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The Effect of Balneotherapy on Body Mass Index, Adipokine Levels, Sleep Disturbances and Quality of Life of Women with Morbid Obesity

Protocol summary

Study aim
The aim of this study is to evaluate the effect of balneotherapy on body mass index, adipokine levels, sleep quality and quality of life in morbidly obese female patients.
Design
50 morbid obese female patients will be studied. Body mass indexes and waist / hip ratios will be calculated. With Skinfoldmeter the subcutaneous fat thickness will be measured and the fat tissue percentage will be calculated. The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality and the Nottingham Health Profile (NSP) will be used to assess quality of life. In addition to routine biochemical tests, leptin, adipokine, visfatin, and cortisol from the saliva sample will be studied from the blood sample. All assessments will be performed both before and after treatment. A total of 15 sessions of 20 minutes of spa treatment will be administered 5 days a week.
Settings and conduct
It will be a non-randomized clinical trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: *Morbidly obesity (BMI greater than 40 kg/m2) women aged between 18-70 Exclusion criteria: *Uncontrolled hypertension, diabetes, coronary artery disease etc systemic diseases *Systemic infections *Malignancy *Pregnancy and/or lactation *Debility *Bleeding diathesis *Psychological pathologies
Intervention groups
Patients will receive 15 sessions of spa treatment. Changes in some clinical and laboratory values before and after treatment will be assessed.
Main outcome variables
Body mass index Waist to hip ratio Total fat percent (according to skinfoldmeter measurements) Sleep quality Quality of life Routine blood biochemistry Eritrocyte sedimantation ratio, C-reactive protein, fibrinogene levels in blood Adipokine (adiponectin, leptin, visfatin) levels in blood

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180108038268N1
Registration date: 2018-02-03, 1396/11/14
Registration timing: prospective

Last update: 2018-02-03, 1396/11/14
Update count: 0
Registration date
2018-02-03, 1396/11/14
Registrant information
Name
Fatmanur Aybala Koçak
Name of organization / entity
Ahi Evran University Faculty of Medicine
Country
Turkey
Phone
+90 386 213 45 15
Email address
aybala.kocak@ahievran.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-15, 1396/11/26
Expected recruitment end date
2018-03-15, 1396/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Balneotherapy on Body Mass Index, Adipokine Levels, Sleep Disturbances and Quality of Life of Women with Morbid Obesity
Public title
Balneotherapy Treatment for Obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Morbidly obesity (BMI greater than 40 kg/m2) Women Aged between 18-70
Exclusion criteria:
Uncontrolled hypertension, diabetes, coronary artery disease etc systemic diseases Systemic infections Malignancy Pregnancy and/or lactation Debility Bleeding diathesis Severe psychological pathologies
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Turgut Özal University
Street address
Çamlıca Mh., Anadolu Blv
City
Ankara
Postal code
06560
Approval date
2015-10-08, 1394/07/16
Ethics committee reference number
99950669/205

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Body mass index, waist to hip ratio, total fat percent (according to skinfoldmeter measurements) sleep quality, quality of life, routine blood biochemistry, eritrocyte sedimantation ratio, C-reactive protein, fibrinogene, adipokines (adiponectin, leptin, visfatin) levels in blood.
Timepoint
Before intervention, after 15 sessions of balneotherapy (after 3 weeks)
Method of measurement
Tape measure, weigher, skinfoldmeter, laboratory tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahi Evran University, Faculty of Medicine
Full name of responsible person
Fatmanur Aybala Koçak
Street address
Bağbaşı Mah, Şehit Sahir Kurutluoğlu Cad., No:100
City
Kırşehir
Postal code
40200
Phone
+90 386 215 45 15
Email
aybala.kocak@ahievran.edu.tr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahi Evran University Scientific Research Projects Coordination Unit
Full name of responsible person
Fatmanur Aybala Koçak
Street address
Bağbaşı Mah. Şehir Sahir Kurutluoğlu Cad. No:100
City
Kırşehir
Postal code
40200
Phone
+90 386 213 45 15
Email
aybala.kocak@ahievran.edu.tr
Grant name
Ahi Evran University Scientific Research Projects Coordination Unit.
Grant code / Reference number
TIP.A3.16.006
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahi Evran University Scientific Research Projects Coordination Unit
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahi Evran University
Full name of responsible person
Fatmanur Aybala Koçak
Position
Asist. Prof.
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Bağbaşı Mah. , Şehir Sahir Kurutluoğlu Cad., No:100
City
Kırşehir
Province
Merkez
Postal code
40200
Phone
+90 386 213 45 15
Email
aybala.kocak@ahievran.edu.tr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahi Evran University
Full name of responsible person
Fatmanur Aybala Koçak
Position
Asist. Prof.
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Bağbaşı Mah., Şehir Sahir Kurutluoğlu Cad. No:100
City
Kırşehir
Province
Merkez
Postal code
40200
Phone
+90 386 213 45 15
Email
aybala.kocak@ahievran.edu.tr

Person responsible for updating data

Contact
Name of organization / entity
Ahi Evran University
Full name of responsible person
Fatmanur Aybala Koçak
Position
Asist. Prof.
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Bağbaşı Mah. , Şehir Sahir Kurutluoğlu Cad., No:100
City
Kırşehir
Province
Merkez
Postal code
40200
Phone
+90 386 213 45 15
Email
aybala.kocak@ahievran.edu.tr

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all colected data will be shared
When the data will become available and for how long
starting 10 manths after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
only for academic purposes
From where data/document is obtainable
via e-mail: aybala.kocak@ahievran.edu.tr
What processes are involved for a request to access data/document
via e-mail: aybala.kocak@ahievran.edu.tr
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