Weight LossNCT03200119
MyHealthKeeper: Clinical Trial Study Based on Personal Health Record Healthcare Management
A study testing Daily health-related lifestyle modification prescription in people with Weight Loss and Obesity, run by Seoul National University Hospital.
Trial summary
In order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback from clinicians Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- Daily health-related lifestyle modification prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2016to 18 Nov 2016
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study participants must agree to support by him/herself at enroll time
- Patients without severe cardiopulmonary disease, cancer, or other acute diseases
- Patients must be over BMI > 23 kg/m2
Who cannot join
- Patient who did not agree with this study
- Patients with severe cardiopulmonary disease, cancer, or other acute diseases
- Patients who were pregnant
About this study
Official title: A Study of the Management of the Patient's Disease Based on the Life Log Data of Patients With Lifestyle-related Diseases Through a Wearable Device
In order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback from clinicians
- Conditions
- Weight Loss, Obesity
- Being tested
- Daily health-related lifestyle modification prescription
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily health-related lifestyle modification prescriptionBehavioural
Daily health-related lifestyle modification prescription
| Study group | Role | What they receive |
|---|---|---|
| Mobile application user group | Experimental | In the active group, participants were educated to modify their lifestyle to lose weight by using a smart phone-based lifestyle app which was designed to collect daily activity and dietary information. The app was composed of two main modules: a diet module, and a physical activity module. Receives: Behavioral: Daily health-related lifestyle modification prescription |
| Control group | No intervention | Conventional lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
weight measurement and calculate BMI(body mass index)
Measured: baseline and after 4weeks of lifestyle intervention
Secondary outcomes (2)
Blood test result change
Blood test and its several results value measurement
Measured: baseline and after 4weeks of lifestyle intervention
Mobile-app usage change
Usage log of mobile application
Measured: baseline and after 4weeks of lifestyle intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start20 Jun 2016
- Primary completion26 Jul 2016
- Study completion18 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se Young Jung, Seoul National University Bundang Hospital
- Investigators
- Se young Jung, MD, MPH, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200119
- Sponsor's protocol ID
- B-1504/296-302
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient personal information is confidential according to the hospital's data protection policy
Publications
Ryu B, Kim N, Heo E, Yoo S, Lee K, Hwang H, Kim JW, Kim Y, Lee J, Jung SY. Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper. J Med Internet Res. 2017 Dec 7;19(12):e401. doi: 10.2196/jmir.8867.
PubMed 29217503
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Management of the Patient's Disease Based on the Life Log Data of Patients With Lifestyle-related Diseases Through a Wearable Device
- ClinicalTrials.gov ID
- NCT03200119
- Acronym / sponsor ID
- B-1504/296-302
- Conditions
- Weight Loss, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 18 Nov 2016 (actual)
- First posted
- 27 Jun 2017 (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.
In order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback from clinicians
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile application user group | Experimental | Behavioral: Daily health-related lifestyle modification prescriptionIn the active group, participants were educated to modify their lifestyle to lose weight by using a smart phone-based lifestyle app which was designed to collect daily activity and dietary information. The app was composed of two main modules: a diet module, and a physical activity module. |
| Control group | No intervention | –Conventional lifestyle modification |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study participants must agree to support by him/herself at enroll time
- Patients without severe cardiopulmonary disease, cancer, or other acute diseases
- Patients must be over BMI > 23 kg/m2
Key exclusion criteria (3 listed)
- Patient who did not agree with this study
- Patients with severe cardiopulmonary disease, cancer, or other acute diseases
- Patients who were pregnant
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 |
|---|---|---|
| Daily health-related lifestyle modification prescriptionDaily health-related lifestyle modification prescription | Behavioural | Mobile application user group |
Primary outcome
Body weight change
Time frame: baseline and after 4weeks of lifestyle intervention
weight measurement and calculate BMI(body mass index)
2 secondary outcomes
Blood test result change
Time frame: baseline and after 4weeks of lifestyle intervention
Mobile-app usage change
Time frame: baseline and after 4weeks of lifestyle intervention
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 27 Jun 2017.
- Derived from this study: PubMed 29217503Ryu B, Kim N, Heo E, Yoo S, Lee K, Hwang H, Kim JW, Kim Y, Lee J, Jung SY. Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper. J Med Internet Res. 2017 Dec 7;19(12):e401. doi: 10.2196/jmir.8867.
- Individual participant dataSharing planned: No. patient personal information is confidential according to the hospital's data protection policy
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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.
Se young Jung, MD, MPH principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Daily health-related lifestyle modification prescription in people with Weight Loss and Obesity, run by Seoul National University Hospital.
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 3 inclusion and 3 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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Body weight change (time frame: baseline and after 4weeks of lifestyle intervention). 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 NCT03200119, which also lists 1 linked publication.
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 27 Jun 2017.