Treatment of Early Childhood Overweight in Primary Care: Pilot Study

描述(申请人提供)：基于家庭的行为矫正(FBM)是治疗儿童超重的“首选疗法”。作为一个全面的一揽子计划，FBM包括一套核心的干预策略(父母技能培训；减少久坐行为和增加体力活动；减少能量密集型和增加营养密集型食物)。FBM也有坚实的理论基础，这使得它能够得到严格的评估。尽管有这些结论，FBM向初级保健的转变几乎没有收到任何调查。FBM几乎只在大学诊所实施，由训练有素的临床研究人员实施，有动力的家庭可以进入诊所。这一模式并没有普及到人口中的绝大多数超重儿童，特别是那些生活在农村社区的儿童。因此，有必要进行“转化性”研究，使FBM适应现有临床工作人员以成本效益的方式实施，并为工作人员和患者所接受。为此，我们建议在盖辛格社区实践网络内进行一项规划、试点和可行性干预研究。盖辛格是一个全面的医疗保健网络，为宾夕法尼亚州中部38个县的250多万个家庭提供服务，其中许多人居住在农村和服务不足的社区。拟议的试点研究是一项两组随机临床试验，将在盖辛格网络内的初级保健诊所进行。参与者将是60名超重或有超重风险的儿童，4至8岁，以及一名照顾者，他们将被随机分为两种情况之一：基于家庭的行为矫正(FBM；N=30)或最低营养信息(MNI；N=30)。FBM将包括简化的家长和儿童小组会议，为初级保健量身定做，并由工作人员、护士和儿科医生实施。MNI将包括营养讲义和传单。主要结果指标将是儿童体重状况、饮食和体力活动、心血管结果(用于效果大小估计)的4个月变化，以及家庭和初级保健人员对治疗可接受性的衡量。这项试点研究将为宾夕法尼亚大学和盖辛格研究人员提供必要的时间、资源和试点数据，以利用R18资助机制在盖辛格初级保健网络中规划一项更大规模的干预研究。

DESCRIPTION (provided by applicant): Family-based behavioral modification (FBM) is the "treatement of choice" for pediatric overweight. A comprehensive package, FBM includes a core set of intervention strategies (parents skills training; reduced sedentary behavior and increased physical activity; and reduced energy-dense and increased nutrient-dense foods). FBM also has strong theoretical foundations, which has allowed it to be rigorously evaluated. Despite these conclusions, the translation of FBM to primary care has received almost no investigation. FBM has been implemented almost exclusively in university-based clinics, by highly-trained clinical researchers, with motivated families having access to the clinic. This model does not reach the vast majority of overweight children in the popuation, especially those living in rural communities. Thus, there is a need for "translational" studies that adapt FBM for implementation by existing clinical staff in a cost-effective manner manner, that is well accepted by staff and patients. To this end, we propose a planning, pilot and feasibility intervention study that will be conducted within Geisinger Community Practice network. Geisinger is a comprehensive health care network that serves more than 2.5 million families across 38 counties of central Pennslyvania, many of whom reside in rural and underserved communities. The proposed pilot study, a 2-group randomized clinical trial, will be conducted out of a primary care clinic within the Geisinger network. Participants will be 60 oveweight or at-risk for overweight children, 4 to 8 years old, and a caregiver, who will be randomized to one of two conditions: Family-based Behavioral Modification (FBM; N= 30) or Minimal Nutrition Information (MNI; N=30). FBM will consist of streamlined parent- and child-group meetings, tailored for primary care and implimented by the staff nurse and pediatrician. MNI will consist of nutritional handouts and fliers. Primary outcomes measures will be 4-month changes in child weight status, diet and physical activity, and cardiovascular outcomes (for effect size estimation), and measures of treatment acceptability by families and primary care staff. This pilot study will provide Penn and Geisinger investigators the time, resources, and pilot data necessary to map out a larger- scale intervention study across the Geisinger primary care nework, using the R18 funding mechanism.