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Background: Preventing obesity is an international health priority and women living in rural communities are at an increased risk of weight gain. Lifestyle programs are needed as part of a comprehensive approach to prevent obesity. Evaluation provides a unique opportunity to investigate and inform improvements in lifestyle program implementation strategies. The Healthy Lifestyle Program for rural women (HeLP-her Rural) is a large scale, cluster randomized control trial, targeting the prevention of weight gain. This program utilises multiple delivery modes for simple lifestyle advice (group sessions, phone coaching, text messages, and an interactive program manual). Here, we describe the acceptability of these various delivery modes., Methods: A mixed-method process evaluation was undertaken measuring program fidelity, recruitment strategies, dose delivered, program acceptability and contextual factors influencing program implementation. Data collection methodologies included qualitative semi-structured interviews for a sub-group of intervention participants [n = 28] via thematic analysis and quantitative methods (program checklists and questionnaires [n = 190]) analysed via chi square and t-tests., Results: We recruited 649 women from 41 rural townships into the HeLP-her Rural program with high levels of program fidelity, dose delivered and acceptability. Participants were from low socioeconomic townships and no differences were detected between socioeconomic characteristics and the number of participants recruited across the towns (p = 0.15). A face-to-face group session was the most commonly reported preferred delivery mode for receiving lifestyle advice, followed by text messages and phone coaching. Multiple sub-themes emerged to support the value of group sessions which included: promoting of a sense of belonging, mutual support and a forum to share ideas. The value of various delivery modes was influenced by participant's various needs and learning styles., Conclusion: This comprehensive evaluation reveals strong implementation fidelity and high levels of dose delivery. We demonstrate reach to women from relatively low income rural townships and highlight the acceptability of low intensity healthy lifestyle programs with mixed face-to-face and remote delivery modes in this population. Group education sessions were the most highly valued component of the intervention, with at least one face-to-face session critical to successful program implementation. However, lifestyle advice via multiple delivery modes is recommended to optimise program acceptability and ultimately effectiveness., Trial Registry: Australia & New Zealand Clinical Trial Registry. Trial number ACTRN12612000115831, date of registration 24/01/2012.

Background: To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities., Methods: Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program., Discussion: Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally., Trial Registration: ANZ clinical trial registry ACTRN12612000115831. Date of registration 24/01/2012.