Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices

摘要 肥胖症在美国的流行几乎有增无减，越来越令人震惊的统计数据显示 其他慢性病的同时增加以及由此导致的医疗费用的增加。美国 预防服务工作组(USPSTF)建议对初级保健患者进行肥胖筛查 那些体重指数(BMI)为30公斤/平方米的人接受了密集的、多成分的行为 减肥干预。然而，在初级保健中实施减肥干预措施的有效性 环境一直受到限制，最近的一项荟萃分析显示，两年后体重仅略有下降(1.2公斤)。 此外，之前在美国研究的减肥干预措施基本上未能改善 心血管疾病(CVD)事件发生率或总死亡率。 越来越多的证据表明地中海(地中海)饮食对健康有好处， 观察性和临床试验数据支持这种饮食模式的健康益处，包括 摄入高质量的脂肪和碳水化合物。积极的健康结果包括心血管疾病事件的减少 最近的数据表明，这对癌症预防、认知健康和全因死亡率都有好处。许多人都有 提出了在美国是否可以遵循地中海式饮食的问题(是否可以被美国人接受)， 特别是在低收入和少数群体中，他们的心血管疾病发病率高得不成比例。 我们的研究团队调整了一种中式饮食，以适应东南部(中南部)的文化偏好 饮食“)，这种饮食模式在低收入者，主要是少数人中实现了很高的可接受性 人口。在一项评估中南饮食干预的大型前期研究中，我们发现体重显著增加 糖尿病患者的体重下降(两年后为初始体重的3.6%)。缺少的是一份解释性说明 (有效性)随机试验测试以初级保健为基础的减肥干预是否强调 健康的饮食模式(中南部)可以带来长期的体重减轻和改善的心血管疾病风险概况。 因此，我们建议进行一项随机试验，以评估以临床为基础的减肥干预措施，以促进MED- 风格饮食模式。它将在5个初级保健地点(n=350名参与者)进行，代表不同的 病人和环境的范围。体重指数≥为30公斤/平方米的患者将被纳入并随机分配到 干预或加强日常护理。为了确保足够的子组代表性，样本的40%的≥将 患有糖尿病，≥将有40%是男性，≥将有40%是非裔美国人。干预措施将在3月内交付 研究人员在24个月内分阶段进行：第一阶段(4个月)侧重于采用中式饮食模式； 第二阶段(8个月)关于减肥；第三阶段(12个月)关于减肥维持。结果将是 分别在4个月、12个月和24个月进行评估。主要结果是在24个月时体重减轻。次要结果 包括生理、行为和心理社会措施的改变。我们还将评估实施情况 成本和干预相对于加强的常规护理组的增量成本-效果。

ABSTRACT The obesity epidemic in the US continues nearly unabated, with increasingly alarming statistics regarding the parallel rise in other chronic diseases and the resulting increase in healthcare costs. The United States Preventive Services Task Force (USPSTF) recommends that primary care patients be screened for obesity and that those with a body mass index (BMI) ≥30 kg/m2 receive an intensive, multicomponent behavioral weight loss intervention. However, the effectiveness of weight loss interventions implemented in primary care settings has been limited, with a recent meta-analysis showing only modest weight loss (1.2 kg) after 2 years. In addition, previously studied weight loss interventions in the US have largely failed to improve cardiovascular disease (CVD) event rates or total mortality. A growing body of evidence points to the health benefits of the Mediterranean (Med) diet, with strong observational and clinical trial data supporting the health benefits of this dietary pattern that includes generous consumption of high-quality fats and carbohydrates. Positive health outcomes include reduced CVD events and recent data suggests benefits for cancer prevention, cognitive health, and all-cause mortality. Many have raised the question whether a Med-style diet can be followed in the US (be acceptable to the American palate), particularly among low-income and minority populations who experience disproportionally high rates of CVD. Our research team has adapted a Med-style diet to the cultural preferences of the Southeast (“Med-South diet”) and this dietary pattern has achieved high levels of acceptability in low-income, primarily minority populations. In a large pre-post study evaluating the Med-South dietary intervention, we saw significant weight loss (3.6% of initial weight at 2 years) among participants with diabetes. What is missing is an explanatory (efficacy) randomized trial testing whether a primary care-based weight loss intervention emphasizing a healthful eating pattern (Med-South) can yield long-term weight loss and improved CVD risk profiles. Thus, we propose a randomized trial to assess a clinic-based, weight loss intervention promoting a Med- style dietary pattern. It will be conducted at 5 primary care sites (n=350 participants) representing a diverse spectrum of patients and settings. Patients with a BMI ≥ 30 kg/m2 will be enrolled and randomized to intervention or augmented usual care. To assure adequate subgroup representation, ≥ 40% of the sample will have diabetes, ≥ 40% will be male, and ≥ 40% will be African American. The intervention will be delivered in 3 phases over 24 months by research staff: Phase I (4 months) focuses on adopting a Med-style dietary pattern; Phase II (8 months) on weight loss; and Phase III (12 months) on weight loss maintenance. Outcomes will be assessed at 4, 12, and 24 months. The primary outcome is weight loss at 24 months. Secondary outcomes include change in physiologic, behavioral, and psychosocial measures. We will also assess implementation cost and the incremental cost-effectiveness of the intervention relative to the augmented usual care group.