In the feasibility trial a pre-set recruitment target of 80 women from routine NHS breast screening clinics was achieved within 12 weeks and 65 (81%) participants completed follow up assessments at 3 months. The primary analysis showed significant between group differences in body weight and (questionnaire reported) physical activity measures.
The mean duration of the face to face coaching session was 90 minutes (range 65 to 130 minutes); the planned protocol time was 60 minutes. Mean duration of the telephone consultations was 22 minutes (range 10 to 54 minutes); the planned protocol time was 15 minutes. Full details are provided elsewhere (18).
The independent assessments showed that the intervention was delivered with high fidelity (close to protocol. Deviations from the protocol included the coach setting goals rather than the participant, not discussing the intervention in terms of personal wellbeing and limited discussion of coping planning strategies.
Feedback on acceptability of the programme from exit questionnaires showed that face to face contact, telephone calls, educational materials, pedometers and topics raised in motivational interviewing were acceptable/very acceptable by at least 70% of participants. Goals (weight management, physical activity and diet) were set by over 75% of participants but only 20% set an alcohol goal, largely because reported intakes were perceived as low. All goals were described as useful by 60% (and 80% of those who set an alcohol goal). Women rated the programme highly and 70% said they would recommend it to others.
Qualitative data obtained from 14 participants who took part in semi-structured interviews highlighted that information about the association between lifestyle factors and cancer risk was new learning. Coaches’ non-judgemental, positive approach was appreciated, and telephone contacts were highly valued. The pedometers were particularly valued by many women because they allowed participants to turn knowledge into experiential learning. One widely expressed view was that the programme should be longer in duration than the current 3 months
The changes made to the design of the full-scale trial made in response to these findings are presented in Table 1 (Row 1)
Changes in intervention resulting from preparatory work
Implications for RCT intervention
Changes implemented in full trial
Feasibility Intervention was effective in achieving changes in physical activity & bodyweight but not diet.
Additional face-to-face contact required.
Participants preferred extended programme and contact period.
Intervention approaches identified as acceptable to participants.
Increase dietary guidance, personalised in line with national guidelines.
Provide two, shorter face-to-face visits.
Increase programme to 12 months enabling contact maintenance and longer-tern evaluation.
Retain acceptable intervention approaches: e.g. written educational materials and behaviour change techniques.
Focus group discussions
The association between lifestyle and breast cancer needs to be clearer
Strong negative views about benefits of alcohol reduction
Ensure coaches appreciate, acknowledge and build on women’s previous engagement in lifestyle changes
Personalised advice is given to increase or maintain current physical activity.
Importance of diet as well as physical activity needs to be clear, particularly for active but overweight women.
Be clear about what the programme offers beyond education about physical activity and weight loss.
Explore flexibility in appointments for intervention delivery.
Include current scientific evidence in coaches’ training to ensure they are fully equipped to respond to questions around breast cancer and lifestyle links.
Enhance infographics used in information packs and ensure reference links updated.
Reinforce association of lifestyle change with other positive health outcomes, including mental health.
Embed alcohol messages with total caloric intake to introduce topic.
Assess and comment on reported lifestyle changes
Be clear that discussion in physical activity relevant for all
Ensure clarity around importance of diet as well as physical activity.
Ensure coaches emphasise their educational and support role in personalised lifestyle change across a wide range of health dimensions.
Provide flexibility in appointment times for participants, including evening and weekends.
ActWELL public advisory group
Written and verbal communications should be inclusive and address current and future co-morbidities
Potential participants with low mobility may be screened out only if physical activity is contra-indicated for medical reasons.
Provide coaches with information on where to find links and assistance, as appropriate.
Written material should clarify concepts of risk reduction rather than prevention per se.
Ensure images for in-house materials are designed appropriately for this target group.
Feedback from peer reviewer
7% target weight loss is only likely to be achieved with greater dietary reduction than that used in the feasibility study.
The 12-month programme needs to take a weight management approach incorporating weight loss and weight maintenance.
Additional support may be required to maintain adherence over a 12- month programme compared to that required for a 3-month programme.
Learning from feasibility study on intervention session timings and improving fidelity.
Enhance interactive learning on sugary drinks, snacks and portion control as these are relevant to excess calorific intake.
Consider including discussions about diet in both face-to-face sessions:
Session 1 - Focus on snacking; Session 2 - Focus on total diet including portion sizes, meal choices, patterns and successful strategies for managing dietary intake.
Advise coaches on weight loss maintenance, but this should be discussed with the research team on a case by case basis – especially if participants wish to continue weight loss.
Participants moving on to maintenance will be encouraged to monitor and record new habits using the ‘Ten Top Tips’ shown to be successful for weight loss maintenance over a 2-year period (22)
Emphasise importance of regular phone call support by offering up to 9 calls during the 12-month period.
To encourage adherence, coaches should:
- identify positive behaviour changes
- give positive feedback
- ask participants to report current body weight and provide supportive advice/comment.
Coaches’ training should include how to offer programme re-starts and revised goals for participants who have breaks in programme participation (e.g. illness, holidays).
A detailed breakdown of the timing of programme delivery will be incorporated in coaches’ training including role modelling approaches, test timings and self-report of first five participants.
|Figure 1a Key components of the lifestyle coach sessions (face to face visits)|
Face to face
2 sessions- 60 min and 45 min within 3 months
Trained lifestyle coach (volunteers for Breast Cancer Now)
Place of delivery
Local leisure centres (in office facilities)
Telephone contact details provided
“Bring a buddy” offered, friend / partner / family member can be invited
Summary of behaviour change techniques utilsed
• Motivational interviewing
• Goal setting (graduated/graduall?, achievable)
• Action plans (implementation intentions)
• Coping planning
• Self-monitoring and feedback• •
body weight and physical activity
Action plans and implementation intentions
Goals will be set for:
• Weekly weight recording
• Daily walking plan
• Agreed Food and drink (including alcohol)
• Implementation intentions agreed (when, where and how)
Coping plans Self-monitoring
Introduce activity focus
• Provide pedometer
• Pedometer / walking plan and diary
• Offer body weight scales
• Explanation of self-monitoring procedures
review of previously set goals and modification, if necessary•
Education- Breast cancer risk reduction
Evidence relating lifestyle breast cancer risk
• Evidence on importance of lifestyle change after age 50
• Further reading links
• Brief background to which lifestyle factors increase risk and why
- Physical activity
• Weight gain and the risk of breast cancer
• Reasons for eligibility (age and weight) and recognition that many women are already active and mindful of diet and body weight
Education – Physical Activity
20 minutes, including interactive walk and talk
• Demonstration of brisk walking + pedometer (interactive) over a 10 minute walk and talk session
• Personalised walking plan (to fit with usual daily agendas)
• Physical activity guidelines
• Tips for decreasing sedentary behaviour
• Links to a range of community opportunities provided
• Introduction to leisure centre staff for access to premises
(Set daily physical activity goal according to personalised walking plan)
Education - Diet
45 minutes including interactive tasks (sugar in drinks/portion size quiz, dietary assessments procedures)
• Drinks – the importance of water
• Sugary drinks- sugar and calorie content
• Alcohol – calories, alcohol, tips for cutting down, links for support
• Snacks and discretionary foods – biscuits, chocolate, crisps, cheese
• Meal patterns and healthy food choices (Eatwell guide)
• Using traffic light labelling to guide food choices
• Personalisation of eating plan (feedback on dietary assessment)
• Importance of small changes and maintenance of these
Education – weight management
20 minutes including interactive task (personal identification of weight category, offer free body scales if required)
• Discussion of goal to achieve (and maintain) 7% weight loss over one year using a 600kcals energy deficit diet
• Importance of diet and physical activity in weight loss
• Personalised daily eating guide – according to body size, caloric requirements and food preferences
General support – listening re health, circumstances, experience of previous weight loss attempts. Non-judgmental approaches required at all times. Clarity that coaches are there to support not judge
Coping plans (following illness, holidays etc)
Getting family members involved for social support
Agree future appointments to suit participant as far as possible
|Figure 1b Key components of lifestyle coach sessions (telephone calls)|
Telephone (within two weeks after visit 1 and visit 2, then 7 calls over next 9 months)
Following on from face to face contact until 3 month follow-up assessment (6 calls total)
Make appointment for next telephone call
General exchange about mental and physical health
Elicit participant’s overview on progress and changes made
Re-enforce importance of modest behavior change for health benefit
Discuss goals/ restarts
Discuss weight loss maintenance goals as appropriate - highlight ten top tips and habit progression
Discuss self-monitoring records
Identify perceived diet/activity challenges
Personal goals (implementation intentions)
Continue to focus on implementation intentions and review these at next call
Engage in coping planning eg reviewing previously set goals and modifying, if necessary
Setting long term goals
Identify perceived achievements and summarise success
Re-evaluate confidence, motivation and importance of changes made
Focus Group Discussions
Several issues emerged from the focus group discussions which had implications for the proposed intervention. Some of the findings were similar to those reported for the feasibility work (18) four years earlier and confirm key issues that remain to be considered in the intervention content. Firstly, the association between lifestyle and breast cancer needed to be clearer. There were varying levels of awareness among women regarding similar statements in the draft invitation flyers about the links between lifestyle factors, particularly weight, and breast cancer risk. While some found the statements credible, others were sceptical, and perceived that breast cancer could develop because of genes recurring within families, that it was related to hormones, or in some cases was ‘just your luck’.
…a lot of people get breast cancer when they are slim, fat or medium. It doesn’t have to be because you are overweight. I have known a lot of people who have had breast cancer and they’re very slim. (Group 2, C2DE)
Others perceived that following a lifestyle involving a healthy diet and plenty of exercise, as well as maintaining a healthy weight, was important for good health and avoidance of a range of health conditions regardless of whether they believed the evidence regarding a specific link with breast cancer.
In one of the second set of groups, where one of the draft invitations highlighted that 30% of breast cancers were due to lifestyle factors, a participant was shocked to hear the extent of these links.
I was quite shocked to see 30% can be...that figure there, associated with your lifestyle to breast cancer. I didn’t realise it was as high as that. (Group 4, C2DE)
Second, messages implying that reducing alcohol intake could reduce breast cancer risk elicited strong sceptical comments with the potential to reduce engagements.
What is the research that has got that? What is that based on? The conclusion is that drinking alcohol … especially breast cancer. What is the evidence for that? What is it based on? (Group 1, ABC1)
I don’t know, they bring out all these things, one thing is good for you, one...next month there's something else that...I think we go around in circles with things really (Group 4, C2DE)
Understanding of the ActWELL programme as outlined in the invitation was good. Participants appreciated that the programme would provide personalised support for increasing activity, making changes to their diet, including alcohol intake, and setting goals in relation to their weight. The concept of a personal lifestyle coach was a familiar one and easily understood. Making changes to achieve a healthier lifestyle and manage their weight was generally an attractive prospect for most of the women interviewed. Some participants were already taking steps to increase their level of exercise, follow a healthy diet and manage their weight.
Third, it became apparent that it could be useful for coaches to acknowledge and reinforce attempts to change lifestyle. It was noted that participants commented regularly on attempts to increase physical activity. For example, one woman mentioned that she didn’t think she could become any more active in her life, given she exercised on a near daily basis.
I’m quite active every day, so I don’t know how much that would help. I go to … 5 mornings a week – swimming everyday I don’t think I could do anymore. (Group 2, C2DE)
Fourth, this statement acted as a reminder that we must be clear that personalised advice is given to increase or maintain current physical activity. Where increases are recommended, these are based on current activity levels (however small or big) recognising that no one size (e.g. 10,000 steps) is appropriate for all. In addition, it is recognised that whilst there has been considerable emphasis on getting people more active, the importance of overall energy balance through dietary changes (reducing calorie intake) may have been underplayed – not least because weight management may be perceived more negatively. It is important to note that our target group are overweight or obese (BMI > 25 kg/m2) and will have a weight loss target which necessities an emphasise dietary intake as the main factor influencing body weight.
There was a sense that ActWELL didn’t necessarily offer new information about how to achieve a healthier lifestyle or weight but rather it would provide the support, opportunity and motivation to make changes. Some were more sceptical about the support proposed by ActWELL. They questioned whether it was necessary to offer such a programme, highlighting that the information needed to make changes was already widely available and that those who wanted a healthier lifestyle could do this alone.
We are responsible for our own health and wellbeing and if we’re interested enough there is plenty of information out there if you are interested in going to find things out. (Group 1, ABC1)
These responses indicate that women can access health information, successfully act upon it and attain good health outcomes. However, as the programme targets overweight and obese women it is likely that these women will benefit from (further) lifestyle changes particularly in this age group where multimorbidity is common. One of the strongest features of the proposed programme is the combination of education with support and it is plausible that emphasising support (especially for women who have attempted weight change before) may be helpful in increasing engagement.
Finally, flexible timing of appointments appeared highly desirable. Participants appeared to have few issues with the structure of the ActWELL intervention or study processes. However, those who were in employment suggested that it would be better to have flexibility over the timing of appointments, with the ability to schedule appointments in the evening to fit around such commitments. Some commented that motivation would be better maintained with regular and relatively frequent contact with a lifestyle coach given the length of time of the programme. Participants appeared satisfied with requirements to attend local hospitals for study or lifestyle coach appointments, though when leisure centres were suggested as venues some participants felt they were preferable, given issues with parking in hospitals and “clinical feel”.
The changes made to the design of the full-scale trial in response to these findings are presented in Table 1 (Row 2)
Actwell Public Advisory Group
Most comments received were about recruitment approaches. Members highlighted that they were not experts on lifestyle change so did not comment on the specific targets of the programme. They did however comment on language and approach.
Three elements that were noted as favourable were the sense of support, that help on behavioural change was being offered (and not demanded) and the activity “such as walking” (as opposed to “exercise”) were highlighted.
In all communications, they highlighted that information on lifestyle should be sensitively communicated to avoid a perception of blame if cancer was diagnosed at a later point.
Consideration should be given to how the programme could be applied for people living with long term disabilities who may be at higher risk because of current low physical activity levels.
The changes made to the design of the full-scale trial in response to these findings are presented in Table 1 (Row 3)
Peer Reviewer Feedback
Most comments related to recruitment, analysis plans, measurements, avoiding cross-contamination and fewer comments on the actual intervention programme. The comments relating to the latter are as follows.
Reviewers noted that the study was ambitiously powered for 7% weight loss at 12 months, highlighting the need to optimise delivery of the dietary component of the intervention to ensure best adherence (and weight loss) amongst the participants.
They also noted that maintaining behaviour change over the longer-term is challenging and requested details on strategies that might be implemented to assist with long-term adherence. Additionally, learning from the timing of the coaching sessions was queried (noting that in the feasibility trial, coaches had exceeded the planned time allowance) and to consider maximising coach adherence to protocol.
The changes made to the design of the full-scale trial in response to these findings are presented in Table 1 (Row 4)
The feasibility intervention was designed largely around the use of behavioural change techniques but failed to consider how to incorporate more sustainable, long term behaviour change strategies. The investigatory team highlighted the applicability of the COM-B model (22) which identifies the key components of Capability, Opportunities and Motivation as determinants of behaviour change. The draft intervention was then reviewed, focusing on how these three aspects were being incorporated.
It was recognised that the draft intervention aimed to increase Capability of dietary choices and weight management through personalised advice and practical, small changes (including portion size guidance). However, one of our previous studies  had increased capability on weight management through the provision of scales (for weekly weighing) and it was concluded these could be offered as part of the redesigned programme. To increase Opportunities for promoting physical activity we negotiated with local leisure centres to enable the face to face visits to take place in local premises, to offer a tour of facilities and to offer free/low cost access to services. We also provided the participants with an information sheet on local walking and cycling groups within local areas. Motivational techniques were used throughout the programme and specifically related to action to change behaviours principally through setting of modest and achievable goals, implementation intentions and the use of coping planning. The pedometers also provided potentially rewarding self-monitoring feedback of physical activity goals achieved.
Finally, a logic model was developed to identify how each component of the intervention programme was likely to moderate behaviours and impact on short- and long-term behavioural outcomes and weight management. See Fig. 1.