Clinical trial NCT07020403: Mindfulness-Based Emotional Eating Intervention Program
Official title: Development and Evaluation of a Mindfulness-Based on Emotional Eating Reduction Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Eating
Keywords: Emotional Eating
Mindfulness
Emotional Appetite
Mindful Eating
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted using a parallel-group experimental design with random assignment. Participants were divided into an intervention group and a control group. The intervention group received a 7-week Mindfulness-Based Emotional Eating Reduction (MB-EER) Program, while the control group received no intervention. Assessments were conducted at pre-test, post-test, and 3-month follow-up.
Primary purpose: OTHER

Brief summary: This study aims to develop and evaluate the effectiveness of a mindfulness-based intervention program called the Mindfulness-Based Emotional Eating Reduction (MB-EER) Program. The program is designed to reduce emotional eating behaviors in adults. Participants were randomly assigned to either an intervention group or a control group. The intervention group attended a 7-week online program with weekly sessions that included psychoeducation, mindfulness exercises (such as body scan and breath awareness), experiential activities, and group discussions. Data were collected at three time points: before the intervention, after the 7th week, and at a 3-month follow-up. Emotional eating, mindful eating, and emotional appetite levels were measured. Results showed that the MB-EER program effectively reduced emotional eating and emotional appetite while increasing mindful eating.

Detailed description: This study aims to develop and evaluate a mindfulness-based intervention program (MB-EER) designed to reduce emotional eating behavior. The program was structured based on needs analyses conducted with experts and individuals with emotional eating experiences.

The MB-EER Program consists of 7 weekly sessions, each lasting approximately 2 hours, conducted online. Each session includes psychoeducational content, mindfulness-based practices (e.g., breath awareness, body scan), experiential activities, and group sharing.

Session Overview:

Focus on How You Eat - Differentiating emotional eating from physical hunger; raisin exercise

Recognizing Autopilot - Emotional triggers and automatic eating behaviors

Attention to Cues - Internal and external stimuli influencing eating behavior

Hunger and Fullness Signals - Awareness of body signals; water-drinking practice

Body Awareness and Self-Compassion - Developing supportive attitudes toward the body

Cultural Beliefs and Eating History - Social rules and learned eating habits

Maintenance and Reflection - Ensuring sustainability of skills, personal awareness

Research Design:

This study used a mixed-methods design, including both the development and experimental evaluation of the program:

Program Development Phase

Experimental Evaluation Phase

Quantitative design:

The experimental phase used a true experimental pre-test-post-test-follow-up control group design. Qualitative data were embedded throughout the process using semi-structured forms.

Participant Selection and Assignment:

Out of 135 initial applicants, Emotional Eating Scale (EES) scores were calculated and converted into Z scores using SPSS, since the scale lacks a clinical cut-off. 91 participants falling within ±2 SD were considered eligible and assessed for exclusion criteria.

8 individuals were excluded due to diagnosed eating disorders (e.g., bulimia, binge eating)

12 were excluded due to chronic conditions affecting appetite regulation (e.g., Hashimoto's, diabetes, thyroid)

2 individuals could not commit to the program

From the remaining 69 eligible participants, 40 were randomly assigned into experimental and control groups (20 each). However, due to dropouts during the process:

15 participants in the experimental group

15 participants in the control group completed the full study process and provided data at all time points.

Implementation:

The MB-EER program was delivered to the experimental group by the lead researcher.

Sessions were held online (Zoom) over 7 weeks, once per week.

The control group received no intervention.

All participants completed measurements at three points:

Pre-test (before the intervention)

Post-test (end of Week 7)

Follow-up test (3 months later)

Data Collection Instruments:

Emotional Eating Scale (EES-30)

Mindful Eating Scale (MES-30)

Emotional Appetite Questionnaire (EAQ-22)

Data Analysis:

Quantitative data were analyzed using SPSS v26.0

Parametric tests were used as normality assumptions were met

Statistical procedures included:

Two-factor mixed ANOVA

Wilks' Lambda multivariate repeated measures (MANOVA)

Bonferroni-adjusted pairwise comparisons

Qualitative data were evaluated using content and descriptive analysis

Findings:

The main hypothesis of the study was that the MB-EER Program is effective in reducing emotional eating and emotional appetite and improving mindful eating. This hypothesis was tested by comparing pre-, post-, and follow-up scores between experimental and control groups.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and older

Individuals reporting high levels of emotional eating

Willingness to participate in a 7-week online intervention program

Access to a computer and stable internet connection

Completion of informed consent form

Exclusion Criteria:

* Current diagnosis of an eating disorder (e.g., bulimia nervosa, binge eating disorder)

Diagnosis of a chronic medical condition that affects appetite (e.g., diabetes, thyroid disorders such as Hashimoto's disease)

Pregnancy

Inability to commit to regular attendance in the 7-week program

Participation in another psychological intervention during the study period

Primary outcomes:
measure: Change in Emotional Eating Score (EES-30) from Baseline to Follow-up
timeFrame: Change from Baseline (Week 0) to Post-test (Week 7) and Follow-up (Week 12)
measure: Mindful eating questionnaire (MEQ-30)
timeFrame: Change from Baseline (Week 0) to Post-test (Week 7) and Follow-up (Week 12)
measure: Emotional appetite questionnaire (EAQ-22)
timeFrame: Change from Baseline (Week 0) to Post-test (Week 7) and Follow-up (Week 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Duzce
country: Turkey
facility: Duzce University
state: Center
Study officials:
affiliation: tugbacolak@duzce.edu.tr
name: Tuğba Seda Çolak Turan
role: PRINCIPAL_INVESTIGATOR
References: