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Ecological Momentary Assessment of Smoking Triggers, Needs, and Cigarette Forgoing (spark Forgo)

28 septembre 2026 mis à jour par: Amanda L. Rebar, University of South Carolina

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

Pas encore de recrutement

Les conditions

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

Interventionnel

Inscription (Estimé)

45

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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)

Armes et Interventions

Groupe de participants / Bras
Intervention / 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

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

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

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

20 septembre 2026

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 septembre 2027

Dates d'inscription aux études

Première soumission

15 septembre 2026

Première soumission répondant aux critères de contrôle qualité

28 septembre 2026

Première publication (Réel)

1 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette 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) ?

NON

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

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .