PLAN for Healthy Living is a cluster randomized clinical trial that will utilize a parent-mediated approach in primary care, which will include parents or primary caregivers attending individual visits and group sessions with providers, to address child overweight and obesity. In addition to weight management, the current study aims to examine the acceptability and feasibility of the approach among parents and primary care providers. We predict that children in the intervention clinics will demonstrate weight loss or maintenance at 3 and 6-month follow-up and parents will report healthier eating habits and increased physical activity as well as health related quality of life for their child during these assessment periods. We also predict that at the conclusion of the intervention parents will report favorable impressions of the program and providers will report acceptability and feasibility of the approach as well as increased competency in assessing and treating child overweight and obesity in their practice.
This pilot study will provide preliminary data that may be helpful in future design of larger-scale trials and is important for several reasons including 1) a need for applied and translational research in primary care settings, 2) attention to provider concerns regarding treatment efficiency and training, 3) utilization and assessment of the latest evidence ased practices/recommendations including brief MI, group sessions, the latest tools recommended by NIH and AAP and available to the public, and parents as targets of change, and 4) attention to an underserved and at-risk population. We follow with a discussion on each of these issues.
Because almost all children receive their health care in primary care settings, primary care providers are optimally positioned to intervene with patients and families in the prevention and management of childhood overweight. Numerous organizations including the AAP [50
] recommend that physicians determine BMI for all children in their practices and offer appropriate interventions to those who are overweight or obese. However, many physicians do not address this issue with their patients [51
]. In fact, studies indicate that health care providers recognize and initiate treatment for fewer than 20% of overweight children [53
]. The content and quality of nutrition and physical activity interventions also vary. Primary care physicians may counsel patients on the risks of overweight and give advice to eat less and exercise more [54
]; however, time constraints often prevent discussion of how to implement the eat-less, exercise-more prescription and may limit the physician’s opportunity to apply principles of behavior change [55
]. Other barriers to treating children who are overweight include lack of patient motivation and parent involvement, limited support services, perceived treatment futility, lack of reimbursement, and inadequate clinician knowledge and treatment skills [56
]. The current program was developed with attention to several of these factors.
Restructuring the delivery of primary care using the Chronic Care Model has been shown to be effective in reducing risk for conditions such as diabetes, asthma, and cardiovascular disease [57
] and has been advocated to address child overweight and obesity [40
]. In the PLAN study intervention, providers will be trained in the use of decision-support tools (i.e., AAP Pediatric Obesity Clinical Support Decision Chart 5210), care delivery will be designed to ensure coordinated care by the primary care provider and registered dietician through group sessions and structured follow-up phone calls, and parents will be educated in approaches to making healthy changes in their family’s eating and physical activity behaviors (i.e., self-management support).
The current project will utilize brief intervention, specifically brief MI and group sessions, in an effort to demonstrate efficiency. MI may be described as a patient-centered and goal-directed treatment approach for eliciting behavior change [61
]. Patients are supported in exploring and resolving ambivalence related to current health behaviors and values as well as future goals [61
]. A recent meta-analytic review [62
] of randomized controlled trials using MI found significant effects across a variety of health behaviors including weight loss. Although the majority of research has been published on MI with adults the value with pediatric populations appears promising [63
]. Due to its adaptability to brief formats it has been considered a brief intervention suited for pediatric health care settings [63
]. Pediatric providers and training programs have even begun to incorporate MI [64
]. In fact, Barlow and the Expert Committee on recommendations for the prevention, assessment, and treatment of child and adolescent overweight and obesity [40
] recommend the use of motivational interviewing. In addition to research and clinical recommendations provided via a conceptual and evidence review of MI for pediatric obesity [65
], a recent feasibility study [66
] found that targeting children via parents attending 1–2 sessions with a pediatrician or a pediatrician and dietician, respectively, found MI to be a promising approach for preventing child obesity. The current study will utilize the 15-minute obesity prevention protocol [40
], which incorporates elements of MI, to facilitate discussions with parents in individual visits.
Group intervention may provide participants an opportunity to benefit through active participation, observation, and collaboratively working through individual concerns in a supportive, confidential environment [67
]. A study with adults by Renjilian and colleagues [68
] examined individual versus group therapy for overweight and found that group treatment resulted in greater weight loss. However, the American Dietetic Association recently reviewed group sessions versus individual visits in terms of effectiveness of treating childhood overweight [69
]. It identified three studies and concluded that within multi-component childhood overweight treatment programs, limited evidence suggests that group versus individual treatment formats have similar effects on improving adiposity outcomes. The Institute of Medicine recently identified key approaches for improving the delivery of primary health care for patients [60
]. Group visits were suggested to provide a cost-effective approach for treating many important health problems by offering ample time for education and discussion [70
]. This study will provide the opportunity to examine both the effectiveness and feasibility of utilizing groups in the treatment of overweight treatment in the primary care setting.
Based on research documenting lack of training, materials, and skills in behavioral techniques [19
], the current study will also provide training in brief MI and group sessions to increase provider competency and skills for addressing child overweight. Providers will complete at least 8 hours of online and face-to-face training in brief intervention, MI, and delivery of group sessions. Providers will receive continuing education credit as well as monetary incentives for participation in training. At the conclusion of the study, we plan to conduct focus groups with providers to evaluate perceptions regarding acceptability and feasibility including the time and quality related to training. Due to the emphasis on acceptability and feasibility we will provide support (i.e., training, answering questions via phone or scheduled meetings) for the individual visits and assistance (i.e., staff presence at group sessions to monitor adherence to the We Can!
protocol and answer questions) but will not serve as interventionists. Thus, we aim to address concerns regarding treatment integrity although this should be considered when interpreting the findings.
In addition to incorporating the latest evidence based tools recommended by the NIH and AAP as well as other organizations, the current study utilizes parents as the target of change. Parents have been recognized as influential in the development of eating and physical activity patterns [71
] and parental involvement has been recommended as a component of treatment of child overweight and obesity [16
]. A Cochrane systematic review of childhood overweight treatment interventions last updated in May 2004 examined 18 randomized controlled trials with a total of 975 participants [73
]. Among their conclusions the authors stated that “there may be some additional benefit to behavior therapy when the parents, rather than the child, are given the primary responsibility for behavior change.” The intervention that we propose to test in this study is based on a behavioral approach in which the parent, rather than the child, is given the primary responsibility for behavior change. Exclusively targeting the parent contributes to the applicability to the primary care setting, a venue in which parent education and anticipatory guidance are delivered regularly. Because this approach limits direct intervention with children, it may limit children’s perception of being “an overweight patient” and result in fewer potentially adverse psychological effects as well as less resistance. Recent studies also suggest a parent only intervention may be cost-effective in treating child overweight and obesity [18
]. However, this parent-mediated approach needs to be tested in the primary care setting.
Participants for the current study will be recruited from the Southern United States, specifically Southern Appalachia. Our study population is of lower socioeconomic status than those in previous studies and resides within the Appalachian region of the Southeastern United States, an area with high rates of overweight in which few studies have been conducted. Among all states, Tennessee, which is the proposed location for the current study, has the 5th
highest rate in adult overweight and 2nd
highest rate of overweight among high school students [74
]. Thus, our study will make valuable progress in determining not only the utility and feasibility of overweight interventions in primary care but also with attention to a population with health disparities.
In summary, the primary care setting is an ideal venue in which to reach a large number of children and their families and a well-positioned setting to identify those in need of lifestyle interventions. If successful, this pilot project utilizing the partnership of primary care providers with parents and the use of brief intervention techniques and the latest recommended NIH and AAP tools can provide evidence for a practical and powerful approach toward reducing child overweight even among high risk populations. Being that PLAN is a family based approach the project may also increase parent’s knowledge of nutrition and physical activity and contribute to healthy lifestyle changes in parents thus having potential far reaching effects. The current report provides information to facilitate replication in different patient populations and larger-scale trials as well as evidence based assessment and intervention practice in the clinical setting.