Ecological Momentary Assessment of Smoking Triggers, Needs, and Cigarette Forgoing (spark Forgo)
This study will evaluate a smartphone-based program designed to support adults who smoke cigarettes. Participants will use the spark app to complete brief surveys during the day and a daily evening survey about their smoking urges, smoking, decisions not to smoke, and everyday experiences. Participants will also log cigarettes when they smoke. After some cigarette logs, participants will answer a few additional questions about their situation and feelings; after others, they will only log the cigarette.
The study has three phases. In the first phase, participants will complete surveys and cigarette logs without receiving intervention messages. In the second phase, they will receive motivational messages at random times. In the third phase, message timing and content will be tailored using information collected during the earlier phases. The study will examine whether personalized motivational messages can help participants forgo smoking in daily life.
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Description détaillée
This study uses a within-person, phased ecological momentary assessment (EMA) and ecological momentary intervention (EMI) design to characterize momentary factors associated with cigarette smoking and smoking forgoing and to evaluate non-adaptive and adaptive motivational messaging delivered via the *spark* smartphone platform.
During all study phases, participants will complete four randomly timed EMA assessments per day during predefined waking hours and a daily evening survey. EMA assessments will assess momentary contextual factors, including current activity or routine, physical environment, social context, affective and cognitive states, smoking urges or craving, cigarette use since the previous assessment, and instances in which a smoking urge occurred without smoking (i.e., smoking forgoing). Evening surveys will assess daily smoking-related attitudes, cognitions, and behaviors.
Participants may also initiate an event-contingent entry whenever they smoke a cigarette. Each self-initiated entry will record the smoking event. Following each cigarette log, the app will randomly assign, with equal probability, whether the participant completes additional questions about the smoking context and feeling states or only logs the cigarette. To minimize assessment burden, randomly timed EMA prompts will not be delivered until at least one hour after completion of a self-initiated cigarette survey.
The study includes three phases. During the EMA Observation Phase, participants will complete EMA assessments, evening surveys, and event-contingent cigarette logs; no intervention messages will be delivered. During the Non-Adaptive EMI Phase, participants will continue these assessments and receive motivational messages delivered at randomly selected times, without tailoring to participant behavior or context. During the Adaptive EMI Phase, participants will continue all assessments and receive motivational messages at times determined by predictive models developed using data from the first two phases. Message content will be adapted based on the estimated likelihood of successful smoking forgoing in response to momentary contexts and internal states.
Where technically feasible and permitted by participant consent, passive smartphone-based data may be collected, including geolocation-derived patterns, time-stamped device-activity indicators, and environmental-context variables such as local weather conditions. These data will be used to enhance characterization of contextual factors associated with smoking urges, smoking behavior, smoking forgoing, and responsiveness to motivational intervention delivery.
Type d'étude
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Amanda L Rebar, PhD
- Numéro de téléphone: 5822030147
- E-mail: arebar@mailbox.sc.edu
Sauvegarde des contacts de l'étude
- Nom: Desiree Vidana-Perez, PhD
- Numéro de téléphone: 839-201-7629
- E-mail: desireev@mailbox.sc.edu
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 21 years or older.
- Has smoked at least 100 cigarettes in their lifetime.
- Currently smokes cigarettes every day.
- Smokes 10 or fewer cigarettes per day.
- Owns a compatible smartphone with reliable internet access and is willing to install and use the *spark* study application.
- Able to read and understand English.
- Willing and able to complete smartphone-based assessments, self-initiated cigarette-event logs, and daily evening surveys for the study duration.
- Able and willing to provide informed consent.
Exclusion Criteria:
- Current use of electronic cigarettes or vaping products.
- Unable to provide informed consent.
- Does not have a compatible smartphone or reliable internet access.
- Unable to complete study procedures because of a cognitive, visual, motor, or other impairment not accommodated by the study procedures.
- Currently enrolled in another smoking-cessation intervention study that would conflict with study participation.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Expérimental: Single Group (EMA/EMI sequence)
All participants complete three phases in sequence: an EMA Observation Phase with no intervention messages; a Non-Adaptive EMI Phase with randomly timed motivational messages; and an Adaptive EMI Phase with motivational messages timed and tailored using predictive models. Participants complete EMA and evening surveys throughout and may self-initiate cigarette-event logs. |
Smartphone-delivered motivational messages provided at randomly selected times during the Non-Adaptive EMI Phase. Message timing and content are not tailored using participant behavior, context, or assessment data. Smartphone-delivered motivational messages provided during the Adaptive EMI Phase. Message timing is determined using predictive models developed from earlier study-phase data, and message content is adapted to the participant's estimated likelihood of successfully forgoing smoking in their current context. |
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of weekly smoking urge episodes in which smoking is forgone
Délai: During the 21-day study period
|
Smoking forgoing will be assessed using study-specific ecological momentary assessment (EMA) item: "Since the last prompt (check-in or smoking report), have you *chosen* to skip any cigarettes that you normally would have smoked?" (yes/no). The outcome is the percentage of participant-reported smoking urge episodes per week. Higher percentages indicate more smoking forgoing. |
During the 21-day study period
|
|
Number of cigarettes smoked per day
Délai: During the 21-day study period
|
Cigarette smoking will be assessed using count of the participant-initiated cigarette-event logs. The outcome is the mean number of cigarettes smoked per participant per week during the study period. |
During the 21-day study period
|
Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean weekly momentary smoking urge/craving intensity score
Délai: During the 21-day study period
|
Current smoking urge or craving will be assessed using a study-specific EMA item: "How much do you crave (have an urging for) a cigarette right now? ". Participants will rate urge/craving on a 1-7 point scale, where 1 = 'not at all' and 7 = 'very much'. Higher scores indicate greater urge/craving. |
During the 21-day study period
|
|
Weekly EMA adherence
Délai: Throughout the study (week 1, 2, and 3).
|
Proportion of scheduled EMA prompts completed by participants per week |
Throughout the study (week 1, 2, and 3).
|
|
Smoking forgoing following motivational-message delivery
Délai: During the two bouts of 7-day Non-Adaptive EMI and Adaptive EMI phases of the 21-day study period.
|
Smoking-forgoing will be assessed using study-specific EMA urge reports and participant-initiated cigarette-event logs. The outcome is the percentage of participant-reported smoking-urge episodes in which the participant does not smoke a cigarette, calculated separately following delivery versus non-delivery of a motivational message at eligible decision points. Higher percentages indicate greater smoking forgoing. |
During the two bouts of 7-day Non-Adaptive EMI and Adaptive EMI phases of the 21-day study period.
|
|
Cigarette smoking following motivational-message delivery
Délai: During the two bouts of 7-day Non-Adaptive EMI and Adaptive EMI phases of the 21-day study period.
|
Cigarette smoking will be assessed using count of participant-initiated cigarette-event logs. The outcome is the mean number of cigarettes smoked per participant per week, calculated separately following delivery versus non-delivery of a motivational message at eligible decision points. |
During the two bouts of 7-day Non-Adaptive EMI and Adaptive EMI phases of the 21-day study period.
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- IRB00002615
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data will not be shared because the intensive, time-stamped ecological momentary assessment data and potential passive smartphone data may create a risk of participant re-identification. Data will be retained and managed in accordance with the approved protocol, informed-consent materials, institutional policies, and applicable regulations.
Informations sur les médicaments et les dispositifs, documents d'étude
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