Clinical trial NCT03465306: 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
Overall status: COMPLETED
Phase: NA
Conditions: Search MeSH
Keywords: Obesity
Cognitive Behavioral Therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Noom Inc.
name: InBody
First posted: 2018-03-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study is been designed to have pre, post, and follow-up phases.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* SIMS score ranks over high 20% of total

Exclusion Criteria:

* Had been prescribed with psychological problems or medical problems.

Primary outcomes:
measure: Change from Baseline
timeFrame: Baseline, at 8 weeks, at 6 months
Secondary outcomes:
measure: weight and height will be combined to report BMI in kg/m^2
timeFrame: Baseline, at 8 weeks, at 6 months
measure: Fat percent
timeFrame: Baseline, at 8 weeks, at 6 months
measure: Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures
timeFrame: Baseline, at 8 weeks, at 6 months
measure: Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)
timeFrame: Baseline, at 8 weeks, at 6 months
measure: Dutch Eating Behavior Questionnaire (DEBQ)
timeFrame: Baseline, at 8 weeks, at 6 months
measure: Yale Food Addiction Scale (YFAS)
timeFrame: Baseline, at 8 weeks, at 6 months
measure: Trait Anxiety Inventory (TAI)
timeFrame: Baseline, at 8 weeks, at 6 months
measure: Korean Beck Depression Inventory (K-BDI)
timeFrame: Baseline, at 8 weeks, at 6 months
measure: Automatic Thoughts Questionnaire-30 (ATQ-30)
timeFrame: Baseline, at 8 weeks, at 6 months
measure: the result of cholesterol total
timeFrame: Baseline, at 8 weeks
measure: the result of triglycerides (TG)
timeFrame: Baseline, at 8 weeks
measure: the result of gamma-glutamyl transferase (GGT)
timeFrame: Baseline, at 8 weeks
measure: the result of glucose
timeFrame: Baseline, at 8 weeks
measure: the result of alanine aminotransferase (ALT)
timeFrame: Baseline, at 8 weeks
measure: the result of aspartate aminotransferase (AST)
timeFrame: Baseline, at 8 weeks
measure: the result of insulin
timeFrame: Baseline, at 8 weeks
measure: the result of leptin
timeFrame: Baseline, at 8 weeks
measure: Buffet index
timeFrame: Baseline, at 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
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.
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.