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Family Spirit Nurture (FSN) – a randomized controlled trial to prevent early childhood obesity in American Indian populations: trial rationale and study protocol

机译:家庭精神培育(FSN) - 一种随机对照试验,以防止美国印度人口的早期儿童肥胖:试验理论和研究议定书

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Childhood overweight and obesity is a persistent public health issue in the US. Risk for obesity and obesity-related morbidity throughout the life course begins in utero. Native Americans suffer the greatest disparities in the US in childhood overweight and obesity status of any racial or ethnic group. Existing early childhood home-visiting interventions provide an opportunity for addressing obesity during the first 1000?days. However, to date, no evidence-based model has been specifically designed to comprehensively target early childhood obesity prevention. This study is a randomized controlled trial to test the efficacy of home-visiting intervention, called Family Spirit Nurture, on reducing early childhood obesity in Native American children. Participants are expectant Native American mothers ages 14-24 and their child, enrolled from pregnancy to 24?months postpartum and randomized 1:1 to receive the Family Spirit Nurture intervention or a control condition. The intervention includes 36 lessons delivered one-on-one by locally-hired Native American Family Health Coaches to participating mothers from pregnancy until 18?months postpartum. A mixed methods assessment includes maternal self-reports, maternal and child observations, and physical and biological data collected at 11 time points from 32?weeks gestation to 2?years postpartum to measure the intervention's primary impact on maternal feeding behaviors; children's healthy diet and physical activity; children's weight status. Secondary measures include maternal psychosocial factors; household food and water security; infant sleep and temperament; and maternal and child metabolic status. None of the 20 current federally-endorsed home-visiting models have demonstrated impacts on preventing early childhood obesity. The original Family Spirit program, upon which Family Spirit Nurture is based, demonstrated effect on maternal and child behavioral health, not including obesity related risk factors. This trial has potential to inform the effectiveness of home-visiting intervention to reduce obesity risk for tribal communities and other vulnerable populations and expand public health solutions for the world's obesity crisis. Clinicaltrials.gov (Identifier: NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18?Months; Retrospectively registered on 07 November 2017).
机译:童年超重和肥胖是美国持续的公共卫生问题。肥胖和肥胖与肥胖相关的风险在整个生命课程中始于子宫。美洲原住民遭受美国童年超重和任何种族或族群的肥胖状态的最大差异。现有的幼儿期间家庭访问干预措施为在前1000 000期间提供了解决肥胖的机会。然而,迄今为止,没有基于证据的模型专门用于全面地瞄准早期儿童肥胖预防。本研究是一个随机对照试验,以测试家庭探访的疗效,称为家庭精神培育,减少美国原住民儿童的早期儿童肥胖。参与者是预期的美国原住民母亲年龄14-24岁及他们的孩子,从怀孕中注册到24个月?月产后和随机1:1接受家庭精神培养干预或控制条件。干预包括36个课程,通过当地聘请的美国原住民家庭健康教练一对一,将母亲从怀孕中参与18岁?月产后。混合方法评估包括母体自我报告,孕产妇和儿童观察,以及在11次妊娠的11个时间点收集的物理和生物数据到2年出妊娠,以衡量干预对母体喂养行为的主要影响;儿童健康的饮食和身体活动;儿童的体重状况。二级措施包括母体心理社会因素;家庭食品和水安全;婴儿睡眠和气质;和母婴代谢地位。 20当前的联邦批准的房主均未对预防幼儿肥胖的影响表现出来。家庭精神培育的原始家庭精神计划,效果对妇幼保健的影响,不包括肥胖相关的风险因素。本次审判有潜力可通知本土化干预的有效性,以减少部落社区和其他弱势群体的肥胖风险,并扩大世界肥胖危机的公共卫生解决方案。 ClinicalTrials.gov(标识符:NCT03334266 - 防止儿童早期肥胖,第2部分:家庭精神培育,产前 - 18?几个月;回顾在2017年11月7日07日)。

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