"HIIT Med Kiloene".

NCT05465057 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-05-02

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05465057 on ClinicalTrials.gov