Minfulness-Based Training Program in Bariatric Surgery Patients

Bariatric Surgery Candidate Clinical Trial

Official title:

Mindfulness-Based Training Program in Bariatric Surgery Patients: An Action Research

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05992662
• Other study ID #: AkdenizBariatricSurgery
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bariatric surgery maintains its place in the literature as the most effective treatment method for obesity. In order for the surgery to be effective, it is important for individuals to adapt to the surgical process. This process has become more manageable with lifestyle changes and health education. Mindfulness practices are (useful forms of intervention) for practicing and restructuring the brain for healthier eating habits. The results of mindfulness studies show that mindful eating practices can be effective in the prevention and treatment of obesity. Studies on mindfulness in obesity are increasing rapidly in the literature; however, few studies have tested this approach in bariatric surgery patients. This research was planned in an action research design to examine the effect of mindfulness-based education program on individuals' mindful eating in bariatric surgery patients. As an action in the research, an mindfullness-based training program will be developed for the bariatric patient group. Then, in the preoperative period, a four-week, weekly session of mindfulness-based exercise and eating training will be given to the action group as an intervention. Mindful Eating Questionnaire will be applied to all participants (action and control group) before the training, and data will be collected from the action group with the vignette technique. A short cut story will be prepared, and the participants will be asked to complete the short story in written form. At the end of the training sessions, a focus group discussion will be held with the participants. An in-depth interview will be conducted with each participant in line with the semi-structured interview form in the third and sixth months after the surgery. The Mindful Eating Questionnaire will be readministered to both the action group and the control group. During and after the training, participants will be asked to write down any changes they notice in their diaries. In the research, quantitative data will be evaluated with descriptive statistical tests, and qualitative data will be evaluated with content analysis, descriptive and thematic analysis. As a result of the research, it is aimed to improve the mindful eating of the participants. It is anticipated that the research will increase the mindfulness level of the participants in their lives and contribute to future research.

Description:

This research was planned in an action research design to examine the effect of mindfulness-based training program on individuals' mindful eating in bariatric surgery patients. As an action in the research, an mindfullness-based training program will be developed for the bariatric patient group. Then, in the preoperative period, a four-week, weekly session of mindfulness-based exercise and eating training will be given to the action group as an intervention. Mindful Eating Questionnaire will be applied to all participants (action and control group) before the training, and data will be collected from the action group with the vignette technique. A short cut story will be prepared, and the participants will be asked to complete the short story in written form. At the end of the training sessions, a focus group discussion will be held with the participants. An in-depth interview will be conducted with each participant in line with the semi-structured interview form in the third and sixth months after the surgery. The Mindful Eating Questionnaire will be readministered to both the action group and the control group. During and after the training, participants will be asked to write down any changes they notice in their diaries. In the research, quantitative data will be evaluated with descriptive statistical tests, and qualitative data will be evaluated with content analysis, descriptive and thematic analysis. As a result of the research, it is aimed to improve the mindful eating of the participants. It is anticipated that the research will increase the mindfulness level of the participants in their lives and contribute to future research. In this research, the training program was designed as an intervention. The training program consists of preparation, implementation, follow-up, and evaluation phases. The implementation plan of the research is summarized below: PREPARATION PHASE Preparation of Mindfulness-based training program in bariatric surgery Inviting adult individuals to participate in research before bariatric surgery and reaching the targeted number of participants. - Participants who agreed to participate in the study should fill out the individual introduction form, complete the cut short story, and apply the Mindful Eating Questionnaire to the participants. - Application of the Mindful Eating Questionnaire to the Control Group ACTION - Conducting mindfulness-based 4-session training program - Focus group discussion after the training FOLLOW-UP PHASE (3rd MONTH/6.MONTH POSTOPERATIVE) - Reminder of weekly practices - Recording changes in mindful eating in participant experience diaries during the follow-up DATA COLLECTION - Individual in-depth interviews with each of the participants in the action group at the end of the follow-up phase (3rd and 6th months) - At the end of the follow-up period, re-administration of the Mindful Eating Questionnaire to both the action and control groups (3rd and 6th months)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: February 2024
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• People who agreed to participate in the research.
• Being included in the bariatric surgery list
• Over 18 years of age old
• Able to understand, speak and write Turkish.
• No cognitive problem in self-expression
• To be able to use the WhatsApp application effectively.
• Absence of alcohol or substance abuse
• No diagnosed psychotic and depressive disorder

Exclusion Criteria:

• Declaring that he will not continue the research at any stage of the research
• Not participating in the entire training program.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Behavioral:
• Mindfulness-Based Training Programme in Bariatric Surgey Patients
ACTION Conducting mindfulness-based 4-session training program Focus group discussion after the training Within the scope of mindfulness-based training: Mindful Eating practices; qigong exercises; meditation exercises; breathing exercises; training specific to the bariatric surgery process was given. FOLLOW-UP PHASE (3rd MONTH/6.MONTH POSTOPERATIVE) Reminder of weekly practices Recording changes in mindful eating in participant experience diaries during the follow-up

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya	Konyaalti

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (22)

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Lyzwinski LN, Caffery L, Bambling M, Edirippulige S. The Mindfulness App Trial for Weight, Weight-Related Behaviors, and Stress in University Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 10;7(4):e12210. doi: 10.2196/12210. — View Citation

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Sairanen E, Tolvanen A, Karhunen L, Kolehmainen M, Jarvela E, Rantala S, Peuhkuri K, Korpela R, Lappalainen R. Psychological flexibility and mindfulness explain intuitive eating in overweight adults. Behav Modif. 2015 Jul;39(4):557-79. doi: 10.1177/0145445515576402. Epub 2015 Mar 25. — View Citation

Sarwer DB, Dilks RJ, West-Smith L. Dietary intake and eating behavior after bariatric surgery: threats to weight loss maintenance and strategies for success. Surg Obes Relat Dis. 2011 Sep-Oct;7(5):644-51. doi: 10.1016/j.soard.2011.06.016. Epub 2011 Jul 13. — View Citation

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Zunker C, Karr T, Saunders R, Mitchell JE. Eating behaviors post-bariatric surgery: a qualitative study of grazing. Obes Surg. 2012 Aug;22(8):1225-31. doi: 10.1007/s11695-012-0647-7. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mindful Eating	Mindful Eating Questionnaire There are 5 sub-factors in a 4-point Likert-type scale with 28 questions, the original name of which is the Mindful Eating Questionnaire (MEQ). The association between MEQ and eating behavior and emotional state can be carefully questioned. MEQ has been proposed by Framson et al. (2009) as a useful weight loss tool that has created non-judgmental awareness of physical and emotional sensations associated with eating. The validity and reliability analyze of the Mindful Eating Questionnaire (MEQ) for the Turkish sample were performed by Köse et al.	Before the surgery, 3. and 6. Months after the surgery