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The Effect of HIIT in Handling Obesity in Children

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ClinicalTrials.gov Identifier: NCT03433690
Recruitment Status : Completed
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Tine Caroc Warner, Vendsyssel Hospital

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.

Condition or disease Intervention/treatment Phase
High Intensity Interval Training Child Obesity Behavioral: HIIT Behavioral: Moderate training Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of High Intensity Interval Training in Handling Obesity in Children and Adolescents. A Randomized Controlled Trial.
Actual Study Start Date : July 28, 2015
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : January 25, 2018

Arm Intervention/treatment
Experimental: High Intensity Interval Training
Twelve weeks of High Intensity Interval Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic.
Behavioral: HIIT
High Intensity Interval Training for twelve weeks

Active Comparator: Moderate training
Twelve weeks of Moderate Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic.
Behavioral: Moderate training
Moderate training for twelve weeks




Primary Outcome Measures :
  1. Weight reduction [ Time Frame: Twelve months ]
    In Kg


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: At baseline, after twelve weeks training and after twelve months ]
    24-hour blood pressure Measurements done by spacelaps 90217A

  2. Sleep Quality [ Time Frame: At baseline, after twelve weeks training and after twelve months ]
    Measured by sensewear armbands which is worn for a week at a time



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Tine Caroc Warner, Principal investigator, M.D., Vendsyssel Hospital
ClinicalTrials.gov Identifier: NCT03433690     History of Changes
Other Study ID Numbers: RHN_TCW_01
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tine Caroc Warner, Vendsyssel Hospital:
Child Obesity
Adolescents
High Intensity Interval Training
Moderate training

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms