Letter on “Sharing trial results directly with trial participants and other stakeholders after the SARS-CoV-2 pandemic hit the UK:experience from the ActWELL trial

Acknowledgements We would like to thank our ActWELL participants who attended the events for their interest and enthusiasm in making the events a success. We would like to thank Susan MacAskill for giving us permission to use a quote from her email to us. We are also grateful to the technical support who got us through all events, Cormac Staunton (of stauntonmedia.ie). We would also like to acknowledge and thank Dr Katie Gillies and Dr Seonaidh Cotton for their contribution to the design of the evaluation survey. HSRU is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. This work was supported by The Scottish Government, grant number BC/ Screening/17/01.Peer reviewedPublisher PD

Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics

Acknowledgements The authors would like to acknowledge the assistance of Amy Hickman, and Eluned Hughes from Breast Cancer Now, for guidance on practical intervention perspectives, and Jill Hampton in manuscript preparation. Thanks also to all the members of our public advisory group. The Health Services Research Unit, University of Aberdeen, receives core funding from Scottish Government Chief Scientist Office. Funding This work was supported by The Scottish Government, grant number BC/Screening/17/01. The funders provided independent referee reports, which guided some of the study parameters (as described in the text). The funders have read this manuscript. In-kind support was given by Breast Cancer Now for facilitating this study.Peer reviewedPublisher PD

Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening

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A novel approach to increasing community capacity for weight management a volunteer-delivered programme (ActWELL) initiated within breast screening clinics:a randomised controlled trial

Background: It is estimated that around 30% of breast cancers in post-menopausal women are related to lifestyle. The breast cancer-pooling project demonstrated that sustained weight loss of 2 to 4.5 kg is associated with an 18% lower risk of breast cancer, highlighting the importance of small changes in body weight. Our study aimed to assess the effectiveness a volunteer-delivered, community based, weight management programme (ActWELL) for women with a BMI > 25 kg/m2 attending NHS Scotland Breast Screening clinics. Methods: A multicentre, 1:1 parallel group, randomised controlled trial was undertaken in 560 women aged 50 to 70 years with BMI > 25 kg/m2. On completion of baseline measures, all participants received a breast cancer prevention leaflet. Intervention group participants received the ActWELL intervention which focussed on personalised diet advice and pedometer walking plans. The programme was delivered in leisure centres by (the charity) Breast Cancer Now volunteer coaches. Primary outcomes were changes between groups at 12 months in body weight (kg) and physical activity (accelerometer measured step count). Results: Two hundred seventy-nine women were allocated to the intervention group and 281 to the comparison group. Twelve-month data were available from 240 (81%) intervention and 227 (85%) comparison group participants. Coaches delivered 523 coaching sessions and 1915 support calls to 279 intervention participants. Mean weight change was − 2.5 kg (95% CI − 3.1 to − 1.9) in the intervention group and − 1.2 kg (− 1.8 to 0.6) in the comparison group. The adjusted mean difference was − 1.3 kg (95% CI − 2.2 to − 0.4, P = 0.003). The odds ratio for losing 5% weight was 2.20 (95% CI 1.4 to 3.4, p = 0.0005) in favour of the intervention. The adjusted mean difference in step counts between groups was 483 steps/day (95% CI − 635 to 1602) (NS). Conclusions: A community weight management intervention initiated at breast screening clinics and delivered by volunteer coaches doubled the likelihood of clinically significant weight loss at 12 months (compared with usual care) offering significant potential to decrease breast cancer risk

Correction to:A novel approach to increasing community capacity for weight management a volunteer-delivered programme (ActWELL) initiated within breast screening clinics: a randomised controlled trial

Acknowledgements Our thanks to Elizabeth Banks who advised and assisted with many aspects of the study and also to the many women who commented on the development and design of this study including those on our Public Advisory Team (Pamela Deponio, Maggie Taylor and Mary Wotherspoon). Funding This work was supported by The Scottish Government, grant number BC/Screening/17/01. The funders provided independent referee reports which guided the final study design. The funders have read this manuscript. In-kind support was given by Breast Cancer Now for facilitating this study.Peer reviewedPublisher PD