Comparison of Different Weight Loss Methods in Obese Individuals

Comparison of Diet, Exercise, and Auricular Vagus Nerve Stimulation Efficacy for Weight Reduction in Obese Individuals

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: DIET; Behavioral: EXERCISE; Device: AURICULAR VAGUS NERVE STIMULATION

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gözde IN; Phone Number: +905314906736; Email: dytgozdein@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34750
    • Recruiting
    • Avicenna Hospital
    • Contact: Gözde IN; Phone Number: +905314906736; Email: dytgozdein@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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); Other Names: A Mediterranean-style, protein-based diet program
Active Comparator: 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.	Behavioral: EXERCISE; Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week); Other Names: Moderate Resistance Exercise and Aerobic Exercise
Active Comparator: 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.	Device: 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.; Other Names: Vagustim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Analysis	BIA measurements include (BMI (kg/m2)).	Study start
Body Analysis	BIA measurements include (BMI (kg/m2)).	2nd week
Body Analysis	BIA measurements include (BMI (kg/m2)).	4th week
Body Analysis	BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).	Study start
Body Analysis	BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).	2nd week
Body Analysis	BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).	4th week
Body Analysis	BIA measurements include (Muscle and fat percentage (%) such as).	Study start
Body Analysis	BIA measurements include (Muscle and fat percentage (%) such as).	2nd week
Body Analysis	BIA measurements include (Muscle and fat percentage (%) such as).	4th week
Body Analysis	BIA measurement include (Body density (mg/dl)).	Study start
Body Analysis	BIA measurement include (Body density (mg/dl)).	2nd week
Body Analysis	BIA measurement include (Body density (mg/dl)).	4th week
Body Analysis	BIA measurement include (internal adiposity).	Study start
Body Analysis	BIA measurement include (internal adiposity).	2nd week
Body Analysis	BIA measurement include (internal adiposity).	4th week
Anthropometric Measurements	It includes length (m) measurement.	Study start
Anthropometric Measurements	It includes length (m) measurement.	2nd week
Anthropometric Measurements	It includes length (m) measurement.	4th week
Anthropometric Measurements	It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.	Study start
Anthropometric Measurements	It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.	2nd week
Anthropometric Measurements	It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.	4th week
Anthropometric Measurements	It includes waist-hip ratio measurements.	Study start
Anthropometric Measurements	It includes waist-hip ratio measurements.	2nd week
Anthropometric Measurements	It includes waist-hip ratio measurements.	4th week
Biochemical parameters	It includes fasting blood sugar (mg/dL) value.	Study start & 4th week
Biochemical parameters	It includes fasting blood sugar (mg/dL) value.	Study start
Biochemical parameters	It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.	4th week
Biophysical Methods	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.)	Study start
Biophysical Methods	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.)	2nd week
Biophysical Methods	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.)	4th week
Biophysical Methods	It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)	Study start
Biophysical Methods	It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)	2nd week
Biophysical Methods	It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)	4th week
Biophysical Methods	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.)	Study start
Biophysical Methods	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.)	2nd week
Biophysical Methods	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.)	4th week
6-Min Walk Test	The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)	Study start
6-Min Walk Test	The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)	2nd week
6-Min Walk Test	The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)	4th week
6-Min Walk Test	The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)	Study start
6-Min Walk Test	The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)	2nd week
6-Min Walk Test	The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)	4th week
6-Min Walk Test	The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)	Study start
6-Min Walk Test	The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)	2nd week
6-Min Walk Test	The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)	4th week
6-Min Walk Test	The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)	Study start
6-Min Walk Test	The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)	2nd week
6-Min Walk Test	The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)	4th week
6-Min Walk Test	The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)	Study start
6-Min Walk Test	The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)	2nd week
6-Min Walk Test	The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)	4th week
Handgrip strength test	The Handgrip strength test (kg) measurement evaluates muscle strength.	Study start
Handgrip strength test	The Handgrip strength test (kg) measurement evaluates muscle strength.	2nd week
Handgrip strength test	The Handgrip strength test (kg) measurement evaluates muscle strength.	4th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire (Short Form- IPAQ)	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.)	Study start, 2nd & 4th week
Quality of Life Questionnaire (Short Form - SF-36)	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.)	Study start, 2nd & 4th week
Food Cravings Questionnaire (FCQ)	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.)	Study start & 4th week
Visual Analog Scale (VAS)	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.)	Study start, 2nd & 4th week

Collaborators and Investigators

• Sponsor: Bahçeşehir University
• Investigators: Principal Investigator: Gözde IN, Bahçeşehir University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Anticipated): August 26, 2022

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BAUGOZDEIN1318303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No