Treatment of Early Childhood Overweight in Primary Care: Pilot Study

描述（由申请人提供）：基于家庭的行为矫正（FBM）是儿科超重的“首选治疗方法”。FBM是一个全面的一揽子计划，包括一套核心干预策略（父母技能培训；减少久坐行为和增加体育活动；减少能量密集和增加营养密集的食物）。FBM还具有强大的理论基础，这使得它能够被严格地评估。尽管有这些结论，但将FBM转化为初级保健几乎没有任何调查。FBM几乎只在以大学为基础的诊所实施，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。这一模式并没有覆盖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”研究，使现有临床工作人员以具有成本效益的方式实施FBM，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规划、试点和可行性干预研究。Geisinger是一个综合性的医疗保健网络，为宾夕法尼亚州中部38个县的250多万家庭提供服务，其中许多家庭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Geisinger网络内的一家初级保健诊所进行。参与者将是60名超重或有超重风险的儿童，4至8岁，以及一名护理人员，他们将被随机分为两种情况：基于家庭的行为矫正（FBM； N=30）或最低营养信息（MNI； N=30）。FBM将包括精简的家长和儿童小组会议，为初级保健量身定制，并由工作人员护士和儿科医生执行。MNI将包括营养救济品和传单。主要结局指标将是4个月儿童体重状况、饮食和身体活动、心血管结局（用于效应量估计）的变化，以及家庭和初级保健人员对治疗可接受性的指标。这项试点研究将为宾大和盖辛格研究人员提供必要的时间、资源和试点数据，以便利用R18资助机制，在盖辛格初级保健网络中制定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.