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，医学治疗往往不能充分控制这种疾病，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，特别是与饮食和身体活动有关的那些方面。据报道，自然疗法医生通过健康生活方式的咨询，让病人对自己的健康负责，从而成功地激励病人控制糖尿病和其他慢性疾病。尽管小型回顾性研究的结果表明自然疗法可能改善糖尿病的预后，但现实世界中整个系统（非协议化）自然疗法治疗改善糖尿病控制的潜力尚未得到前瞻性评估。这项前瞻性观察性研究将检查对2型糖尿病患者进行一年的辅助自然疗法治疗的效果，这些患者有自然疗法治疗的保险福利。所有年龄在21岁至65岁之间、患有2型糖尿病且血红蛋白A1c （HbA1c）值在7.5%至9.5%之间且未使用胰岛素的综合医疗保健系统成员将被确定，并随机抽样进行访谈并邀请参与。前30名同意参加的受访会员将接受辅助的自然疗法治疗糖尿病。同意参与的30人的特征（如临床和社会人口学测量，自然疗法的知识/观点）将与拒绝参与的人进行比较。自然疗法以生活方式/自我管理咨询（运动、饮食、压力管理、自我血糖监测）和植物和营养补充剂的建议为特色。在一年的时间里，允许在健康计划的签约自然疗法医生网络中最多访问8次有执照的自然疗法医生。临床结果的数据将从健康计划先进的自动化医疗记录系统中提取。在一年的治疗期间，将测量HbA1c（主要结局）、体重指数、血脂、血压和甘油三酯的变化。以患者为中心的结果（如糖尿病生活质量、感知压力、饮食和运动自我效能）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名参与者的样本量将提供超过90%的能力来检测平均HbA1c降低1.0个百分点。这项研究的设计和临床结果电子数据的可用性，将允许将30名参与者发现的任何改善与从参与者中抽样的整个符合研究条件的糖尿病患者人群的改善进行比较。如果这项观察性研究的结果是有希望的，将提出一项评估糖尿病自然疗法护理的随机对照试验。

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.