"HIIT Med Kiloene".

NCT05465057 | Active Not Recruiting

• 1 other identifier: N-20200035
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

In Denmark, 15% of children are overweight and 5% obese. Obese children and adolescents have several metabolic complications, such as pre-diabetes, hypertension, dyslipidaemia, and excess fat deposition in liver, already at a young age. In addition, obese children suffer from psychological issues such as low quality of life and anxiety. These findings underline the need for effective treatment strategies to eliminate the development of obesity-related complications. We will conduct a two-study project in order to investigate the effect of high-intensity interval training (HIIT) and lifestyle intervention in obese children and adolescents on several metabolic risk factors and psychological problems. Study 1 is a randomized controlled study including 150 obese children and adolescents recruited from the municipal obesity clinics in Northern Jutland. Study 1 will examine the value of a group based HIIT intervention in the children's local environment and investigate the association between HIIT and psychosocial wellbeing. Study 2 is a randomized controlled study including 60 severe obese children and adolescents recruited from Videnscenter for Børn og Unge med Overvægt (VIBUO) at Aalborg University Hospital. Study 2 investigates the effect of HIIT and lifestyle intervention on metabolic and cardiovascular risk factors. In both studies, the children and adolescents are 9-16 years old and will be randomized to lifestyle guidance or a combination of HIIT and lifestyle guidance for 3 months, both followed by 9 months of lifestyle guidance only. Our primary goal is to show the efficacy of HIIT and facilitate the establishment of permanent targeted training propositions for obese children and adolescents with local anchoring in the municipalities.

Conditions

Obesity, Childhood; High Intensity Interval Training

Outcome Measures

Primary Outcomes (1)

• Change in BMI and BMI z-score from baseline and 3 and 12-month follow-up between children randomized to either the HIIT+ lifestyle intervention (TCOCT) group or the lifestyle intervention (TCOCT) group.

  Our primary objective is to compare the change in BMI and BMI z-scores from baseline and three and 12-month follow-up between children randomized to either the HIIT+TCOCT group or the TCOCT group. BMI will be measured by Weight (kg) / Height (m) 2. Different measurements have been used throughout in the literature to assess childhood obesity. In BMI z-scores, the variation of BMI according to age and gender is accounted for. The variability of BMI z-scores have been shown to fall with increasing obesity, so a given change in BMI will correlate to a smaller change in BMI z-scores. We therefore decided to investigate our data using both BMI and BMI z scores as the primary outcomes.

  Baseline, 3 month and 12 month

Secondary Outcomes (5)

• Changes in biochemical variables from baseline and 3 and 12-month follow-up between children randomized to either the HIIT+TCOCT group or the TCOCT group.

  Baseline, 3 month and 12 month

• Changes in blood pressure from baseline and 3 and 12-month follow-up between children randomized to either the HIIT+TCOCT group or the TCOCT group.

  Baseline, 3 month and 12 month

• Changes in MRI fat accumulation variables from baseline and 3 and 12-month follow-up between children randomized to either the HIIT+TCOCT group or the TCOCT group

  Baseline, 3 month and 12 month

• Changes in variables for psychological problems and quality of life from baseline and 3 and 12-month follow-up between children randomized to either the HIIT+ lifestyle intervention (TCOCT) group or the lifestyle intervention (TCOCT) group.

  Baseline, 3 month and 12 month

• Changes in level of general physical activity from baseline and 3 and 12-month follow-up between children randomized to either the HIIT+ lifestyle intervention (TCOCT) group or the lifestyle intervention (TCOCT) group.

  Baseline, 3 month and 12 month

Other Outcomes (1)

• Comparison of the levels of biological and MRI parameters between the groups of children with obesity and a normal weight age matched control group.

  Baseline

Study Arms (2)

HIIT + lifestyle intervention

ACTIVE COMPARATOR

Allocation of HIIT training in conjuction with lifestyle intervention (TCOCT protocol) through computerbased randomization proces.

Behavioral: High intensity interval training (HIIT) + lifestyle intervention (TCOCT); Behavioral: Lifestyle intervention (TCOCT)

Lifestyle intervention

ACTIVE COMPARATOR

Allocation of lifestyle intervention (TCOCT protocol) through computerbased randomization proces.

Behavioral: Lifestyle intervention (TCOCT)

Interventions

High intensity interval training (HIIT) + lifestyle intervention (TCOCT) BEHAVIORAL

The participants randomized for HIIT will perform supervised training sessions three times a week for 3 months. All HIIT programs consist of activities that involve 4 x 4 min. intervals at 90-95% of HRmax. The lifestyle intervention (TCOCT) comprises a lifestyle intervention targeting all aspects of everyday life, incl. guidance on diet, physical activity, sleep, screen time, and social problems. The participant will be scheduled for follow up in the out-patient clinic or municipal obesity clinic by a trained pediatric nurse and dietician after 6-12 weeks.

HIIT + lifestyle intervention

Lifestyle intervention (TCOCT) BEHAVIORAL

The lifestyle intervention (TCOCT) comprises a lifestyle intervention targeting all aspects of everyday life, incl. guidance on diet, physical activity, sleep, screen time, and social problems. The participant will be scheduled for follow up in the out-patient clinic or municipal obesity clinic by a trained pediatric nurse and dietician after 6-12 weeks.

HIIT + lifestyle intervention; Lifestyle intervention

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• BMI \> 90th percentile for study 1 and BMI \> 99th percentile for age and gender for study 2.
• Age 9-16 years

You may not qualify if:

• Mental illness in the child, that complicates attendance at activities.
• Physical limitations or illness that prevent the child from performing high intensity training, e.g. broken limbs, known heart or lung disease, severe asthma, diabetes or metabolic disease.
• If participant is not able to perform all 12 weeks of exercise for other reasons.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Steno Diabetes Centre North Denmark: collaborator
• Aalborg University: collaborator
• Municipalities of Northern Jutland, Denmark: collaborator
• TrygFonden, Denmark: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Pediatrics, University Hospital of Aalborg

Aalborg, 9000, Denmark

Location

Related Publications (1)

• Eggertsen CN, Vestergaard ET, Simonsen MB, Warner TC, Frokjaer JB, Handberg A, Olesen LG, Grontved A, Olesen AV, Hagstrom S, Brond JC, Larsen RG. Adding High-Intensity Interval Training to a Multidisciplinary Lifestyle Intervention for Childhood Obesity: Secondary Analysis of a Randomized Controlled Trial to Examine the Effects on Physical Activity Behavior. Scand J Med Sci Sports. 2026 Jan;36(1):e70185. doi: 10.1111/sms.70185.

  PMID: 41460768 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Søren Hagstrøm, MD, PHD

  Department of pediatrics, University hospital of Aalborg, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.d. stud.

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 19, 2022
• Study Start: October 5, 2020
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)