Search MeSHNCT03465306
Developing and Validating Clinical Efficacy for Obesity Digital CBT Model
A study testing Cognitive Behavioral Therapy and Self-guided in people with Search MeSH, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Search MeSH
- What is being tested?
- Cognitive Behavioral Therapy and Self-guided
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- SIMS score ranks over high 20% of total
Who cannot join
- Had been prescribed with psychological problems or medical problems.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Search MeSH
- Being tested
- Cognitive Behavioral Therapy, Self-guided
- Keywords
- Obesity, Cognitive Behavioral Therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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-guidedDevice
Self-guided refers to any contact between the participants and a therapist or coach.
| Study group | Role | What they receive |
|---|---|---|
| Intensive digital CBT | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
| Standard digital CBT | Active comparator | Not described Receives: Device: Self-guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline
Weight difference
Measured: Baseline, at 8 weeks, at 6 months
Secondary outcomes (18)
weight and height will be combined to report BMI in kg/m^2
BMI difference
Measured: Baseline, at 8 weeks, at 6 months
Fat percent
Fat percent difference
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, at 8 weeks, at 6 months
the result of cholesterol total
Biological index
Measured: Baseline, at 8 weeks
the result of triglycerides (TG)
Biological index
Measured: Baseline, at 8 weeks
the result of gamma-glutamyl transferase (GGT)
Biological index
Measured: Baseline, at 8 weeks
the result of glucose
Biological index
Measured: Baseline, at 8 weeks
the result of alanine aminotransferase (ALT)
Biological index
Measured: Baseline, at 8 weeks
the result of aspartate aminotransferase (AST)
Biological index
Measured: Baseline, at 8 weeks
the result of insulin
Biological index
Measured: Baseline, at 8 weeks
the result of leptin
Biological index
Measured: 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.
Measured: Baseline, at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start18 Sep 2017
- Primary completion20 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Search MeSHStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study is been designed to have pre, post, and follow-up phases.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Noom Inc., InBody
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465306
- Sponsor's protocol ID
- ObesityCBT
- Status last verified
- Apr 2019
- First submitted
- 15 Jan 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38375882Kim 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.
PubMed 38062157Kim 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.
PubMed 34184991Kim 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.
PubMed 32352391
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Validating Clinical Efficacy for Obesity Digital CBT Model
- ClinicalTrials.gov ID
- NCT03465306
- Acronym / sponsor ID
- ObesityCBT
- Conditions
- Search MeSH
- Keywords
- Obesity, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Noom Inc., InBody
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is been designed to have pre, post, and follow-up phases.
| Arm | Type | Receives |
|---|---|---|
| Intensive digital CBT | Experimental | Behavioral: Cognitive Behavioral Therapy |
| Standard digital CBT | Active comparator | Device: Self-guided |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- SIMS score ranks over high 20% of total
Key exclusion criteria (1 listed)
- Had been prescribed with psychological problems or medical problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyCognitive-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. | Behavioural | Intensive digital CBT |
| Self-guidedSelf-guided refers to any contact between the participants and a therapist or coach. | Device | Standard digital CBT |
Primary outcome
Change from Baseline
Time frame: Baseline, at 8 weeks, at 6 months
Weight difference
18 secondary outcomes
weight and height will be combined to report BMI in kg/m^2
Time frame: Baseline, at 8 weeks, at 6 months
Fat percent
Time frame: Baseline, at 8 weeks, at 6 months
Rosenberg Self-Esteem Scale (RSES). Child / Adolescent Measures
Time frame: Baseline, at 8 weeks, at 6 months
Body Shape Questionnaire: Psychometric properties of the short version (BSQ-8C)
Time frame: Baseline, at 8 weeks, at 6 months
Dutch Eating Behavior Questionnaire (DEBQ)
Time frame: Baseline, at 8 weeks, at 6 months
Yale Food Addiction Scale (YFAS)
Time frame: Baseline, at 8 weeks, at 6 months
Trait Anxiety Inventory (TAI)
Time frame: Baseline, at 8 weeks, at 6 months
Korean Beck Depression Inventory (K-BDI)
Time frame: Baseline, at 8 weeks, at 6 months
Automatic Thoughts Questionnaire-30 (ATQ-30)
Time frame: Baseline, at 8 weeks, at 6 months
the result of cholesterol total
Time frame: Baseline, at 8 weeks
the result of triglycerides (TG)
Time frame: Baseline, at 8 weeks
the result of gamma-glutamyl transferase (GGT)
Time frame: Baseline, at 8 weeks
the result of glucose
Time frame: Baseline, at 8 weeks
the result of alanine aminotransferase (ALT)
Time frame: Baseline, at 8 weeks
the result of aspartate aminotransferase (AST)
Time frame: Baseline, at 8 weeks
the result of insulin
Time frame: Baseline, at 8 weeks
the result of leptin
Time frame: Baseline, at 8 weeks
Buffet index
Time frame: Baseline, at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 38375882Metzendorf 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.
- Derived from this study: PubMed 38062157Kim 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.
- Derived from this study: PubMed 34184991Kim 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.
- Derived from this study: PubMed 32352391Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Self-guided in people with Search MeSH, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline (time frame: Baseline, at 8 weeks, at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465306, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.