Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedStudy Start
First participant enrolled
January 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedSeptember 22, 2021
September 1, 2021
8 months
December 10, 2019
September 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BSQ-8C
Body Shape Questionnaire
4 weeks, 8-item, scale 1 through 6
Secondary Outcomes (21)
fMRI
24 hours
Computerized cognitive behavioral task
24 hours
KoQoL
24 hours, 13-item, scale 1 through 4
DEBQ
24 hours, 33-item, scale 1 through 5
K-BDI
24 hours, 21-item, scale 1 through 4
- +16 more secondary outcomes
Study Arms (4)
Integrated Therapy Group
EXPERIMENTALBoth liposuction and psychological therapy are delivered to the participants in this group.
Liposuction Group
ACTIVE COMPARATORThis group experiences only liposuction and do self-help care after the liposuction.
Psychological Therapy Group
ACTIVE COMPARATORThis group experiences only cognitive behavioral therapy (CBT; psychological therapy) during the intervention period.
Self-help Group
NO INTERVENTIONThis group do not receive any interventions and do self-help care.
Interventions
This is a type of fat removal procedure used in plastic surgery.
This is a psycho-social intervention that aims to improve mental health.
Eligibility Criteria
You may qualify if:
- BMI 25\~30
- The score over 68 in SIMS (The situational motivation scale)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Global 365MC Hospitalcollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Meelim Kim
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 10, 2019
First Posted
December 16, 2019
Study Start
January 3, 2020
Primary Completion
August 31, 2020
Study Completion
December 30, 2020
Last Updated
September 22, 2021
Record last verified: 2021-09