Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.
Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, St Leonard's Land, Holyrood Road, Edinburgh, EH8 8AQ, UK.
Trials. 2020 Jun 5;21(1):484. doi: 10.1186/s13063-020-04405-z.
Around 30% of post-menopausal breast cancer is related to excess body fat, alcohol intake and low levels of physical activity. Current estimates suggest that there is a 12% increased risk in post-menopausal breast cancer for every 5 kg/m increase in body mass index (BMI). Despite this evidence there are few lifestyle programmes directed towards breast cancer risk reduction. This paper describes the process of optimising of the ActWELL programme which aims to support weight management in women invited to attend routine National Health Service (NHS) breast screening clinics.
A feasibility study of a prototype programme aiming to change lifestyle behaviours was successfully undertaken. The programme used educational approaches and behaviour change techniques delivered by lifestyle coaches using individual face to face meetings and telephone sessions. To optimise the intervention for a definitive randomised controlled trial of weight management, data from the feasibility trial, focus group discussions conducted with the target population, feedback from the trial public advisory group and comments from peer reviewers were obtained. Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group.
The results from the feasibility trial were considered appropriate for moving on to a full trial with 70% of participants finding the programme acceptable. The primary outcomes (weight loss and physical activity) provided an important focus for design input from the target group. The contributions highlighted the need to review programme duration, coach contact time, content and use of behaviour change techniques and communications generally (e.g. science and evidence, non-judgemental approaches and avoiding guilt). In addition, the need for emphasis on support rather than education became apparent. The recommendations from peer reviewers focussed on the magnitude of effort required to achieve the intended weight loss and weight loss maintenance. Implementation science supported the use of the capability/opportunity/motivation (COM-B)model in overall design.
The optimisation process has facilitated the development and evaluation of a programme that enables the delivery of a promising intervention to achieve weight management in post-menopausal women.
ISRCTN: ISRCTN11057518. Registered on 21 July 2017. Retrospectively registered.
大约 30%的绝经后乳腺癌与体脂过多、饮酒和低水平的身体活动有关。目前的估计表明,绝经后乳腺癌的风险每增加 5kg/m2 体重指数(BMI)就会增加 12%。尽管有这方面的证据,但针对降低乳腺癌风险的生活方式方案很少。本文描述了优化 ActWELL 计划的过程,该计划旨在支持受邀参加常规国家卫生服务(NHS)乳房筛查诊所的女性进行体重管理。
成功进行了一项旨在改变生活方式行为的原型方案的可行性研究。该方案使用教育方法和行为改变技术,由生活方式教练通过面对面会议和电话会议进行。为了优化干预措施,以便对体重管理进行确定性随机对照试验,从可行性试验中获取数据,与目标人群进行焦点小组讨论,从试验公众咨询小组获得反馈,并征求同行评审的意见。实施研究的概念为协助改进干预措施提供了进一步的指导,然后由所有研究人员和试验指导委员会进行讨论和商定。
可行性试验的结果被认为适合进行全面试验,70%的参与者认为该方案可以接受。主要结果(体重减轻和身体活动)为目标人群的设计输入提供了重要重点。这些意见突出表明需要审查方案的持续时间、教练的联系时间、内容和行为改变技术的使用以及一般的沟通(例如科学和证据、非评判方法和避免内疚)。此外,需要强调支持而不是教育。同行评审的建议侧重于实现预期体重减轻和体重维持所需的努力程度。实施科学支持在总体设计中使用能力/机会/动机(COM-B)模型。
优化过程促进了一项计划的制定和评估,该计划能够提供一种有前途的干预措施,以实现绝经后妇女的体重管理。
ISRCTN:ISRCTN11057518。于 2017 年 7 月 21 日注册。回顾性注册。