Minfulness-Based Training Program in Bariatric Surgery Patients

NCT ID: NCT05992662

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2024-02-29

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.

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)

Conditions

Bariatric Surgery Candidate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Mindfulness-Based Training Programme in Bariatric Surgey Patients

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Defne Dizlek

Research Asssistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Defne Dizlek Bayraktar

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Emine Catal

Role: STUDY_CHAIR

Akdeniz University

Huseyin Ciyiltepe

Role: STUDY_DIRECTOR

Antalya Training and Research Hospital

Locations

Antalya Training and Research Hospital

Antalya, Konyaalti, Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

AkdenizBariatricSurgery

Identifier Type: -

Identifier Source: org_study_id