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Clinical Trials/NCT03465306
NCT03465306
Completed
Not Applicable

Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Seoul National University Hospital1 site in 1 country70 target enrollmentSeptember 18, 2017
ConditionsSearch MeSH

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Search MeSH
Sponsor
Seoul National University Hospital
Enrollment
70
Locations
1
Primary Endpoint
Change from Baseline
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2017
End Date
April 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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