"HIIT Med Kiloene" Investigating the Physical, Metabolic, and Psychosocial Effects of High-intensity Interval Training (HIIT) in Childhood Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Purpose:
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. Moreover, we wish to facilitate the establishment of permanent targeted training propositions for children and adolescents with obesity with local anchoring in the municipalities. Hereby, enhance and maintain the engagement of an active lifestyle throughout adolescence.
Study 1 will examine the value of a group based HIIT intervention in the children's local environment in addition to a validated lifestyle intervention protocol and investigate the association between HIIT, physical activity and quality of life. Moreover, we wish to investigate the applicability and adherence of the HIIT program in a community-based setting.
Study 2 will investigate the effect of a combined HIIT and validated lifestyle intervention on ectopic fat deposition, insulin sensitivity, inflammation, and muscle microvascular function in children with severe obesity. This study will give us a better understanding of the interplay between important components of the pathophysiology of obesity-related complications and the possible positive effects of HIIT intervention.
Background:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > 90th percentile for study 1 and BMI > 99th percentile for age and gender for study
- •Age 9-16 years
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Baseline, 3 month and 12 month
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.
次要结局
- 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 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)
- 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)
研究者
Charlotte Nørkjær Eggertsen, MD
MD, Ph.d. stud.
Aalborg University Hospital