BackgroundPediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations.MethodsThis (type II) hybrid effectiveness–implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children’s hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods.DiscussionThis study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care.Trial registrationNCT03013309 ClinicalTrials.govElectronic supplementary materialThe online version of this article (10.1186/s13012-017-0697-2) contains supplementary material, which is available to authorized users.

Implementation experts have recently argued for a process of “scaling out” evidence-based interventions, programs, and practices (EBPs) to improve reach to new populations and new service delivery systems. A process of planned adaptation is typically required to integrate EBPs into new service delivery systems and address the needs of targeted populations while simultaneously maintaining fidelity to core components. This process-oriented paper describes the application of an implementation science framework and coding system to the adaptation of the Family Check-Up (FCU), for a new clinical target and service delivery system—prevention of obesity and excess weight game in primary care. The original FCU has demonstrated both short- and long-term effects on obesity with underserved families across a wide age range. The advantage of adapting such a program is the existing empirical evidence that the intervention improves the primary mediator of effects on the new target outcome. We offer a guide for determining the levels of evidence to undertake the adaptation of an existing EBP for a new clinical target. In this paper, adaptation included shifting the frame of the intervention from one of risk reduction to health promotion; adding health-specific assessments in the areas of nutrition, physical activity, sleep, and media parenting behaviors; family interaction tasks related to goals for health and health behaviors; and coordinating with community resources for physical health. We discuss the multi-year process of adaptation that began by engaging the FCU developer, community stakeholders, and families, which was then followed by a pilot feasibility study, and continues in an ongoing randomized effectiveness-implementation hybrid trial. The adapted program is called the Family Check-Up 4 Health (FCU4Health). We apply a comprehensive coding system for the adaptation of EBPs to our process and also provide a side-by-side comparison of behavior change techniques for obesity prevention and management used in the original FCU and in the FCU4Health. These provide a rigorous means of classification as well as a common language that can be used when adapting other EBPs for context, content, population, or clinical target. Limitations of such an approach to adaptation and future directions of this work are discussed.

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Aims: To translate evidence-based programs (EBP) for a new setting, attention must be given to the characteristics of the intervention and the local setting, as well as evidence that is compelling to decision-makers. This paper describes the history of a partnership and stakeholder recommendations to inform the adaptation of an EBP for primary care. Methods: We established a community advisory board (CAB) consisting of stakeholders with expertize in primary care delivery. A thematic analysis was conducted with fieldnotes and transcriptions from CAB meetings and regular meetings with participating clinics. Results: We found that (a) parenting programs with a focus on behavioral and physical health are appropriate for this setting, (b) variability in the structure of primary care means implementation must be tailorable, and (c) financial and organizational outcomes are compelling for decision-makers. Conclusion: Factors related to the content and structure of evidence-based programs are uniquely related to distinct implementation outcomes of interest to key stakeholders. K E Y W O R D S health services research, implementation science, integrated delivery of health care, organizational decision making, parenting, pediatric obesity, primary health care