NCT03465306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

September 19, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

January 15, 2018

Last Update Submit

September 17, 2019

Conditions

Search MeSH

Keywords

ObesityCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline

    Weight difference

    Baseline, at 8 weeks, at 6 months

Secondary Outcomes (18)

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

    Baseline, at 8 weeks, at 6 months

  • Fat percent

    Baseline, at 8 weeks, at 6 months

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

    Baseline, at 8 weeks, at 6 months

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

    Baseline, at 8 weeks, at 6 months

  • Dutch Eating Behavior Questionnaire (DEBQ)

    Baseline, at 8 weeks, at 6 months

  • +13 more secondary outcomes

Study Arms (2)

Intensive digital CBT

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy

Standard digital CBT

ACTIVE COMPARATOR
Device: Self-guided

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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.

Intensive digital CBT
Self-guidedDEVICE

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

Standard digital CBT

Eligibility Criteria

Age19 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • SIMS score ranks over high 20% of total

You may not qualify if:

  • Had been prescribed with psychological problems or medical problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (4)

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PMID: 38375882DERIVED

  • Kim M, Lee S, Cho E, Hong KW, You SJ, Choi HJ. CETP and APOA2 polymorphisms are associated with weight loss and healthy eating behavior changes in response to digital lifestyle modifications. Sci Rep. 2023 Dec 7;13(1):21615. doi: 10.1038/s41598-023-48823-w.

    PMID: 38062157DERIVED

  • Kim M, Yang J, Ahn WY, Choi HJ. Machine Learning Analysis to Identify Digital Behavioral Phenotypes for Engagement and Health Outcome Efficacy of an mHealth Intervention for Obesity: Randomized Controlled Trial. J Med Internet Res. 2021 Jun 24;23(6):e27218. doi: 10.2196/27218.

    PMID: 34184991DERIVED

  • Kim M, Kim Y, Go Y, Lee S, Na M, Lee Y, Choi S, Choi HJ. Multidimensional Cognitive Behavioral Therapy for Obesity Applied by Psychologists Using a Digital Platform: Open-Label Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 30;8(4):e14817. doi: 10.2196/14817.

    PMID: 32352391DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: This study is been designed to have pre, post, and follow-up phases.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2018

First Posted

March 14, 2018

Study Start

September 18, 2017

Primary Completion

April 20, 2018

Study Completion

April 30, 2018

Last Updated

September 19, 2019

Record last verified: 2019-04

Locations

KR(1)