Table 2 Changes in intervention resulting from preparatory work
Data source | Implications for RCT intervention | Changes implemented in full trial |
|---|---|---|
Feasibility study | Feasibility intervention was effective in achieving changes in physical activity and bodyweight but not diet | Increase dietary guidance, personalised in line with national guidelines |
Additional face to face contact required | Provide two, shorter face to face visits | |
Participants preferred extended programme and contact period | Increase programme to 12 months, enabling contact maintenance and longer-tern evaluation | |
Intervention approaches identified as acceptable to participants | 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 | 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 | ||
Strong negative views about benefits of alcohol reduction | Embed alcohol messages with total caloric intake to introduce topic | |
Ensure coaches appreciate, acknowledge and build on women’s previous engagement in lifestyle changes | Assess and comment on reported lifestyle changes | |
Personalised advice is given to increase or maintain current physical activity | Be clear that discussion in physical activity relevant for all | |
Importance of diet as well as physical activity needs to be clear, particularly for active but overweight women | Ensure clarity around importance of diet as well as physical activity | |
Be clear about what the programme offers beyond education about physical activity and weight loss | Ensure coaches emphasise their educational and support role in personalised lifestyle change across a wide range of health dimensions | |
Explore flexibility in appointments for intervention delivery | 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 | Target weight loss of 7% is only likely to be achieved with greater dietary reduction than that used in the feasibility study | 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 | ||
The 12-month programme needs to take a weight management approach incorporating weight loss and weight maintenance | 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 | ||
Additional support may be required to maintain adherence over a 12- month programme compared to that required for a 3-month programme | 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) | ||
Learning from feasibility study on intervention session timings and improving fidelity | 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 |