Obesity
Conditions
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.
Interventions
For 4 weeks With the Vagustim device, in Biphasic, Frequency 10 Hz, Modulation mode, the pulse width of 300 μs, where the participants feel comfortable, the current intensity is kept constant for 30 minutes / 3 days/week. It will be applied as bilateral VSS from the tragus and turbinate parts of the ear.
BEHAVIORALDIET
For 4 weeks, Protein intake to 30% of total daily calories or 1-1.2 g/kg Personal nutrition program created for ideal body weight (by BMI values for age)
BEHAVIORALEXERCISE
Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week)
Sponsors
Bahçeşehir University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength test | Study start | The Handgrip strength test (kg) measurement evaluates muscle strength. |
| Anthropometric Measurements | Study start | It includes length (m) measurement. |
| Biochemical parameters | Study start & 4th week | It includes fasting blood sugar (mg/dL) value. |
| Biophysical Methods | Study start | It includes 5 X Sit-to-Stand Up 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 | Study start | The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.) |
| Body Analysis | Study start | BIA measurements include (BMI (kg/m2)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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.) |
| 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.) |
| 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.) |
Countries
Turkey (Türkiye)
Contacts
Primary ContactGözde IN
Outcome results
None listed