- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100871
- Peking University China Center for Health Economic Research
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: 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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Aktiv komparator: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-reported drinking quantity
Tidsramme: 3 months
|
(drinks per week)
|
3 months
|
|
Self-reported binge drinking frequency
Tidsramme: 3 months
|
(number of binges per week)
|
3 months
|
|
Self-reported drinking frequency.
Tidsramme: 3 months
|
(drinking days per week)
|
3 months
|
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Self-reported drinking intensity.
Tidsramme: 3 months
|
(number of drinks per drinking day)
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ccher_liangshan alcohol
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
- Formular til informeret samtykke (ICF)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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