Comparison of Different Weight Loss Methods in Obese Individuals
- Conditions
- Obesity
- Interventions
- Behavioral: EXERCISEDevice: AURICULAR VAGUS NERVE STIMULATIONBehavioral: DIET
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- Age range 18 - 65
- Being in the stage I, II and III obesity class
- 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
- Arm && Interventions
Group Intervention Description EXERCISE EXERCISE A pre-exercise breathing exercise study was planned. Exercise: It was planned to apply the Moderate Resistant Exercise Protocol (3 days a week for 60 minutes) and as aerobic exercise, walking 5 days a week (150 minutes / week) as 30 minutes / day. AURICULAR VAGUS NERVE STIMULATION AURICULAR VAGUS NERVE STIMULATION The Vagustim device was applied in Biphasic, Frequency 10 Hz, Modulation mode, with a pulse width of 300 μs, for 30 minutes /3 days/week by keeping the current intensity constant where the participants felt comfortable. It will be applied as bilateral VSS from the tragus and turbinate parts of the ear. DIET DIET Personal nutrition programs were prepared according to ideal body weight, with protein intake as 30% of total daily calories or 1-1.2 g/kg.
- 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