A brief intervention in reducing alcohol consumption in China: study protocol for a cluster randomized controlled trial

Last registered on July 28, 2021

Pre-Trial

Trial Information

General Information

Title
A brief intervention in reducing alcohol consumption in China: study protocol for a cluster randomized controlled trial
RCT ID
AEARCTR-0008004
Initial registration date
July 25, 2021
Last updated
July 28, 2021, 5:31 PM EDT

Locations

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Primary Investigator

Affiliation

Other Primary Investigator(s)

Additional Trial Information

Status
On going
Start date
2021-07-22
End date
2021-10-31
Secondary IDs
Abstract
Alcohol is the 7th leading risk factor of Disabled Adjusted Life Years (DALYs) all over the world according to the Global Burden of Disease study 2017 .As the largest developing country, Chinese people consume a large amount of alcohol, and suffer from related health risk. The aim of this paper is to provide an overview of alcohol consumption among the ethnic population in China, and to test the feasibility and efficacy of small financial incentives with brief advice intervention targeting the reduction of harmful drinking behaviors among poor people.
External Link(s)

Registration Citation

Citation
Li, Shanshan. 2021. "A brief intervention in reducing alcohol consumption in China: study protocol for a cluster randomized controlled trial." AEA RCT Registry. July 28. https://doi.org/10.1257/rct.8004-1.0
Experimental Details

Interventions

Intervention(s)


Intervention Start Date
2021-08-01
Intervention End Date
2021-09-30

Primary Outcomes

Primary Outcomes (end points)
Primary outcomes:
1. Self-reported drinking quantity (drinks per week).
2. Self-reported binge drinking frequency (number of binges per week).
3. Self-reported drinking frequency (drinking days per week).
4. Self-reported drinking intensity (number of drinks per drinking day).
5. The proportion of people who drink alcohol according to the EtG test.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary outcomes:
1. Health status indicators, including sleep quality, and mental health in the past one month.
2. Life satisfaction.
3. Health-care utilization, including emergency/outpatient visits, medical hospitalization, mean days in hospital in the past one month.
4. Productivity and income, which are income per day, and working hours per day in the past one month.
5. Household expenditure includes the daily expenditure for alcohol, children, parents, and health care services in the past one month.
6. Score on the knowledge about the harm of alcohol consumption.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Participants are assessed at baseline, 1,2,3 month after treatment initiation (Table 1). Participants are required to take a test four times a week for 1-4 weeks, twice a week for 5-8 weeks, and once a week for 9-11 weeks. In order to avoid cheating by abstaining from alcohol only the day before the test, the time of each test was randomly determined by the program team and participants are informed the night before. The baseline questionnaire measures participants’ drinking behavior (eg, Daily alcohol consumption, age of starting drinking, whether and the number of attempts to quit or reduce, methods for quitting used in past). At weeks 2, 6 and 10 after the intervention initiation, participants are followed up by trained counselors with a phone call. The Prime Screen single panel urine test paper is used to conduct the ethyl glucuronide (EtG) test. Participants are informed that they may withdraw from the study at any time without giving a reason.
Experimental Design Details
Not available
Randomization Method
Random at the individual level by layering by a computer.
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
0
Sample size: planned number of observations
442 local residents
Sample size (or number of clusters) by treatment arms
154 local residents control, 154 local residents brief intervention, 154 local residents brief intervention with financial incentives.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Peking University Institutional Review Board
IRB Approval Date
2020-08-08
IRB Approval Number
IRB00001052-20049