Minfulness-Based Training Program in Bariatric Surgery Patients

NCT05992662 | Unknown DMC

• 1 other identifier: AkdenizBariatricSurgery
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Keywords

bariatric surgery; mindfulness; mindful eating; training program; surgery nursing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Mindfulness-Based Training Programme in Bariatric Surgey Patients 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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Konyaalti, 07070, Turkey (Türkiye)

Location

Related Publications (22)

• 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.

  PMID: 18958537 BACKGROUND

• 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.

  PMID: 30729366 BACKGROUND

• 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.

  PMID: 35388342 BACKGROUND

• 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.

  PMID: 30268840 BACKGROUND

• 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.

  PMID: 27670865 BACKGROUND

• 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.

  PMID: 29446036 BACKGROUND

• 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.

  PMID: 27048439 BACKGROUND

• 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.

  PMID: 34567220 BACKGROUND

• 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.

  PMID: 29926653 BACKGROUND

• 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.

  PMID: 30969174 BACKGROUND

• 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.

  PMID: 28918456 BACKGROUND

• 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.

  PMID: 29417489 BACKGROUND

• 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.

  PMID: 34106133 BACKGROUND

• 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.

  PMID: 25810381 BACKGROUND

• 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.

  PMID: 21962227 BACKGROUND

• 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.

  PMID: 34058100 BACKGROUND

• 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.

  PMID: 28718396 BACKGROUND

• 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.

  PMID: 22527594 BACKGROUND

• 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.

  PMID: 31552507 BACKGROUND

• Saunders R. "Grazing": a high-risk behavior. Obes Surg. 2004 Jan;14(1):98-102. doi: 10.1381/096089204772787374.

  PMID: 14980042 BACKGROUND

• 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.

  PMID: 19837012 BACKGROUND

• 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.

  PMID: 31313253 BACKGROUND

Study Officials

• Defne Dizlek Bayraktar

  Akdeniz University

  PRINCIPAL INVESTIGATOR

• Emine Catal

  Akdeniz University

  STUDY CHAIR

• Huseyin Ciyiltepe

  Antalya Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asssistant

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: August 2, 2022
• Primary Completion: September 24, 2023
• Study Completion: February 1, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)