NCT07374770

Brief Summary

In recent years, the increasing interest in healthy eating and access to "pure" foods has led to the widespread adoption of selective and control-oriented eating attitudes. In some individuals, this situation has contributed to an increase in tendencies toward Orthorexia Nervosa (ON), in which the pursuit of healthy eating takes on a pathological dimension. ON is characterized by perfectionism related to healthy eating, intense anxiety, cognitive rigidity, and, over time, the development of guilt, avoidance behaviors, and social restriction. The promotion of such behaviors through media and social media further hinders the recognition of ON and facilitates its hidden spread. The concept of mindfulness, which has gained prominence in recent years, aims to help individuals observe bodily sensations, emotional responses, and thoughts that arise during the eating process with a nonjudgmental awareness. In the literature, the relationship between ON and mindfulness has mostly been examined through cross-sectional studies, while intervention-based studies targeting orthorexic individuals remain limited. The aim of this study is to examine the effects of a mindfulness-based eating behavior training program developed for orthorexic individuals on eating attitudes. The study will be conducted using a randomized controlled experimental design within the framework of an original program developed with contributions from expert researchers in the fields of psychology and nutrition. The effects of the training program applied to the intervention group will be evaluated comparatively with those of the control group. Data obtained from the study will be analyzed using SPSS, RStudio, and JASP software packages. The distributional properties of the variables will be examined using visual and analytical methods. Group comparisons, changes over time, and group-by-time interaction effects will be analyzed using appropriate parametric and nonparametric statistical methods, and the level of statistical significance will be set at p \< 0.05.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

January 11, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 10, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

January 11, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

eating disordersmindfullness

Outcome Measures

Primary Outcomes (1)

  • Number of participants who completed the training program

    Completion is defined as full participation in all components of the education program during the study period.

    Approximately 6-8 weeks after the initiation of the study

Secondary Outcomes (1)

  • Proportion of participants who completed the six-week training program

    approximately 6-8 weeks after the initiation of the study

Study Arms (2)

Education group

EXPERIMENTAL

Education group: Participants assigned to the education group will receive structured educational sessions related to the study topic

Behavioral: Mindfulness based nutrition education intervention

Control group

NO INTERVENTION

Control group: Participants assigned to the control group will receive standard of care and will not receive the investigational intervention.

Interventions

This study will be conducted using a randomized controlled experimental design. Participants will be randomly assigned to an intervention group and a control group. Individuals in the intervention group will receive a mindfulness-based eating behavior training program delivered over a six-week period, while the control group will not receive any intervention during this time. Pre- and post-intervention assessments will be administered to both groups to evaluate changes in eating-related outcomes.

Education group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with the cognitive capacity to understand the online questionnaires and the training program
  • Access to the internet
  • Score 30 or higher on the Düsseldorf Orthorexia Scale (DOS)

You may not qualify if:

  • Presence of any neuropsychiatric disorder
  • Diagnosed eating disorder
  • Current participation in a mindfulness-based intervention
  • Score below 30 on the Düsseldorf Orthorexia Scale (DOS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya Uni

Amasya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Orthorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Prof

Study Record Dates

First Submitted

January 11, 2026

First Posted

January 29, 2026

Study Start (Estimated)

July 10, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations