- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03905070
Investigation of Body Awareness and Affecting Factors in Bariatric Surgery Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: ÜMİT VARLI, BSc
- Phone Number: +905068401041
- Email: umit.varlii@gmail.com
Study Contact Backup
- Name: İlknur NAZ GÜRŞAN, PhD
- Phone Number: +902323293535
- Email: ilknurnaz4@gmail.com
Study Locations
-
-
Çiğli
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Izmir, Çiğli, Turkey, 35640
- Recruiting
- Izmir Katip Celebi University
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Contact:
- Ümit VARLI, BSc
- Phone Number: 0905068401041
- Email: umit.varlii@gmail.com
-
Principal Investigator:
- Ümit VARLI, BSc
-
Principal Investigator:
- İlknur NAZ GÜRŞAN, PhD
-
Sub-Investigator:
- Hüsnü YILMAZ, MD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Study Group
The study group consisted of people who had undergone bariatric surgery and who had at least 6 months after the operation.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Awareness
Time Frame: Data collection will continue until September 2019. Data analysis and report preparation will be completed by December 2019.
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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.
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Data collection will continue until September 2019. Data analysis and report preparation will be completed by December 2019.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: İlknur NAZ GÜRŞAN, PhD, Izmir Katip Celebi University, Faculty of Health Science
Publications and helpful links
General 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.
- Major 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.
- Mundbjerg 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.
- Natvik 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.
- Skjaerven 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.
- Guardia 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.
- Jung 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.
- Warholm 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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