Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT07020403
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.
Study:
NCT07020403
Study Brief:
Protocol Section:
NCT07020403