Abstract
BACKGROUND: The impact of physical inactivity and unhealthy diet on health is increasingly profound. Lifestyle interventions targeting both behaviors simultaneously might decrease the prevalence of overweight and comorbidities. The Dutch 'BeweegKuur' is a combined lifestyle intervention (CLI) in primary care, to improve physical activity and dietary behavior in overweight people. In a cluster randomized controlled trial, the (cost-) effectiveness of an intensively guided program has been compared to a less intensively guided program. This process evaluation aimed to assess protocol adherence and potential differences between clusters. In addition, sustainability (i.e. continuation of the CLI in practice after study termination) was evaluated. METHODS: Existing frameworks were combined to design the process evaluation for our intervention and setting specifically. We assessed reach, fidelity, dose delivered and received, context and implementation strategy. Both qualitative and quantitative data were used for a comprehensive evaluation. Data were collected in semi-structured interviews with health care providers (HCPs, n = 25), drop-out registration by HCPs, regular questionnaires among participants (n = 411) and logbooks kept by researchers during the trial. RESULTS: Protocol adherence by professionals and participants varied between the programs and clusters. In both programs the number of meetings with all HCPs was lower than planned in the protocol. Participants of the supervised program attended, compared to participants of the start-up program, more meetings with physiotherapists, but fewer with lifestyle advisors and dieticians. The 'BeweegKuur' was not sustained, but intervention aspects, networks and experiences were still utilized after finalization of the project. Whether clusters continued to offer a CLI seemed dependent on funding opportunities and collaborations. CONCLUSIONS: Protocol adherence in a CLI was problematic in both HCPs and participants. Mainly the amount of dietary guidance was lower than planned, and decreased with increasing guidance by PT. Thus, feasibility of changing physical activity and dietary habits simultaneously by one intervention in one year was not as high as expected. Also the sustainability of CLI was poor. When a CLI program is started, re-invention should be allowed and maximum effort should be taken to guarantee long term continuation, by planning both implementation and sustainability carefully. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46574304 . Registered 23 December 2010.