A Community-Based Intervention to Reduce Alcohol Use in Vietnamese Men
NCT ID: NCT06713304
Last Updated: 2024-12-16
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
104 participants
INTERVENTIONAL
2025-01-01
2025-05-01
Brief Summary
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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.
Detailed Description
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* Study objectives:
1. 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.
2. 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.
The sessions will be delivered by the researcher in an in-person group format (10-12 participants per group) at a healthcare facility. Each session is structured as follows: Part 1-30 minutes: Introduction, relationship-building, and reviewing previous content. This segment focuses on fostering a supportive environment and reinforcing participants' connection with the program. Part 2-60 minutes: Learning and practicing PBS. Participants will be introduced to specific strategies each week, followed by hands-on practice, group discussions, and scenario-based exercises that encourage the application of PBS in real-life situations.
After each session, participants will receive three Short Message Service (SMS) text messages per week (a random day, Friday, and Saturday). These messages encourage participants to apply the PBS learned in the group sessions. The main activities in each session are briefly summarized below.
\* Usual care: Usual care refers to the standard services provided by primary care nurses to people with HAU in the community, as per national guidelines. This typically includes educational sessions on the adverse effects of alcohol, guidance on relevant laws and health regulations, and referrals to healthcare services.
* Outcome measures:
* 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) × Alcohol by Volume (%) × 0.79, where Alcohol by Volume is the alcohol by volume percentage and 0.79 is the conversion factor for the density of ethanol (Vietnamese Ministry of Health, 2020). 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.
* The severity of alcohol-related problems refers to the participants' self-report of the extent and intensity of negative consequences resulting from alcohol use, measured at baseline and 3 months post-intervention. These consequences are categorized into physical, intrapersonal, interpersonal, social responsibility, and impulse control domains. This variable is measured using the Drinker Inventory of Consequences.
* Intention to use alcohol is operationally defined as participants' self-reported intention or willingness to consume alcohol within the next 30 days. This is measured using a 7-point Likert scale at baseline and 3 months post-intervention in response to the statement: "I intend to drink alcohol in the next 30 days" with responses ranging from 1 to 7.
* Data Analysis:
Data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 28.0. Two-way repeated measures Multivariate analysis of variance (MANOVA) will be employed to assess changes in outcomes over time and between groups. Regression models will be utilized to explore the relationship between the intervention and changes in alcohol use and associated outcomes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A Community-Based Protective Behavioral Strategies Program
Participants receive the community-based Protective Behavioral Strategies program
A community-based Protective Behavioral Strategies program
A 5-week group program delivered in a healthcare setting to teach and practice protective behavioral strategies. The objectives of each session are:
Session 1: Setting Safe Drinking Limit: The participants can identify the risk related to their drinking behavior, calculate a standard drink, and set a safe drinking limit.
Session 2: Choosing Nonalcoholic Drinks: The participants can understand the benefits of using nonalcoholic beverages and identify and select nonalcoholic beverages.
Session 3: Planning Ahead: The participants can make a plan to stop using during drinking events and know how to say "no" to alcohol use.
Session 4: Slowing down drinking: The participants can understand the benefits of slowing down drinking and know how to slow down their drinks.
Session 5: Avoid Risky Drinking Situations: The participants can understand the negative effects of excessive drinking and know how to avoid excessive drinking.
Control Group
Participants receiving the usual care
No interventions assigned to this group
Interventions
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A community-based Protective Behavioral Strategies program
A 5-week group program delivered in a healthcare setting to teach and practice protective behavioral strategies. The objectives of each session are:
Session 1: Setting Safe Drinking Limit: The participants can identify the risk related to their drinking behavior, calculate a standard drink, and set a safe drinking limit.
Session 2: Choosing Nonalcoholic Drinks: The participants can understand the benefits of using nonalcoholic beverages and identify and select nonalcoholic beverages.
Session 3: Planning Ahead: The participants can make a plan to stop using during drinking events and know how to say "no" to alcohol use.
Session 4: Slowing down drinking: The participants can understand the benefits of slowing down drinking and know how to slow down their drinks.
Session 5: Avoid Risky Drinking Situations: The participants can understand the negative effects of excessive drinking and know how to avoid excessive drinking.
Eligibility Criteria
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Inclusion Criteria
* Completing at least primary school
* Able to use the Vietnamese language
* Having a mobile phone
* Willing to participate in this study
Exclusion Criteria
* Having any physical illness or psychiatric disorders
35 Years
44 Years
MALE
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Locations
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Chulalongkorn University, Faculty of Nursing
Bangkok, Bangkok, Thailand, Thailand
Countries
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Central Contacts
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Facility Contacts
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Penpaktr Uthis, Associate Professor
Role: primary
Sudaporn Stithyudhakarn, Assistant Professor
Role: backup
Other Identifiers
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FONCU2601
Identifier Type: -
Identifier Source: org_study_id