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

Annie S Anderson, Angela Mary Craigie, Stephanie Gallant, Chloe McAdam, E Jane Macaskill, Nanette Mutrie, Aileen Rae Neilson, Ronan E O'Carroll, Petra Rauchhaus, Naveed Sattar, Martine Stead, Shaun Treweek

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Abstract

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) gt;25 kg/m2 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 gt;25 kg/m2 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.
Original languageEnglish
Article numbere024136
JournalBMJ Open
Volume8
Issue number11
DOIs
Publication statusPublished - 8 Nov 2018

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Life Style
Breast
Randomized Controlled Trials
Breast Neoplasms
Early Detection of Cancer
Scotland
Exercise
Weights and Measures
Cost-Benefit Analysis
Appointments and Schedules
Body Mass Index
Diet
Body Weight Changes
Research Ethics Committees
National Health Programs
Waist Circumference
Feeding Behavior
Informed Consent
Telephone
Ethics

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Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening. / Anderson, Annie S; Craigie, Angela Mary; Gallant, Stephanie; McAdam, Chloe; Macaskill, E Jane; Mutrie, Nanette; Neilson, Aileen Rae; O'Carroll, Ronan E; Rauchhaus, Petra; Sattar, Naveed; Stead, Martine; Treweek, Shaun.

In: BMJ Open, Vol. 8, No. 11, e024136, 08.11.2018.

Research output: Contribution to journalArticle

Anderson, AS, Craigie, AM, Gallant, S, McAdam, C, Macaskill, EJ, Mutrie, N, Neilson, AR, O'Carroll, RE, Rauchhaus, P, Sattar, N, Stead, M & Treweek, S 2018, 'Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening', BMJ Open, vol. 8, no. 11, e024136. https://doi.org/10.1136/bmjopen-2018-024136
Anderson, Annie S ; Craigie, Angela Mary ; Gallant, Stephanie ; McAdam, Chloe ; Macaskill, E Jane ; Mutrie, Nanette ; Neilson, Aileen Rae ; O'Carroll, Ronan E ; Rauchhaus, Petra ; Sattar, Naveed ; Stead, Martine ; Treweek, Shaun. / Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening. In: BMJ Open. 2018 ; Vol. 8, No. 11.
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AU - Anderson, Annie S

AU - Craigie, Angela Mary

AU - Gallant, Stephanie

AU - McAdam, Chloe

AU - Macaskill, E Jane

AU - Mutrie, Nanette

AU - Neilson, Aileen Rae

AU - O'Carroll, Ronan E

AU - Rauchhaus, Petra

AU - Sattar, Naveed

AU - Stead, Martine

AU - Treweek, Shaun

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N2 - 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) gt;25 kg/m2 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 gt;25 kg/m2 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.

AB - 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) gt;25 kg/m2 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 gt;25 kg/m2 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.

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DO - 10.1136/bmjopen-2018-024136

M3 - Article

VL - 8

JO - BMJ Open

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SN - 2044-6055

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ER -