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
- •Participation is open to those who meet the following eligibility criteria:
- •aged ≥ 18 years;
- •living with obesity (BMI ≥ 30 if of white ethnicity; ≥ 27.5 for all other ethnic groups);
- •full- time residents in the UK, without the intention to move outside the UK within the next 12 months;
- •able to access the internet with a smartphone;
- •able to access and use a digital weighing scale;
- •can understand English;
- •not presently signed up with an intention to attend, or have in the previous three months attended, a weight management programme;
- •not currently participating in another weight management study;
- •not lost > 5 kg (10 pounds) body weight in the previous six months;
- •not undergone bariatric surgery, or presently scheduled to have bariatric surgery;
- •not pregnant, or planning a pregnancy in the next 12 months;
- •not previously been diagnosed with an eating disorder;
- •not recently been diagnosed with a disease, or expected to undergo treatment for a disease, associated with substantial weight loss e.g., cancer treatment.
排除标准
- 未提供
研究组 & 干预措施
ARTEMIS mobile app
Intervention participants will be asked to download the ARTEMIS app in the Apple or Google Play app stores. The app will comprise of daily self-weighing, daily weight-recording, daily action-planning, and weekly reports and reflection. Daily weight loss action plans will predominantly relate to diet, physical activity and sleep, and comprise of eight categories, to be chosen by participants and rotated on a weekly basis, each with 5-10 actions, to be chosen by participants and rotated on a daily basis. Participants can explore and engage in all of these actions for as long as they wish within the 26-weeks of the intervention but will be recommended to continue within the 'active exploratory phase' of the intervention for at least four weeks, before moving to a 'maintenance phase', where participants continue with the actions which worked best for them in the 'active exploratory phase'.
干预措施: ARTEMIS mobile app (Behavioral)
Control
Control group participants will receive no intervention. They will be thanked for taking part in the study, advised that they may want to lose weight on their own and reminded of the next assessment at 12 weeks. The investigators will explain the value of control groups in randomised trials and the impact that remaining in follow-up has for the impact of the trial. They will also be reminded that they will receive equal financial reimbursement.
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))