- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07784972
Effects of a Digital AI-Mediated Mindful Eating Intervention on Eating Behavior and Well-Being Outcomes in College Students
26 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
250
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Tracy X Chen
- Telefonnummer: +6591691725
- E-post: Tracychen.2023@phdps.smu.edu.sg
Studieorter
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Singapore
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Singapore, Singapore, Singapore, 178903
- Singapore Management University, Online
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Kontakt:
- Tracy X Chen
- Telefonnummer: +65 91691725
- E-post: Tracychen.2023@phdps.smu.edu.sg
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Student of Singapore Management University
- Uses Telegram
Exclusion Criteria:
- Below 18 Years Old
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Insatsgrupp
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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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Inget ingripande: Väntelistkontroll
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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State Anxiety
Tidsram: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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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
Tidsram: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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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
Tidsram: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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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
Tidsram: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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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
Tidsram: 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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Life Satisfaction
Tidsram: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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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.
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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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Perceived Health
Tidsram: 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
Tidsram: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
21 augusti 2026
Primärt slutförande (Beräknad)
17 oktober 2026
Avslutad studie (Beräknad)
17 oktober 2026
Studieregistreringsdatum
Först inskickad
19 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
19 augusti 2026
Första postat (Faktisk)
25 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IRB-26-176-A144(826)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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