NCT03433690

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

2.5 years

First QC Date

January 25, 2018

Last Update Submit

February 7, 2018

Conditions

High Intensity Interval TrainingChild Obesity

Keywords

Child ObesityAdolescentsHigh Intensity Interval TrainingModerate training

Outcome Measures

Primary Outcomes (1)

  • Weight reduction

    In Kg

    Twelve months

Secondary Outcomes (2)

  • Blood pressure

    At baseline, after twelve weeks training and after twelve months

  • Sleep Quality

    At baseline, after twelve weeks training and after twelve months

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

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

Behavioral: HIIT

Moderate training

ACTIVE COMPARATOR

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

Behavioral: Moderate training

Interventions

HIITBEHAVIORAL

High Intensity Interval Training for twelve weeks

High Intensity Interval Training
Moderate trainingBEHAVIORAL

Moderate training for twelve weeks

Moderate training

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Iso-BMI \> 30 according to the IOTF iso-BMI cut-off points
  • Age 8-18 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, M.D.

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 14, 2018

Study Start

July 28, 2015

Primary Completion

January 25, 2018

Study Completion

January 25, 2018

Last Updated

February 14, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share