Department of Medicine, Division of General Internal Medicine and Clinical Innovation, New York University School of Medicine, 550 1st Avenue, New York, NY 10016, USA.
Department of Family and Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461, USA.
Contemp Clin Trials. 2019 Aug;83:37-45. doi: 10.1016/j.cct.2019.06.005. Epub 2019 Jun 20.
Over one-third of American adults have obesity with increased risk of chronic disease. Primary care providers often do not counsel patients about weight management due to barriers such as lack of time and training. To address this problem, we developed a technology-assisted health coaching intervention called Goals for Eating and Moving (GEM) to facilitate obesity counseling within the patient-centered medical home (PCMH) model of primary care. The objective of this paper is to describe the rationale and design of a cluster-randomized controlled trial to test the GEM intervention when compared to Enhanced Usual Care (EUC).
We have randomized 19 PCMH teams from two NYC healthcare systems (VA New York Harbor Healthcare System and Montefiore Medical Group practices) to either the GEM intervention or EUC. Eligible participants are English and Spanish-speaking primary care patients (ages 18-69 years) with obesity or who are overweight with comorbidity (e.g., arthritis, sleep apnea, hypertension). The GEM intervention consists of a tablet-delivered goal setting tool, a health coaching visit and twelve telephone calls for patients, and provider counseling training. Patients in the EUC arm receive health education materials. The primary outcome is mean weight loss at 1 year. Secondary outcomes include changes in waist circumference, diet, and physical activity. We will also examine the impact of GEM on obesity-related provider counseling competency and attitudes.
If GEM is found to be efficacious, it could provide a structured approach for improving weight management for diverse primary care patient populations with elevated cardiovascular disease risk.
超过三分之一的美国成年人肥胖，患慢性病的风险增加。由于缺乏时间和培训等障碍，初级保健提供者通常不会就体重管理问题向患者提供咨询。为了解决这个问题，我们开发了一种名为“饮食和运动目标”（GEM）的技术辅助健康辅导干预措施，以便在以患者为中心的医疗之家（PCMH）模式的初级保健中促进肥胖咨询。本文的目的是描述一项群组随机对照试验的基本原理和设计，以测试 GEM 干预措施与增强常规护理（EUC）相比的效果。
我们已将来自两个纽约市医疗系统（VA 纽约港医疗保健系统和蒙特菲奥雷医学集团的实践）的 19 个 PCMH 团队随机分为 GEM 干预组或 EUC 组。合格的参与者为讲英语和西班牙语的初级保健患者（年龄 18-69 岁），患有肥胖症或超重合并有并发症（例如关节炎、睡眠呼吸暂停、高血压）。GEM 干预包括一个基于平板电脑的目标设定工具、一次健康辅导访问和 12 次针对患者的电话随访，以及对提供者的咨询培训。EUC 组的患者接受健康教育材料。主要结果是 1 年内的平均体重减轻量。次要结果包括腰围、饮食和身体活动的变化。我们还将研究 GEM 对肥胖相关提供者咨询能力和态度的影响。
如果 GEM 被证明有效，它可以为改善具有较高心血管疾病风险的不同初级保健患者群体的体重管理提供一种结构化方法。
