NCT04999371

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

July 24, 2021

Last Update Submit

February 18, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Self-reported drinking quantity

    (drinks per week)

    3 months

  • Self-reported binge drinking frequency

    (number of binges per week)

    3 months

  • Self-reported drinking frequency.

    (drinking days per week)

    3 months

  • Self-reported drinking intensity.

    (number of drinks per drinking day)

    3 months

Study Arms (3)

Control without intervention

NO 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).

Mobile-based information intervention

ACTIVE COMPARATOR

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.

Behavioral: Brief Alcohol Intervention

Mobile-based information intervention with performance-based incentive

ACTIVE COMPARATOR

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.

Behavioral: Brief Alcohol InterventionBehavioral: Financial Incentive Intervention

Interventions

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.

Mobile-based information interventionMobile-based information intervention with performance-based incentive

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.

Mobile-based information intervention with performance-based incentive

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University China Center for Health Economic Research

Beijing, Beijing Municipality, 100871, China

Location

Related Publications (1)

  • Li S, Wu Z, Liu S, Sun Y, Liu GG. Effect of a brief intervention with small financial incentives on alcohol consumption in China: study protocol for a randomised controlled trial. BMJ Open. 2022 May 18;12(5):e056550. doi: 10.1136/bmjopen-2021-056550.

MeSH Terms

Conditions

Alcoholism

Interventions

EthanolMethods

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D., Assistant Director, PKU China Center for Health Economic Research (CCHER)Yu Sun, Ph.D. Assistant Director, PKU China Center for Health Economic Research (CCHER)

Study Record Dates

First Submitted

July 24, 2021

First Posted

August 10, 2021

Study Start

July 29, 2021

Primary Completion

December 31, 2021

Study Completion

July 31, 2022

Last Updated

March 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will be available in 2024
Access Criteria
The data are for research purposes only

Locations