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

地中海饮食模式减肥干预初级保健实践的随机解释性试验

基本信息

批准号：
10890282
负责人：
THOMAS C KEYSERLING
金额：
$ 11.3万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-06-01 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10890282
关键词：
Address Adopted African American African American population American Behavior Therapy Behavior assessment Behavioral Blood Pressure Body Weight Body Weight decreased Body mass index Carbohydrates Cardiovascular Diseases Carotenoids Chronic Disease Clinic Clinical Clinical Trials Cognitive Communities Consumption Control Groups Data Diabetes Mellitus Diet Dietary Fiber Dietary Intervention Dietary Practices Eating Effectiveness Effectiveness of Interventions Enrollment Event Fatty acid glycerol esters Female Food Foundations Fruit Goals Health Health Benefit Health Care Costs Informal Social Control Intake Intervention Life Style Low income Maintenance Measures Mediterranean Diet Meta-Analysis Minority Groups Modification Monitor Motivation North Carolina Obesity Obesity Epidemic Observational Study Online Systems Outcome Palate Participant Patient Self-Report Patients Pattern Phase Physiological Population Premature Mortality Primary Care Printing Process Process Assessment Psychosocial Factor Quality of life Randomized Randomized, Controlled Trials Recommendation Research Research Project Grants Retraction of Publication Risk Factors Sampling Self Efficacy Site Skin Southeastern United States Specific qualifier value Subgroup Testing United States United States Preventative Services Task Force Vegetable Oils Vegetables Weight Weight Gain adult obesity cancer prevention cardiovascular disorder risk community setting comorbidity cost cost per quality-adjusted life year economic outcome effectiveness evaluation efficacy evaluation experience follow-up group intervention health inequalities high risk implementation cost implementation evaluation improved incremental cost-effectiveness inflammatory marker intervention delivery male minority patient mortality obese patients obesity management preference primary care clinician primary care patient primary care practice primary care setting primary outcome psychosocial randomized trial secondary outcome skills statistics treatment as usual weight loss intervention weight loss program

项目摘要

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.

抽象的美国的肥胖流行仍几乎没有减弱，关于越来越令人震惊的统计数据其他慢性疾病的平行增加以及医疗保健成本的增加。美国预防服务工作队（USPSTF）建议对初级保健患者进行筛查以进行对象并且那些体重指数（BMI）≥30kg/m2的人会接受密集的多组分行为减肥干预。但是，在初级保健中实施的减肥干预措施的有效性设置受到限制，最近的荟萃分析显示2年后仅显示适度的体重减轻（1.2 kg）。此外，在美国先前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了地中海（MED）饮食的健康益处，观察和临床试验数据支持这种饮食模式的健康益处，包括慷慨消耗高质量的脂肪和碳水合物。积极的健康结果包括减少CVD事件最近的数据表明，预防癌症，认知健康和全因死亡率有益。许多人有提出了一个问题，是否可以在美国遵循MedSyle饮食（美国口味可以接受），特别是在低收入和少数族裔中，CVD的比例过高。我们的研究团队已将Med Style饮食适应了东南的文化喜好（“ Med-South 饮食”），这种饮食模式在低收入，初级少数族裔中实现了高水平的可接受性人群。在一项评估Med-South饮食干预措施的大量前研究中，我们看到了显着的体重患有糖尿病的参与者的损失（2年的初始体重的3.6％）。缺少的是爆炸性（功效）随机试验测试基于初级保健的减肥干预措施是否强调健康饮食模式（Med-South）可以长期体重减轻并改善CVD风险概况。这，我们提出了一项随机试验，以评估基于诊所的减肥干预措施，以促进医学饮食模式。它将在代表潜水员的5个初级保健站点（n = 350名参与者）上进行患者和环境的范围。 BMI≥30kg/m2的患者将被招募并随机分配给干预或增强通常的护理。为了确保足够的亚组表示，样本的40％将患有糖尿病，≥40％将是男性，≥40％将是非裔美国人。干预措施将在3中进行研究人员在24个月内进行了24个月的阶段：第一阶段（4个月）的重点是采用MED型饮食模式；体重减轻的第二阶段（8个月）；和第三阶段（12个月）的减肥维持。结果将是评估为4、12和24个月。主要结果是在24个月时减肥。次要结果包括改变生理，行为和社会心理措施。我们还将评估实施成本和干预措施相对于增强常规护理组的增量成本效益。