Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

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.

Study Overview

• Status: Completed
• Conditions: Search MeSH
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Device: Self-guided

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• 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: 19 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• SIMS score ranks over high 20% of total

Exclusion Criteria:

• Had been prescribed with psychological problems or medical problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive digital CBT	Behavioral: Cognitive Behavioral Therapy; 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.
Active Comparator: Standard digital CBT	Device: Self-guided; Self-guided refers to any contact between the participants and a therapist or coach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline	Weight difference	Baseline, at 8 weeks, at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight and height will be combined to report BMI in kg/m^2	BMI difference	Baseline, at 8 weeks, at 6 months
Fat percent	Fat percent difference	Baseline, at 8 weeks, at 6 months
Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures	Psychological index, total scores range from 10~40, higher the score lower the self-esteem.	Baseline, at 8 weeks, at 6 months
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.	Baseline, at 8 weeks, at 6 months
Dutch Eating Behavior Questionnaire (DEBQ)	Psychological index, total scores range from 33~165, higher the score more problems in eating behavior.	Baseline, at 8 weeks, at 6 months
Yale Food Addiction Scale (YFAS)	Psychological index, total scores range from 0~7, higher the score more expected to have food addiction.	Baseline, at 8 weeks, at 6 months
Trait Anxiety Inventory (TAI)	Psychological index, total scores range from 20~80, higher the score higher in feelings of anxiety.	Baseline, at 8 weeks, at 6 months
Korean Beck Depression Inventory (K-BDI)	Psychological index, total scores range from 0~63, higher the score higher in feelings of depressed.	Baseline, at 8 weeks, at 6 months
Automatic Thoughts Questionnaire-30 (ATQ-30)	Psychological index, total scores range from 30~150, higher the score higher tendency to have negative automatic thoughts.	Baseline, at 8 weeks, at 6 months
the result of cholesterol total	Biological index	Baseline, at 8 weeks
the result of triglycerides (TG)	Biological index	Baseline, at 8 weeks
the result of gamma-glutamyl transferase (GGT)	Biological index	Baseline, at 8 weeks
the result of glucose	Biological index	Baseline, at 8 weeks
the result of alanine aminotransferase (ALT)	Biological index	Baseline, at 8 weeks
the result of aspartate aminotransferase (AST)	Biological index	Baseline, at 8 weeks
the result of insulin	Biological index	Baseline, at 8 weeks
the result of leptin	Biological index	Baseline, at 8 weeks
Buffet index	Buffet test, total scores range from 0~100, higher the score better in healthy food choice and amount of intake.	Baseline, at 8 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Noom Inc.; InBody

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Cognitive Behavioral Therapy
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: ObesityCBT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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