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

September 20, 2021 updated by: Hyung Jin Choi, Seoul National University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BSQ-8C
Time Frame: 4 weeks, 8-item, scale 1 through 6
Body Shape Questionnaire
4 weeks, 8-item, scale 1 through 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
fMRI
Time Frame: 24 hours
Brain response to the task-based fMRI
24 hours
Computerized cognitive behavioral task
Time Frame: 24 hours
dot-probe task and implicit association task
24 hours
KoQoL
Time Frame: 24 hours, 13-item, scale 1 through 4
Korean version of Obesity-related Quality of Life
24 hours, 13-item, scale 1 through 4
DEBQ
Time Frame: 24 hours, 33-item, scale 1 through 5
Dutch Eating Behavioral Questionnaire
24 hours, 33-item, scale 1 through 5
K-BDI
Time Frame: 24 hours, 21-item, scale 1 through 4
Korean Beck Depression Inventory
24 hours, 21-item, scale 1 through 4
RSES
Time Frame: 24 hours, 10-item, scale 1 through 4
Rosenberg Self Esteem Scale
24 hours, 10-item, scale 1 through 4
TAI
Time Frame: 24 hours, 20-item, scale 1 through 4
Trait Anxiety Inventory
24 hours, 20-item, scale 1 through 4
PANAS
Time Frame: 24 hours, 20-item, scale 1 through 5
Positive and Negative Affect Schedule
24 hours, 20-item, scale 1 through 5
SCL-90-R
Time Frame: 24 hours, 90-item, scale 1 through 5
The Symptom Checklist-90-R
24 hours, 90-item, scale 1 through 5
EAT-26
Time Frame: 24 hours, 26-item, scale 1 through 6
The Eating Attitudes Test 26
24 hours, 26-item, scale 1 through 6
K-AAQ-II
Time Frame: 24 hours, 10-item, scale 1 through 7
Korean version of The Acceptance and Action Questionnaire - II
24 hours, 10-item, scale 1 through 7
Cognitive bias on the body image
Time Frame: 24 hours, one-item, scale 1 through 4
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
Time Frame: 24 hours
body weight and height
24 hours
Body fat percent
Time Frame: 24 hours
the total mass of fat divided by total body mass, multiplied by 100
24 hours
Leg circumference
Time Frame: 24 hours
locating the biggest part of your upper leg
24 hours
Waist circumference
Time Frame: 24 hours
a measurement taken around the abdomen at the level of the umbilicus.
24 hours
Glucose
Time Frame: 24 hours
blood sample
24 hours
ALT
Time Frame: 24 hours
Alanine transaminase
24 hours
AST
Time Frame: 24 hours
Aspartate transaminase
24 hours
GGT
Time Frame: 24 hours
Gamma-glutamyltransferase
24 hours
Total Cholesterol
Time Frame: 24 hours
blood sample
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Global 365MC Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Meelim Kim, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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