- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Beijing
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Beijing, Beijing, Čína, 100871
- Peking University China Center for Health Economic Research
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: 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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Aktivní komparátor: 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.
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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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Aktivní komparátor: 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.
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Self-reported drinking quantity
Časové okno: 3 months
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(drinks per week)
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3 months
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Self-reported binge drinking frequency
Časové okno: 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.
Časové okno: 3 months
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(drinking days per week)
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3 months
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Self-reported drinking intensity.
Časové okno: 3 months
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(number of drinks per drinking day)
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3 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ccher_liangshan alcohol
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- Protokol studie
- Plán statistické analýzy (SAP)
- Formulář informovaného souhlasu (ICF)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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