The Effect of HIIT in Handling Obesity in Children

• ClinicalTrials.gov Identifier: NCT03433690
• Recruitment Status: Completed
• First Posted: February 14, 2018
• Last Update Posted: February 14, 2018
• Sponsor: Vendsyssel Hospital
• Information provided by (Responsible Party): Tine Caroc Warner, Vendsyssel Hospital

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
High Intensity Interval Training; Child Obesity	Behavioral: HIIT; Behavioral: Moderate training	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized 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: July 28, 2015
• Actual Primary Completion Date: January 25, 2018
• Actual Study Completion Date: January 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 [ Time Frame: Twelve months ]
   In Kg

Secondary Outcome Measures :

1. Blood pressure [ Time Frame: At baseline, after twelve weeks training and after twelve months ]
   24-hour blood pressure Measurements done by spacelaps 90217A
2. 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

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

No Contacts or Locations Provided

More Information

• Responsible Party: Tine Caroc Warner, Principal investigator, M.D., Vendsyssel Hospital
• ClinicalTrials.gov Identifier: NCT03433690
• Other Study ID Numbers: RHN_TCW_01
• First Posted: February 14, 2018
• Last Update Posted: February 14, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• 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, Vendsyssel Hospital:

Child Obesity; Adolescents; High Intensity Interval Training; Moderate training

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight