Bariatric SurgeryNCT03905070
Investigation of Body Awareness and Affecting Factors in Bariatric Surgery Patients
An observational study of Bariatric Surgery and Body Image, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Body Image
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 22 Dec 2021
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: There will be two groups in the study: Study and Control groups. The study group consisted of people who had undergone bariatric surgery and who had at least 6 months after the operation. The control group will consist of asymptomatic individuals whose BMI is 18-25 kg / m2 and has not participated in any exercise program in the last one year.
Who may be able to join
- Having a bariatric surgery,
- At least 6 months after surgery
- Being between the ages of 18-65,
- To read and understand Turkish
- Volunteer to participate in the study
Who cannot join
- Musculoskeletal problems to prevent the tests to be applied,
- Psychiatric diagnosis,
- Drinking alcohol and / or drugs,
- Refusal to volunteer
- For the control group to be included in the study, the BMI should be between 18-25 kg / m2, read and write in Turkish, and be voluntary. Those who have been included in any exercise program (plates, yoga, dance, etc.) in the last 1 year will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University
Izmir, Çiğli, 35640
About this study
The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery.
Read the detailed description
In the treatment of obesity, bariatric surgery allows for significant and permanent weight loss and is the most effective treatment. Although the effect of changing body image on occupational and social experiences in patients undergoing bariatric surgery has been examined, there is not enough information about the body awareness and the factors affecting these patients. The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery.
In this study, body composition (with body analyzer), body awareness (with Body Awareness Questionnaire), physical activity level (with International Physical Activity Questionnaire-Short Form), joint position feeling (with photography method), quality of life (with Short Form-36), depression status (with Beck Depression Inventory) and cognition (with Montreal Cognitive Assessment Test) of all participants will be evaluated when they come routine doctor control.
- Conditions
- Bariatric Surgery, Body Image
- Keywords
- bariatric surgery, body awareness, physical therapy, metabolic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The study group consisted of people who had undergone bariatric surgery and who had at least 6 months after the operation. | |
| Control Group | The control group will consist of asymptomatic individuals whose BMI is 18-25 kg / m2 and has not participated in any exercise program in the last one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Awareness
Body awareness of patients will be evaluated with Body Awareness Questionnaire (BAQ). It is a survey of 18 statements. Each statement is scored from 1 to 7 points. The total score can be 18 to 126. High score indicates that body awareness is good.
Measured: Data collection will continue until September 2019. Data analysis and report preparation will be completed by December 2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Nov 2020
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ümit VARLI, Izmir Katip Celebi University
- Investigators
- İlknur NAZ GÜRŞAN, PhD, Study director, Izmir Katip Celebi University, Faculty of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905070
- Sponsor's protocol ID
- 103
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2019
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the study is completed and published, the investigators are considering the update the plan.
Publications
Morana C, Collignon M, Nocca D. Effectiveness of a Functional Rehabilitation Program After Bariatric Surgery: a Pilot Study. Obes Surg. 2018 Aug;28(8):2321-2326. doi: 10.1007/s11695-018-3154-7.
PubMed 29484608Major P, Matlok M, Pedziwiatr M, Migaczewski M, Budzynski P, Stanek M, Kisielewski M, Natkaniec M, Budzynski A. Quality of Life After Bariatric Surgery. Obes Surg. 2015 Sep;25(9):1703-10. doi: 10.1007/s11695-015-1601-2.
PubMed 25676156Mundbjerg LH, Stolberg CR, Cecere S, Bladbjerg EM, Funch-Jensen P, Gram B, Juhl CB. Supervised Physical Training Improves Weight Loss After Roux-en-Y Gastric Bypass Surgery: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 May;26(5):828-837. doi: 10.1002/oby.22143. Epub 2018 Mar 22.
PubMed 29566463Natvik E, Groven KS, Raheim M, Gjengedal E, Gallagher S. Space perception, movement, and insight: attuning to the space of everyday life after major weight loss. Physiother Theory Pract. 2019 Feb;35(2):101-108. doi: 10.1080/09593985.2018.1441934. Epub 2018 Feb 27.
PubMed 29485300Skjaerven LH, Mattsson M, Catalan-Matamoros D, Parker A, Gard G, Gyllensten AL. Consensus on core phenomena and statements describing Basic Body Awareness Therapy within the movement awareness domain in physiotherapy. Physiother Theory Pract. 2019 Jan;35(1):80-93. doi: 10.1080/09593985.2018.1434578. Epub 2018 Feb 26.
PubMed 29482403Guardia D, Metral M, Pigeyre M, Bauwens I, Cottencin O, Luyat M. Body distortions after massive weight loss: lack of updating of the body schema hypothesis. Eat Weight Disord. 2013 Sep;18(3):333-6. doi: 10.1007/s40519-013-0032-0. Epub 2013 Apr 20.
PubMed 23760908Jung F, Spahlholz J, Hilbert A, Riedel-Heller SG, Luck-Sikorski C. Impact of Weight-Related Discrimination, Body Dissatisfaction and Self-Stigma on the Desire to Weigh Less. Obes Facts. 2017;10(2):139-151. doi: 10.1159/000468154. Epub 2017 Apr 22.
PubMed 28434008Warholm C, Marie Oien A, Raheim M. The ambivalence of losing weight after bariatric surgery. Int J Qual Stud Health Well-being. 2014 Jan 29;9:22876. doi: 10.3402/qhw.v9.22876. eCollection 2014.
PubMed 24480033
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Body Awareness and Affecting Factors in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT03905070
- Acronym / sponsor ID
- 103
- Conditions
- Bariatric Surgery, Body Image
- Keywords
- bariatric surgery, body awareness, physical therapy, metabolic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 5 Apr 2019 (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.
The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery.
Detailed description
In the treatment of obesity, bariatric surgery allows for significant and permanent weight loss and is the most effective treatment. Although the effect of changing body image on occupational and social experiences in patients undergoing bariatric surgery has been examined, there is not enough information about the body awareness and the factors affecting these patients. The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery.
In this study, body composition (with body analyzer), body awareness (with Body Awareness Questionnaire), physical activity level (with International Physical Activity Questionnaire-Short Form), joint position feeling (with photography method), quality of life (with Short Form-36), depression status (with Beck Depression Inventory) and cognition (with Montreal Cognitive Assessment Test) of all participants will be evaluated when they come routine doctor control.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –The study group consisted of people who had undergone bariatric surgery and who had at least 6 months after the operation. |
| Control Group | – | –The control group will consist of asymptomatic individuals whose BMI is 18-25 kg / m2 and has not participated in any exercise program in the last one year. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There will be two groups in the study: Study and Control groups. The study group consisted of people who had undergone bariatric surgery and who had at least 6 months after the operation. The control group will consist of asymptomatic individuals whose BMI is 18-25 kg / m2 and has not participated in any exercise program in the last one year.
Key inclusion criteria (5 listed)
- Having a bariatric surgery,
- At least 6 months after surgery
- Being between the ages of 18-65,
- To read and understand Turkish
- Volunteer to participate in the study
Key exclusion criteria (5 listed)
- Musculoskeletal problems to prevent the tests to be applied,
- Psychiatric diagnosis,
- Drinking alcohol and / or drugs,
- Refusal to volunteer
- For the control group to be included in the study, the BMI should be between 18-25 kg / m2, read and write in Turkish, and be voluntary. Those who have been included in any exercise program (plates, yoga, dance, etc.) in the last 1 year will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Awareness
Time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by December 2019.
Body awareness of patients will be evaluated with Body Awareness Questionnaire (BAQ). It is a survey of 18 statements. Each statement is scored from 1 to 7 points. The total score can be 18 to 126. High score indicates that body awareness is good.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 29484608Morana C, Collignon M, Nocca D. Effectiveness of a Functional Rehabilitation Program After Bariatric Surgery: a Pilot Study. Obes Surg. 2018 Aug;28(8):2321-2326. doi: 10.1007/s11695-018-3154-7.
- Background: PubMed 25676156Major P, Matlok M, Pedziwiatr M, Migaczewski M, Budzynski P, Stanek M, Kisielewski M, Natkaniec M, Budzynski A. Quality of Life After Bariatric Surgery. Obes Surg. 2015 Sep;25(9):1703-10. doi: 10.1007/s11695-015-1601-2.
- Background: PubMed 29566463Mundbjerg LH, Stolberg CR, Cecere S, Bladbjerg EM, Funch-Jensen P, Gram B, Juhl CB. Supervised Physical Training Improves Weight Loss After Roux-en-Y Gastric Bypass Surgery: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 May;26(5):828-837. doi: 10.1002/oby.22143. Epub 2018 Mar 22.
- Background: PubMed 29485300Natvik E, Groven KS, Raheim M, Gjengedal E, Gallagher S. Space perception, movement, and insight: attuning to the space of everyday life after major weight loss. Physiother Theory Pract. 2019 Feb;35(2):101-108. doi: 10.1080/09593985.2018.1441934. Epub 2018 Feb 27.
- Background: PubMed 29482403Skjaerven LH, Mattsson M, Catalan-Matamoros D, Parker A, Gard G, Gyllensten AL. Consensus on core phenomena and statements describing Basic Body Awareness Therapy within the movement awareness domain in physiotherapy. Physiother Theory Pract. 2019 Jan;35(1):80-93. doi: 10.1080/09593985.2018.1434578. Epub 2018 Feb 26.
- Background: PubMed 23760908Guardia D, Metral M, Pigeyre M, Bauwens I, Cottencin O, Luyat M. Body distortions after massive weight loss: lack of updating of the body schema hypothesis. Eat Weight Disord. 2013 Sep;18(3):333-6. doi: 10.1007/s40519-013-0032-0. Epub 2013 Apr 20.
- Background: PubMed 28434008Jung F, Spahlholz J, Hilbert A, Riedel-Heller SG, Luck-Sikorski C. Impact of Weight-Related Discrimination, Body Dissatisfaction and Self-Stigma on the Desire to Weigh Less. Obes Facts. 2017;10(2):139-151. doi: 10.1159/000468154. Epub 2017 Apr 22.
- Background: PubMed 24480033Warholm C, Marie Oien A, Raheim M. The ambivalence of losing weight after bariatric surgery. Int J Qual Stud Health Well-being. 2014 Jan 29;9:22876. doi: 10.3402/qhw.v9.22876. eCollection 2014.
- Individual participant dataSharing planned: No. After the study is completed and published, the investigators are considering the update the plan.
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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.
İlknur NAZ GÜRŞAN, PhD study director
Izmir Katip Celebi University, Faculty of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Body Image, run by Izmir Katip Celebi 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 2 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Awareness (time frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by December 2019.). 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 NCT03905070, which also lists 8 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 2 May 2025.