CArdioMetabolic Prevention in Adolescents With Body Weight Issues: the Effect of Group Intervention and Telemedicine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect on anthropometry parameters
研究概览
简要总结
The aim of the CArdioMetabolic Prevention (CAMP) pilot study is to investigate the effect of a group intervention on lifestyle in adolescents and on at least one adult family member. This will be followed by telemedicine tools for 12-week-time period. A face-to-face group intervention addressing nutrition, physical activity and well being together with an assessment of anthropometry parameters, body composition, questionnaires, blood and stool sampling will be done before and after 12 weeks of telemedicine.
The study aims to investigate:
- the effect of 12-week intervention on body weight, anthropometry parameters and cardiometabolic markers in comparison to the conventionally led obesity clinic for adolescents
- the compliance with telemedicine tools that will focus on the support of balance nutrition, physical activity (evaluation of daily steps through smart bands) and family well being in regards to the effect on anthropometry and laboratory parameters
- the effect of the intervention on data from questionnaires (eating disorders, quality of life, psychological health) before and after the intervention
- data analysis of family members with respect to theirs offspring
详细描述
In a 12-month pilot study it is expected to include four groups composed of 10-12 adolescent participants with increased body weight. The participants will be recruited from new patients attending pediatric endocrine clinics in the Department of Children and Adolescents of Faculty Hospital Kralovske Vinohrady and Third Faculty of Medicine Charles University.
For those included, a detailed history, laboratory (routine investigation additionally to serum storage and stool for microbiome analysis) and physical examination will be assessed during the initial visit in the outpatient clinic. During one day group intervention each adolescent with at least one family member will undergo education session on nutrition, healthy eating and physiological support incl. cognitive behavioral sessions. There will be an assessment of individual fitness and participants will try different suitable options to increase their daily physical activity. Participants will be asked to bring filled questionnaires that address different aspects of lifestyle and psychological well being. A detailed anthropometry examination and body composition will also be performed. An ultrasound examination of carotid intima-media thickness and visceral fat mass measurements will be assessed in all adolescents. The body composition, body weight and height will also be measured in all accompanied family members. All participants will receive smart bands for the following 12 weeks to support physical activity and monitor their daily step count.
This group intervention will be followed by a12-week time period in which telemedicine tools and frequent virtual contacts will be done to support family healthy lifestyle.
After 12 weeks a group session will be undertaken in order to evaluate all aspects of lifestyle through repeated questionnaire survey. Laboratory, ultrasound and anthropometry examination will be done in order to monitor the effect of this intervention and compared to participants visiting the conventional obesity clinic of our hospital. A further follow-up will be offered to all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range: 12-19 years
- •diagnosis of obesity = body mass index (in kg/m2) above 97th centile for age and sex
- •obesity likely due to impaired healthy lifestyle
排除标准
- •genetic forms of obesity
- •obesity due to endocrinopathy
研究组 & 干预措施
group supported through group education and telemedicine tools
the group of this pilot study will be compared to conventional obesity clinic
干预措施: lifestyle education (Behavioral)
结局指标
主要结局
Effect on anthropometry parameters
时间窗: 12 weeks
change of z-score of body mass index (in kg/m2) before and after the 12-week intervention (successful intervention should lead to a decline of z-score BMI)
Effect on depression
时间窗: 12 weeks
change in Beck depression score before and after the 12 weeks of intervention (range: 0-60 points, no depression = 0-10 points, mild depression = 10-20 points, moderate depression = 20-40 points, severe depression = 40-60 points)
Effect on fitness
时间窗: 12 weeks
change of fitness level assessed by 6-minute walk test before and after the 12 weeks of intervention (evaluated by the distance reached within the 6-minute walk test)
Effect on eating behavior
时间窗: 12 weeks
change of score assessing cognitive restraint (greater the score, greater the restraint), disinhibition of control over eating (greater the score, greater the disinhibition) and perceived hunger (greater the score, greater the hunger) via Eating Inventory questionnaire before and after the 12 weeks of intervention
Effect on quality of life
时间窗: 12 weeks
change of score of quality of life (assessed by KIDSCREEN questionnaire, the higher the score, the higher quality of life)
次要结局
- Effect on body composition of an accompanied adult person(12 weeks)
- Effect on body weight of an accompanied adult person(12 weeks)
研究者
Irena Aldhoon Hainerova
Assoc. Prof. M.D., Ph.D.
Faculty Hospital Kralovske Vinohrady