Duke Global Digital Health Science Center, Duke University, Campus Box 90086, Durham, NC, 27708-0086, USA.
Duke University School of Nursing, 307 Trent Drive, Pearson Room 2055, DUMC 3322, Durham, NC, 27708, USA.
BMC Public Health. 2019 May 17;19(1):596. doi: 10.1186/s12889-019-6926-7.
For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina.
Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network.
For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care.
NCT03003403 . Registered December 28, 2016.
对于那些尚未准备好或面临减肥障碍的肥胖患者，临床实践指南建议医生在为其提供治疗时将预防体重进一步增加作为一线治疗方法。然而，基于证据的体重预防干预措施在基层医疗中并不常见。为了解决这一差距，我们将在北卡罗来纳州中部的一个联邦合格社区卫生中心网络中为接受初级保健的患者实施一项为期 12 个月的实用随机对照试验，以评估一种数字体重预防干预措施。
“平衡”（西班牙语为“Equilibrio”）是一项实用效果试验，将随机分配超重或肥胖（BMI 为 25-40kg/m²）的成年患者至以下两组之一：1）体重预防干预组，包括个性化的行为改变目标和跟踪、在网络连接的电子秤上每天称重以及由卫生中心注册营养师远程提供的响应式体重和目标指导；2）常规护理组，包括自动健康生活短信和印刷材料以及常规初级保健。主要结局指标为 24 个月时的体重预防效果，定义为体重较基线的变化≤3%。为了与其实用设计保持一致，试验结果数据将从社区卫生中心网络的电子健康记录中提取。
对于肥胖且服务不足的患者，特别是居住在农村地区的患者，数字方法可以促进健康的生活方式，从而防止体重进一步增加。然而，招募身体脆弱的患者参加体重预防试验，尤其是那些来自少数民族的患者，可能会很困难。尽管存在这些潜在挑战，我们仍计划从农村地区招募大量的、多样化的样本，并为身体脆弱的患者实施远程体重预防干预措施。即将公布的试验结果将展示这种实用方法在基层医疗中实施和评估数字体重预防干预措施的有效性。
NCT03003403。于 2016 年 12 月 28 日注册。
