There were no changes to protocol except those concerned with the way that outcomes were expressed. See Table 5.
Public involvement
Extensive public engagement was built into the development of the FFIT intervention and the evaluation design. This principally involved ongoing engagement during the programme development phase with key stakeholders (the SPL Trust, the football clubs and the programme delivery funders) and consultation with
men who took part in the first pilot deliveries of FFIT at 11 clubs in the 2010–11 football season. Input
from the coaches, the SPL Trust and the target group of men thus all fed directly into the final shaping of the intervention and the research design.
Representatives of the SPL Trust were actively involved throughout the development of the delivery protocol for the pilot FFIT programme. Following these initial meetings, we also met with community managers from the football clubs who would be involved in the pilot programme prior to the finalisation of the pilot delivery protocol. These meetings allowed the community managers to input into the programme design and to discuss the importance of undertaking a programme that was evidence based and generalisable, and of gathering gold standard evidence of its effectiveness by conducting an
evaluation using a randomised design. We also met with the coaches who were delivering the autumn 2010 pilot programme at a training workshop in October 2010 to ask for feedback on the initial sessions. At the end of the autumn 2010 delivery, we held in-depth interviews with coaches at the two clubs which took part in our pilot trial to obtain their views about the programme and research design and received
written feedback from coaches at the other clubs.28In addition, CMG visited all clubs during spring 2011
to observe delivery sessions of the second pilot programme and to speak informally to the coaches and in April 2011 we fed back the emerging the pilot findings at a plenary meeting organised by the SPL Trust at the National Football Stadium, Hampden Park. All comments were carefully considered in the development of the final version of the FFIT programme that was delivered in the intervention arm of the trial as
reported by Gray et al.28
The views and experiences of the men who participated in the pilot deliveries also fed into the
development of the intervention. All men taking part in the autumn 2010 pilot deliveries were asked to complete a programme evaluation form, which asked for their suggestions for changes. Men at the two clubs involved in the feasibility study also took part in focus groups following the autumn 2010 and spring 2011 pilot deliveries where they gave their views on the content of the programme and on the planned
research procedures for the RCT.28,32In addition, when a reviewer of the grant application for this trial
suggested that the evidence on men and health raised questions about whether or not men would engage with the pedometer-based walking programme, we undertook a series of semistructured telephone
interviews (n= 27) with men from a number of clubs who had taken part in the autumn 2010 pilot
deliveries, to ask them about their experience of this aspect of the programme. These interviews strongly reinforced our first hand experiences that men saw the pedometer-based walking programme as an
appropriate way to begin to regain some fitness and (re-)engage with physical activity;31furthermore,
it demonstrated that this was a part of the programme that was highly valued by our target group
(men aged 35–65 years with a BMI ≥ 28 kg/m2).
Participants in the pilot deliveries of FFIT in 2010/11 were also engaged in outreach work on FFIT prior to and during our intense period of recruitment to this trial. Many participated in various public engagement activities including the five-a-side football tournament held in June 2011 at St Mirren Football Club for ex-participants and a video diary made by a BBC journalist, Paul Bradley, who took part in the spring 2011 pilot FFIT programme, which illustrated week by week (each week being filmed at a different club)
interviews about their experiences of FFIT (including a 1-hour-long BBC Radio Scotland documentary about the programme that was first broadcast on 18 June 2011). They also played an active role in recruitment by telling their friends and family about the programme, advertising it in their workplaces and local community venues (e.g. libraries) and supporting fieldworkers during match day visits to home fixtures. In February 2012, a half-hour TV documentary on FFIT, which involved interviews with several participants from the autumn 2011 deliveries of FFIT (the intervention group in the trial), was screened on BBC 2 Scotland. Finally, in September 2013, representatives from each of the groups of men who undertook the intervention in autumn 2011 readily agreed to come to a bespoke event at Hampden Park to talk about their experiences of FFIT for future dissemination purposes, including the FFIT research website (www.ffit.org.uk).63
Chapter 3 Results: the randomised controlled trial
Participant flow
Figure 2 shows participant flow through the trial. Of the 1231 men registering an interest during the recruitment period, 483 were excluded from the trial (101 decided against participation, 76 had a BMI
< 28 kg/m2, 306 were allocated to the non-trial delivery of FFIT). Three hundred and seventy-four were
randomly allocated to the intervention group and 374 to the comparison group. One comparison group participant subsequently withdrew and requested we destroy his data.
Multifaceted recruitment (1) Media based
For example, newspaper, radio, websites (2) Club based
For example, match-day adverts, manager, player endorsement (3) Other
For example, signposting from NHS, workforce mail shots
FFIT enrollment and baseline measurement (n = 1231) Loss to follow-up n = 44 (12%) Loss to follow-up n = 27 (7%) Loss to follow-up n = 19 (5%) Loss to follow-up n = 41 (11%) Follow-up Analysis Allocated intervention group
(n = 374)
Allocated to comparison group (n = 373)a 12-week measurement n = 347 (93%) 12-week measurement n = 330 (88%) 12-month measurement n = 330 (89%) 12-month measurement n = 355 (95%) Analysed n = 333 (no imputation) n = 374 (with imputation) Analysed n = 355 (no imputation) n = 373 (with imputation) • Did not wish to participate, n = 101
• Ineligible (BMI < 28 kg/m2), n = 76
Randomisation Excluded
(n = 177)
Allocated to FFIT programme groups that are not included in RCT
Excluded (n = 306)
FIGURE 2 Flow of participants through the FFIT RCT. a, After randomisation, one participant requested to have all of his data destroyed. Reprinted with permission from Elsevier (The Lancet, 2014, 383, 1211–21).33