Skip to main content
OpenTrials
Completed

NCT Number: NCT03465306

Developing and Validating Clinical Efficacy for Obesity Digital CBT Model

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Search MeSH Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • SIMS score ranks over high 20% of total

Exclusion criteria

  • Had been prescribed with psychological problems or medical problems.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Device

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

Primary outcomes

  1. Change from Baseline

    Time frame: Baseline, at 8 weeks, at 6 months

    Weight difference

Secondary outcomes

  1. weight and height will be combined to report BMI in kg/m^2

    Time frame: Baseline, at 8 weeks, at 6 months

    BMI difference

  2. Fat percent

    Time frame: Baseline, at 8 weeks, at 6 months

    Fat percent difference

  3. Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures

    Time frame: Baseline, at 8 weeks, at 6 months

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

  4. Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)

    Time frame: 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.

  5. Dutch Eating Behavior Questionnaire (DEBQ)

    Time frame: Baseline, at 8 weeks, at 6 months

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

  6. Yale Food Addiction Scale (YFAS)

    Time frame: Baseline, at 8 weeks, at 6 months

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

  7. Trait Anxiety Inventory (TAI)

    Time frame: Baseline, at 8 weeks, at 6 months

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

  8. Korean Beck Depression Inventory (K-BDI)

    Time frame: Baseline, at 8 weeks, at 6 months

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

  9. Automatic Thoughts Questionnaire-30 (ATQ-30)

    Time frame: 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.

  10. the result of cholesterol total

    Time frame: Baseline, at 8 weeks

    Biological index

  11. the result of triglycerides (TG)

    Time frame: Baseline, at 8 weeks

    Biological index

  12. the result of gamma-glutamyl transferase (GGT)

    Time frame: Baseline, at 8 weeks

    Biological index

  13. the result of glucose

    Time frame: Baseline, at 8 weeks

    Biological index

  14. the result of alanine aminotransferase (ALT)

    Time frame: Baseline, at 8 weeks

    Biological index

  15. the result of aspartate aminotransferase (AST)

    Time frame: Baseline, at 8 weeks

    Biological index

  16. the result of insulin

    Time frame: Baseline, at 8 weeks

    Biological index

  17. the result of leptin

    Time frame: Baseline, at 8 weeks

    Biological index

  18. Buffet index

    Time frame: Baseline, at 8 weeks

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • InBody
  • Noom Inc.

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2018
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.