Outcomes of Community Naturopathic Medical Care for Type 2 Diabetes

描述（由申请人提供）：糖尿病是美国最严重和最昂贵的慢性疾病之一，医学治疗往往无法充分控制这种疾病，有时会导致昂贵和灾难性的后果。有效护理的一个关键但具有挑战性的组成部分是激励糖尿病患者改变他们的生活方式，特别是与饮食和体育活动有关的方面。自然疗法医生已经成功地激励他们的病人控制糖尿病和其他慢性疾病，通过尝试让他们通过咨询健康的生活方式来对自己的健康负责。虽然小型回顾性研究的结果表明自然疗法护理可能会改善糖尿病的结局，但真实的世界整体系统（非协议化）自然疗法护理改善糖尿病控制的潜力尚未进行前瞻性评估。这项前瞻性观察性研究将检查一年连续自然疗法护理对2型糖尿病患者的影响，这些患者的保险福利包括自然疗法护理。将确定年龄在21岁至65岁之间、患有2型糖尿病且血红蛋白A1 c（HbA 1c）值在7.5%至9.5%之间且未使用胰岛素的综合医疗保健提供系统的所有成员，并将随机抽样进行访谈并邀请其参加。前30名同意参加的受访成员将接受连续的自然疗法治疗糖尿病。特征（例如，临床和社会人口统计学测量、自然疗法护理的知识/观点）将与那些拒绝参加的30人进行比较。自然疗法治疗将以生活方式/自我管理咨询（运动，饮食，压力管理，自我监测血糖）和植物和营养补充剂的建议为特色。在一年的时间内，将允许最多8次访问健康计划签约自然疗法医生网络中的持牌自然疗法医生。有关临床结果的数据将从健康计划的先进自动医疗记录系统中提取。将测量1年治疗期间HbA 1c（主要结局）和体重指数、血脂、血压和甘油三酯的变化。以患者为中心的结局（例如，糖尿病生活质量、感知压力、饮食和锻炼自我效能）以及对治疗建议的依从性将在6个月和12个月后通过电话访谈进行评估。30例受试者的样本量将提供超过90%的把握度，以检测平均HbA 1c降低1.0个百分点。本研究设计和临床结局电子数据的可用性将允许将30名参与者的任何改善与整个研究合格的糖尿病患者人群（参与者从中抽样）的任何改善进行比较。如果这项观察性研究的结果是有希望的，一个随机对照试验评估自然疗法护理糖尿病将被提出。

DESCRIPTION (provided by applicant): Diabetes is one of the most consequential and expensive chronic diseases in the U.S. Medical treatments often fail to adequately control this disease, sometimes resulting in costly and catastrophic outcomes later in life. A critical, but challenging, component of effective care is motivating persons with diabetes to change their lifestyles, particularly those aspects related to diet and physical activity. Naturopathic physicians have anecdotally reported successes in motivating their patients to control diabetes and other chronic conditions by trying to empower them to take responsibility for their health through counseling about healthy lifestyles. Although results of small retrospective studies suggest naturopathic care may improve diabetes outcomes, the potential for real world whole systems (non-protocolized) naturopathic care to improve control of diabetes has yet to be prospectively evaluated. This prospective observational study will examine the effect of one year of adjunctive naturopathic care for persons with type 2 diabetes who have an insurance benefit that covers naturopathic care. All members of an integrated health care delivery system between the ages of 21 and 65, who have type 2 diabetes with hemoglobin A1c (HbA1c) values between 7.5% and 9.5% and who are not using insulin will be identified and a random sample will be interviewed and invited to participate. The first 30 interviewed members who agree to participate will receive adjunctive naturopathic medical care for their diabetes. The characteristics (e.g., clinical and sociodemographic measures, knowledge/views of naturopathic care) of the 30 who agree to participate will be compared with those who decline. Naturopathic treatment will feature lifestyle/self-management counseling (exercise, diet, stress management, self-monitoring of blood glucose) and recommendations of botanical and nutritional supplements. Up to 8 visits over a one year period to licensed naturopathic physicians in the health plan's contracted naturopathic physician network will be allowed. Data on clinical outcomes will be extracted from the health plan's advanced automated medical records systems. Changes in HbA1c (primary outcome) and in body mass index, lipids, blood pressure and triglycerides over the one year treatment period will be measured. Patient-centered outcomes (e.g., diabetes quality of life, perceived stress, diet and exercise self-efficacy), and adherence to treatment recommendations will be assessed by telephone interviews after 6 and 12 months. A sample size of 30 participants will provide over 90% power to detect a 1.0 percentage point decrease in mean HbA1c. This study design and the availability of electronic data on clinical outcomes, will allow comparison of any improvements found for the 30 participants with those occurring for the entire study-eligible population of diabetes patients from which participants were sampled. If the results of this observational study are promising, a randomized controlled trial evaluating naturopathic care for diabetes will be proposed.