Obesity, Childhood Clinical Trial
Official title:
"HIIT Med Kiloene" Investigating the Physical, Metabolic, and Psychosocial Effects of High-intensity Interval Training (HIIT) in Childhood Obesity
Verified date | May 2024 |
Source | Aalborg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 172 |
Est. completion date | November 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 16 Years |
Eligibility | Inclusion Criteria: - BMI > 90th percentile for study 1 and BMI > 99th percentile for age and gender for study 2. - Age 9-16 years Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Pediatrics, University Hospital of Aalborg | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg University Hospital | Aalborg University, Municipalities of Northern Jutland, Denmark, Steno Diabetes Centre North Denmark, TrygFonden, Denmark, University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Comparison of the levels of biological and MRI parameters between the groups of children with obesity and a normal weight age matched control group. | As explorative objectives, we want to compare the levels of our different parameters (especially parametres of inflammation, extracellular vesicles and measurements of fat accumulation from MRI) between the groups of obese children and a normal weight control group. | Baseline | |
Primary | 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 | 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. | As secondary objective, the changes in biochemical variables measuring inflammation, insulin sensitivity, lipidemia, thyroid function and adipocytokines, from baseline and 3 and 12-month follow-up between children randomized to either the HIIT+TCOCT group or the TCOCT group, will be evaluated.
We hypothesize that the findings will be more substantiated in children with obesity undergoing HIIT and TCOCT compared to only TCOCT. The biochemical measurements obtained will be: C-Reactive Protein (mg/l) hemoglobin (mml/l) white blood cell count (10E9/l) Uric acid (mmol/l) Interleukin 6,8,10,15 (pg/l) Glucose (mmol/l) HbA1C (mmol/mol) Insulin (pmol/l) C-peptide (mg/l) TSH (miu/l) ALAT (U/l) ASAT (U/l) Basp (U/l) LDH (U/l) GGT (U/l) Cholesterol total (mmol/l) Cholesterol LDL (mmol/l) Cholesterol HDL (mmol/l) Triglyceride (mmol/l) Leptin (µg/ml) Adiponectin (µg/ml) |
Baseline, 3 month and 12 month | |
Secondary | 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. | As secondary objective, the 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, will be analysed. We hypothesize that the findings will be more substantiated in children with obesity undergoing HIIT and TCOCT compared to only TCOCT. | Baseline, 3 month and 12 month | |
Secondary | 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 | Quantification of liver fat, subcutaneous fat and visceral fat is performed using magnetic resonance imaging in a 3 Tesla MRI scanner (GE Premier) at Aalborg University Hospital. The participants is positioned supine on the scanner bed with a 30-channel (AIRTM) coil placed over the abdomen and a 60-channel in-bed coil. Proton-density fat fraction (PDFF) images will be obtained using a multi-point Dixon sequence (IDEAL IQ, axial direction), slice thickness 2 mm; TE min full; TR 5.9 ms; FOV 44 cm; acquisition matrix (160x160) generating in-phase and out-of-phase images and reconstruction of fat-only and water-only images as well as of a PDFF map.
The software quantifing the amount of fat as cm2 by multiplying the cross-sectional areas of the pixels containing fat in the slice of interest. |
Baseline, 3 month and 12 month | |
Secondary | 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. | Changes in variables for psychological problems and health-related quality of life (HRQOL) from baseline and 3 and 12-month follow-up between the HIIT+TCOCT group or the TCOCT group, will be evaluated.
Three validated questionnaires; WHO-5, Pediatric Quality of Life (PedsQL) and Beck Youth Inventories (BYI), is used to evaluate these parameters. WHO-5 evaluates quality of life through 5 questions. PedsQL is available for three different age groups and contains a parental proxy report. The score for PedsQL contains 3 subscores; physical functioning, psychosocial score, and total score. The raw score is on a 0-100 scale, where a higher score indicates a better health related quality of life. BYI is developed for children aged 7-18 years and contains of five self-reported inventories: depression, anxiety, anger, disruptive behavior, and self-concept. A raw score and a T-score is calculated for each inventory and a score > 55 indicates a risk of having a psychological problem. |
Baseline, 3 month and 12 month | |
Secondary | 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. | Changes in level of general physical activity from baseline and 3 and 12-month follow-up will be measured by accelerometers (Axivity, AX3, Newcastle, UK).
We hypothesis that HIIT intervention leads to an increase in the general physical activity level immediately after HIIT intervention at 3 months, and that this will sustain at 12 months follow-up. |
Baseline, 3 month and 12 month |
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