The Effect of HIIT in Handling Obesity in Children

February 7, 2018 updated by: Tine Caroc Warner, Vendsyssel Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight reduction
Time Frame: Twelve months
In Kg
Twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: At baseline, after twelve weeks training and after twelve months
24-hour blood pressure Measurements done by spacelaps 90217A
At baseline, after twelve weeks training and after twelve months
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
At baseline, after twelve weeks training and after twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vendsyssel Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2015

Primary Completion (Actual)

January 25, 2018

Study Completion (Actual)

January 25, 2018

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHN_TCW_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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