"HIIT Med Kiloene".
NCT05465057 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172
Last updated 2024-05-02
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
Interventions
- BEHAVIORAL
-
High intensity interval training (HIIT) + lifestyle intervention (TCOCT)
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.
- BEHAVIORAL
-
Lifestyle intervention (TCOCT)
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.
Sponsors & Collaborators
-
Steno Diabetes Centre North Denmark
collaborator OTHER -
Aalborg University
collaborator OTHER -
Municipalities of Northern Jutland, Denmark
collaborator UNKNOWN -
TrygFonden, Denmark
collaborator INDUSTRY -
University of Southern Denmark
collaborator OTHER -
Aalborg University Hospital
lead OTHER
Principal Investigators
-
Søren Hagstrøm, MD, PHD · Department of pediatrics, University hospital of Aalborg, Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-05
- Primary Completion
- 2024-11-30
- Completion
- 2024-11-30
Countries
- Denmark
Study Locations
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