Armstrong Sarah C, Windom McAllister, Bihlmeyer Nathan A, Li Jennifer S, Shah Svati H, Story Mary, Zucker Nancy, Kraus William E, Pagidipati Neha, Peterson Eric, Wong Charlene, Wiedemeier Manuela, Sibley Lauren, Berchuck Samuel I, Merrill Peter, Zizzi Alexandra, Sarria Charles, Dressman Holly K, Rawls John F, Skinner Asheley C
Department of Pediatrics, Duke University, Durham, NC, 27710, USA.
Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.
BMC Pediatr. 2020 Jun 26;20(1):308. doi: 10.1186/s12887-020-02190-x.
The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems.
Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification.
We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research-defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response.
NCT03339440 .
尽管数十年来一直致力于预防儿童和青少年肥胖及重度肥胖，但它们的患病率仍在持续上升。肥胖是心血管和代谢疾病风险的有力预测指标；这些疾病均始于儿童期。接受强化行为干预的儿童可以降低体重指数（BMI）并逆转疾病风险。然而，大规模地忠实实施这些干预措施仍然是一项挑战。诊所与社区的合作提供了一种有前景的策略，即在当地公园和娱乐场所提供高质量的临床护理并开展行为治疗。“心脏与公园”研究有三个主要目标：（1）评估诊所 - 社区模式治疗儿童肥胖的有效性；（2）确定肥胖及对生活方式改变的反应的微生物组和代谢组特征；（3）为临床系统中类似模式的实施提供信息。
本方法设计用于一项务实的随机对照临床试验（n = 270），以测试综合诊所 - 社区儿童肥胖干预措施与常规护理相比的有效性。我们有足够的样本量来检测6个月时两组之间体重指数（BMI）的差异，并随访至12个月。次要结局包括心血管疾病生物标志物、心理社会风险和生活质量的变化。通过收集生物标本（血清和粪便），额外的探索性结局包括对生活方式改变反应的微生物组和代谢组学生物标志物。
我们展示了一项随机临床试验的研究设计、入组策略和干预细节，以衡量诊所 - 社区儿童肥胖治疗干预措施的有效性。这项研究将为儿童肥胖和心血管风险研究中的一个关键领域提供信息——确定结局、实施可行性以及识别治疗反应的潜在分子机制。
NCT03339440 。
