An Online Self-regulation Intervention to Support Weight Loss Among Adults Living With Obesity: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,294
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
Adults Regulating Their weight Everyday with Mobile Internet Support (ARTEMIS) is a randomised controlled trial evaluating the effectiveness of a mobile app based weight loss intervention designed to increase self-regulation in adults living with obesity.
详细描述
Adults Regulating Their weight Everyday with Mobile Internet Support (ARTEMIS) is a randomised, controlled trial examining the effectiveness of the self-regulation intervention to promote weight loss, when delivered through a mobile application, with no in-person contact, among a sample of ~ 1,294 adults living with obesity in the United Kingdom. Further, the investigators will assess the safety of the intervention regarding any a potential unintended consequence, which is the development of disordered eating. The intervention comprises daily self-weighing and daily reflection on the day's task of controlling weight through implementation of actions, and selection of new actions for the next day. It encourages users to build up a repertoire of actions for life that suit them in controlling weight.
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
盲法说明
It will not be possible to blind participants or trial staff to treatment allocation, as the control group receives no intervention and participants will be aware of the general nature of the study. However, all follow-up is done remotely and will therefore be unbiased.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in body weight
时间窗: 6 months (baseline to 26-week follow up)
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
Proportion of participants achieving ≥ 5% loss in body weight
时间窗: 6 months (baseline to 26-week follow up)
To assess if the intervention achieves significantly greater weight loss than the no-treatment control group.
次要结局
- Change in body weight(12 weeks (baseline to 12-week follow up))
- Proportion of participants achieving ≥ 5% loss in body weight(12 weeks (baseline to 12-week follow up))
- Change in the proportion of participants scoring above threshold (> 7) on a modified Eating Disorders Examination - Questionnaire Short Form (EDE-QS)(12- and 26-week follow up (baseline to 12 and 26-week follow up))