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）是儿童超重的“首选治疗方法”。 FBM 是一个综合性的一揽子计划，包括一套核心干预策略（父母技能培训；减少久坐行为并增加体力活动；以及减少能量密集型食品和增加营养密集型食品）。 FBM 还拥有坚实的理论基础，这使其能够得到严格的评估。尽管有这些结论，但将 FBM 转化为初级保健几乎没有受到任何调查。 FBM 几乎完全由训练有素的临床研究人员在大学诊所实施，有积极性的家庭也可以进入诊所。这种模式并没有惠及人口中的绝大多数超重儿童，尤其是生活在农村社区的儿童。因此，需要进行“转化”研究，使 FBM 适合现有临床工作人员以经济高效的方式实施，并得到工作人员和患者的广泛接受。为此，我们提出了一项规划、试点和可行性干预研究，该研究将在盖辛格社区实践网络内进行。 Geisinger 是一个综合性医疗保健网络，为宾夕法尼亚州中部 38 个县的超过 250 万个家庭提供服务，其中许多家庭居住在农村和服务欠缺的社区。拟议的试点研究是一项两组随机临床试验，将在 Geisinger 网络内的初级保健诊所进行。参与者将包括 60 名超重或有超重风险的 4 至 8 岁儿童和一名看护者，他们将被随机分配到以下两种情况之一：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，专为初级保健量身定制，并由护士和儿科医生实施。 MNI 将包括营养讲义和传单。主要结局指标将是儿童体重状况、饮食和体力活动以及心血管结局（用于效应大小估计）的 4 个月变化，以及家庭和初级保健人员的治疗可接受性指标。这项试点研究将为 Penn 和 Geisinger 的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 Geisinger 初级保健网络中开展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.