Clinical trial NCT05511376: Comparison of Different Weight Loss Methods in Obese Individuals
Official title: Comparison of Diet, Exercise, and Auricular Vagus Nerve Stimulation Efficacy for Weight Reduction in Obese Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body Analysis
timeFrame: Study start
measure: Body Analysis
timeFrame: 2nd week
measure: Body Analysis
timeFrame: 4th week
measure: Body Analysis
timeFrame: Study start
measure: Body Analysis
timeFrame: 2nd week
measure: Body Analysis
timeFrame: 4th week
measure: Body Analysis
timeFrame: Study start
measure: Body Analysis
timeFrame: 2nd week
measure: Body Analysis
timeFrame: 4th week
measure: Body Analysis
timeFrame: Study start
measure: Body Analysis
timeFrame: 2nd week
measure: Body Analysis
timeFrame: 4th week
measure: Body Analysis
timeFrame: Study start
measure: Body Analysis
timeFrame: 2nd week
measure: Body Analysis
timeFrame: 4th week
measure: Anthropometric Measurements
timeFrame: Study start
measure: Anthropometric Measurements
timeFrame: 2nd week
measure: Anthropometric Measurements
timeFrame: 4th week
measure: Anthropometric Measurements
timeFrame: Study start
measure: Anthropometric Measurements
timeFrame: 2nd week
measure: Anthropometric Measurements
timeFrame: 4th week
measure: Anthropometric Measurements
timeFrame: Study start
measure: Anthropometric Measurements
timeFrame: 2nd week
measure: Anthropometric Measurements
timeFrame: 4th week
measure: Biochemical parameters
timeFrame: Study start & 4th week
measure: Biochemical parameters
timeFrame: Study start
measure: Biochemical parameters
timeFrame: 4th week
measure: Biophysical Methods
timeFrame: Study start
measure: Biophysical Methods
timeFrame: 2nd week
measure: Biophysical Methods
timeFrame: 4th week
measure: Biophysical Methods
timeFrame: Study start
measure: Biophysical Methods
timeFrame: 2nd week
measure: Biophysical Methods
timeFrame: 4th week
measure: Biophysical Methods
timeFrame: Study start
measure: Biophysical Methods
timeFrame: 2nd week
measure: Biophysical Methods
timeFrame: 4th week
measure: 6-Min Walk Test
timeFrame: Study start
measure: 6-Min Walk Test
timeFrame: 2nd week
measure: 6-Min Walk Test
timeFrame: 4th week
measure: 6-Min Walk Test
timeFrame: Study start
measure: 6-Min Walk Test
timeFrame: 2nd week
measure: 6-Min Walk Test
timeFrame: 4th week
measure: 6-Min Walk Test
timeFrame: Study start
measure: 6-Min Walk Test
timeFrame: 2nd week
measure: 6-Min Walk Test
timeFrame: 4th week
measure: 6-Min Walk Test
timeFrame: Study start
measure: 6-Min Walk Test
timeFrame: 2nd week
measure: 6-Min Walk Test
timeFrame: 4th week
measure: 6-Min Walk Test
timeFrame: Study start
measure: 6-Min Walk Test
timeFrame: 2nd week
measure: 6-Min Walk Test
timeFrame: 4th week
measure: Handgrip strength test
timeFrame: Study start
measure: Handgrip strength test
timeFrame: 2nd week
measure: Handgrip strength test
timeFrame: 4th week
Secondary outcomes:
measure: International Physical Activity Questionnaire (Short Form- IPAQ)
timeFrame: Study start, 2nd & 4th week
measure: Quality of Life Questionnaire (Short Form - SF-36)
timeFrame: Study start, 2nd & 4th week
measure: Food Cravings Questionnaire (FCQ)
timeFrame: Study start & 4th week
measure: Visual Analog Scale (VAS)
timeFrame: Study start, 2nd & 4th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Avicenna Hospital
Study officials:
affiliation: Bahçeşehir University
name: Gözde IN
role: PRINCIPAL_INVESTIGATOR
References: