Bariatric Surgery CandidateNCT05992662
Minfulness-Based Training Program in Bariatric Surgery Patients
A study testing Mindfulness-Based Training Programme in Bariatric Surgey Patients in people with Bariatric Surgery Candidate, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Mindfulness-Based Training Programme in Bariatric Surgey Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Declaring that he will not continue the research at any stage of the research
- Not participating in the entire training program.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, Konyaalti, 07070
About this study
Official title: Mindfulness-Based Training Program in Bariatric Surgery Patients: An Action Research
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.
Read the 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
- Being tested
- Mindfulness-Based Training Programme in Bariatric Surgey Patients
- Keywords
- bariatric surgery, mindfulness, mindful eating, training program, surgery nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Training Programme in Bariatric Surgey PatientsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the surgery, 3. and 6. Months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start2 Aug 2022
- Primary completion24 Sep 2023
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Defne Dizlek, Akdeniz University
- Investigators
- Defne Dizlek Bayraktar, Principal investigator, Akdeniz UniversityEmine Catal, Study chair, Akdeniz UniversityHuseyin Ciyiltepe, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992662
- Sponsor's protocol ID
- AkdenizBariatricSurgery
- Status last verified
- Nov 2023
- First submitted
- 8 Aug 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18958537Baig 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.
PubMed 30729366Caldwell 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.
PubMed 35388342Carbone 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.
PubMed 30268840Chacko 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.
PubMed 27670865Dunn 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.
PubMed 29446036Lauti 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.
PubMed 27048439Leung 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.
PubMed 34567220Liu 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.
PubMed 29926653Lyzwinski 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.
PubMed 30969174Mason 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.
PubMed 28918456Miller-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.
PubMed 29417489Palacio 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.
PubMed 34106133Sairanen 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.
PubMed 25810381Sarwer 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.
PubMed 21962227
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Training Program in Bariatric Surgery Patients: An Action Research
- ClinicalTrials.gov ID
- NCT05992662
- Acronym / sponsor ID
- AkdenizBariatricSurgery
- Conditions
- Bariatric Surgery Candidate
- Keywords
- bariatric surgery, mindfulness, mindful eating, training program, surgery nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- Feb 2024 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mindfulness-Based Training Programme in Bariatric Surgey PatientsIn 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Declaring that he will not continue the research at any stage of the research
- Not participating in the entire training program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Training Programme in Bariatric Surgey PatientsACTION 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 | Behavioural | Intervention Group |
Primary outcome
Mindful Eating
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Background: PubMed 18958537Abiles 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.
- Background: PubMed 30729366Baig 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.
- Background: PubMed 35388342Caldwell 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.
- Background: PubMed 30268840Carbone 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.
- Background: PubMed 27670865Chacko 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.
- Background: PubMed 29446036Dunn 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.
- Background: PubMed 27048439Lauti 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.
- Background: PubMed 34567220Leung 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.
- Background: PubMed 29926653Liu 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.
- Background: PubMed 30969174Lyzwinski 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.
- Background: PubMed 28918456Mason 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.
- Background: PubMed 29417489Miller-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Defne Dizlek Bayraktar principal investigator
Akdeniz University
Emine Catal study chair
Akdeniz University
Huseyin Ciyiltepe study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Training Programme in Bariatric Surgey Patients in people with Bariatric Surgery Candidate, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindful Eating (time frame: Before the surgery, 3. and 6. Months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992662, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.