Comparison of Different Weight Loss Methods in Obese Individuals

Not Applicable

• Conditions: Obesity

• Registration Number: NCT05511376
• Lead Sponsor: Bahçeşehir University

Brief Summary

Although obesity is a rapidly increasing epidemic worldwide, it is associated with many health-related comorbidities. As a result of the developments in social life and observes the sedentary life in individuals, an effect of the age of technology the fact that this epidemic will cause even massive health problems in the coming period affecting the health systems of countries and indirectly their economies that, This situation necessitates the creation of alternative treatment methods for the prevention of obesity. This study aims to determine the effect of a therapy approach that can be applied to the vagus nervous system, which is associated with many organs and systems, on weight loss and general health. As an alternative treatment against lifestyle changes such as diet and exercise, individuals have made for weight loss.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2022-08
• Primary Completion: 2022-08-01
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-18
• Last Update Submitted: 2022-08-22
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-24
• Study Completion: 2022-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age range 18 - 65
• Being in the stage I, II and III obesity class

Exclusion Criteria

• Those with unstable DM
• Those with stage II hypertension
• Those who have had cardiovascular disease (especially those who have had an attack)
• Those with pulmonary disease
• Those with kidney disease
• Orthopedic restrictions
• Those with MND
• Those tied to the chair

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biophysical Methods	4th week	It includes The Timed Up and Go Test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
6-Min Walk Test	4th week	The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Handgrip strength test	4th week	The Handgrip strength test (kg) measurement evaluates muscle strength.
Body Analysis	4th week	BIA measurement include (internal adiposity).
Anthropometric Measurements	4th week	It includes waist-hip ratio measurements.
Biochemical parameters	4th week	It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Questionnaire (Short Form - SF-36)	Study start, 2nd & 4th week	It was used to evaluate the effect of weight on quality of life. (It is evaluated in the range of 0 - 100 points. Energy/vitality, physical function, mental health, general health perception, social functionality scores show a positive development as they approach the maximum value. Physical role difficulty, emotional role difficulty and Pain scores show a positive development as they approach the minimum value.)
International Physical Activity Questionnaire (Short Form- IPAQ)	Study start, 2nd & 4th week	It has been used to examine physical activity levels. (Weekly physical activity levels are measured by MET value calculations. An increase in MET values indicates an increase in activity.)
Food Cravings Questionnaire (FCQ)	Study start & 4th week	It was used to determine the cravings for foods. (In the scale, a scoring system between 39-234 points is used for sub-dimensions.It shows that there is a positive development as the scale approaches the minimum result.)
Visual Analog Scale (VAS)	Study start, 2nd & 4th week	It was used to determine the cravings for foods. (A scoring system from 0 to 10 is used.It shows that there is a positive development as the scale approaches the minimum result.)

Trial Locations

Locations (1)

Avicenna Hospital; 🇹🇷 Istanbul, Turkey