The Effect of HIIT in Handling Obesity in Children

Sponsor
Vendsyssel Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03433690
Collaborator
(none)
30
2
30

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HIIT
  • Behavioral: Moderate training
N/A

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

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled trialRandomized 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 :
Jul 28, 2015
Actual Primary Completion Date :
Jan 25, 2018
Actual Study Completion Date :
Jan 25, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Weight reduction [Twelve months]

    In Kg

Secondary Outcome Measures

  1. Blood pressure [At baseline, after twelve weeks training and after twelve months]

    24-hour blood pressure Measurements done by spacelaps 90217A

  2. Sleep Quality [At baseline, after twelve weeks training and after twelve months]

    Measured by sensewear armbands which is worn for a week at a time

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vendsyssel Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tine Caroc Warner, Principal investigator, M.D., Vendsyssel Hospital
ClinicalTrials.gov Identifier:
NCT03433690
Other Study ID Numbers:
  • RHN_TCW_01
First Posted:
Feb 14, 2018
Last Update Posted:
Feb 14, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
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, Principal investigator, M.D., Vendsyssel Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2018