The Effect of HIIT in Handling Obesity in Children
Primary Purpose
High Intensity Interval Training, Child Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HIIT
Moderate training
Sponsored by
About this trial
This is an interventional treatment trial for High Intensity Interval Training focused on measuring Child Obesity, Adolescents, High Intensity Interval Training, Moderate training
Eligibility Criteria
Inclusion Criteria:
- Iso-BMI > 30 according to the IOTF iso-BMI cut-off points
- Age 8-18 years of age
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Intensity Interval Training
Moderate training
Arm Description
Twelve weeks of High Intensity Interval Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic.
Twelve weeks of Moderate Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic.
Outcomes
Primary Outcome Measures
Weight reduction
In Kg
Secondary Outcome Measures
Blood pressure
24-hour blood pressure Measurements done by spacelaps 90217A
Sleep Quality
Measured by sensewear armbands which is worn for a week at a time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03433690
Brief Title
The Effect of HIIT in Handling Obesity in Children
Official Title
The Effect of High Intensity Interval Training in Handling Obesity in Children and Adolescents. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 28, 2015 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
January 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vendsyssel Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Intensity Interval Training, Child Obesity
Keywords
Child Obesity, Adolescents, High Intensity Interval Training, Moderate training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Description
Twelve weeks of High Intensity Interval Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic.
Arm Title
Moderate training
Arm Type
Active Comparator
Arm Description
Twelve weeks of Moderate Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic.
Intervention Type
Behavioral
Intervention Name(s)
HIIT
Intervention Description
High Intensity Interval Training for twelve weeks
Intervention Type
Behavioral
Intervention Name(s)
Moderate training
Intervention Description
Moderate training for twelve weeks
Primary Outcome Measure Information:
Title
Weight reduction
Description
In Kg
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
24-hour blood pressure Measurements done by spacelaps 90217A
Time Frame
At baseline, after twelve weeks training and after twelve months
Title
Sleep Quality
Description
Measured by sensewear armbands which is worn for a week at a time
Time Frame
At baseline, after twelve weeks training and after twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Iso-BMI > 30 according to the IOTF iso-BMI cut-off points
Age 8-18 years of age
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of HIIT in Handling Obesity in Children
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