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

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.

Study Overview

• Status: Completed
• Conditions: Body Image; Mental Health Issue
• Intervention / Treatment: Procedure: Liposuction; Behavioral: Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Integrated Therapy Group; Both liposuction and psychological therapy are delivered to the participants in this group.	Procedure: Liposuction; This is a type of fat removal procedure used in plastic surgery.; Behavioral: Cognitive Behavioral Therapy; This is a psycho-social intervention that aims to improve mental health.; Other Names: CBT
ACTIVE_COMPARATOR: Liposuction Group; This group experiences only liposuction and do self-help care after the liposuction.	Procedure: Liposuction; This is a type of fat removal procedure used in plastic surgery.
ACTIVE_COMPARATOR: Psychological Therapy Group; This group experiences only cognitive behavioral therapy (CBT; psychological therapy) during the intervention period.	Behavioral: Cognitive Behavioral Therapy; This is a psycho-social intervention that aims to improve mental health.; Other Names: CBT
NO_INTERVENTION: Self-help Group; This group do not receive any interventions and do self-help care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BSQ-8C	Body Shape Questionnaire	4 weeks, 8-item, scale 1 through 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI	Brain response to the task-based fMRI	24 hours
Computerized cognitive behavioral task	dot-probe task and implicit association task	24 hours
KoQoL	Korean version of Obesity-related Quality of Life	24 hours, 13-item, scale 1 through 4
DEBQ	Dutch Eating Behavioral Questionnaire	24 hours, 33-item, scale 1 through 5
K-BDI	Korean Beck Depression Inventory	24 hours, 21-item, scale 1 through 4
RSES	Rosenberg Self Esteem Scale	24 hours, 10-item, scale 1 through 4
TAI	Trait Anxiety Inventory	24 hours, 20-item, scale 1 through 4
PANAS	Positive and Negative Affect Schedule	24 hours, 20-item, scale 1 through 5
SCL-90-R	The Symptom Checklist-90-R	24 hours, 90-item, scale 1 through 5
EAT-26	The Eating Attitudes Test 26	24 hours, 26-item, scale 1 through 6
K-AAQ-II	Korean version of The Acceptance and Action Questionnaire - II	24 hours, 10-item, scale 1 through 7
Cognitive bias on the body image	What do you think about your body image based on the BMI criteria?	24 hours, one-item, scale 1 through 4
BMI in kg/m^2	body weight and height	24 hours
Body fat percent	the total mass of fat divided by total body mass, multiplied by 100	24 hours
Leg circumference	locating the biggest part of your upper leg	24 hours
Waist circumference	a measurement taken around the abdomen at the level of the umbilicus.	24 hours
Glucose	blood sample	24 hours
ALT	Alanine transaminase	24 hours
AST	Aspartate transaminase	24 hours
GGT	Gamma-glutamyltransferase	24 hours
Total Cholesterol	blood sample	24 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Global 365MC Hospital
• Investigators: Study Director: Meelim Kim, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2020
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Psychological Therapy; Liposuction; Body Image Satisfaction
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: C-1811-124-990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Clinical Study Report (CSR)

Drug and device information, study documents

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