NCT07605104

Brief Summary

This study aims to evaluate the efficacy of a mindful eating intervention focused on listening to podcast. The intervention is delivered via mobile application in a sample drawn from the healthy adult population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
666

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

22 days

First QC Date

May 7, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

Mindful Eatingbodily awarenessmHealthwell-beingfood educationMindfulness

Outcome Measures

Primary Outcomes (3)

  • Mood assessment

    Mood was assessed daily throughout the 14-day intervention period using five single-item Likert scales (1-10). Participants rated their momentary levels of stress, mental clarity, calmness, happiness, and restlessness.

    Immediately before and after each daily session over the 14-day period

  • Mindful Eating Awareness

    To assess Mindful Eating Awareness, we used the Mindful Eating Questionnaire (MEQ), a tool developed to measure the degree of awareness during eating behavior. In the Italian abbreviated version (Clementi, Casu, \& Gremigni, 2017), the instrument consists of 20 items rated on a 4-point Likert scale (from 1 = 'Never' to 4 = 'Always') and is divided into two subscales: awareness and recognition.

    At baseline and at the end of the 14-day intervention period

  • Bodily Sensation

    Bodily sensation was assessed daily throughout the 14-day intervention period using five single-item Likert scales (1-10).

    Immediately after each daily session over the 14-day period

Secondary Outcomes (2)

  • WHO-5 Well-Being Index score

    At baseline and at the end of the 14-day intervention period

  • Cognitive Failures Questionnaire (CFQ) score

    At baseline and at the end of the 14-day intervention period

Study Arms (3)

Mindful Eating Practice

EXPERIMENTAL

Participants receive notifications focused on experiential mindful eating components, including awareness of the five senses and interoceptive skills. They also complete specific guided exercises designed to cultivate these abilities.

Behavioral: Mindful Eating Practice

Mindful Eating Theory

EXPERIMENTAL

Participants receive notifications focused exclusively on the theoretical aspects of mindful eating, without the experiential exercises included in the practice condition.

Behavioral: Mindful Eating Theory

Mindful Eating Education

EXPERIMENTAL

Participants receive notifications promoting evidence-based healthy eating practices, such as adequate water intake and reduced consumption of refined foods, based on findings from authoritative scientific research.

Behavioral: Mindful Eating Education

Interventions

Participants complete a 14-day app-based program delivered through daily notifications and short audio content focused on experiential mindful eating components, including awareness of the five senses and interoceptive skills. They also complete specific guided exercises designed to cultivate these abilities. Each day, participants receive two notifications and one short audio, accompanied by brief self-report assessments evaluating mood, attention, and engagement.

Mindful Eating Practice

Participants complete a 14-day app-based program delivered through daily notifications and short audio content focused exclusively on the theoretical aspects of mindful eating, without the experiential exercises included in the practice condition. They also complete specific guided exercises designed to cultivate these abilities. Each day, participants receive two notifications and one short audio, accompanied by brief self-report assessments evaluating mood, attention, and engagement.

Mindful Eating Theory

Participants complete a 14-day app-based program delivered through daily notifications and short audio content promoting evidence-based healthy eating practices, such as adequate water intake and reduced consumption of refined foods, based on findings from authoritative scientific research. They also complete specific guided exercises designed to cultivate these abilities. Each day, participants receive two notifications and one short audio, accompanied by brief self-report assessments evaluating mood, attention, and engagement.

Mindful Eating Education

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • owning a smartphone

You may not qualify if:

  • presence of diagnosed eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piazza dell'Ateneo Nuovo 1

Milan, 20126, Italy

Location

Related Publications (5)

  • Salvo V, Curado DF, Sanudo A, Kristeller J, Schveitzer MC, Favarato ML, Isidoro W, Demarzo M. Comparative effectiveness of mindfulness and mindful eating programmes among low-income overweight women in primary health care: A randomised controlled pragmatic study with psychological, biochemical, and anthropometric outcomes. Appetite. 2022 Oct 1;177:106131. doi: 10.1016/j.appet.2022.106131. Epub 2022 Jun 23.

    PMID: 35753441BACKGROUND
  • Lyzwinski LN, Edirippulige S, Caffery L, Bambling M. Mindful Eating Mobile Health Apps: Review and Appraisal. JMIR Ment Health. 2019 Aug 22;6(8):e12820. doi: 10.2196/12820.

    PMID: 31441431BACKGROUND
  • Janssen LK, Duif I, van Loon I, de Vries JHM, Speckens AEM, Cools R, Aarts E. Greater mindful eating practice is associated with better reversal learning. Sci Rep. 2018 Apr 9;8(1):5702. doi: 10.1038/s41598-018-24001-1.

    PMID: 29632306BACKGROUND
  • Dalen J, Smith BW, Shelley BM, Sloan AL, Leahigh L, Begay D. Pilot study: Mindful Eating and Living (MEAL): weight, eating behavior, and psychological outcomes associated with a mindfulness-based intervention for people with obesity. Complement Ther Med. 2010 Dec;18(6):260-4. doi: 10.1016/j.ctim.2010.09.008. Epub 2010 Nov 11.

    PMID: 21130363BACKGROUND
  • Begin C, Berthod J, Martinez LZ, Truchon M. Use of Mobile Apps and Online Programs of Mindfulness and Self-Compassion Training in Workers: A Scoping Review. J Technol Behav Sci. 2022;7(4):477-515. doi: 10.1007/s41347-022-00267-1. Epub 2022 Sep 6.

    PMID: 36091081BACKGROUND

Study Officials

  • Patrizia Steca

    University of Milan-Bicocca

    STUDY DIRECTOR
  • Maria Elide Vanutelli

    University of Milan-Bicocca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The baseline assessment, the intervention, and the post-intervention assessment are provided automatically via the mobile app. In addition, participants are randomly assigned to a specific experimental group before starting the study and do not know which experimental group they are assigned. These features of the study minimize observer bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 22, 2026

Study Start

December 17, 2025

Primary Completion

January 8, 2026

Study Completion

January 8, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations