RCT on comanagement of obesity, depression, and elevated CVD risk in primary care

关于初级保健中肥胖、抑郁和心血管疾病风险升高共同管理的随机对照试验

• 批准号: 9038180
• 负责人: Jun Ma
• 金额: $ 72.68万
• 依托单位: PALO ALTO MEDICAL FOUNDATION RES INST
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-05-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9038180
• 关键词: 18 year old; Address; Adoption; Adult; Affect; Aftercare; Antidepressive Agents; Behavior Therapy; Behavioral; Body Weight decreased; Body mass index; Cardiovascular Diseases; Caring; Chronic; Clinic; Clinical; Clinical effectiveness; Combined Modality Therapy; Communities; Comorbidity; Complement; Consent; Consult; Consultations; Cost Effectiveness Analysis; Cost Savings; Data; Depressed mood; Diabetes Mellitus; Diet; Disease remission; Dose; Early-life trauma; Effectiveness; Effectiveness of Interventions; Electronic Mail; Equilibrium; Evaluation; Feedback; Glucose; Goals; Group Homes; Group Practice; Health; Health system; Heart Diseases; Home environment; Hybrids; Hyperphagia; Individual; Internet; Intervention; Intervention Studies; Interview; Lead; Life Style; Lipids; Maintenance; Mediating; Mediator of activation protein; Medical; Mental Depression; Metabolic syndrome; Methods; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Office Visits; Outcome; Participant; Patient Participation Rates; Patient-Centered Care; Patients; Perception; Pharmaceutical Preparations; Physical activity; Policy Maker; Practice Guidelines; Prevalence; Primary Health Care; Primary Prevention; Process; Protocols documentation; Provider; Psychiatrist; Public Health; Quality-Adjusted Life Years; Questionnaires; Randomized; Recommendation; Recording of previous events; Recruitment Activity; Research; Risk Factors; Secure; Shapes; Stress; Structure; Supervision; Surveys; Symptoms; Target Populations; Technology; Testing; Time; Training; Translating; Use Effectiveness; Woman; Work; base; behavior change; cardiometabolic risk; cardiovascular disorder risk; care delivery; clinically significant; computerized data processing; cost; cost effectiveness; depressed patient; depressive symptoms; design; diabetes prevention program; effective therapy; evidence base; follow-up; group intervention; health information technology; health related quality of life; health training; high risk; improved; innovation; intervention effect; lifestyle intervention; lifetime risk; men; novel; obesity management; patient population; primary care setting; problem solving therapy; programs; provider intervention; response; routine practice; sex; treatment as usual

DESCRIPTION (provided by applicant): Patients with coexisting obesity and depression and common cardiometabolic risk factors are a critical target group for primary prevention because of their increasing prevalence and increased, but potentially reversible, lifetime risk for diabete mellitus (DM) and cardiovascular disease. But little is known about how to treat them in concert in ways that are evidence-based and practical in primary care settings. The proposed study will test, for the first time, a clinical intervention that uniquely integrates the Group Lifestyle Balace (GLB) program for weight loss, which is a "real-world" translated model of the Diabetes Prevention Program lifestyle intervention, with the PEARLS collaborative stepped care program for depression, which uses problem-solving therapy (PST) as first-line with as-needed intensification through stepwise increases in doses and number of antidepressant medications. Obese, depressed adults with coexisting metabolic syndrome, pre- DM, and/or history of gestational DM will be the target patient population. Eligible and consenting primary care patients (n=404) from a large, community-based, multispecialty group practice will be randomized to receive the combined treatment or usual care for 12 months. Trained health coaches, working under co-located psychiatric and medical supervision, will provide 8 1-on-1 PST sessions over 5 months followed by 6 monthly calls. At the 4th 1-on-1 session, the coach will introduce the take-home GLB DVD, which has 12 weekly sessions and is supplemented by ongoing Web-, mobile- and email-mediated coach support for weight loss and behavior change. Following a stepped-care protocol, the supervising psychiatrist will recommend initiating or adjusting anti- depressant medications to primary providers of patients with unremitting symptoms, and if necessary, provide phone consultations to patients. Follow-up assessments will occur at 6, 12, 18, and 24 months. The primary aim is to determine the effectiveness of the intervention ("E" in the RE-AIM model). We hypothesize (1) that compared with controls, intervention participants will have better co-primary endpoints, i.e., lower mean BMI and score on the 20-item Depression Symptom Checklist at 12 months (end of treatment); (2) that these incremental intervention benefits will persist through 24 months (end of follow-up); and (3) that the intervention will show cost-effectiveness within 2 years and over a projected longer term, based on the ratio of incremental costs (estimated from health system and societal perspectives) to incremental benefits (expressed as quality-adjusted life years gained). The secondary aim is to conduct process evaluation with mixed methods for the other RE-AIM attributes: Reach (e.g., participation rate of the target population), Adoption (e.g., characteristcs of participating clinics and providers), Implementation (e.g., fidelity of intervention delivery), nd Maintenance (e.g., stakeholders' perceptions of intervention sustainability). We will also explore effect modifiers and mediators to enable intervention refinement for maximum impact. The proposed integrated multicondition approach to treating obesity and depression and cardiometabolic risk factors in primary care is novel and likely scalable, with high public health impact potential.

描述（由申请人提供）：同时存在肥胖和抑郁以及常见心脏代谢危险因素的患者是一级预防的关键目标群体，因为他们的患病率不断增加，并且糖尿病（DM）和心血管疾病的终生风险增加，但可能是可逆的。但对于如何在初级保健机构中以循证且实用的方式协同治疗它们，人们知之甚少。拟议的研究将首次测试一种临床干预措施，该干预措施独特地将团体生活方式平衡 (GLB) 减肥计划与 PEARLS 结合起来，该计划是糖尿病预防计划生活方式干预的“真实世界”翻译模型针对抑郁症的协作阶梯护理计划，该计划使用问题解决疗法（PST）作为一线，并通过逐步增加抗抑郁药物的剂量和数量来按需强化。患有代谢综合征、糖尿病前期和/或妊娠期糖尿病病史的肥胖、抑郁成年人将是目标患者群体。来自大型社区多专科团体诊所的合格且同意的初级保健患者 (n=404) 将被随机分配接受联合治疗或常规护理，为期 12 个月。训练有素的健康教练在同一地点的精神科和医疗监督下工作，将在 5 个月内提供 8 次一对一的 PST 课程，随后每月进行 6 次电话咨询。在第四次一对一课程中，教练将介绍带回家的 GLB DVD，该 DVD 每周有 12 次课程，并辅以持续的网络、移动和电子邮件介导的教练支持，以实现减肥和行为改变。按照阶梯式护理方案，主管精神科医生将向症状持续的患者的主要提供者建议启动或调整抗抑郁药物，并在必要时为患者提供电话咨询。后续评估将在 6、12、18 和 24 个月时进行。主要目的是确定干预措施的有效性（RE-AIM 模型中的“E”）。我们假设 (1) 与对照组相比，干预参与者将有更好的共同主要终点，即 12 个月（治疗结束）时平均 BMI 和 20 项抑郁症状检查表得分较低； (2) 这些增量干预益处将持续 24 个月（随访结束）； (3) 根据增量成本（从卫生系统和社会角度估计）与增量收益（表示为获得的质量调整生命年）之比，干预措施将在 2 年内和预计的较长时期内显示出成本效益）。第二个目标是使用混合方法对 RE-AIM 的其他属性进行过程评估：范围（例如，目标人群的参与率）、采用（例如，参与诊所和提供者的特征）、实施（例如，干预的保真度）交付）和维护（例如，利益相关者对干预可持续性的看法）。我们还将探索效果调节剂和调节剂，以实现干预细化以获得最大影响。拟议的在初级保健中治疗肥胖、抑郁和心脏代谢危险因素的综合多条件方法是新颖的，并且可能可扩展，具有很高的公共卫生影响潜力。