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CompletedNCT03433690Updated Feb 14, 2018

The Effect of HIIT in Handling Obesity in Children

An interventional study of HIIT and Moderate training in High Intensity Interval Training and Child Obesity, sponsored by Regionshospital Nordjylland. Completed. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-02-14.

Sponsored by Regionshospital Nordjylland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • High Intensity Interval Training
  • Child Obesity

Keywords

  • Child Obesity
  • Adolescents
  • High Intensity Interval Training
  • Moderate training
03

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • Active comparator
    Moderate training

    Twelve weeks of Moderate Training, twice a week, in combination with multidisciplinary treatment at outpatient obesity clinic.

    Behavioral: Moderate training

Interventions

  • BehavioralHIIT

    High Intensity Interval Training for twelve weeks

  • BehavioralModerate training

    Moderate training for twelve weeks

05

What researchers measure

Primary outcomes

  1. Weight reduction

    In Kg

    Time frame: Twelve months

Secondary outcomes

  1. Blood pressure

    24-hour blood pressure Measurements done by spacelaps 90217A

    Time frame: At baseline, after twelve weeks training and after twelve months

  2. Sleep Quality

    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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03433690
Lead sponsor
Regionshospital Nordjylland
Responsible party
Tine Caroc Warner (Principal investigator, M.D., Regionshospital Nordjylland) — Principal investigator
First posted
Feb 14, 2018
Start date
Jul 28, 2015
Primary completion
Jan 25, 2018
Completion
Jan 25, 2018
Last update
Feb 14, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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