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Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening
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 weigh...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231585/ https://www.ncbi.nlm.nih.gov/pubmed/30413516 http://dx.doi.org/10.1136/bmjopen-2018-024136 |
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author | 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 |
author_facet | 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 |
author_sort | Anderson, Annie S |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6231585 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-62315852018-12-11 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 BMJ Open Public Health 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. BMJ Publishing Group 2018-11-08 /pmc/articles/PMC6231585/ /pubmed/30413516 http://dx.doi.org/10.1136/bmjopen-2018-024136 Text en © 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. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Public Health 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 |
title | Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening |
title_full | Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening |
title_fullStr | Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening |
title_full_unstemmed | Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening |
title_short | Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening |
title_sort | randomised controlled trial to assess the impact of a lifestyle intervention (actwell) in women invited to nhs breast screening |
topic | Public Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231585/ https://www.ncbi.nlm.nih.gov/pubmed/30413516 http://dx.doi.org/10.1136/bmjopen-2018-024136 |
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