Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption

February 18, 2022 updated by: Yu Sun, Peking University

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

Study Type

Interventional

Enrollment (Anticipated)

443

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100871
        • Peking University China Center for Health Economic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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).
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported drinking quantity
Time Frame: 3 months
(drinks per week)
3 months
Self-reported binge drinking frequency
Time Frame: 3 months
(number of binges per week)
3 months
Self-reported drinking frequency.
Time Frame: 3 months
(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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

July 24, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data can be provided according to the needs of the researcher, but does not include all personal data

IPD Sharing Time Frame

The data will be available in 2024

IPD Sharing Access Criteria

The data are for research purposes only

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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