A Technology-based Intervention to Reduce Alcohol Use after Bariatric Surgery

减肥手术后减少饮酒的基于技术的干预措施

• 批准号: 10266807
• 负责人: Jordan Michel Braciszewski
• 金额: $ 21.63万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266807
• 关键词: Abstinence; Address; Adoption; Aftercare; Alcohol abuse; Alcohol consumption; Alcohols; Behavior; Behavioral; Blood alcohol level measurement; Body Weight decreased; Caring; Cellular Phone; Clinical Trials; Control Groups; Coping Skills; Data; Development; Ecological momentary assessment; Education; Enrollment; Ethanol Metabolism; Evidence based intervention; Feedback; Food; Freezing; Gastrectomy; Gastric Bypass; Goals; Grant; Guidelines; Hormones; Hour; Incidence; Individual; Intervention; Intervention Trial; Interview; Length; Low Prevalence; Mental Health; Metabolic hormone; Metabolism; Methods; Mission; Modeling; Morbid Obesity; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patient Preferences; Patients; Persons; Phase; Physiological; Pilot Projects; Plant Roots; Population; Population Intervention; Populations at Risk; Prevalence; Prevention; Procedures; Public Health; Questionnaires; Randomized; Readiness; Recommendation; Reporting; Research; Rewards; Risk; Surveys; System; Techniques; Technology; Testing; Text Messaging; Time; Treatment Efficacy; United States; United States National Institutes of Health; absorption; acceptability and feasibility; alcohol abstinence; alcohol effect; alcohol prevention; alcohol use disorder; alcohol use initiation; bariatric surgery; base; brief intervention; clinical practice; clinically significant; computerized; coping mechanism; cost; cost effective; deter alcohol use; disorder later incidence prevention; drinking; evidence base; experience; feasibility testing; food consumption; group intervention; hazard; hazardous drinking; innovation; mHealth; meetings; motivational enhancement therapy; novel; patient population; physical conditioning; post intervention; preference; prevent; preventive intervention; primary outcome; programs; psychoeducation; recruit; reduced alcohol use; response; retention rate; satisfaction; service delivery; skills; smoking cessation; substance use; surgical risk; therapy design; traditional therapy; treatment as usual; weight loss intervention

Despite bariatric surgery being the most effective weight loss intervention for patients who are severely obese, as many as 1 in 5 patients will develop an alcohol use disorder after their surgery. Changes in metabolism, hormone levels, and behavior as a result of bariatric surgery alter the rewarding effects of alcohol while concurrently changing its absorption rate, putting patients at significantly elevated risk of hazardous drinking. Simply providing education to this vulnerable patient population about post-surgical risks has not been sufficient to reduce alcohol use, yet comprehensive in-person interventions are met with significant challenges, including hours-long distances between patients and their bariatric surgery programs. Thus, our long-term goal is to increase access to an empirically-supported intervention for reducing alcohol use among patients who undergo bariatric surgery by leveraging technology. Our intervention, rooted in motivational interviewing and the transtheoretical model, is a two-session computerized brief intervention (CBI), supplemented by six months of tailored text messaging based on participants’ CBI results and subsequent fluctuations in their readiness to change. The purpose of the proposed study is to optimize this technology-based intervention for patients who undergo bariatric surgery and to examine feasibility and acceptability of the intervention. In the first phase, patient interviews (n= 20) will be utilized to identify preferences for intervention content and treatment delivery. Ten patients will then participate in an open trial of the intervention, which will be subsequently revised based on feedback from these patients. In Phase 2, patients (N = 60) will be recruited between 3 and 6 months following bariatric surgery and randomized to the intervention or treatment as usual control group. All patients will complete baseline questionnaires and at 1, 3, 6, and 9 month post-assessments. We expect that this intervention will be both feasible and acceptable to patients. Results will be used as preliminary data to inform a large, fully-powered clinical trial to test the larger efficacy of this intervention. Although primary outcomes focus on feasibility and acceptability, we also expect that patients assigned to the intervention will have a longer time to their first post-surgical drink, report more days of abstinence, fewer drinks per drinking day, and a lower prevalence of alcohol use disorder after bariatric surgery compared to controls. This project is innovative because it expands upon existing interventions for bariatric surgery patients by implementing evidence-based strategies for alcohol use. By utilizing a technology-based approach, we can also reach a larger number of patients to prevent initiation of drinking, reduce current alcohol use, and facilitate better engagement in care, should individuals opt into traditional treatment approaches. The proposed line of research is significant and relevant to NIH’s mission because the intervention is expected to reduce the likelihood that patients will develop an alcohol use disorder following bariatric surgery. Given the potential of wide dissemination at low cost, the proposed study has high potential public health and clinical significance.

尽管减肥手术是严重肥胖患者最有效的减肥干预措施， 多达五分之一的患者在手术后会出现酒精使用障碍。新陈代谢的变化， 激素水平和减肥手术后的行为改变了酒精的奖励作用， 同时改变其吸收率，使患者危险饮酒的风险显著增加。 简单地向这一脆弱的患者群体提供有关手术后风险的教育， 足以减少酒精使用，但全面的面对面干预面临重大挑战， 包括病人和他们的减肥手术计划之间长达数小时的距离。因此，我们的长期目标 是增加获得医疗支持的干预措施，以减少患者的酒精使用， 通过利用技术进行减肥手术。我们的干预，植根于动机性面试， 跨理论模型，是一个两个会议的计算机化简短干预（CBI），辅以六个月 根据参与者的CBI结果和随后的波动， 变化拟议研究的目的是优化这种基于技术的干预措施， 进行减肥手术，并检查干预的可行性和可接受性。在第一阶段， 将利用患者访谈（n = 20）来确定对干预内容和治疗实施的偏好。 然后，10名患者将参加干预的开放试验，随后将根据 这些病人的反馈。在II期研究中，将招募3 - 6个月的患者（N = 60） 在减肥手术后，随机分为干预组或常规治疗对照组。所有患者 将在评估后1个月、3个月、6个月和9个月完成基线问卷。我们期望这 干预是可行的，也是病人可以接受的。结果将作为初步数据， 一个大型的，完全有效的临床试验，以测试这种干预措施的更大功效。虽然主要结果 关注可行性和可接受性，我们还希望分配到干预的患者将有一个 术后首次饮酒的时间更长，报告禁欲天数更多，每次饮酒日饮酒量更少， 与对照组相比，减肥手术后酒精使用障碍的患病率较低。这个项目是 创新，因为它扩展了减肥手术患者的现有干预措施， 酒精使用的循证策略。通过利用基于技术的方法，我们还可以实现 更多的患者，以防止开始饮酒，减少目前的酒精使用，并促进更好的 如果个人选择传统治疗方法，则应参与护理。拟议的路线 研究是重要的，与NIH的使命相关，因为干预有望减少 患者在减肥手术后出现酒精使用障碍的可能性。考虑到 低成本的广泛传播，拟议的研究具有很高的潜在公共卫生和临床意义。