The Effect of a Community-Based Protective Behavioral Strategies Program on Alcohol Use Among Adult Men With Hazardous Alcohol Use in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Alcohol use
研究概览
简要总结
This study aims to evaluate the effectiveness of a community-based Protective Behavioral Strategies (PBS) program in reducing alcohol use, severity of alcohol-related problems, and intention to use alcohol among people with hazardous alcohol use (HAU) in Vietnam. In this randomized controlled trial, 104 men aged 35-44 years, identified as having HAU (Alcohol Use Disorders Identification Test score = 8-15), will be recruited from a rural area in Thai Nguyen province, Vietnam. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group using stratified blocked randomization. The intervention group will participate in a community-based PBS program, which includes five weekly 90-minute sessions, with Short Message Service (SMS) reminders sent three times weekly after each session to reinforce PBS practices. The control group will receive usual care only.
The primary outcome is alcohol use, assessing both the quantity and frequency of consumption, measured at 1 month and 3 months post-intervention. Secondary outcomes include the severity of alcohol-related problems and intention to use alcohol. These will be assessed at baseline and the 3-month follow-up. Two-way repeated measures Multivariate analysis of variance (MANOVA) and regression models will be conducted to evaluate the effects of the intervention on the primary and secondary outcomes.
详细描述
* Background and significance: Hazardous alcohol use (HAU) represents a significant public health concern, particularly among adult men in Vietnam. Effective interventions are needed to reduce HAU and its associated health risks. Protective Behavioral Strategies (PBS) have shown promise in mitigating HAU behaviors by promoting safer drinking practices and enhancing self-regulation among individuals.
- Study objectives:
- To compare the differences in the primary outcome (alcohol use) between the intervention and control groups at 1 month and 3 months post-intervention, and the differences in the secondary outcomes (severity of alcohol-related problems and intention to use alcohol) at 3 months post-intervention.
- To compare the differences in the primary outcome (alcohol use) at 1 month and 3 months post-intervention, and the differences in the secondary outcomes (severity of alcohol-related problems and intention to use alcohol) at 3 months post-intervention, within the intervention group compared to the pre-test.
- Study design:
This study employs a randomized controlled design. Alcohol use will be measured at both 1 month and 3 months after the intervention, whereas the secondary outcomes will be measured at 3 months. The 1-month follow-up allows for the evaluation of immediate changes in drinking behavior, while the 3-month follow-up assesses whether these changes are sustained. By comparing outcomes across both time points, the study can track the trajectory of the intervention's impact and identify any patterns of relapse or continued improvement. These follow-up periods align with common practice in alcohol intervention research.
* Intervention: The intervention group will participate in a community-based PBS program, which is structured around PBS as its central framework, enhanced by Alcohol Brief Intervention (functioning as a motivating component), and Behavioral Skills Training model (enhancing the learning of each PBS skill through a structured approach: instruction, modeling, rehearsal, and feedback). The community-based PBS program consists of 5 weekly sessions including Setting safe drinking limits, Choosing non-alcoholic drinks, Planning Ahead, Slowing down drinking, and Avoiding Risky Drinking situations each lasting 90 minutes.
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
- None
入排标准
- 年龄范围
- 35 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Having a total AUDIT score from 8 to 15
- •Completing at least primary school
- •Able to use the Vietnamese language
- •Having a mobile phone
- •Willing to participate in this study
排除标准
- •Using alcohol and other illicit drugs at the same time
- •Having any physical illness or psychiatric disorders
研究组 & 干预措施
A Community-Based Protective Behavioral Strategies Program
Participants receive the community-based Protective Behavioral Strategies program
干预措施: A community-based Protective Behavioral Strategies program (Behavioral)
Control Group
Participants receiving the usual care
结局指标
主要结局
Alcohol use
时间窗: Baseline, 1 month and 3 months post-intervention
Alcohol use is measured by both the amount and frequency of alcohol consumption. The amount of alcohol use is quantified as the total grams of pure alcohol that participants consumed per week in the previous month measuring at baseline, 1 month, and 3 months post-intervention. This is calculated using the formula: Volume (ml) × ABV(%) × 0.79, where ABV is the alcohol by volume percentage and 0.79 is the conversion factor for the density of ethanol. Frequency of alcohol use is defined as the number of days per week in the previous month that participants consume alcohol measuring at baseline, 1 month, and 3 months post-intervention. These variables are measured using the Alcohol Timeline Follow back (TLFB).
次要结局
- Severity of alcohol-related problems(Baseline and 3 months post-intervention)
- Intention to use alcohol(Baseline and 3 months post-intervention)