- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351214
THE EFFECT OF MOTİVATİONAL INTERVİEWİNG-BASED MİNDFULNESS INTERVENTION ON WEİGHT MANAGEMENT AFTER WEİGT LOSS,7SLİMMİNG SURGERY: A RANDOMİZED CONTROLLED TRIAL.
THE EFFECT OF A MOTİVATİONAL İNTERVİEWİNG-BASED MİNDFULNESS İNTERVENTİON ON WEİGHT CONTROL AFTER BARİATRİC SURGERY: A RANDOMİZED CONTROLLED TRİAL.
Obesity is one of the most critical health problems in developed and developing countries, recognized as a chronic disease that adversely affects both individual and societal health. The World Health Organization (WHO) and other health authorities classify obesity based on Body Mass Index (BMI). Individuals with a BMI above 30 are categorized as obese, while those with a BMI above 40 are considered severely obese. Global statistics show a rapid increase in obesity prevalence, predicting that the number of obese individuals will reach 1.53 billion by 2035. In Turkey, the rate of women with high BMI has risen to 76%, and obesity prevalence has surpassed 30%.
Obesity is caused by unhealthy dietary habits, physical inactivity, genetic predisposition, and environmental factors, leading to serious health problems such as diabetes, hypertension, and cardiovascular diseases. Treatment methods include diet, exercise, medication, behavioral therapies, and surgical interventions. However, post-surgery patients are at risk of regaining lost weight if they fail to regulate their eating behaviors.
In recent years, motivational interviewing and mindfulness-based interventions have come to the forefront in obesity treatment. Motivational interviewing is an evidence-based technique that supports behavioral change by enhancing an individual's intrinsic motivation. Mindfulness-based approaches have proven effective in emotional regulation, stress management, and improving eating behaviors. Research has shown that these methods help post-bariatric surgery patients adjust their eating habits, maintain weight control, and improve their quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Baskent University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Literacy,
- Being between 18-65 years old,
- Regaining 5% or more of the minimum weight achieved at least 6 months after the surgery.
Exclusion Criteria:
- Having a diagnosed cognitive or psychiatric illness that would make it difficult for them to understand and adapt to the training content
- Having previously received cognitive awareness training
- Having undergone revision surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Group
a mindfulness initiative based on motivational interviewing: Motivational interviewing over the phone three times, Mindfulness practices are face to face once a week for 8 weeks
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Awareness initiatives were conducted face-to-face with 31 patients once a week for 8 weeks.
Other Names:
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No Intervention: Control Group
standard training in an obesity clinic: In an obesity clinic, standard follow-up training is provided once a month by a dietitian, psychologist, nurse, and physiotherapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in weight loss maintenance awareness
Time Frame: Baseline and at 8 weeks after the intervention
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Awareness related to weight loss maintenance will be assessed using a validated awareness questionnaire administered by a trained researcher.
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Baseline and at 8 weeks after the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA25/84
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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