- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07784972
Effects of a Digital AI-Mediated Mindful Eating Intervention on Eating Behavior and Well-Being Outcomes in College Students
26. august 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Tracy X Chen
- Telefonnummer: +6591691725
- E-post: Tracychen.2023@phdps.smu.edu.sg
Studiesteder
-
-
Singapore
-
Singapore, Singapore, Singapore, 178903
- Singapore Management University, Online
-
Ta kontakt med:
- Tracy X Chen
- Telefonnummer: +65 91691725
- E-post: Tracychen.2023@phdps.smu.edu.sg
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Student of Singapore Management University
- Uses Telegram
Exclusion Criteria:
- Below 18 Years Old
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervensjonsgruppe
|
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.
|
|
Ingen inngripen: Ventelistekontroll
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
State Anxiety
Tidsramme: 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.
|
Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
|
Stress
Tidsramme: 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.
|
Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
|
Positive and Negative Affect
Tidsramme: 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.
|
Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
|
Mindful eating
Tidsramme: 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.
|
Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
|
Eating Behavior
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
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.
|
Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Life Satisfaction
Tidsramme: 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
|
|
Perceived Health
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
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.
|
Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
|
AI Attitude
Tidsramme: 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.
|
Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
21. august 2026
Primær fullføring (Antatt)
17. oktober 2026
Studiet fullført (Antatt)
17. oktober 2026
Datoer for studieregistrering
Først innsendt
19. august 2026
Først innsendt som oppfylte QC-kriteriene
19. august 2026
Først lagt ut (Faktiske)
25. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB-26-176-A144(826)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .