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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：
10683441
负责人：
THOMAS C KEYSERLING
金额：
$ 11.48万
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/10683441
关键词：
Address Adopted Advisory Committees African American African American population American Behavior Therapy 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 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 Care Patient Self-Report Patients Pattern Phase Physiological Population Premature Mortality Preventive service Primary Health Care Process Psychosocial Factor Quality of life Quality-Adjusted Life Years Randomized Randomized Controlled Trials Research Research Project Grants Risk Factors Sampling Self Efficacy Site Skin Southeastern United States Specific qualifier value Subgroup Testing United States Vegetable Oils Weight Weight Gain adult obesity base cancer prevention cardiovascular disorder risk community setting comorbidity cost economic outcome effectiveness evaluation experience follow-up fruits and vegetables 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 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.

摘要美国的肥胖流行病几乎有增无减，越来越令人担忧的统计数据显示，其他慢性疾病的平行上升以及由此导致的医疗保健费用的增加。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体重指数（BMI）≥30 kg/m2的受试者接受了强化的多成分行为干预，减肥干预。然而，在初级保健中实施的减肥干预措施的有效性最近的一项荟萃分析显示，2年后体重仅轻微减轻（1.2 kg）。此外，之前在美国研究的减肥干预措施在很大程度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饮食对健康有益，观察和临床试验数据支持这种饮食模式的健康益处，高质量的脂肪和碳水化合物的消费。积极的健康结果包括减少CVD事件最近的数据表明，它对癌症预防、认知健康和全因死亡率都有好处。许多人提出了一个问题，即地中海式饮食是否可以在美国遵循（美国人的口味可以接受），特别是在低收入和少数民族人群中，他们的心血管疾病发病率非常高。我们的研究团队已经根据东南部的文化偏好（“Med-South 这种饮食模式在低收入人群中，主要是少数民族，人口。在一项评估Med-South饮食干预的大型前后研究中，糖尿病患者的体重减轻（2年时为初始体重的3.6%）。缺少的是一种解释（疗效）随机试验测试是否以初级保健为基础的减肥干预，强调健康的饮食模式（Med-South）可以产生长期的体重减轻和改善CVD风险状况。因此，我们提出了一项随机试验，以评估一种基于临床的减肥干预措施，风格的饮食模式。将在5个初级保健中心（n=350名参与者）进行，代表不同的患者和环境的范围。BMI ≥ 30 kg/m2的患者将入组并随机分配至干预或加强常规护理。为确保充分的亚组代表性，将≥ 40%的样本糖尿病患者中，≥ 40%为男性，≥ 40%为非裔美国人。干预措施将在3 研究人员在24个月内分阶段进行：第一阶段（4个月）侧重于采用地中海式饮食模式; 第二阶段（8个月）体重减轻;第三阶段（12个月）体重减轻维持。成果将在4、12和24个月时进行评估。主要结局是24个月时的体重减轻。次要结局包括生理、行为和心理社会指标变化。我们还将评估执行情况成本和增量成本效益的干预相对于增强的日常护理组。