Pennington Biomedical Research Center, Baton Rouge, LA, United States.
Pennington Biomedical Research Center, Baton Rouge, LA, United States.
Contemp Clin Trials. 2018 Apr;67:1-10. doi: 10.1016/j.cct.2018.02.002. Epub 2018 Feb 8.
Underserved and minority populations suffer from a disproportionately high prevalence of obesity and related comorbidities. Effective obesity treatment programs delivered in primary care that produce significant weight loss are currently lacking. The purpose of this trial is to test the effectiveness of a pragmatic, high intensity lifestyle-based obesity treatment program delivered within primary care among an underserved population. We hypothesize that, relative to patients who receive usual care, patients who receive a high-intensity, health literacy- and culturally-appropriate lifestyle intervention will have greater percent reductions in body weight over 24 months. Eighteen clinics (N = 803 patients) serving low income populations with a high proportion of African Americans in Louisiana were randomized to the intervention or usual car. Patients in the intervention participate in a high-intensity lifestyle program delivered by health coaches employed by an academic health center and embedded in the primary care clinics. The program consists of weekly (16 in-person/6 telephone) sessions in the first six months, followed by sessions held at least monthly for the remaining 18 months. Primary care practitioners in usual care receive information on weight management and the current Centers for Medicare and Medicaid Services reimbursement for obesity treatment. The primary outcome is percent weight loss at 24 months. Secondary outcomes include absolute 24-month changes in body weight, waist circumference, blood pressure, fasting glucose and lipids, health-related quality of life, and weight-related quality of life. The results will provide evidence on the effectiveness of implementing high-intensity lifestyle and obesity counseling in primary care settings among underserved populations.
ClinicalTrials.gov Identifier NCT02561221.
目的：本试验旨在检验在初级保健中实施基于生活方式的高强度肥胖治疗方案对服务不足人群的有效性。我们假设，与接受常规护理的患者相比，接受高强度、注重健康素养和文化适宜性的生活方式干预的患者在 24 个月内体重减轻的百分比更大。
方法：路易斯安那州的 18 家诊所（服务于低收入人群，其中非裔美国人比例较高，共 803 名患者）被随机分为干预组和常规护理组。干预组的患者参加由学术医疗中心雇佣的健康教练在初级保健诊所中实施的高强度生活方式项目。该方案在前 6 个月内每周进行 16 次面对面咨询和 6 次电话咨询，之后在剩余的 18 个月内至少每月进行一次咨询。常规护理组的初级保健医生会获得有关体重管理和当前医疗保险和医疗补助服务中心对肥胖治疗的报销信息。主要结局指标为 24 个月时的体重减轻百分比。次要结局指标包括体重、腰围、血压、空腹血糖和血脂的 24 个月绝对变化、健康相关生活质量和体重相关生活质量。
结果：该研究结果将为在服务不足人群的初级保健环境中实施高强度生活方式和肥胖咨询提供有效性证据。
结论：这项研究将评估一种高强度生活方式干预措施在初级保健环境中对服务不足和少数民族人群肥胖和相关合并症的影响。
