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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03433690
Other study ID # RHN_TCW_01
Secondary ID
Status Completed
Phase N/A
First received January 25, 2018
Last updated February 7, 2018
Start date July 28, 2015
Est. completion date January 25, 2018

Study information

Verified date February 2018
Source Vendsyssel Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 25, 2018
Est. primary completion date January 25, 2018
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility 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 Design


Intervention

Behavioral:
HIIT
High Intensity Interval Training for twelve weeks
Moderate training
Moderate training for twelve weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Vendsyssel Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Weight reduction In Kg Twelve months
Secondary Blood pressure 24-hour blood pressure Measurements done by spacelaps 90217A At baseline, after twelve weeks training and after twelve months
Secondary Sleep Quality Measured by sensewear armbands which is worn for a week at a time At baseline, after twelve weeks training and after twelve months
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