Alcohol Use DisorderNCT04999371
Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption
A study testing Brief Alcohol Intervention and Financial Incentive Intervention in people with Alcohol Use Disorder, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Brief Alcohol Intervention and Financial Incentive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University China Center for Health Economic Research
Beijing, Beijing Municipality, 100871
About this study
Official title: 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Brief Alcohol Intervention, Financial Incentive Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Alcohol InterventionBehavioural
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.
Financial Incentive InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Brief Alcohol Intervention; Behavioral: Financial Incentive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported drinking quantity
(drinks per week)
Measured: 3 months
Self-reported binge drinking frequency
(number of binges per week)
Measured: 3 months
Self-reported drinking frequency.
(drinking days per week)
Measured: 3 months
Self-reported drinking intensity.
(number of drinks per drinking day)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start29 Jul 2021
- Primary completion31 Dec 2021
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 443 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Sun, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999371
- Sponsor's protocol ID
- ccher_liangshan alcohol
- Status last verified
- Feb 2022
- First submitted
- 24 Jul 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data can be provided according to the needs of the researcher, but does not include all personal data
Publications
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.
PubMed 35584882
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption: Study Protocol for a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04999371
- Acronym / sponsor ID
- ccher_liangshan alcohol
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 443 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Brief Alcohol InterventionThe 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. |
| Mobile-based information intervention with performance-based incentive | Active comparator | Behavioral: Brief Alcohol Intervention, Behavioral: Financial Incentive InterventionThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Alcohol InterventionThe 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. | Behavioural | Mobile-based information intervention, Mobile-based information intervention with performance-based incentive |
| Financial Incentive InterventionThe 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. | Behavioural | Mobile-based information intervention with performance-based incentive |
Primary outcome
Self-reported drinking quantity
Time frame: 3 months
(drinks per week)
Self-reported binge drinking frequency
Time frame: 3 months
(number of binges per week)
Self-reported drinking frequency.
Time frame: 3 months
(drinking days per week)
Self-reported drinking intensity.
Time frame: 3 months
(number of drinks per drinking day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Derived from this study: PubMed 35584882Li 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.
- Individual participant dataSharing planned: Yes. The data can be provided according to the needs of the researcher, but does not include all personal data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Alcohol Intervention and Financial Incentive Intervention in people with Alcohol Use Disorder, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported drinking quantity (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.