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Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03465306
Enrollment
70
Registered
2018-03-14
Start date
2017-09-18
Completion date
2018-04-30
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Search MeSH

Keywords

Obesity, Cognitive Behavioral Therapy

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.

Interventions

BEHAVIORALCognitive 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.

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

Sponsors

Noom Inc.
CollaboratorINDUSTRY
InBody
CollaboratorUNKNOWN
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

This study is been designed to have pre, post, and follow-up phases.

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

* SIMS score ranks over high 20% of total

Exclusion criteria

* Had been prescribed with psychological problems or medical problems.

Design outcomes

Primary

MeasureTime frameDescription
Change from BaselineBaseline, at 8 weeks, at 6 monthsWeight difference

Secondary

MeasureTime frameDescription
Fat percentBaseline, at 8 weeks, at 6 monthsFat percent difference
Rosenberg Self-Esteem Scale (RSES). Child / Adolescent MeasuresBaseline, at 8 weeks, at 6 monthsPsychological index, total scores range from 10\ 40, higher the score lower the self-esteem.
Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)Baseline, at 8 weeks, at 6 monthsPsychological index, total scores range from 8\ 48, higher the score lower the satisfaction to self-body image.
Dutch Eating Behavior Questionnaire (DEBQ)Baseline, at 8 weeks, at 6 monthsPsychological index, total scores range from 33\ 165, higher the score more problems in eating behavior.
Yale Food Addiction Scale (YFAS)Baseline, at 8 weeks, at 6 monthsPsychological index, total scores range from 0\ 7, higher the score more expected to have food addiction.
Trait Anxiety Inventory (TAI)Baseline, at 8 weeks, at 6 monthsPsychological index, total scores range from 20\ 80, higher the score higher in feelings of anxiety.
Korean Beck Depression Inventory (K-BDI)Baseline, at 8 weeks, at 6 monthsPsychological index, total scores range from 0\ 63, higher the score higher in feelings of depressed.
Automatic Thoughts Questionnaire-30 (ATQ-30)Baseline, at 8 weeks, at 6 monthsPsychological index, total scores range from 30\ 150, higher the score higher tendency to have negative automatic thoughts.
weight and height will be combined to report BMI in kg/m^2Baseline, at 8 weeks, at 6 monthsBMI difference
the result of triglycerides (TG)Baseline, at 8 weeksBiological index
the result of gamma-glutamyl transferase (GGT)Baseline, at 8 weeksBiological index
the result of glucoseBaseline, at 8 weeksBiological index
the result of alanine aminotransferase (ALT)Baseline, at 8 weeksBiological index
the result of aspartate aminotransferase (AST)Baseline, at 8 weeksBiological index
the result of insulinBaseline, at 8 weeksBiological index
the result of leptinBaseline, at 8 weeksBiological index
Buffet indexBaseline, at 8 weeksBuffet test, total scores range from 0\ 100, higher the score better in healthy food choice and amount of intake.
the result of cholesterol totalBaseline, at 8 weeksBiological index

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026