Design and participant characteristics of a primary care adaptation of the Look AHEAD Lifestyle Intervention for weight loss in type 2 diabetes: The updates REAL HEALTH-diabetes study
Design and participant characteristics of a primary care adaptation of the Look AHEAD Lifestyle Intervention for weight loss in type 2 diabetes: The updates REAL HEALTH-diabetes study
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DOI：
10.1016/j.cct.2018.05.018
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发表时间：
2018-08-01
影响因子：
2.2
通讯作者：
Wexler, Deborah J.
中科院分区：
文献类型：
--
作者：
Delahanty, Linda M.;Chang, Yuchiao;Wexler, Deborah J.
背景/目的：REAL健康-糖尿病研究是一项基于实践的临床试验，采用前瞻性生活方式干预措施在初级保健机构实施。该试验将比较面对面的群体生活方式干预、电话群体生活方式干预和个人医学营养治疗（MNT）的有效性和成本效益，MNT是目前推荐的2型糖尿病治疗标准。主要结果是6个月时体重减轻的百分比，同时也测量了12、18、24（干预完成）和36个月时的结果。在这里，我们描述了适应、试验设计、实施策略和入组参与者的基线特征。方法：该研究是一项三组、患者水平的随机试验，在三个社区卫生中心（CHCs）和一个隶属于一个学术医疗中心的糖尿病实践中进行。结果：该研究利用现有的临床基础设施从研究地点招募参与者。成功进行试验的策略包括与卫生中心临床医师合作，让初级保健提供者参与，以及适应临床工作流程。在248名参加筛查访问的符合条件的患者中，211名入组，其中70名随机分配到面对面组生活方式干预，72名进行电话组生活方式干预，69名进行MNT。该队列55%为女性，29%为非白人，平均年龄62岁，平均BMI为35 kg/m(2)。CHC站点的入学率较高。结论：基于实践的2型糖尿病复杂行为生活方式干预的随机试验可以在社区卫生和常规临床环境中实施。在当地CHC站点，参与者和提供者的参与度更高，反映了研究实施的重点。
Background/Aims: The REAL HEALTH -Diabetes Study is a practice-based clinical trial that adapted the Look AHEAD lifestyle intervention for implementation in primary care settings. The trial will compare the effectiveness and cost-effectiveness of in-person group lifestyle intervention, telephone group lifestyle intervention, and individual medical nutrition therapy (MNT), the current recommended standard of care in type 2 diabetes. The primary outcome is percent weight loss at 6 months with outcomes also measured at 12, 18, 24 (intervention completion), and 36 months. Here, we describe the adaptation, trial design, implementation strategies, and baseline characteristics of enrolled participants.Methods: The study is a three-arm, patient-level, randomized trial conducted in three community health centers (CHCs) and one diabetes practice affiliated with one academic medical center.Results: The study used existing clinical infrastructure to recruit participants from study sites. Strategies for successful conduct of the trial included partnering with health-center based co-investigator clinicians, engaging primary care providers, and accommodating clinical workflows. Of 248 eligible patients who attended a screening visit, 211 enrolled, with 70 randomly assigned to in-person group lifestyle intervention, 72 to telephone group lifestyle intervention, and 69 to MNT. The cohort was 55% female, 29% non-white, with mean age 62 years and mean BMI 35 kg/m(2). Enrollment rates were higher at CHC sites.Conclusions: A practice-based randomized trial of a complex behavioral lifestyle intervention for type 2 diabetes can be implemented in community health and usual clinical settings. Participant and provider engagement was higher at local CHC sites reflecting the study implementation focus.