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Comparison of Different Weight Loss Methods in Obese Individuals

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
AURICULAR VAGUS NERVE STIMULATION
DIET
EXERCISE
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Avicenna HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

DIET

EXERCISE

AURICULAR VAGUS NERVE STIMULATION

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Body Analysis
BIA measurements include (BMI (kg/m2)).
Body Analysis
BIA measurements include (BMI (kg/m2)).
Body Analysis
BIA measurements include (BMI (kg/m2)).
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Body Analysis
BIA measurement include (Body density (mg/dl)).
Body Analysis
BIA measurement include (Body density (mg/dl)).
Body Analysis
BIA measurement include (Body density (mg/dl)).
Body Analysis
BIA measurement include (internal adiposity).
Body Analysis
BIA measurement include (internal adiposity).
Body Analysis
BIA measurement include (internal adiposity).
Anthropometric Measurements
It includes length (m) measurement.
Anthropometric Measurements
It includes length (m) measurement.
Anthropometric Measurements
It includes length (m) measurement.
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Anthropometric Measurements
It includes waist-hip ratio measurements.
Anthropometric Measurements
It includes waist-hip ratio measurements.
Anthropometric Measurements
It includes waist-hip ratio measurements.
Biochemical parameters
It includes fasting blood sugar (mg/dL) value.
Biochemical parameters
It includes fasting blood sugar (mg/dL) value.
Biochemical parameters
It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
6-Min Walk Test
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
6-Min Walk Test
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
6-Min Walk Test
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
6-Min Walk Test
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
6-Min Walk Test
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
6-Min Walk Test
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.

Secondary Outcome Measures

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.)
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.)
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.)
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.)

Full Information

First Posted
August 4, 2022
Last Updated
August 22, 2022
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05511376
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 26, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DIET
Arm Type
Active Comparator
Arm 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.
Arm Title
EXERCISE
Arm Type
Active Comparator
Arm 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.
Arm Title
AURICULAR VAGUS NERVE STIMULATION
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
AURICULAR VAGUS NERVE STIMULATION
Other Intervention Name(s)
Vagustim
Intervention Description
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
Behavioral
Intervention Name(s)
DIET
Other Intervention Name(s)
A Mediterranean-style, protein-based diet program
Intervention Description
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
Intervention Name(s)
EXERCISE
Other Intervention Name(s)
Moderate Resistance Exercise and Aerobic Exercise
Intervention Description
Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week)
Primary Outcome Measure Information:
Title
Body Analysis
Description
BIA measurements include (BMI (kg/m2)).
Time Frame
Study start
Title
Body Analysis
Description
BIA measurements include (BMI (kg/m2)).
Time Frame
2nd week
Title
Body Analysis
Description
BIA measurements include (BMI (kg/m2)).
Time Frame
4th week
Title
Body Analysis
Description
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Time Frame
Study start
Title
Body Analysis
Description
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Time Frame
2nd week
Title
Body Analysis
Description
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Time Frame
4th week
Title
Body Analysis
Description
BIA measurements include (Muscle and fat percentage (%) such as).
Time Frame
Study start
Title
Body Analysis
Description
BIA measurements include (Muscle and fat percentage (%) such as).
Time Frame
2nd week
Title
Body Analysis
Description
BIA measurements include (Muscle and fat percentage (%) such as).
Time Frame
4th week
Title
Body Analysis
Description
BIA measurement include (Body density (mg/dl)).
Time Frame
Study start
Title
Body Analysis
Description
BIA measurement include (Body density (mg/dl)).
Time Frame
2nd week
Title
Body Analysis
Description
BIA measurement include (Body density (mg/dl)).
Time Frame
4th week
Title
Body Analysis
Description
BIA measurement include (internal adiposity).
Time Frame
Study start
Title
Body Analysis
Description
BIA measurement include (internal adiposity).
Time Frame
2nd week
Title
Body Analysis
Description
BIA measurement include (internal adiposity).
Time Frame
4th week
Title
Anthropometric Measurements
Description
It includes length (m) measurement.
Time Frame
Study start
Title
Anthropometric Measurements
Description
It includes length (m) measurement.
Time Frame
2nd week
Title
Anthropometric Measurements
Description
It includes length (m) measurement.
Time Frame
4th week
Title
Anthropometric Measurements
Description
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Time Frame
Study start
Title
Anthropometric Measurements
Description
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Time Frame
2nd week
Title
Anthropometric Measurements
Description
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Time Frame
4th week
Title
Anthropometric Measurements
Description
It includes waist-hip ratio measurements.
Time Frame
Study start
Title
Anthropometric Measurements
Description
It includes waist-hip ratio measurements.
Time Frame
2nd week
Title
Anthropometric Measurements
Description
It includes waist-hip ratio measurements.
Time Frame
4th week
Title
Biochemical parameters
Description
It includes fasting blood sugar (mg/dL) value.
Time Frame
Study start & 4th week
Title
Biochemical parameters
Description
It includes fasting blood sugar (mg/dL) value.
Time Frame
Study start
Title
Biochemical parameters
Description
It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.
Time Frame
4th week
Title
Biophysical Methods
Description
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.)
Time Frame
Study start
Title
Biophysical Methods
Description
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.)
Time Frame
2nd week
Title
Biophysical Methods
Description
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.)
Time Frame
4th week
Title
Biophysical Methods
Description
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.)
Time Frame
Study start
Title
Biophysical Methods
Description
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.)
Time Frame
2nd week
Title
Biophysical Methods
Description
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.)
Time Frame
4th week
Title
Biophysical Methods
Description
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.)
Time Frame
Study start
Title
Biophysical Methods
Description
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.)
Time Frame
2nd week
Title
Biophysical Methods
Description
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.)
Time Frame
4th week
Title
6-Min Walk Test
Description
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
Time Frame
Study start
Title
6-Min Walk Test
Description
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
Time Frame
2nd week
Title
6-Min Walk Test
Description
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
Time Frame
4th week
Title
6-Min Walk Test
Description
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.)
Time Frame
Study start
Title
6-Min Walk Test
Description
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.)
Time Frame
2nd week
Title
6-Min Walk Test
Description
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.)
Time Frame
4th week
Title
6-Min Walk Test
Description
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
Time Frame
Study start
Title
6-Min Walk Test
Description
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
Time Frame
2nd week
Title
6-Min Walk Test
Description
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
Time Frame
4th week
Title
6-Min Walk Test
Description
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.)
Time Frame
Study start
Title
6-Min Walk Test
Description
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.)
Time Frame
2nd week
Title
6-Min Walk Test
Description
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.)
Time Frame
4th week
Title
6-Min Walk Test
Description
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Time Frame
Study start
Title
6-Min Walk Test
Description
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Time Frame
2nd week
Title
6-Min Walk Test
Description
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Time Frame
4th week
Title
Handgrip strength test
Description
The Handgrip strength test (kg) measurement evaluates muscle strength.
Time Frame
Study start
Title
Handgrip strength test
Description
The Handgrip strength test (kg) measurement evaluates muscle strength.
Time Frame
2nd week
Title
Handgrip strength test
Description
The Handgrip strength test (kg) measurement evaluates muscle strength.
Time Frame
4th week
Secondary Outcome Measure Information:
Title
International Physical Activity Questionnaire (Short Form- IPAQ)
Description
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.)
Time Frame
Study start, 2nd & 4th week
Title
Quality of Life Questionnaire (Short Form - SF-36)
Description
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.)
Time Frame
Study start, 2nd & 4th week
Title
Food Cravings Questionnaire (FCQ)
Description
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.)
Time Frame
Study start & 4th week
Title
Visual Analog Scale (VAS)
Description
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.)
Time Frame
Study start, 2nd & 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gözde IN
Phone
+905314906736
Email
dytgozdein@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gözde IN
Organizational Affiliation
Bahçeşehir University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avicenna Hospital
City
Istanbul
ZIP/Postal Code
34750
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gözde IN
Phone
+905314906736
Email
dytgozdein@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Different Weight Loss Methods in Obese Individuals

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