A Technology-based Intervention to Reduce Alcohol Use After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Drinks per day
研究概览
简要总结
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, the 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. This 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 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 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. The investigators 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Underwent a bariatric surgery procedure between 3 and 6 months prior to the recruitment date
- •Has not consumed alcohol since undergoing bariatric surgery
排除标准
- •History of an alcohol use disorder
- •Never consumed alcohol prior to surgery
- •Does not have a cellular phone that can receive and send text messages
- •No access to internet to complete the computerized brief intervention (CBI)
结局指标
主要结局
Drinks per day
时间窗: 6 months post-baseline
Average drinks per sitting
Time to alcohol use
时间窗: 6 months post-baseline
The number of days that elapsed from surgery until the first alcoholic drink
Number of drinking days
时间窗: 6 months post-baseline
The number of drinking days/days abstinent
次要结局
- Hazardous alcohol use(6 months post-baseline)
- Importance of and confidence in the ability to abstain from alcohol(6 months post-baseline)
- Risky alcohol use(6 months post-baseline)
研究者
Lisa Matero
Assistant Scientist
Henry Ford Health System
