跳至主要内容
临床试验/NCT04788316
NCT04788316已完成不适用

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

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月23日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Matero

Assistant Scientist

Henry Ford Health System

研究点 (2)

Loading locations...

相似试验