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Investigation of Body Awareness and Affecting Factors in Bariatric Surgery Patients

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ClinicalTrials.gov Identifier: NCT03905070
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ümit VARLI, Izmir Katip Celebi University

Study Description
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Brief Summary:
The aim of this study is to investigate the body awareness and the factors affecting the bariatric surgery.

Condition or disease
Bariatric Surgery Body Image

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
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Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Investigation of Body Awareness and Affecting Factors in Bariatric Surgery Patients
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905070


Contacts
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Contact: ÜMİT VARLI, BSc +905068401041 umit.varlii@gmail.com
Contact: İlknur NAZ GÜRŞAN, PhD +902323293535 ilknurnaz4@gmail.com

Locations
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Turkey
Izmir Katip Celebi University Recruiting
Izmir, Çiğli, Turkey, 35640
Contact: Ümit VARLI, BSc    0905068401041    umit.varlii@gmail.com   
Principal Investigator: Ümit VARLI, BSc         
Principal Investigator: İlknur NAZ GÜRŞAN, PhD         
Sub-Investigator: Hüsnü YILMAZ, MD         
Sponsors and Collaborators
Izmir Katip Celebi University
Investigators
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Study Director: İlknur NAZ GÜRŞAN, PhD Izmir Katip Celebi University, Faculty of Health Science
More Information
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Publications:

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Responsible Party: Ümit VARLI, Principal Investigator, Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT03905070    
Other Study ID Numbers: 103
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: After the study is completed and published, the investigators are considering the update the plan.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ümit VARLI, Izmir Katip Celebi University:
bariatric surgery
body awareness
physical therapy
metabolic surgery