Use of New Technologies for the Follow-up in Adolescent Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change from Baseline in Body Mass Index Z-score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a distance follow-up on body mass index decrease at 15 months compared to traditional management in obese adolescents.
详细描述
Childhood obesity continues to be a key challenge in France. The unit is facing a high demand with limited resources, moreover despite an intensive program of care with a multidisciplinary dedicated team, the impact on weight loss is moderate.
The hypothesis is to ameliorate results by using distance monitoring in maintenance phase.
After a traditional intensive period consisting in a weekly family-based multidisciplinary intervention, patients are randomized in two arms, traditional or distance follow-up.
Traditional follow-up is based on face-to-face multidisciplinary consultations every three months.
The distance monitoring is based on a mobile application dedicated to food behavior change and physical activity, with weekly self-monitoring, goal setting, physical activity and healthy eating support, monthly weight assessment. Pre-programmed feedbacks "motivational strategies" are included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •11-17 years old
- •Body Mass Index > 97th percentile using French reference
- •Non Syndromic obesity
- •Appropriate understanding of the study
- •Appropriate understanding of french language, and ability in writing and reading
排除标准
- •Mental disability, severe and uncontrolled psychiatric disorders.
- •Syndromic obesity, endocrine disorders or drug-induced obesity
- •Other therapeutic: bariatric surgery, medications for weight loss
- •Enrolment in an other therapeutic study
结局指标
主要结局
Change from Baseline in Body Mass Index Z-score
时间窗: 15 months
Body mass index z score is calculated using french reference data. success: decrease of Body Mass Index Z-score from baseline to 15 months of 0.5 standard deviation
次要结局
- Blood pressure (mmHg)(15 months)
- Change from baseline in mean difference of Body Mass Index Z-score between the two groups(15 months)
- Fasting insulinemia (µmol/l)(15 months)
- Change from baseline in Eating Behavior assessed by a dietitian from a questionnaire(15 months)
- Dyslipidemia (mmol/l)(15 months)
- Percent of loss to follow-up(15 months)
- Change from baseline in PedsQL score(15 months)
- Change from baseline in Physical activity and sedentary behavior assessed by the number of hours of physical activity per week(15 months)
- Glycemia (mmol/l)(15 months)
- Homeostasis Model assessment (HOMA)(15 months)