Health behaviour outcomes of a family based intervention for paediatric obesity in primary care: A randomized type II hybrid effectiveness-implementation trial.

BACKGROUND: Paediatric obesity is a multifaceted public health problem. Family based behavioural interventions are the recommended approach for the prevention of excess weight gain in children and adolescents, yet few have been tested under "real-world" conditions. OBJECTIVES: To evaluate the effectiveness of a family based intervention, delivered in coordination with paediatric primary care, on child and family health outcomes. METHODS: A sample of 240 families with racially and ethnically diverse (86% non-White) and predominantly low-income children (49% female) ages 6 to 12 years (M = 9.5 years) with body mass index (BMI) ≥85th percentile for age and gender were identified in paediatric primary care. Participants were randomized to either the Family Check-Up 4 Health (FCU4Health) program (N = 141) or usual care plus information (N = 99). FCU4Health, an assessment-driven individually tailored intervention designed to preempt excess weight gain by improving parenting skills was delivered for 6 months in clinic, at home and in the community. Child BMI and body fat were assessed using a bioelectrical impedance scale and caregiver-reported health behaviours (eg, diet, physical activity and family health routines) were obtained at baseline, 3, 6 and 12 months. RESULTS: Change in child BMI and percent body fat did not differ by group assignment. Path analysis indicated significant group differences in child health behaviours at 12 months, mediated by improved family health routines at 6 months. CONCLUSION: The FCU4Health, delivered in coordination with paediatric primary care, significantly impacted child and family health behaviours that are associated with the development and maintenance of paediatric obesity. BMI did not significantly differ.

The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).

BACKGROUND: Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting. METHODS: We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU. PROJECTED OUTCOMES: This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.

The Family Check-Up 4 Health (FCU4Health): Applying Implementation Science Frameworks to the Process of Adapting an Evidence-Based Parenting Program for Prevention of Pediatric Obesity and Excess Weight Gain in Primary Care.

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.

An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study).

BACKGROUND: Pediatric 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. METHODS: This (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. DISCUSSION: This 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 REGISTRATION: NCT03013309 ClinicalTrials.gov.