An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study).

An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study).
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DOI:
10.1186/s13012-017-0697-2
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发表时间:
2018-01-15
期刊:
Implementation science : IS
影响因子:
--
通讯作者:
Bruening MM
Bruening MM
中科院分区:
其他
文献类型:
--
作者:
Smith JD;Berkel C;Jordan N;Atkins DC;Narayanan SS;Gallo C;Grimm KJ;Dishion TJ;Mauricio AM;Rudo-Stern J;Meachum MK;Winslow E;Bruening MM

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儿童肥胖是一个多方面的公共卫生问题,可能导致心血管疾病、癌症和早期死亡。饮食、体力活动或体重指数的微小变化可以显着降低出现心脏代谢危险因素的可能性。基于家庭的行为干预是一种未得到充分利用的循证方法,已被发现可以显着预防儿童和青少年体重过度增加和肥胖。计划可用性差、参与率低和不遵守是取得积极成果的障碍。家庭功能低下、积极性低和对建议的遵守程度低,阻碍了初级保健中对儿童肥胖的有效干预。这项(II 型)混合有效性实施随机试验测试了 Family Check-Up 4 Health (FCU4Health) 计划,该计划旨在通过改善家庭管理实践和育儿技能来改变儿童的健康行为,以防止肥胖和体重过度增加。 FCU4Health 以评估为驱动,旨在定制服务并提高家长积极性。三个初级保健诊所(两个联邦合格医疗中心 (FQHC) 和一家儿童医院)将纳入 350 个有 6 至 12 岁儿童的家庭样本,这些儿童被确定为超重或肥胖(BMI ≥ 年龄和性别的第 85 个百分位)。所有诊所主要服务于医疗补助患者和大量少数民族人口,包括拉丁裔、非裔美国人和美洲印第安人,他们在肥胖、心脏代谢风险和获得护理方面面临着差异。 FCU4Health 将使用两种不同的交付策略与常规护理相协调:两个 FQHC 的嵌入式方法和医院诊所的转诊模式。为了评估计划的有效性(BMI、身体成分、儿童健康行为、养育和支持服务的利用)和实施结果(例如可接受性、采用性、可行性、适当性、保真度和成本等结果),我们采用多方法和多信息评估策略,包括电子健康记录数据、行为观察、问卷、访谈和成本捕获方法。这项研究有可能通过确定 FCU4Health 的有效性并收集对医疗保健决策者至关重要的信息来防止儿童体重过度增加、肥胖和健康差异,以支持初级保健中基于家庭的计划的可持续实施。 NCT03013309 ClinicalTrials.gov 本文的在线版本 (10.1186/s13012-017-0697-2) 包含补充材料,可供授权用户使用。
Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations. This (type II) hybrid effectiveness–implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children’s hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods. This study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care. NCT03013309 ClinicalTrials.gov The online version of this article (10.1186/s13012-017-0697-2) contains supplementary material, which is available to authorized users.
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