Minfulness-Based Training Program in Bariatric Surgery Patients

Sponsor

Akdeniz University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05992662

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate	Behavioral: Mindfulness-Based Training Programme in Bariatric Surgey Patients	N/A

Detailed 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)

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 2, 2022

Actual Primary Completion Date :

Dec 24, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group In this research, the training program was designed as an intervention. Summary of the research's implementation plan: Preparation of Mindfulness-based training program in bariatric surgery Inviting adult individuals to participate in the research before bariatric surgery and reaching the targeted number of participants Participants who agreed to participate in the study fill out the individual introduction form, complete the short story, and administer the Mindful Eating Questionnaire to the participants Conducting mindfulness-based 4-session training program Focus group discussion after the training Reminder of weekly practices Recording changes in mindful eating in participant experience diaries during the follow-up At the end of the monitoring phase (3rd-6th months), individual in-depth interviews and Mindful Eating Questionnaires are conducted with each participant in the action group	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
No Intervention: Control Group Mindful Eating Questionnaire will be applied before the surgery, at the 3rd and 6th months after the surgery. No intervention will be applied to the control group.

Arm

Intervention/Treatment

Experimental: Intervention Group

In this research, the training program was designed as an intervention. Summary of the research's implementation plan: Preparation of Mindfulness-based training program in bariatric surgery Inviting adult individuals to participate in the research before bariatric surgery and reaching the targeted number of participants Participants who agreed to participate in the study fill out the individual introduction form, complete the short story, and administer the Mindful Eating Questionnaire to the participants Conducting mindfulness-based 4-session training program Focus group discussion after the training Reminder of weekly practices Recording changes in mindful eating in participant experience diaries during the follow-up At the end of the monitoring phase (3rd-6th months), individual in-depth interviews and Mindful Eating Questionnaires are conducted with each participant in the action group

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

No Intervention: Control Group

Mindful Eating Questionnaire will be applied before the surgery, at the 3rd and 6th months after the surgery. No intervention will be applied to the control group.

Outcome Measures

Primary Outcome Measures

Mindful Eating [Before the surgery, 3. and 6. Months after the surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antalya Training and Research Hospital	Antalya	Konyaalti	Turkey	07070

Sponsors and Collaborators

Akdeniz University

Investigators

Principal Investigator: Defne Dizlek Bayraktar, Akdeniz University
Study Chair: Emine Catal, Akdeniz University
Study Director: Huseyin Ciyiltepe, Antalya Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Defne Dizlek, Research Asssistant, Akdeniz University

ClinicalTrials.gov Identifier:

NCT05992662

Other Study ID Numbers:

AkdenizBariatricSurgery

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 18, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Defne Dizlek, Research Asssistant, Akdeniz University

Study Results

No Results Posted as of Aug 18, 2023