
- If participant is not able to perform all 12 weeks of exercise for other reasons.
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 |
|---|---|---|
| HIITHigh Intensity Interval Training for twelve weeks | Behavioural | High Intensity Interval Training |
| Moderate trainingModerate training for twelve weeks | Behavioural | Moderate training |
Primary outcome
Weight reduction
Time frame: Twelve months
In Kg
2 secondary outcomes
Blood pressure
Time frame: At baseline, after twelve weeks training and after twelve months
Sleep Quality
Time frame: At baseline, after twelve weeks training and after twelve months
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 14 Feb 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and Moderate training in people with High Intensity Interval Training and Child Obesity, run by Regionshospital Nordjylland.
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 2 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Weight reduction (time frame: Twelve months). 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 14 Feb 2018.