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

Autor:	Anderson AS; Division of Cancer Research, Centre for Research into Cancer Prevention and Screening, Division of Population Health and Genomics, University of Dundee, Ninewells Hospital & Medical School, Dundee, UK., Craigie AM; Division of Cancer Research, Centre for Research into Cancer Prevention and Screening, Division of Population Health and Genomics, University of Dundee, Ninewells Hospital & Medical School, Dundee, UK., Gallant S; Division of Cancer Research, Centre for Research into Cancer Prevention and Screening, Division of Population Health and Genomics, University of Dundee, Ninewells Hospital & Medical School, Dundee, UK., McAdam C; Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, Edinburgh, UK., Macaskill EJ; Department of Breast Surgery, NHS Tayside, Ninewells Hospital & Medical School, Dundee, UK., Mutrie N; Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, Edinburgh, UK., Neilson AR; Health Economics Research Unit, University of Aberdeen, Aberdeen, UK., O'Carroll RE; Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, UK., Rauchhaus P; Tayside Clinical Trials Unit, Tayside Medical Sciences Centre, Ninewells Hospital and Medical School, Dundee, UK., Sattar N; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK., Stead M; Institute for Social Marketing, University of Stirling, Stirling, UK., Treweek S; Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2018 Nov 08; Vol. 8 (11), pp. e024136. Date of Electronic Publication: 2018 Nov 08.
DOI:	10.1136/bmjopen-2018-024136
Abstrakt:	Introduction: In Scotland, the incidence of breast cancer is predicted to rise significantly in the next few decades and while there are measures to support reductions in morbidity and mortality, the breast cancer community is currently exploring preventative opportunities including supporting weight management programmes in postmenopausal women. This study aims to assess the effectiveness and cost-effectiveness of a theory-based, community delivered, minimal contact, weight management (diet, physical activity and behaviour change techniques) programme (ActWELL) in women with a body mass index (BMI) >25 kg/m 2 attending routine breast cancer screening appointments. Methods and Analysis: The study will be a four-centre, 1:1 parallel group randomised controlled trial of a 12-month weight management intervention initiated in breast cancer screening centres, delivered by trained Breast Cancer Now lifestyle coaches in community settings. The intervention programme involves two intervention meetings with coaches plus (up to) nine telephone contacts over 12 months. The programme will focus on personalised diet (including alcoholic and sugary drinks) and physical activity habits. Behaviour change techniques include self-monitoring, goal setting, implementation intentions, action and coping plans. The study has a sample size of 414 women with a BMI >25 kg/m 2 attending routine National Health Service breast cancer screening appointments. Measures will be taken at baseline, 12 weeks and at 12-month follow-up, complemented by qualitative interviews exploring perceived acceptability and impact on habitual behaviours. The two co-primary outcomes are mean change in measured body weight and change in physical activity between groups to 12 months. Secondary outcomes are changes in eating habits, alcohol intake, sedentary time, quality of life, waist circumference, lipid, haemoglobin A1c and insulin profiles, blood pressure and cost-effectiveness of the intervention. Ethics and Dissemination: The protocol has been approved by East of Scotland Research Ethics Committee (17/ES/0073). All participants provide written informed consent. Dissemination will be through peer-reviewed publication and conference presentations. Trial Registration Number: ISRCTN11057518; Pre-results. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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