Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Study Overview
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Brief Summary
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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
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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.

Official Title
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Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Conditions
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Search MeSH

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Device: Self-guided


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SIMS score ranks over high 20% of total Exclusion Criteria: Had been prescribed with psychological problems or medical problems.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This study is been designed to have pre, post, and follow-up phases.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Cognitive Behavioral Therapy