NCT07492056

Brief Summary

Overweight and obesity are an increasing tendencies worldwide. Disordered Eating Behaviors (DEBs) are feeding dynamics commonly present on them, as in Feeding Disorders (FD). These eating and body conditions are highly correlated with specific psychopathological symtoms, such as anxiety and depression, weight-related shame and stigma, and academic stress. Additionally, electroencephalographic findings suggest that weight- and eating-related conditions may be mediated by neural pathways specific to executive functions, such as selective attention and inhibitory control. Therefore, this cuasi-experimental design, pre- and post- measurement, longitudinal cross-sectional study aims to evaluate the effect of a training on psychological flexibility skills, based on Acceptance and Commitment Therapy (ACT) processes, on psychological, electroencephalographic and body composition measures.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 30, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

April 1, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

March 19, 2026

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (11)

  • Disordered Eating Behaviors.

    A scale called "Dutch Eating Behaviour Questionnarie", that is validated on mexican population to mesure Disordered Eating Behaviors on three dimennsions, 1) Restrictive Eating. 2) Emotional Eating. 3) External Eating. Reactives: 33. Estimated application time: 20 minutes. No parametric data on mexican population, however, raw data will be taken from pre- and post-messures.

    Pre-post intervention assessment, after 12 weeks.

  • Disordered Eating Behaviors.

    A scale called "Binge Eating Scale". Scores range from 0 min-46 max, normal score ranges from ≤17. Reactives: 16. Estimated application time: 6 to 8 minutes.

    Pre-post intervention assessment, after 12 weeks.

  • Disordered Eating Behaviors.

    A scale called "Three-Factor Eating Questionnaire-R18 (TFEQ-R18)", that is validated on mexican population to mesure Disordered Eating Behaviors on three dimennsions, 1) Cognitive Restraint. 2) Emotional Eating. 3) Uncontrolled Eating. Scores range from min-18 to max-72, normal score ranges from 2.1 to 2.9. Reactives: 18. Estimated application time: 6 to 8 minutes.Estimated application time: 6 to 8 minutes.

    Pre-post intervention assessment, after 12 weeks.

  • Anxiety Symtoms.

    Anxiety Beck inventory, adapted and validated version to Mexican population, will be used. Scores range from 0 min-63 max. Normal score ranges ≤12.

    Pre-post intervention assessment, after 12 weeks

  • Depression Symtoms.

    Beck Depression inventory, adapted and validated version to Mexican population, will be used. Scores range from 0 min-63 max. Normal score ranges ≤10.

    Pre-post intervention assessment, after 12 weeks.

  • Inhibitory Control

    Stroop test, will be measured from the standardized executive function test BANFE, using accuracy of response, stroop type error, no-Stroop errors, and time, Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

    Pre-post intervention assessment, after 12 weeks.

  • Cognitive Flexibility

    Card Sorting Test, will be measured from the standardized executive function test BANFE, using accurcy of response, perseverations, time, and errors. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

    Pre-post intervention assessment, after 12 weeks.

  • Social Cognition

    Index from computarized adapted version of the Mind in the Eyes test, index 0 (min) - 36 (max) score, expected score ranges from 25-36.

    Pre-post intervention assessment, after 12 weeks.

  • Perceived Stress

    Perceived Stress Scale (PSS), for mexican population. Scores range from min-3 to max-46, normal score ranges from 2.1 to 2.9. Estimated application time: 2 to 4 minutes.

    Pre-post intervention assessment, after 12 weeks.

  • Body image satisfaction

    Body Shape Questionnaire (BSQ). Scores range from 18 min-108max, normal score ranges from ≤80. Estimated application time: 5 to 7 minutes.

    Time Frame: Pre-post intervention assessment, after 12 weeks.

  • Neuroelectrical activity.

    Global Brain Activity (GBA) electroencephalography neurophysiological recording of each participant will be performed, using food pictures taken from selected from the International Affective Picture System (IAPS) in an artifact-free room using a 14-channel Emotiv EPOC. Only 8 channels are going to be monitorized: Fp1, Fp2, F3, F4, F7, F8, P3 \& P4, and only frequencies between 8-12, and 13 to 30, for Alpha and Beta, respectively. On Alpha frecuencies we are looking for Alpha suppression, desynchronization, when viewing food cues, interpreted as increased attentional engagement, while on Beta Higher power in frontal areas, linked to reward sensitivity, cognitive control, or arousal. The datasets will be stored in the research mainframe for subsequent property extraction and offline analysis using artificial intelligence tools and techniques.

    Pre-post intervention assessment, after 12 weeks

Study Arms (2)

Direct intervention over outcomes.

EXPERIMENTAL
Behavioral: A Psychological Flexibility Skills Training based on ACT.

Wait list

NO INTERVENTION

No intervention.

Interventions

Based on ACT procesess; defusion, presence, acceptance, perspective taking, values and commited action.

Direct intervention over outcomes.

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 30 years old.
  • Currently enrrolled in university studies.
  • Attend at least 80% of the intervention sessions.

You may not qualify if:

  • Having a diagnosis of personality disorder.
  • Failure to attend post-assessment.
  • Currently attending psychological therapy or psychiatric care..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full time Professor

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

March 15, 2027

Last Updated

April 1, 2026

Record last verified: 2026-02