xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05992662</url>
    </required_header>
    <id_info>
      <org_study_id>AkdenizBariatricSurgery</org_study_id>
      <nct_id>NCT05992662</nct_id>
    </id_info>
    <brief_title>Minfulness-Based Training Program in Bariatric Surgery Patients</brief_title>
    <official_title>Mindfulness-Based Training Program in Bariatric Surgery Patients: An Action Research</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Akdeniz University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Akdeniz University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Bariatric surgery maintains its place in the literature as the most effective treatment&#xD;
        method for obesity. In order for the surgery to be effective, it is important for individuals&#xD;
        to adapt to the surgical process. This process has become more manageable with lifestyle&#xD;
        changes and health education. Mindfulness practices are (useful forms of intervention) for&#xD;
        practicing and restructuring the brain for healthier eating habits. The results of&#xD;
        mindfulness studies show that mindful eating practices can be effective in the prevention and&#xD;
        treatment of obesity. Studies on mindfulness in obesity are increasing rapidly in the&#xD;
        literature; however, few studies have tested this approach in bariatric surgery patients.&#xD;
        This research was planned in an action research design to examine the effect of&#xD;
        mindfulness-based education program on individuals' mindful eating in bariatric surgery&#xD;
        patients. As an action in the research, an mindfullness-based training program will be&#xD;
        developed for the bariatric patient group. Then, in the preoperative period, a four-week,&#xD;
        weekly session of mindfulness-based exercise and eating training will be given to the action&#xD;
        group as an intervention. Mindful Eating Questionnaire will be applied to all participants&#xD;
        (action and control group) before the training, and data will be collected from the action&#xD;
        group with the vignette technique. A short cut story will be prepared, and the participants&#xD;
        will be asked to complete the short story in written form. At the end of the training&#xD;
        sessions, a focus group discussion will be held with the participants. An in-depth interview&#xD;
        will be conducted with each participant in line with the semi-structured interview form in&#xD;
        the third and sixth months after the surgery. The Mindful Eating Questionnaire will be&#xD;
        readministered to both the action group and the control group. During and after the training,&#xD;
        participants will be asked to write down any changes they notice in their diaries. In the&#xD;
        research, quantitative data will be evaluated with descriptive statistical tests, and&#xD;
        qualitative data will be evaluated with content analysis, descriptive and thematic analysis.&#xD;
        As a result of the research, it is aimed to improve the mindful eating of the participants.&#xD;
        It is anticipated that the research will increase the mindfulness level of the participants&#xD;
        in their lives and contribute to future research.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research was planned in an action research design to examine the effect of&#xD;
        mindfulness-based training program on individuals' mindful eating in bariatric surgery&#xD;
        patients. As an action in the research, an mindfullness-based training program will be&#xD;
        developed for the bariatric patient group. Then, in the preoperative period, a four-week,&#xD;
        weekly session of mindfulness-based exercise and eating training will be given to the action&#xD;
        group as an intervention. Mindful Eating Questionnaire will be applied to all participants&#xD;
        (action and control group) before the training, and data will be collected from the action&#xD;
        group with the vignette technique. A short cut story will be prepared, and the participants&#xD;
        will be asked to complete the short story in written form. At the end of the training&#xD;
        sessions, a focus group discussion will be held with the participants. An in-depth interview&#xD;
        will be conducted with each participant in line with the semi-structured interview form in&#xD;
        the third and sixth months after the surgery. The Mindful Eating Questionnaire will be&#xD;
        readministered to both the action group and the control group. During and after the training,&#xD;
        participants will be asked to write down any changes they notice in their diaries. In the&#xD;
        research, quantitative data will be evaluated with descriptive statistical tests, and&#xD;
        qualitative data will be evaluated with content analysis, descriptive and thematic analysis.&#xD;
        As a result of the research, it is aimed to improve the mindful eating of the participants.&#xD;
        It is anticipated that the research will increase the mindfulness level of the participants&#xD;
        in their lives and contribute to future research.&#xD;
  &#xD;
        In this research, the training program was designed as an intervention. The training program&#xD;
        consists of preparation, implementation, follow-up, and evaluation phases. The implementation&#xD;
        plan of the research is summarized below:&#xD;
  &#xD;
        PREPARATION PHASE Preparation of Mindfulness-based training program in bariatric surgery&#xD;
        Inviting adult individuals to participate in research before bariatric surgery and reaching&#xD;
        the targeted number of participants.&#xD;
  &#xD;
          -  Participants who agreed to participate in the study should fill out the individual&#xD;
             introduction form, complete the cut short story, and apply the Mindful Eating&#xD;
             Questionnaire to the participants.&#xD;
  &#xD;
          -  Application of the Mindful Eating Questionnaire to the Control Group&#xD;
  &#xD;
        ACTION&#xD;
  &#xD;
          -  Conducting mindfulness-based 4-session training program&#xD;
  &#xD;
          -  Focus group discussion after the training&#xD;
  &#xD;
        FOLLOW-UP PHASE (3rd MONTH/6.MONTH POSTOPERATIVE)&#xD;
  &#xD;
          -  Reminder of weekly practices&#xD;
  &#xD;
          -  Recording changes in mindful eating in participant experience diaries during the&#xD;
             follow-up&#xD;
  &#xD;
        DATA COLLECTION&#xD;
  &#xD;
          -  Individual in-depth interviews with each of the participants in the action group at the&#xD;
             end of the follow-up phase (3rd and 6th months)&#xD;
  &#xD;
          -  At the end of the follow-up period, re-administration of the Mindful Eating&#xD;
             Questionnaire to both the action and control groups (3rd and 6th months)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 2, 2022</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Actual">December 24, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mindful Eating</measure>
      <time_frame>Before the surgery, 3. and 6. Months after the surgery</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">15</enrollment>
    <condition>Bariatric Surgery Candidate</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this research, the training program was designed as an intervention.&#xD;
  Summary of the research's implementation plan:&#xD;
  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</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mindfulness-Based Training Programme in Bariatric Surgey Patients</intervention_name>
      <description>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.&#xD;
  FOLLOW-UP PHASE (3rd MONTH/6.MONTH POSTOPERATIVE)&#xD;
  Reminder of weekly practices&#xD;
  Recording changes in mindful eating in participant experience diaries during the follow-up</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People who agreed to participate in the research.&#xD;
  &#xD;
            -  Being included in the bariatric surgery list&#xD;
  &#xD;
            -  Over 18 years of age old&#xD;
  &#xD;
            -  Able to understand, speak and write Turkish.&#xD;
  &#xD;
            -  No cognitive problem in self-expression&#xD;
  &#xD;
            -  To be able to use the WhatsApp application effectively.&#xD;
  &#xD;
            -  Absence of alcohol or substance abuse&#xD;
  &#xD;
            -  No diagnosed psychotic and depressive disorder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Declaring that he will not continue the research at any stage of the research&#xD;
  &#xD;
            -  Not participating in the entire training program.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Defne Dizlek Bayraktar</last_name>
      <role>Principal Investigator</role>
      <affiliation>Akdeniz University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Emine Catal</last_name>
      <role>Study Chair</role>
      <affiliation>Akdeniz University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Huseyin Ciyiltepe</last_name>
      <role>Study Director</role>
      <affiliation>Antalya Training and Research Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Antalya Training and Research Hospital</name>
        <address>
          <city>Antalya</city>
          <state>Konyaalti</state>
          <zip>07070</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Abiles V, Rodriguez-Ruiz S, Abiles J, Mellado C, Garcia A, Perez de la Cruz A, Fernandez-Santaella MC. Psychological characteristics of morbidly obese candidates for bariatric surgery. Obes Surg. 2010 Feb;20(2):161-7. doi: 10.1007/s11695-008-9726-1. Epub 2008 Oct 29.</citation>
      <PMID>18958537</PMID>
    </reference>
    <reference>
      <citation>Baig SJ, Priya P, Mahawar KK, Shah S; Indian Bariatric Surgery Outcome Reporting (IBSOR) Group. Weight Regain After Bariatric Surgery-A Multicentre Study of 9617 Patients from Indian Bariatric Surgery Outcome Reporting Group. Obes Surg. 2019 May;29(5):1583-1592. doi: 10.1007/s11695-019-03734-6.</citation>
      <PMID>30729366</PMID>
    </reference>
    <reference>
      <citation>Caldwell AE, Purcell SA, Gray B, Smieja H, Catenacci VA. The impact of yoga on components of energy balance in adults with overweight or obesity: A systematic review. Obes Sci Pract. 2021 Aug 19;8(2):219-232. doi: 10.1002/osp4.552. eCollection 2022 Apr.</citation>
      <PMID>35388342</PMID>
    </reference>
    <reference>
      <citation>Carbone F, Adami G, Liberale L, Bonaventura A, Bertolotto M, Andraghetti G, Scopinaro N, Camerini GB, Papadia FS, Cordera R, Dallegri F, Montecucco F. Serum levels of osteopontin predict diabetes remission after bariatric surgery. Diabetes Metab. 2019 Sep;45(4):356-362. doi: 10.1016/j.diabet.2018.09.007. Epub 2018 Sep 27.</citation>
      <PMID>30268840</PMID>
    </reference>
    <reference>
      <citation>Chacko SA, Yeh GY, Davis RB, Wee CC. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial. Complement Ther Med. 2016 Oct;28:13-21. doi: 10.1016/j.ctim.2016.07.001. Epub 2016 Jul 12.</citation>
      <PMID>27670865</PMID>
    </reference>
    <reference>
      <citation>Dunn C, Haubenreiser M, Johnson M, Nordby K, Aggarwal S, Myer S, Thomas C. Mindfulness Approaches and Weight Loss, Weight Maintenance, and Weight Regain. Curr Obes Rep. 2018 Mar;7(1):37-49. doi: 10.1007/s13679-018-0299-6.</citation>
      <PMID>29446036</PMID>
    </reference>
    <reference>
      <citation>Lauti M, Kularatna M, Hill AG, MacCormick AD. Weight Regain Following Sleeve Gastrectomy-a Systematic Review. Obes Surg. 2016 Jun;26(6):1326-34. doi: 10.1007/s11695-016-2152-x.</citation>
      <PMID>27048439</PMID>
    </reference>
    <reference>
      <citation>Leung KW, Yang YJ, Hui SS, Woo J. Mind-Body Health Benefits of Traditional Chinese Qigong on Women: A Systematic Review of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2021 Sep 14;2021:7443498. doi: 10.1155/2021/7443498. eCollection 2021.</citation>
      <PMID>34567220</PMID>
    </reference>
    <reference>
      <citation>Liu T, Bai S, Zhang RC. [Effects of Health Qigong Baduanjin on diabetes related indexes in middle-aged obese women]. Zhongguo Ying Yong Sheng Li Xue Za Zhi. 2018 Jan 8;34(1):19-22. doi: 10.12047/j.cjap.5484.2018.006. Chinese.</citation>
      <PMID>29926653</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30969174</PMID>
    </reference>
    <reference>
      <citation>Mason AE, Jhaveri K, Cohn M, Brewer JA. Testing a mobile mindful eating intervention targeting craving-related eating: feasibility and proof of concept. J Behav Med. 2018 Apr;41(2):160-173. doi: 10.1007/s10865-017-9884-5. Epub 2017 Sep 16.</citation>
      <PMID>28918456</PMID>
    </reference>
    <reference>
      <citation>Miller-Matero LR, Bryce K, Saulino CK, Dykhuis KE, Genaw J, Carlin AM. Problematic Eating Behaviors Predict Outcomes After Bariatric Surgery. Obes Surg. 2018 Jul;28(7):1910-1915. doi: 10.1007/s11695-018-3124-0.</citation>
      <PMID>29417489</PMID>
    </reference>
    <reference>
      <citation>Palacio A, Luna C, Maiz C, Blanco E. Nutritional and behavioral factors related to weight gain after bariatric surgery. Rev Med Chil. 2021 Jan;149(1):30-36. doi: 10.4067/S0034-98872021000100030.</citation>
      <PMID>34106133</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>25810381</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21962227</PMID>
    </reference>
    <reference>
      <citation>Siu PM, Yu AP, Chin EC, Yu DS, Hui SS, Woo J, Fong DY, Wei GX, Irwin MR. Effects of Tai Chi or Conventional Exercise on Central Obesity in Middle-Aged and Older Adults : A Three-Group Randomized Controlled Trial. Ann Intern Med. 2021 Aug;174(8):1050-1057. doi: 10.7326/M20-7014. Epub 2021 Jun 1.</citation>
      <PMID>34058100</PMID>
    </reference>
    <reference>
      <citation>Warren JM, Smith N, Ashwell M. A structured literature review on the role of mindfulness, mindful eating and intuitive eating in changing eating behaviours: effectiveness and associated potential mechanisms. Nutr Res Rev. 2017 Dec;30(2):272-283. doi: 10.1017/S0954422417000154. Epub 2017 Jul 18.</citation>
      <PMID>28718396</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>22527594</PMID>
    </reference>
    <reference>
      <citation>Tsai C, Steffen R, Kessler U, Merki H, Zehetner J. Short-term outcomes of endoscopic gastro-jejunal revisions for treatment of dumping syndrome after Roux-En-Y gastric bypass. Surg Endosc. 2020 Aug;34(8):3626-3632. doi: 10.1007/s00464-019-07137-7. Epub 2019 Sep 24.</citation>
      <PMID>31552507</PMID>
    </reference>
    <reference>
      <citation>Saunders R. &quot;Grazing&quot;: a high-risk behavior. Obes Surg. 2004 Jan;14(1):98-102. doi: 10.1381/096089204772787374.</citation>
      <PMID>14980042</PMID>
    </reference>
    <reference>
      <citation>de Zwaan M, Hilbert A, Swan-Kremeier L, Simonich H, Lancaster K, Howell LM, Monson T, Crosby RD, Mitchell JE. Comprehensive interview assessment of eating behavior 18-35 months after gastric bypass surgery for morbid obesity. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):79-85. doi: 10.1016/j.soard.2009.08.011. Epub 2009 Sep 3.</citation>
      <PMID>19837012</PMID>
    </reference>
    <reference>
      <citation>Czepczor-Bernat K, Brytek-Matera A, Gramaglia C, Zeppegno P. The moderating effects of mindful eating on the relationship between emotional functioning and eating styles in overweight and obese women. Eat Weight Disord. 2020 Aug;25(4):841-849. doi: 10.1007/s40519-019-00740-6. Epub 2019 Jul 16.</citation>
      <PMID>31313253</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Akdeniz University</investigator_affiliation>
      <investigator_full_name>Defne Dizlek</investigator_full_name>
      <investigator_title>Research Asssistant</investigator_title>
    </responsible_party>
    <keyword>bariatric surgery</keyword>
    <keyword>mindfulness</keyword>
    <keyword>mindful eating</keyword>
    <keyword>training program</keyword>
    <keyword>surgery nursing</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05992662
  org study id: AkdenizBariatricSurgery
  nct id: NCT05992662
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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)
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Mindful Eating
  time frame: Before the surgery, 3. and 6. Months after the surgery
  description: 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.
  arm group label: Intervention Group
  arm group type: Experimental
  description: 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
  arm group label: Control Group
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Mindfulness-Based Training Programme in Bariatric Surgey Patients
  description: 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
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Defne Dizlek Bayraktar
  role: Principal Investigator
  affiliation: Akdeniz University
  last name: Emine Catal
  role: Study Chair
  affiliation: Akdeniz University
  last name: Huseyin Ciyiltepe
  role: Study Director
  affiliation: Antalya Training and Research Hospital
  facility: 
  country: Turkey
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  PMID: 31313253
  responsible party type: Principal Investigator
  investigator affiliation: Akdeniz University
  investigator full name: Defne Dizlek
  investigator title: Research Asssistant
  sharing ipd: No