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Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Primary Purpose

Search MeSH

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

About this trial

This is an interventional treatment trial for Search MeSH focused on measuring Obesity, Cognitive Behavioral Therapy

Eligibility Criteria

19 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • SIMS score ranks over high 20% of total

Exclusion Criteria:

  • Had been prescribed with psychological problems or medical problems.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive digital CBT

Standard digital CBT

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline
Weight difference

Secondary Outcome Measures

weight and height will be combined to report BMI in kg/m^2
BMI difference
Fat percent
Fat percent difference
Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures
Psychological index, total scores range from 10~40, higher the score lower the self-esteem.
Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)
Psychological index, total scores range from 8~48, higher the score lower the satisfaction to self-body image.
Dutch Eating Behavior Questionnaire (DEBQ)
Psychological index, total scores range from 33~165, higher the score more problems in eating behavior.
Yale Food Addiction Scale (YFAS)
Psychological index, total scores range from 0~7, higher the score more expected to have food addiction.
Trait Anxiety Inventory (TAI)
Psychological index, total scores range from 20~80, higher the score higher in feelings of anxiety.
Korean Beck Depression Inventory (K-BDI)
Psychological index, total scores range from 0~63, higher the score higher in feelings of depressed.
Automatic Thoughts Questionnaire-30 (ATQ-30)
Psychological index, total scores range from 30~150, higher the score higher tendency to have negative automatic thoughts.
the result of cholesterol total
Biological index
the result of triglycerides (TG)
Biological index
the result of gamma-glutamyl transferase (GGT)
Biological index
the result of glucose
Biological index
the result of alanine aminotransferase (ALT)
Biological index
the result of aspartate aminotransferase (AST)
Biological index
the result of insulin
Biological index
the result of leptin
Biological index
Buffet index
Buffet test, total scores range from 0~100, higher the score better in healthy food choice and amount of intake.

Full Information

First Posted
January 15, 2018
Last Updated
September 17, 2019
Sponsor
Seoul National University Hospital
Collaborators
Noom Inc., InBody
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1. Study Identification

Unique Protocol Identification Number
NCT03465306
Brief Title
Developing and Validating Clinical Efficacy for Obesity Digital CBT Model
Official Title
Developing and Validating Clinical Efficacy for Obesity Digital CBT Model
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Noom Inc., InBody

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
The aim of the present study is to develop and validate the effects of a new cognitive behavioral therapy (CBT) using digital healthcare mobile apps such as Noom Coach and InBody.
Detailed Description
Seventy female participants whose BMI scores were above 23 and who had no other clinical problem except obesity were randomized into an experimental and a control group. Forty-five people in the experimental group were connected with the therapist using digital healthcare apps, so they got daily feedbacks and assignments for 8 weeks. Twenty-five people in the control group also used digital healthcare apps but they were asked to do self-care without intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Search MeSH
Keywords
Obesity, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This study is been designed to have pre, post, and follow-up phases.
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive digital CBT
Arm Type
Experimental
Arm Title
Standard digital CBT
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Cognitive-behavioral therapy is a psycho-social intervention that is the most widely used evidence-based practice for improving mental health and requires active interactions between the participants and a therapist or coach.
Intervention Type
Device
Intervention Name(s)
Self-guided
Intervention Description
Self-guided refers to any contact between the participants and a therapist or coach.
Primary Outcome Measure Information:
Title
Change from Baseline
Description
Weight difference
Time Frame
Baseline, at 8 weeks, at 6 months
Secondary Outcome Measure Information:
Title
weight and height will be combined to report BMI in kg/m^2
Description
BMI difference
Time Frame
Baseline, at 8 weeks, at 6 months
Title
Fat percent
Description
Fat percent difference
Time Frame
Baseline, at 8 weeks, at 6 months
Title
Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures
Description
Psychological index, total scores range from 10~40, higher the score lower the self-esteem.
Time Frame
Baseline, at 8 weeks, at 6 months
Title
Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)
Description
Psychological index, total scores range from 8~48, higher the score lower the satisfaction to self-body image.
Time Frame
Baseline, at 8 weeks, at 6 months
Title
Dutch Eating Behavior Questionnaire (DEBQ)
Description
Psychological index, total scores range from 33~165, higher the score more problems in eating behavior.
Time Frame
Baseline, at 8 weeks, at 6 months
Title
Yale Food Addiction Scale (YFAS)
Description
Psychological index, total scores range from 0~7, higher the score more expected to have food addiction.
Time Frame
Baseline, at 8 weeks, at 6 months
Title
Trait Anxiety Inventory (TAI)
Description
Psychological index, total scores range from 20~80, higher the score higher in feelings of anxiety.
Time Frame
Baseline, at 8 weeks, at 6 months
Title
Korean Beck Depression Inventory (K-BDI)
Description
Psychological index, total scores range from 0~63, higher the score higher in feelings of depressed.
Time Frame
Baseline, at 8 weeks, at 6 months
Title
Automatic Thoughts Questionnaire-30 (ATQ-30)
Description
Psychological index, total scores range from 30~150, higher the score higher tendency to have negative automatic thoughts.
Time Frame
Baseline, at 8 weeks, at 6 months
Title
the result of cholesterol total
Description
Biological index
Time Frame
Baseline, at 8 weeks
Title
the result of triglycerides (TG)
Description
Biological index
Time Frame
Baseline, at 8 weeks
Title
the result of gamma-glutamyl transferase (GGT)
Description
Biological index
Time Frame
Baseline, at 8 weeks
Title
the result of glucose
Description
Biological index
Time Frame
Baseline, at 8 weeks
Title
the result of alanine aminotransferase (ALT)
Description
Biological index
Time Frame
Baseline, at 8 weeks
Title
the result of aspartate aminotransferase (AST)
Description
Biological index
Time Frame
Baseline, at 8 weeks
Title
the result of insulin
Description
Biological index
Time Frame
Baseline, at 8 weeks
Title
the result of leptin
Description
Biological index
Time Frame
Baseline, at 8 weeks
Title
Buffet index
Description
Buffet test, total scores range from 0~100, higher the score better in healthy food choice and amount of intake.
Time Frame
Baseline, at 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: SIMS score ranks over high 20% of total Exclusion Criteria: Had been prescribed with psychological problems or medical problems.
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
Citations:
PubMed Identifier
34184991
Citation
Kim M, Yang J, Ahn WY, Choi HJ. Machine Learning Analysis to Identify Digital Behavioral Phenotypes for Engagement and Health Outcome Efficacy of an mHealth Intervention for Obesity: Randomized Controlled Trial. J Med Internet Res. 2021 Jun 24;23(6):e27218. doi: 10.2196/27218.
Results Reference
derived
PubMed Identifier
32352391
Citation
Kim M, Kim Y, Go Y, Lee S, Na M, Lee Y, Choi S, Choi HJ. Multidimensional Cognitive Behavioral Therapy for Obesity Applied by Psychologists Using a Digital Platform: Open-Label Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 30;8(4):e14817. doi: 10.2196/14817.
Results Reference
derived

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Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

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