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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
Vendsyssel Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 25, 2018
    Last Updated
    February 7, 2018
    Sponsor
    Vendsyssel Hospital
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    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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