Search

Background: Failure to include socio-economically deprived or ethnic minority groups in physical activity (PA) trials may limit representativeness and could lead to implementation of interventions that then increase health inequalities. Randomised intervention trials often have low recruitment rates and rarely assess recruitment bias. A previous trial by the same team using similar methods recruited 30% of the eligible population but was in an affluent setting with few non-white residents and was limited to those over 60 years of age., Methods: PACE-UP is a large, effective, population-based walking trial in inactive 45-75 year-olds that recruited through seven London general practices. Anonymised practice demographic data were available for all those invited, enabling investigation of inequalities in trial recruitment. Non-participants were invited to complete a questionnaire., Results: From 10,927 postal invitations, 1150 (10.5%) completed baseline assessment. Participation rate ratios (95% CI), adjusted for age and gender as appropriate, were lower in men 0.59 (0.52, 0.67) than women, in those under 55 compared with those ≥65, 0.60 (0.51, 0.71), in the most deprived quintile compared with the least deprived 0.52 (0.39, 0.70) and in Asian individuals compared with whites 0.62 (0.50, 0.76). Black individuals were equally likely to participate as white individuals. Participation was also associated with having a co-morbidity or some degree of health limitation. The most common reasons for non-participation were considering themselves as being too active or lack of time., Conclusions: Conducting the trial in this diverse setting reduced overall response, with lower response in socio-economically deprived and Asian sub-groups. Trials with greater reach are likely to be more expensive in terms of recruitment and gains in generalizability need to be balanced with greater costs. Differential uptake of successful trial interventions may increase inequalities in PA levels and should be monitored., Trial Registration: ISRCTN.com ISRCTN98538934 . Registered 2nd March 2012.

There is real need to change how we do some of our clinical trials, as currently the testing and development process is too slow, too costly and too failure-prone often we find that a new treatment is no better than the current standard. Much of the focus on the development and testing pathway has been in improving the design of phase I and II trials. In this article, we present examples of new methods for improving the design of phase III trials (and the necessary lead up to them) as they are the most time-consuming and expensive part of the pathway. Key to all these methods is the aim to test many treatments and/or pose many therapeutic questions within one protocol.

Background: We report the main results, among adults, of a cluster-randomised-trial of Well London, a community-engagement programme promoting healthy eating, physical activity and mental well-being in deprived neighbourhoods. The hypothesis was that benefits would be neighbourhood-wide, and not restricted to intervention participants. The trial was part of a multicomponent process/outcome evaluation which included non-experimental components (self-reported behaviour change amongst participants, case studies and evaluations of individual projects) which suggested health, well-being and social benefits to participants., Methods: Twenty matched pairs of neighbourhoods in London were randomised to intervention/control condition. Primary outcomes (five portions fruit/vegetables/day; 5×30 m of moderate intensity physical activity/week, abnormal General Health Questionnaire (GHQ)-12 score and Warwick-Edinburgh Mental Well-being Scale (WEMWBS) score) were measured by postintervention questionnaire survey, among 3986 adults in a random sample of households across neighbourhoods., Results: There was no evidence of impact on primary outcomes: healthy eating (relative risk [RR] 1.04, 95% CI 0.93 to 1.17); physical activity (RR:1.01, 95% CI 0.88 to 1.16); abnormal GHQ12 (RR:1.15, 95% CI 0.84 to 1.61); WEMWBS (mean difference [MD]: -1.52, 95% CI -3.93 to 0.88). There was evidence of impact on some secondary outcomes: reducing unhealthy eating-score (MD: -0.14, 95% CI -0.02 to 0.27) and increased perception that people in the neighbourhood pulled together (RR: 1.92, 95% CI 1.12 to 3.29)., Conclusions: The trial findings do not provide evidence supporting the conclusion of non-experimental components of the evaluation that intervention improved health behaviours, well-being and social outcomes. Low participation rates and population churn likely compromised any impact of the intervention. Imprecise estimation of outcomes and sampling bias may also have influenced findings. There is a need for greater investment in refining such programmes before implementation; new methods to understand, longitudinally different pathways residents take through such interventions and their outcomes, and new theories of change that apply to each pathway., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)