search
Back to results

Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy

Primary Purpose

Mental Health Issue, Body Image

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Liposuction
Cognitive Behavioral Therapy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Issue focused on measuring Body Image Satisfaction, Liposuction, Psychological Therapy

Eligibility Criteria

20 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 25~30
  • The score over 68 in SIMS (The situational motivation scale)

Exclusion Criteria:

  • Diagnosed in any chronic disease
  • Trouble using smartphone
  • Pregnant or planning to be pregnant
  • Unable to be in the fMRI
  • Limited to be involved in physical activities over 30 minutes
  • already had an experience in liposuction

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

Integrated Therapy Group

Liposuction Group

Psychological Therapy Group

Self-help Group

Arm Description

Both liposuction and psychological therapy are delivered to the participants in this group.

This group experiences only liposuction and do self-help care after the liposuction.

This group experiences only cognitive behavioral therapy (CBT; psychological therapy) during the intervention period.

This group do not receive any interventions and do self-help care.

Outcomes

Primary Outcome Measures

BSQ-8C
Body Shape Questionnaire

Secondary Outcome Measures

fMRI
Brain response to the task-based fMRI
Computerized cognitive behavioral task
dot-probe task and implicit association task
KoQoL
Korean version of Obesity-related Quality of Life
DEBQ
Dutch Eating Behavioral Questionnaire
K-BDI
Korean Beck Depression Inventory
RSES
Rosenberg Self Esteem Scale
TAI
Trait Anxiety Inventory
PANAS
Positive and Negative Affect Schedule
SCL-90-R
The Symptom Checklist-90-R
EAT-26
The Eating Attitudes Test 26
K-AAQ-II
Korean version of The Acceptance and Action Questionnaire - II
Cognitive bias on the body image
What do you think about your body image based on the BMI criteria?
BMI in kg/m^2
body weight and height
Body fat percent
the total mass of fat divided by total body mass, multiplied by 100
Leg circumference
locating the biggest part of your upper leg
Waist circumference
a measurement taken around the abdomen at the level of the umbilicus.
Glucose
blood sample
ALT
Alanine transaminase
AST
Aspartate transaminase
GGT
Gamma-glutamyltransferase
Total Cholesterol
blood sample

Full Information

First Posted
December 10, 2019
Last Updated
September 20, 2021
Sponsor
Seoul National University Hospital
Collaborators
Global 365MC Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04199611
Brief Title
Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy
Official Title
Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Global 365MC Hospital

4. Oversight

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

5. Study Description

Brief Summary
This study is to develop an integrated therapy (physical therapy and psychotherapy) to treat cognitive distortion for body image. Then, validate its efficacy to make an improvement in both physical and mental health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Body Image
Keywords
Body Image Satisfaction, Liposuction, Psychological Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Therapy Group
Arm Type
Experimental
Arm Description
Both liposuction and psychological therapy are delivered to the participants in this group.
Arm Title
Liposuction Group
Arm Type
Active Comparator
Arm Description
This group experiences only liposuction and do self-help care after the liposuction.
Arm Title
Psychological Therapy Group
Arm Type
Active Comparator
Arm Description
This group experiences only cognitive behavioral therapy (CBT; psychological therapy) during the intervention period.
Arm Title
Self-help Group
Arm Type
No Intervention
Arm Description
This group do not receive any interventions and do self-help care.
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Description
This is a type of fat removal procedure used in plastic surgery.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
This is a psycho-social intervention that aims to improve mental health.
Primary Outcome Measure Information:
Title
BSQ-8C
Description
Body Shape Questionnaire
Time Frame
4 weeks, 8-item, scale 1 through 6
Secondary Outcome Measure Information:
Title
fMRI
Description
Brain response to the task-based fMRI
Time Frame
24 hours
Title
Computerized cognitive behavioral task
Description
dot-probe task and implicit association task
Time Frame
24 hours
Title
KoQoL
Description
Korean version of Obesity-related Quality of Life
Time Frame
24 hours, 13-item, scale 1 through 4
Title
DEBQ
Description
Dutch Eating Behavioral Questionnaire
Time Frame
24 hours, 33-item, scale 1 through 5
Title
K-BDI
Description
Korean Beck Depression Inventory
Time Frame
24 hours, 21-item, scale 1 through 4
Title
RSES
Description
Rosenberg Self Esteem Scale
Time Frame
24 hours, 10-item, scale 1 through 4
Title
TAI
Description
Trait Anxiety Inventory
Time Frame
24 hours, 20-item, scale 1 through 4
Title
PANAS
Description
Positive and Negative Affect Schedule
Time Frame
24 hours, 20-item, scale 1 through 5
Title
SCL-90-R
Description
The Symptom Checklist-90-R
Time Frame
24 hours, 90-item, scale 1 through 5
Title
EAT-26
Description
The Eating Attitudes Test 26
Time Frame
24 hours, 26-item, scale 1 through 6
Title
K-AAQ-II
Description
Korean version of The Acceptance and Action Questionnaire - II
Time Frame
24 hours, 10-item, scale 1 through 7
Title
Cognitive bias on the body image
Description
What do you think about your body image based on the BMI criteria?
Time Frame
24 hours, one-item, scale 1 through 4
Title
BMI in kg/m^2
Description
body weight and height
Time Frame
24 hours
Title
Body fat percent
Description
the total mass of fat divided by total body mass, multiplied by 100
Time Frame
24 hours
Title
Leg circumference
Description
locating the biggest part of your upper leg
Time Frame
24 hours
Title
Waist circumference
Description
a measurement taken around the abdomen at the level of the umbilicus.
Time Frame
24 hours
Title
Glucose
Description
blood sample
Time Frame
24 hours
Title
ALT
Description
Alanine transaminase
Time Frame
24 hours
Title
AST
Description
Aspartate transaminase
Time Frame
24 hours
Title
GGT
Description
Gamma-glutamyltransferase
Time Frame
24 hours
Title
Total Cholesterol
Description
blood sample
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 25~30 The score over 68 in SIMS (The situational motivation scale) Exclusion Criteria: Diagnosed in any chronic disease Trouble using smartphone Pregnant or planning to be pregnant Unable to be in the fMRI Limited to be involved in physical activities over 30 minutes already had an experience in liposuction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meelim Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Clinical Study Report (CSR)

Learn more about this trial

Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy

We'll reach out to this number within 24 hrs