Comparison of Different Weight Loss Methods in Obese Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-08-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

DIET

Intervention Type BEHAVIORAL

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)

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.

Group Type ACTIVE_COMPARATOR

EXERCISE

Intervention Type BEHAVIORAL

Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week)

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.

Group Type ACTIVE_COMPARATOR

AURICULAR VAGUS NERVE STIMULATION

Intervention Type DEVICE

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.

Interventions

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AURICULAR VAGUS NERVE STIMULATION

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.

Intervention Type DEVICE

DIET

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)

Intervention Type BEHAVIORAL

EXERCISE

Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week)

Intervention Type BEHAVIORAL

Other Intervention Names

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Vagustim A Mediterranean-style, protein-based diet program Moderate Resistance Exercise and Aerobic Exercise

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes