Comparison of Different Weight Loss Methods in Obese Individuals

Bahçeşehir University

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: DIET; Behavioral: EXERCISE; Device: AURICULAR VAGUS NERVE STIMULATION

Study type: Interventional

Funder types: Other

Identifiers

NCT05511376

BAUGOZDEIN1318303

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

DIET

Active Comparator group

Description:

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.

Treatment:

Behavioral: DIET

EXERCISE

Active Comparator group

Description:

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.

Treatment:

Behavioral: EXERCISE

AURICULAR VAGUS NERVE STIMULATION

Active Comparator group

Description:

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.

Treatment:

Device: AURICULAR VAGUS NERVE STIMULATION