NCT03465306CompletedNot Applicable
Developing and Validating Clinical Efficacy for Obesity Digital CBT Model
Seoul National University Hospital2 sites in 2 countries70 target enrollmentStarted: September 18, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Change from Baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •SIMS score ranks over high 20% of total
Exclusion Criteria
- •Had been prescribed with psychological problems or medical problems.
Outcomes
Primary Outcomes
Change from Baseline
Time Frame: Baseline, at 8 weeks, at 6 months
Weight difference
Secondary Outcomes
- Trait Anxiety Inventory (TAI)(Baseline, at 8 weeks, at 6 months)
- the result of leptin(Baseline, at 8 weeks)
- weight and height will be combined to report BMI in kg/m^2(Baseline, at 8 weeks, at 6 months)
- Fat percent(Baseline, at 8 weeks, at 6 months)
- Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures(Baseline, at 8 weeks, at 6 months)
- Dutch Eating Behavior Questionnaire (DEBQ)(Baseline, at 8 weeks, at 6 months)
- the result of alanine aminotransferase (ALT)(Baseline, at 8 weeks)
- Buffet index(Baseline, at 8 weeks)
- Automatic Thoughts Questionnaire-30 (ATQ-30)(Baseline, at 8 weeks, at 6 months)
- the result of triglycerides (TG)(Baseline, at 8 weeks)
- the result of glucose(Baseline, at 8 weeks)
- the result of insulin(Baseline, at 8 weeks)
- the result of cholesterol total(Baseline, at 8 weeks)
- the result of aspartate aminotransferase (AST)(Baseline, at 8 weeks)
- Korean Beck Depression Inventory (K-BDI)(Baseline, at 8 weeks, at 6 months)
- Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)(Baseline, at 8 weeks, at 6 months)
- Yale Food Addiction Scale (YFAS)(Baseline, at 8 weeks, at 6 months)
- the result of gamma-glutamyl transferase (GGT)(Baseline, at 8 weeks)
Investigators
Study Sites (2)
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