- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07784972
Effects of a Digital AI-Mediated Mindful Eating Intervention on Eating Behavior and Well-Being Outcomes in College Students
2026년 8월 26일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
250
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Tracy X Chen
- 전화번호: +6591691725
- 이메일: Tracychen.2023@phdps.smu.edu.sg
연구 장소
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Singapore
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Singapore, Singapore, 싱가포르, 178903
- Singapore Management University, Online
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연락하다:
- Tracy X Chen
- 전화번호: +65 91691725
- 이메일: Tracychen.2023@phdps.smu.edu.sg
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Student of Singapore Management University
- Uses Telegram
Exclusion Criteria:
- Below 18 Years Old
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 개입 그룹
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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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간섭 없음: 대기자 명단 제어
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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State Anxiety
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Life Satisfaction
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 21일
기본 완료 (추정된)
2026년 10월 17일
연구 완료 (추정된)
2026년 10월 17일
연구 등록 날짜
최초 제출
2026년 8월 19일
QC 기준을 충족하는 최초 제출
2026년 8월 19일
처음 게시됨 (실제)
2026년 8월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 26일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .