The Effects of a Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
The aim of the trial is to study the effect of a mobile application-based lifestyle change program on body weight loss in adult subjects with obesity. The main focus is to motivate and support beneficial lifestyle changes targeting long-term weight management.
This study comprises two randomly assigned study arms: mobile application-based lifestyle change program and "waiting-list" control. The mobile application-based lifestyle change program consists of twice a week content for the first 6 months, continuing with less frequent contents for the following 6 months (the length of intervention 12 months). The "waiting-list" control group will receive mobile application-based lifestyle change program after 6 months followed by intervention for 12 months. The main aim is to demonstrate that the users of mobile application-based lifestyle change program lose more weight than controls at 6 month timepoint and weight loss is maintained for 18 months (6 months after the end of mobile application-based lifestyle change program use). Weight is measured and blood samples (lipids, glucose and metabolic syndrome measures) are collected at 0, 6, 12, and 18 months.
The mobile application-based counselling contains aspects of cognitive behavior therapy and persuasive system design and consists of twice a week reminders, tasks, self-monitoring, and reflection.
The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, psychological factors, components of metabolic syndrome (waist circumference, plasma lipid and glucose values, blood pressure), and calculated scores of metabolic condition and adiposity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index 30 to 40 kg/m2
- •Ownership of a smartphone
排除标准
- •Untreated hypothyroidism
- •Oral glucocorticoid treatment
- •Pregnancy or lactation
- •No possibility to use mobile phone or tablet
- •No knowledge of Finnish language
- •Presumed lack of adherence to the study
- •Participation in another ongoing weight management program
- •Diagnosed or suspicion of cardiovascular disease causing restrictions to exercising
- •Bariatric operation planned
- •Usage of any anti-obesity drug
结局指标
主要结局
Change in body weight
时间窗: Baseline to 6 months
次要结局
- Change in eating behavior(Baseline to 6 months)
- Change in body weight(Baseline to 18 months)
- Change in blood pressure(Baseline to 6 months)
- Change in waist circumference(Baseline to 6 months)
- Change in metabolic syndrome status(Baseline to 6 months)
研究者
Janne Hukkanen
Professor of Internal Medicine
University of Oulu