Department of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Suite 210, Durham, NC, 27701, USA.
Duke Clinical Research Institute, Durham, NC, USA.
Implement Sci. 2023 Feb 24;18(1):6. doi: 10.1186/s13012-023-01264-5.
Safe and effective treatment exists for childhood obesity, but treatment recommendations have largely not been translated into practice, particularly among racial and ethnic minorities and low-wealth populations. A key gap is meeting the recommended treatment of ≥26 h of lifestyle modification over 6-12 months. Fit Together is an effective treatment model that meets these recommendations by integrating healthcare and community resources. Pediatric providers screen children for obesity, deliver counseling, and treat co-morbidities, while Parks and Recreation partners provide recreation space for a community nutrition and physical activity program.
This study will use a hybrid type II implementation-effectiveness design to evaluate the effectiveness of an online implementation platform (the Playbook) for delivering Fit Together. Clinical and community partners in two North Carolina communities will implement Fit Together, using the Playbook, an implementation package designed to facilitate new partnerships, guide training activities, and provide curricular materials needed to implement Fit Together. An interrupted time series design anchored in the Process Redesign Framework will be used to evaluate implementation and effectiveness outcomes in intervention sites. Implementation measures include semi-structured interviews with partners, before and after the implementation of Fit Together, and quantitative measures assessing several constructs within the Process Redesign Framework. The participants will be children 6-11 years old with obesity and their families (n=400). Effectiveness outcomes include a change in child body mass index and physical activity from baseline to 6 and 12 months, as compared with children receiving usual care. Findings will be used to inform the design of a dissemination strategy guided by the PCORI Dissemination Framework.
This project addresses the knowledge-to-action gap by developing evidence-based implementation tools that allow clinicians and communities to deliver effective pediatric obesity treatment recommendations. Future dissemination of these tools will allow more children who have obesity and their families to have access to effective, evidence-based care in diverse communities.
ClinicalTrials.gov identifier: NCT05455190 . Registered on 13 July 2022.
儿童肥胖症已有安全有效的治疗方法，但这些治疗建议在很大程度上并未转化为实践，尤其是在少数族裔和贫困人群中。一个关键的差距是无法达到建议的治疗时长（6-12 个月内，每周进行 26 小时或以上的生活方式改变）。Fit Together 是一种有效的治疗模式，通过整合医疗保健和社区资源来满足这些建议。儿科医生对儿童进行肥胖筛查、提供咨询，并治疗合并症，而公园和娱乐合作伙伴则为社区营养和体育活动项目提供娱乐空间。
本研究将采用混合式 II 型实施-有效性设计来评估在线实施平台（Playbook）在提供 Fit Together 方面的有效性。北卡罗来纳州的两个社区的临床和社区合作伙伴将使用 Playbook 实施 Fit Together，Playbook 是一个实施工具包，旨在促进新的合作关系、指导培训活动，并提供实施 Fit Together 所需的课程材料。基于流程再造框架的中断时间序列设计将用于评估干预点的实施和有效性结果。实施措施包括在实施 Fit Together 之前和之后对合作伙伴进行半结构化访谈，以及评估流程再造框架内几个结构的定量措施。参与者将是肥胖症 6-11 岁的儿童及其家庭（n=400）。有效性结果包括从基线到 6 个月和 12 个月时儿童体重指数和身体活动的变化，与接受常规护理的儿童相比。研究结果将用于为基于 PCORI 传播框架的传播策略提供信息。
该项目通过开发基于证据的实施工具来解决从知识到行动的差距，使临床医生和社区能够提供有效的儿科肥胖治疗建议。未来这些工具的传播将使更多患有肥胖症的儿童及其家庭能够在不同的社区获得有效的、基于证据的护理。
ClinicalTrials.gov 标识符：NCT05455190。注册于 2022 年 7 月 13 日。
