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- Essai clinique NCT07784972
Effects of a Digital AI-Mediated Mindful Eating Intervention on Eating Behavior and Well-Being Outcomes in College Students
26 août 2026 mis à jour par: Tracy Chen Xi, Singapore Management University
Effects of a Digital AI-Mediated Mindful Eating Intervention on Eating Behavior and Well-Being Outcomes in College Students: A Randomized Controlled Trial
The goal of this randomized controlled study is to learn whether a 21-day mindful eating program can improve mental well-being and eating behavior outcomes in university students.
The main questions it aims to answer are: Does participation in a 21-day mindful eating program improve students' well-being (e.g., anxiety, stress, affect, life satisfaction, perceived health)?
Does the program improve students' eating behavior outcomes (e.g., mindful eating, emotional eating)?
Researchers will compare students who complete the mindful eating program immediately to students in a waitlist control group to see whether participation in the program leads to greater improvements in well-being and eating behavior outcomes.
Participants will sign up online and provide informed consent, be randomly assigned to either the intervention group or a waitlist control group, receive daily mindful eating tasks and reminders via Telegram for 21 days (intervention group), reflect daily about the task with a chatbot, as well as complete online questionnaire surveys at baseline, post-intervention, and a 2-week follow-up for those who opt in.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
250
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
- Nom: Tracy X Chen
- Numéro de téléphone: +6591691725
- E-mail: Tracychen.2023@phdps.smu.edu.sg
Lieux d'étude
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Singapore
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Singapore, Singapore, Singapour, 178903
- Singapore Management University, Online
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Contact:
- Tracy X Chen
- Numéro de téléphone: +65 91691725
- E-mail: Tracychen.2023@phdps.smu.edu.sg
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-
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
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Student of Singapore Management University
- Uses Telegram
Exclusion Criteria:
- Below 18 Years Old
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: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Groupe d'intervention
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The intervention is a 21-day, digitally delivered mindful eating program consisting of daily, brief, mindful eating tasks as well as brief post-task reflections with an AI bot, designed to support eating behavior and mental well-being in university students.
The program includes low-intensity mindful eating practices that can be completed independently without specialized equipment or prior training, e.g.
observing one's meal for one minute before taking the first bite.
Participants assigned to the intervention group receive one structured mindful eating task per day for 21 consecutive days.
Tasks are delivered via a Telegram channel, accompanied by brief reminders to prompt engagement.
Each task is designed to be short in duration, flexible in timing, and feasible within daily meal routines, emphasizing consistency.
Participants then reflect on the tasks with an AI bot.
The intervention is self-guided and asynchronous, with no in-person contact, live sessions, or direct supervision.
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Aucune intervention: Contrôle des listes d'attente
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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State Anxiety
Délai: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
State anxiety will be measured using the 6-item State-Trait Anxiety Inventory STAI-6.
Six items (e.g., "I felt upset these past 2 weeks.")
rated from 1 (Not at all) to 4 (Very much so) will be averaged.
Higher composite scores indicate higher levels of anxiety.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Stress
Délai: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
Perceived stress will be measured by an adapted version of the 4-item Perceived Stress Scale (PSS).
One sample item is "In the last 2 weeks, how often have you felt that you were unable to control the important things in your life?
", and items are scored from 0 (Never) to 4 (Very often).
The composite score is calculated by averaging the scores of all items after reverse coding two of the items; higher scores indicate greater levels of perceived stress.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Positive and Negative Affect
Délai: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
Positive Affect (PA) and Negative Affect (NA) will be evaluated using the affect scale developed by Conner and Silvia, according to principles of the Circumplex Model of Affect.
Participants will rate feelings such as 'Enthusiastic' and 'Hostile' experienced over the past two weeks, from a scale of 1 to 5 (1 = Not at all, 5 = Extremely).
Composite scores will be calculated by averaging the positive affect items and negative affect items accordingly.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Mindful eating
Délai: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
Mindful eating will be measured by the 17-item Mindful Eating Behavior Scale (MEBS) which consists of 4 domains: Focused Eating (e.g.
"I notice flavors and textures when I'm eating my food"), Hunger and Satiety Cues (e.g.
"I trust my body to tell me when to eat"), Eating with Awareness (reverse scored, e.g.
"I snack without being aware that I am eating"), and Eating Without Distraction (reverse scored, e.g.
"My thoughts tend to wander while I am eating.")
Each item is scored from 1 (Never) to 5 (Very often).
Scores will be averaged across domains.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Eating Behavior
Délai: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Eating behavior is measured by the Dutch Eating Behavior Questionnaire (DEBQ).
Items are scored by calculating the average score for three eating styles of restrained eating, emotional eating and external eating.
It contains 33 items (11 each style), each rated on a 5-point Likert scale (1 = Never, 5 = Very Often).
Scores are averaged across domains.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Life Satisfaction
Délai: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
Life satisfaction will be measured using an adapted version of Diener's Satisfaction With Life Scale (SWLS).
The scale consists of 5 items e.g.
"The conditions of my life these past 2 weeks are excellent."
and is scored from 1 (Strongly disagree) to 7 (Strongly agree).
Scores will be averaged and higher scores indicate higher life satisfaction.
|
Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
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Perceived Health
Délai: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Perceived physical and mental health will be assessed using a self-report single-item measure of general health status.
Participants will respond to the question, "How would you rate your physical(mental) health over the past two weeks?"
Responses will be rated on a 5-point scale from 1 (Poor) to 5 (Excellent).
Higher scores indicate better perceived physical health.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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AI Attitude
Délai: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
AI Attitude is measured by the 12-item Attitudes towards artificial intelligence Scale (ATTARI).
One example item is "I look forward to future AI developments", and items are scored from 1 (Strongly Disagree) to 5 (Strongly Agree).
There are three facets: Cognitive, Affective and Behavioral.
Scores are averaged across domains and higher scores indicate more favorable attitudes toward AI.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
- Conner, T. S., & Silvia, P. J. (2015). Creative Days: A Daily Diary Study of Emotion, Personality, and Everyday Creativity. Psychology of Aesthetics, Creativity, and the Arts, 9(4), 463-470. https://doi.org/10.1037/aca0000022
- Russell, J. A. (1980). A circumplex model of affect. Journal of Personality and Social Psychology, 39(6), 1161-1178. https://doi.org/10.1037/h0077714
- Van Strien, T., Frijters, J. E. R., Bergers, G. P. A., & Defares, P. B. (1986). The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. The International Journal of Eating Disorders, 5(2), 295-315. https://doi.org/10.1002/1098-108X(198602)5:2<295::AID-EAT2260050209>3.0.CO;2-T
- Winkens LHH, van Strien T, Barrada JR, Brouwer IA, Penninx BWJH, Visser M. The Mindful Eating Behavior Scale: Development and Psychometric Properties in a Sample of Dutch Adults Aged 55 Years and Older. J Acad Nutr Diet. 2018 Jul;118(7):1277-1290.e4. doi: 10.1016/j.jand.2018.01.015. Epub 2018 Apr 11.
- Stein JP, Messingschlager T, Gnambs T, Hutmacher F, Appel M. Attitudes towards AI: measurement and associations with personality. Sci Rep. 2024 Feb 5;14(1):2909. doi: 10.1038/s41598-024-53335-2.
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)
21 août 2026
Achèvement primaire (Estimé)
17 octobre 2026
Achèvement de l'étude (Estimé)
17 octobre 2026
Dates d'inscription aux études
Première soumission
19 août 2026
Première soumission répondant aux critères de contrôle qualité
19 août 2026
Première publication (Réel)
25 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB-26-176-A144(826)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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 .