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Published in: Trials 1/2020

Open Access 01-12-2020 | Breast Cancer | Research

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

Authors: Annie S. Anderson, Angela M. Craigie, Stephanie Gallant, Chloe McAdam, E. Jane Macaskill, Jennifer McKell, Nanette Mutrie, Ronan E. O’Carroll, Naveed Sattar, Martine Stead, Shaun Treweek

Published in: Trials | Issue 1/2020

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Abstract

Background

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/m2 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.

Methods

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.

Results

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.

Conclusions

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.

Trial registration

ISRCTN: ISRCTN11057518. Registered on 21 July 2017. Retrospectively registered.
Literature
6.
go back to reference Howell A, Anderson AS, Clarke RB, et al. Risk determination and prevention of breast cancer. Breast Cancer Res. 2014;16(5):446.CrossRef Howell A, Anderson AS, Clarke RB, et al. Risk determination and prevention of breast cancer. Breast Cancer Res. 2014;16(5):446.CrossRef
8.
go back to reference Anderson AS, Mackison D, Boath C, et al. Promoting changes in diet and physical activity in breast and colorectal cancer screening settings: an unexplored opportunity for endorsing healthy behaviors. Cancer Prev Res. 2013;6:165–72.CrossRef Anderson AS, Mackison D, Boath C, et al. Promoting changes in diet and physical activity in breast and colorectal cancer screening settings: an unexplored opportunity for endorsing healthy behaviors. Cancer Prev Res. 2013;6:165–72.CrossRef
10.
go back to reference Escoffery C, Lebow-Skelley E, Haardoerfer R, et al. A systematic review of adaptations of evidence-based public health interventions globally. Implement Sci. 2018;13(1):125.CrossRef Escoffery C, Lebow-Skelley E, Haardoerfer R, et al. A systematic review of adaptations of evidence-based public health interventions globally. Implement Sci. 2018;13(1):125.CrossRef
11.
go back to reference Heerman WJ, JaKa MM, Berge JM, et al. The dose of behavioral interventions to prevent and treat childhood obesity: a systematic review and meta-regression. Int J Behav Nutr Phys Act. 2017;14:157.CrossRef Heerman WJ, JaKa MM, Berge JM, et al. The dose of behavioral interventions to prevent and treat childhood obesity: a systematic review and meta-regression. Int J Behav Nutr Phys Act. 2017;14:157.CrossRef
13.
go back to reference Hoddinott P. A new era for intervention development studies. Pilot Feasibility Stud. 2015;1:36.CrossRef Hoddinott P. A new era for intervention development studies. Pilot Feasibility Stud. 2015;1:36.CrossRef
14.
go back to reference Blatch-Jones AJ, Pek W, Kirkpatrick E, Ashton-Key M. Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study. BMJ Open. 2018;8(9):e022233.CrossRef Blatch-Jones AJ, Pek W, Kirkpatrick E, Ashton-Key M. Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study. BMJ Open. 2018;8(9):e022233.CrossRef
15.
go back to reference Levati S, Campbell P, Frost R, Dougall N, Wells M, Donaldson C, Hagen S. Optimisation of complex health interventions prior to a randomised controlled trial: a scoping review of strategies used. Pilot Feasibility Stud. 2016;2:17.CrossRef Levati S, Campbell P, Frost R, Dougall N, Wells M, Donaldson C, Hagen S. Optimisation of complex health interventions prior to a randomised controlled trial: a scoping review of strategies used. Pilot Feasibility Stud. 2016;2:17.CrossRef
17.
go back to reference Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403.CrossRef Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403.CrossRef
18.
go back to reference Anderson AS, Macleod M, Mutrie N, et al. Breast cancer risk reduction–is it feasible to initiate a randomised controlled trial of a screening programme? Int J Behav Nutr Phys Act. 2014;11:156.CrossRef Anderson AS, Macleod M, Mutrie N, et al. Breast cancer risk reduction–is it feasible to initiate a randomised controlled trial of a screening programme? Int J Behav Nutr Phys Act. 2014;11:156.CrossRef
19.
go back to reference Conway E, Wyke S, Sugden J, et al. Can a lifestyle intervention be offered through NHS breast cancer screening? Challenges and opportunities identified in a qualitative study of women attending screening. BMC Public Health. 2016;16:758.CrossRef Conway E, Wyke S, Sugden J, et al. Can a lifestyle intervention be offered through NHS breast cancer screening? Challenges and opportunities identified in a qualitative study of women attending screening. BMC Public Health. 2016;16:758.CrossRef
22.
go back to reference Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6:42.CrossRef Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6:42.CrossRef
23.
go back to reference Anderson AS, Craigie AM, Caswell S, et al. The impact of a body weight and physical activity weight loss intervention (BeWEL) initiated through a national colorectal cancer screening programme. BMJ. 2014;348:g1823.CrossRef Anderson AS, Craigie AM, Caswell S, et al. The impact of a body weight and physical activity weight loss intervention (BeWEL) initiated through a national colorectal cancer screening programme. BMJ. 2014;348:g1823.CrossRef
24.
go back to reference Anderson AS, Craigie AM, Gallant S, et al. Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening. BMJ Open. 2018;8(11):e024136.CrossRef Anderson AS, Craigie AM, Gallant S, et al. Randomised controlled trial to assess the impact of a lifestyle intervention (ActWELL) in women invited to NHS breast screening. BMJ Open. 2018;8(11):e024136.CrossRef
26.
go back to reference Campbell NC, Murray E, Darbyshire J, et al. Designing and evaluating complex interventions to improve health care. BMJ. 2007;334(7591):455–9.CrossRef Campbell NC, Murray E, Darbyshire J, et al. Designing and evaluating complex interventions to improve health care. BMJ. 2007;334(7591):455–9.CrossRef
27.
go back to reference O’Cathain A, Croot L, Sworn K, et al. Taxonomy of approaches to developing interventions to improve health: a systematic methods overview. Pilot Feasibility Stud. 2019;5:41.CrossRef O’Cathain A, Croot L, Sworn K, et al. Taxonomy of approaches to developing interventions to improve health: a systematic methods overview. Pilot Feasibility Stud. 2019;5:41.CrossRef
28.
go back to reference French SD, Green SE, O’Connor DA, et al. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the theoretical domains framework. Implement Sci. 2012;7:38.CrossRef French SD, Green SE, O’Connor DA, et al. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the theoretical domains framework. Implement Sci. 2012;7:38.CrossRef
29.
go back to reference Hawkins J, Madden K, Fletcher A, et al. Development of a framework for the co-production and prototyping of public health interventions. BMC Public Health. 2017;17(1):689.CrossRef Hawkins J, Madden K, Fletcher A, et al. Development of a framework for the co-production and prototyping of public health interventions. BMC Public Health. 2017;17(1):689.CrossRef
30.
go back to reference Collins LM, Murphy SA, Nair VN, Strecher VJ. A strategy for optimizing and evaluating behavioural interventions. Ann Behav Med. 2005;30(1):65–73.CrossRef Collins LM, Murphy SA, Nair VN, Strecher VJ. A strategy for optimizing and evaluating behavioural interventions. Ann Behav Med. 2005;30(1):65–73.CrossRef
31.
go back to reference Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRef Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRef
33.
go back to reference Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009;28:690–701.CrossRef Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009;28:690–701.CrossRef
Metadata
Title
Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics
Authors
Annie S. Anderson
Angela M. Craigie
Stephanie Gallant
Chloe McAdam
E. Jane Macaskill
Jennifer McKell
Nanette Mutrie
Ronan E. O’Carroll
Naveed Sattar
Martine Stead
Shaun Treweek
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04405-z

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