- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461740
Effect of a Mindful Eating Education Program on Mindful Eating, Hedonic Hunger, and Anthropometric Measures in Obese Individuals With High Hedonic Hunger
The Impact of Mindful Eating Education on Hedonic Hunger in Obese Adults
The aim of this clinical trial is to evaluate the effect of mindful eating training on mindful eating behaviors and hedonic hunger levels in adults with obesity.
The primary research questions are as follows:
- Does mindful eating training combined with a weight loss diet improve mindful eating behaviors?
- Does mindful eating training combined with a weight loss diet reduce hedonic hunger levels?
- Does mindful eating training combined with a weight loss diet lead to changes in anthropometric measurements?
Researchers compared participants receiving a weight loss diet alone (control group) with those receiving mindful eating training in addition to a weight loss diet (intervention group) to determine differences in mindful eating behaviors, hedonic hunger scores, and anthropometric measurements.
Participants who are already enrolled in a weight loss diet program was invited to participate in a mindful eating training program.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Adana, Turkey (Türkiye)
- Kozan Healthy Living Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being at the range of 18-65 years,
- Having a BMI over 30.0 kg/m2,
- Being able to read and communicate in Turkish
- Available to attend repeated follow-up sessions.
Exclusion Criteria:
- Being pregnant, lactating, or postmenopausal
- Diagnosed with a chronic disease other than obesity
- Receiving medical nutrition therapy other than a weight-loss diet
- Having a history of eating disorders or any psychiatric disease affecting eating behavior and emotional responses within the last two years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
Participants in the control group were adults with obesity who were already enrolled in a structured weight loss diet program.
They continued their diet as planned without receiving mindful eating training.
Outcome measures, including mindful eating scores, hedonic hunger, and anthropometric measurements, assessed at baseline and at the end of the study period.
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Experimental: Intervention
Participants in the intervention group were adults with obesity who were already enrolled in a structured weight loss diet program.
In addition to continuing their diet, they participated in a structured mindful eating training program.
The training focused on awareness of hunger and satiety cues, recognition of emotional and hedonic triggers for eating, and mindful food consumption practices.
Outcome measures, including mindful eating scores, hedonic hunger, and anthropometric measurements, assessed at baseline and at the end of the study period.
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The mindful eating training was delivered once a week for 4 weeks, with each session lasting 50-60 minutes.
Weekly homework assignments were given to reinforce the training and increase retention.
During the intervention period, the control group continued their weight loss diet program, which had been planned with a dietitian prior to the study.
The mindful eating training sessions focused on increasing awareness of hunger and satiety cues, identifying emotional triggers for eating, and promoting mindful food consumption practices.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in mindful eating questionnaire scores from baseline to the end of the study
Time Frame: From enrollment to the eight weeks after the end of the intervention
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Mindful eating assessed using the validated Turkish version of the Mindful Eating Questionnaire (MEQ) to evaluate changes in participants' eating awareness and eating behaviors during the study period.
The scale consists of 30 items rated on a 5-point Likert scale.
Total and subscale scores are calculated as the mean of the item scores.
The total score ranges from 1 to 5, with higher scores indicating greater levels of mindful eating.
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From enrollment to the eight weeks after the end of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in power of food scale score from baseline to the end of the study
Time Frame: From enrollment to eight weeks after the end of the intervention
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Hedonic hunger assessed using the validated Turkish version of the Power of Food Scale (PFS) to evaluate participants' responsiveness to food cues and changes in hedonic hunger over the study period.
The scale consists of 15 items rated on a 5-point Likert scale.
Total and subscale scores are calculated as the mean of the item scores.
The total score ranges from 1 to 5, with higher scores indicating greater hedonic hunger.
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From enrollment to eight weeks after the end of the intervention
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Change in body weight from baseline to the end of the study
Time Frame: From enrollment to eight weeks after the end of the intervention
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Body weight measured in kilograms using a calibrated digital scale to evaluate changes in participants' body weight over the study period. Unit of measure: kg |
From enrollment to eight weeks after the end of the intervention
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Changes in waist circumference from baseline to the end of the study
Time Frame: From enrollment to eight weeks after the end of the intervention
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Waist circumference measured in centimeters using a non-stretchable measuring tape at a standardized anatomical site to evaluate changes in participants' waist circumference over the study period. Units of measure: cm |
From enrollment to eight weeks after the end of the intervention
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Change in hip circumference from baseline to the end of the study
Time Frame: From enrollment to eight weeks after the end of the intervention
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Hip circumference measured in centimeters using a non-stretchable measuring tape at a standardized anatomical site to evaluate changes in participants' hip circumference over the study period.
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From enrollment to eight weeks after the end of the intervention
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Change in body mass index from baseline to the end of the study
Time Frame: From enrollment to eight weeks after the end of the intervention
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Body mass index (BMI) calculated as weight in kilograms divided by height in meters squared to evaluate changes in participants' BMI over the study period. Unit of measure: kg/m² |
From enrollment to eight weeks after the end of the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ARMAĞAN AYTUĞ YÜRÜK, PhD, TC Erciyes University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/411
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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