- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04999371
Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption
Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption: Study Protocol for a Cluster-randomized Controlled Trial
The existing alcohol intervention studies are mainly conducted in developed countries, few studies have focused on alcohol consumption among ethnic minority migrant people in developing countries. To address this gap, the investigators aim to evaluate the effects of a brief intervention combined with a small financial incentive on alcohol consumption and health outcomes among the migrated population in Liangshan Prefecture. This study was conducted in Liangshan Prefecture for two reasons: first, Liangshan is a region located in the southwestern of Sichuan province and is populated by Yi minority, and the average income in Liangshan is just about two-thirds of the national average income. Second, a study found that the drinking rate of the Yi minority (47.9%) is higher than that of other regions in China.
The aim of this paper is to provide an overview of alcohol consumption among the ethnic populations 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100871
- Peking University China Center for Health Economic Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Exclusion Criteria:
- Age<18 and Age>65
- Scores of AUDIT<8
- Do not speak mandarin
- Less than three-months residence at Xichang
- Income not calculated by hour wage or piece-rate wage
- Those who have previous abstinence experience, epilepsy, liver disease, and is using sedative drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control without intervention
No information or cash incentives are provided to the participants in the control group, but it is also necessary to collect the information of the participants in the control group and perform an alcohol test.
Therefore, the project team will provide a certain degree of compensation for participants in the control group (participants of the intervention group also will receive this part of compensation).
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Active Comparator: Mobile-based information intervention
The participants in this group received free three-time counsel and constant multi-media messages about the topic of alcohol consumption for three months.
One-to-one counseling services will be provided via a telephone call, which is based on World Health Organization (WHO) recommendations.
A total of three counsels are conducted, which are set on the second week, sixth and tenth week after the baseline survey.
|
The participants in the treatment group received free three-time counsel and constant multi-media messages about the topic of alcohol consumption for three months. One-to-one counseling services will be provided via a telephone call, which is based on World Health Organization (WHO) recommendations. A total of three counsels are conducted, which are set on the second week, sixth and tenth week after the baseline survey. Brief intervention counselors are from the team of this study and trained by Hongkong University. All counselors are required to attend a full-day workshop before participant recruitment. The contents of the workshop include (1) knowledge of excessive drinking harms and benefits of controlling drinking; (2) overview of AUDIT; (3) alcohol reduction advice; (4) a standard procedure of brief intervention. |
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Active Comparator: Mobile-based information intervention with performance-based incentive
The participants in this group were conducted by deducting money.
Firstly, a certain amount of vouchers were given to the participants, which was equivalent to the reward for passing seven tests.
Then, the voucher would be deducted according to every test result.
Finally, the participants will receive cash according to the vouchers.
|
The participants in the treatment group received free three-time counsel and constant multi-media messages about the topic of alcohol consumption for three months. One-to-one counseling services will be provided via a telephone call, which is based on World Health Organization (WHO) recommendations. A total of three counsels are conducted, which are set on the second week, sixth and tenth week after the baseline survey. Brief intervention counselors are from the team of this study and trained by Hongkong University. All counselors are required to attend a full-day workshop before participant recruitment. The contents of the workshop include (1) knowledge of excessive drinking harms and benefits of controlling drinking; (2) overview of AUDIT; (3) alcohol reduction advice; (4) a standard procedure of brief intervention.
The participants in financial Incentive intervention group were conducted by deducting money.
Firstly, a certain amount of vouchers were given to the participants, which was equivalent to the reward for passing seven tests.
Then, the voucher would be deducted according to every test result.
Finally, the participants will receive cash according to the vouchers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-reported drinking quantity
Time Frame: 3 months
|
(drinks per week)
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3 months
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Self-reported binge drinking frequency
Time Frame: 3 months
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(number of binges per week)
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3 months
|
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Self-reported drinking frequency.
Time Frame: 3 months
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(drinking days per week)
|
3 months
|
|
Self-reported drinking intensity.
Time Frame: 3 months
|
(number of drinks per drinking day)
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ccher_liangshan alcohol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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