- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03342768
An RCT of a Smartphone-based TID Programme
A Smartphone Messaging Programme for Tobacco Industry Denormalisation - a Randomised Controlled Trial
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Hong Kong, Hong Kong
- Local primary schools
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Parents and children should all understand Chinese.
- Parents should have a smartphone and use WhatsApp (a smartphone-based app)
Exclusion Criteria:
- n/a
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: TID
Messages will be sent 1-2 times per week containing information that aims to denormalise the tobacco industry.
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For the TID arm, the messages' contents include the tobacco industry's (TI's) anti-smoking campaigns that made smoking more grown-up and more appealing to youth; the TI's role in smoking in movies; etc. For the sugar sweetened beverage (SSB) arm, the messages' contents include the disease conditions linked to SSBs, and the interference of sugar industry in scientific research. |
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Autre: Sugar sweetened beverages
Messages will be sent 1-2 times per week containing information on the adverse health effects of sugar sweetened beverages.
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For the TID arm, the messages' contents include the tobacco industry's (TI's) anti-smoking campaigns that made smoking more grown-up and more appealing to youth; the TI's role in smoking in movies; etc. For the sugar sweetened beverage (SSB) arm, the messages' contents include the disease conditions linked to SSBs, and the interference of sugar industry in scientific research. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
TID beliefs in parents
Délai: 1 month
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Parents will report their opinions towards 4 sentences: 1) Tobacco companies are a respectable industry; 2) the tobacco industry does everything it can to get young people to smoke; 2) the tobacco industry use many tactics to resist tobacco control regulations; 4) the tobacco industry deceived the public for financial interests.
All the 4 questions have 5 options from definitely yes to definitely no.
The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry.
A sum of scores from the 4 questions will be deemed a measurement of TID beliefs.
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1 month
|
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TID beliefs in children
Délai: 1 month
|
Students will report their opinions towards 4 sentences: 1) Tobacco companies are a respectable industry; 2) the tobacco industry does everything it can to get young people to smoke; 2) the tobacco industry use many tactics to resist tobacco control regulations; 4) the tobacco industry deceived the public for financial interests.
All the 4 questions have 5 options from definitely yes to definitely no.
The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry.
A sum of scores from the 4 questions will be deemed a measurement of TID beliefs.
|
1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tobacco related communication reported by parents
Délai: 1 month
|
Parents will report whether they said the following to children in the past 30 days: 1) harm of smoking 2) harm of secondhand smoking 3) criticise smoking behaviour 4) approve tobacco control measures.
Each of the messages will be analyse as a binary outcome.
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1 month
|
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Sugar sweetened beverage (SSB) related communication reported by parents
Délai: 1 month
|
Parents will report whether they said the following to children in the past 30 days: 1) harm of SSB 2) certain kind of drinks contain sugar 3) don't drink or drink less SSB.
Each of the messages will be analyse as a binary outcome.
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1 month
|
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Tobacco related communication reported by children
Délai: 1 month
|
Students will report whether they heard the following from parents in the past 30 days: 1) harm of smoking 2) harm of secondhand smoking 3) criticize smoking behaviour 4) approve tobacco control measures.
Each of the messages will be analyse as a binary outcome.
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1 month
|
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SSB related communication reported by children
Délai: 1 month
|
Students will report whether they heard the following from parents in the past 30 days: 1) harm of SSB 2) certain kind of drinks contain sugar 3) don't drink or drink less SSB.
Each of the messages will be analyse as a binary outcome.
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1 month
|
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Intention to smoke in children
Délai: 1 month
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Two questions will be used to assess this outcome: 1) do you think you will smoke in the next 12 months?
2) If one of your good friends offers you a cigarette, will you smoke it?
Response options are definitely not/probably not/probably yes/definitely yes.
Those choosing options other than "definitely not" for either of the questions will be deemed having intention to smoke; the other students will be deemed having no intention to smoke.
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1 month
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Home exposure to secondhand smoke in children reported by children
Délai: 1 month
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One question will be asked: 1) On how many of the past 7 days did someone smoke near you at home? (Options 0 day/1/2/3/4/5/6/7).
The responses will dichotomised into a binary indicator of secondhand smoke exposure (no/any) and analysed as an outcome.
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1 month
|
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Home exposure to secondhand smoke in children reported by parents
Délai: 1 month
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One question will be asked: 1) On how many of the past 7 days did someone smoke near your children at home? (Options 0 day/1/2/3/4/5/6/7).
The responses will dichotomised into a binary indicator of secondhand smoke exposure (no/any) and analysed as an outcome.
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1 month
|
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Parents' support for tobacco control
Délai: 1 month
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Parents will report their opinions towards 4 sentences: 1) government should adopt plain packaging; 2) government should impose stronger regulation on tobacco; 3) government should strengthen the prevention of the harm of tobacco.
The options were strongly support/support/neutral/oppose/strongly oppose.
The options will be recoded into 4-0, with higher scores indicating stronger support for tobacco control.
A sum of scores from the 4 questions will be deemed a measurement of parents' support for tobacco control.
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1 month
|
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Negative attitude towards smoking in parents
Délai: 1 month
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Parents will be asked "your attitude towards smoking is" with options of very positive/positive/neutral/negative/very negative.
The options will be dichotomised as very negative vs others (negative/neutral/positive/very positive) for analysis.
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1 month
|
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Negative attitude towards smoking in children
Délai: 1 month
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Children will be asked "your attitude towards smoking is" with options of very positive/positive/neutral/negative/very negative.
The options will be dichotomised as very negative vs others (negative/neutral/positive/very positive) for analysis.
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1 month
|
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Past 7-day consumption of SSB and water in children reported by children
Délai: 1 month
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Children will be asked "On how many of the past 7 days did you drink SSBs?" and "On how many of the past 7 days did you drink water?"
For both questions, the options were 0/1/2/3/4/5/6/7 days.
These two variables will be analysed as both binary (No (0 day) vs any (1/2/3/4/5/6/7 days)) and continuous variables.
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1 month
|
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Past 7-day consumption of SSB and water in children reported by parents
Délai: 1 month
|
Parents will be asked "On how many of the past 7 days did you drink SSBs?" and "On how many of the past 7 days did you drink water?"
For both questions, the options were 0/1/2/3/4/5/6/7 days.
These two variables will be analysed as both binary (No (0 day) vs any (1/2/3/4/5/6/7 days)) and continuous variables.
|
1 month
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
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Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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