NMAHP Research Unit, Stirling University, Pathfoot Building, Stirling, FK9 4LA, UK.
Health Services Research Unit, 3Rd Floor Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Trials. 2022 Jul 22;23(1):582. doi: 10.1186/s13063-022-06504-5.
Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity.
A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies.
The trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men's experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services.
ISRCTN 91974895 . Registered on 14/04/2021.
肥胖增加了 2 型糖尿病、心脏病、中风、行动问题和某些癌症的风险，其患病率正在上升。男性参与现有的减肥干预措施的程度低于女性。《石头游戏》是在一项成功的可行性研究的基础上进行的，旨在确定对于肥胖男性，与等待对照组相比，带有或不带有捐赠激励的自动化短信在 12 个月时是否对减肥有效且具有成本效益。
一项 3 臂、平行组、评估者盲法优势随机对照试验，结合过程评估，将在英国三个中心（贝尔法斯特、布里斯托尔、格拉斯哥）及其周边地区招募 585 名身体质量指数为 30kg/m2 或以上的成年肥胖男性，有针对性地针对贫困地区。干预组：（i）12 个月内每天自动发送理论指导的短信，加上与 3、6 和 12 个月时验证的体重目标相关的捐赠激励；（ii）相同的短信和体重评估方案；（iii）对照组：12 个月的等待名单，然后是 3 个月的短信。主要结果是从基线到 12 个月时体重的百分比变化。次要结果在 12 个月时为：生活质量、幸福感、心理健康、体重耻辱感、行为、满意度和信心。随访包括 24 个月时的体重。健康经济评估将衡量试验期间和模型终身的成本效益：包括卫生服务资源利用和调整后的生命年。成本效益分析将报告每获得一个调整后的生命年的增量成本。通过电话访谈探索参与者和服务提供者的观点，探索性混合方法的过程评估分析将重点关注心理健康、多种长期疾病、健康不平等和实施策略。
该试验将报告短信（带或不带现金激励）是否可以帮助男性在 1 年内减肥，并与对照组相比在另 1 年内保持体重；对卫生服务的成本和收益；以及男性对干预措施的体验。具有公众参与和服务专员投入的过程分析将确保这种开源数字自我保健干预措施可以由一系列 NHS 或公共服务可持续和可扩展。
ISRCTN 91974895。于 2021 年 4 月 14 日注册。
