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Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Not Applicable
Completed
Conditions
Search MeSH
Interventions
Device: Self-guided
Behavioral: Cognitive Behavioral Therapy
Registration Number
NCT03465306
Lead Sponsor
Seoul National University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
70
Inclusion Criteria
  • SIMS score ranks over high 20% of total
Exclusion Criteria
  • Had been prescribed with psychological problems or medical problems.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Standard digital CBTSelf-guided-
Intensive digital CBTCognitive Behavioral Therapy-
Primary Outcome Measures
NameTimeMethod
Change from BaselineBaseline, at 8 weeks, at 6 months

Weight difference

Secondary Outcome Measures
NameTimeMethod
Trait Anxiety Inventory (TAI)Baseline, at 8 weeks, at 6 months

Psychological index, total scores range from 20\~80, higher the score higher in feelings of anxiety.

the result of leptinBaseline, at 8 weeks

Biological index

weight and height will be combined to report BMI in kg/m^2Baseline, at 8 weeks, at 6 months

BMI difference

Fat percentBaseline, at 8 weeks, at 6 months

Fat percent difference

Rosenberg Self-Esteem Scale (RSES). Child / Adolescent MeasuresBaseline, at 8 weeks, at 6 months

Psychological index, total scores range from 10\~40, higher the score lower the self-esteem.

Dutch Eating Behavior Questionnaire (DEBQ)Baseline, at 8 weeks, at 6 months

Psychological index, total scores range from 33\~165, higher the score more problems in eating behavior.

the result of alanine aminotransferase (ALT)Baseline, at 8 weeks

Biological index

Buffet indexBaseline, at 8 weeks

Buffet test, total scores range from 0\~100, higher the score better in healthy food choice and amount of intake.

Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)Baseline, at 8 weeks, at 6 months

Psychological index, total scores range from 8\~48, higher the score lower the satisfaction to self-body image.

Automatic Thoughts Questionnaire-30 (ATQ-30)Baseline, at 8 weeks, at 6 months

Psychological index, total scores range from 30\~150, higher the score higher tendency to have negative automatic thoughts.

the result of triglycerides (TG)Baseline, at 8 weeks

Biological index

the result of glucoseBaseline, at 8 weeks

Biological index

the result of insulinBaseline, at 8 weeks

Biological index

the result of cholesterol totalBaseline, at 8 weeks

Biological index

the result of aspartate aminotransferase (AST)Baseline, at 8 weeks

Biological index

Yale Food Addiction Scale (YFAS)Baseline, at 8 weeks, at 6 months

Psychological index, total scores range from 0\~7, higher the score more expected to have food addiction.

Korean Beck Depression Inventory (K-BDI)Baseline, at 8 weeks, at 6 months

Psychological index, total scores range from 0\~63, higher the score higher in feelings of depressed.

the result of gamma-glutamyl transferase (GGT)Baseline, at 8 weeks

Biological index

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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