Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Search MeSH Clinical Trial

Official title:

Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465306
• Other study ID #: ObesityCBT
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 39 Years

Eligibility

Inclusion Criteria:

• SIMS score ranks over high 20% of total

Exclusion Criteria:

• Had been prescribed with psychological problems or medical problems.

Related Conditions & MeSH terms

• Obesity
• Search MeSH

Intervention

Behavioral:
• Cognitive Behavioral Therapy
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.

Device:
• Self-guided
Self-guided refers to any contact between the participants and a therapist or coach.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	InBody, Noom Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline	Weight difference	Baseline, at 8 weeks, at 6 months
Secondary	weight and height will be combined to report BMI in kg/m^2	BMI difference	Baseline, at 8 weeks, at 6 months
Secondary	Fat percent	Fat percent difference	Baseline, at 8 weeks, at 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	the result of cholesterol total	Biological index	Baseline, at 8 weeks
Secondary	the result of triglycerides (TG)	Biological index	Baseline, at 8 weeks
Secondary	the result of gamma-glutamyl transferase (GGT)	Biological index	Baseline, at 8 weeks
Secondary	the result of glucose	Biological index	Baseline, at 8 weeks
Secondary	the result of alanine aminotransferase (ALT)	Biological index	Baseline, at 8 weeks
Secondary	the result of aspartate aminotransferase (AST)	Biological index	Baseline, at 8 weeks
Secondary	the result of insulin	Biological index	Baseline, at 8 weeks
Secondary	the result of leptin	Biological index	Baseline, at 8 weeks
Secondary	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