Treatment of Overweight in Children on Distance. A Comparison Between Consultations on the Hospital With Video-Consultations on Distance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Body mass index standard deviation score (BMI Z-score) during treatment of overweight
研究概览
简要总结
The present study is a public health project with the aim to treat overweight in children 9-11 years of age. After the first consultation the children are randomized to either continue the treatment at The Child Obesity Clinic, Child Department or to have the following 2-3 consultations on distance with Lync. Last visit for all children is on the Child Obesity Clinic after approximately 12 months. Follow up after at least 1 years will be performed.
详细描述
This superiority study is a randomized trial with two independent treatment arms. The target for the enrollment is 50% in each of the two treatment groups.
With 60 patients in each group, the study has 80% statistical power at 5% significance level to detect an average difference between the treatment groups in the intra-individual change in the BMI Z-score that is 0.51 x the standard deviation in the intra-individual change. Previous data from the investigators own group suggest that a reasonable estimate of the standard deviation in the intra-individual change in the BMI Z-score following intervention is 0.42. Thus, the study has 80% statistical power at 5% significance level to detect a difference in the intra-individual change in the BMI Z-score that is 0.51 x 0.42 = 0.21 on average. The study will with the present funding end its follow up in June 2017.
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
- None
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •\- Children with overweight and not obese according to the definitions developed by Cole et al (4). It implies that we include children with the following age specific BMI Inclusion criteria
- •* 9 years = AGE \< 9 years, 6 months AND 19,0\< BMI\<23,0
- •* 9 years, 6 months =\> AGE \< 10 Years AND 19,5 \AGE\< 11 years AND 20,5\AGE\<12 years AND 21,5\
排除标准
- •Children and his/her parents not able to communicate in Swedish.
- •Children with monogenic obesity
- •Present less than 80% at school in the latest school year.
- •No foster care for the child or his/her brothers or sisters
研究组 & 干预措施
SOFT
All Children have their first and their last consultation at The Child Obesity Unit.
The investigators use Standardized Obesity Family Therapy "SOFT" as described by Nowicka & Flodmark (1-3). The intervention use psychological techniques developed in systemic family therapy applied on advice regarding exercise and diet as well as behavioural Life style Changes.
At each consultation with the overweight child and his/her biological parents there are two therapists present.
干预措施: SOFT (Behavioral)
TeleSOFT
The same method Lifestyle intervention "SOFT" is used. The only difference is that the communication in the second, third (and fourth) visit is made by use of video on distance. The investigators use Standardized Obesity Family Therapy "SOFT" as described by Nowicka & Flodmark (1-3).
干预措施: TeleSOFT (Behavioral)
结局指标
主要结局
Body mass index standard deviation score (BMI Z-score) during treatment of overweight
时间窗: Change from Baseline in body weight at an average of 12 months
Body weight measured by Tanita device
次要结局
- Change child's metabolic health (triglycerides)(Change from Baseline in metabolic health at an average of 12 months)
- Change child's metabolic health (F-blood glucose)(Change from Baseline in metabolic health at an average of 12 months)
- Change child's metabolic health (HDL-cholesterol)(Change from Baseline in metabolic health at an average of 12 months)
- Change in fat distribution measured by waist circumference(Change from Baseline in waist circumference at an average of 12 months)
- Change child's metabolic health (Blood pressure)(Change from Baseline in metabolic health at an average of 12 months)
- Change child's metabolic health (ccK-18)(Change from Baseline in metabolic health at an average of 12 months)
- Change in Outcome Rating Scale and Session Rating Scale(Change from Baseline in Outcome Rating Scale at an average of 2, 4, 6, 8, 12 months)
- Change in Session Rating Scale(Change from Baseline in Session Rating scale at an average of 2, 4, 6, 8, 12 months)
- Change in KIDSCREEN-index(Change from Baseline in Kidscreen index at an average of 12 months)
- Change child's metabolic health (HbA1c)(Change from Baseline in metabolic health at an average of 12 months)
- Change child's metabolic health (f-insulin)(Change from Baseline in metabolic health at an average of 12 months)
- Change in fat percent measured by TANITA(Change from Baseline in fat percent at an average of 12 months)
- Change in fat distribution measured by abdominal height (F-indicator)(Change from Baseline in fat distribution at an average of 12 months)
- Change in physical activity measured by Moves application to smartphone(Change from Baseline in physical activity at an average of 2, 4, 6, 8, 12 months)
- Change child's metabolic health (LDL-cholesterol)(Change from Baseline in metabolic health at an average of 12 months)
- Change child's metabolic health (ALAT)(Change from Baseline in metabolic health at an average of 12 months)
- Change in dietary habits(Change from Baseline in dietary habits at an average of 12 months)
研究者
Carl-Erik Flodmark
Docent
Skane University Hospital