Adolescent ObesityNCT04760587
Application of Smart Devices in Adolescent Weight Control
An observational study of Adolescent Obesity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
According to the definition of Health Literacy, health literacy means that a person can apply his or her reading, writing, and computing abilities to health-related information and activities. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Adolescent Obesity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jun 2020to 1 Jan 2023
- Phase
- Observational
- 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 13 to 19 years
- All sexes
- Child, Adult
Study population: The study in this study will be 13-19 years old adolescents.
Who may be able to join
- 13-19 years old adolescents;
- Could use their mobile phones to upload diet records and fill out the questionnaire;
- Adolescents and their parents agree to involve in the study and sign the consent form.
Who cannot join
- Severe diseases;
- Participate in other weight control program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Smart Devices in Adolescent Weight Control: A Longitudinal Panel Study
According to the definition of Health Literacy, health literacy means that a person can apply his or her reading, writing, and computing abilities to health-related information and activities. WHO consider Health Literacy is the cognitive and social skills which determine the motivation and ability of individuals to gain access, to understand and use information.
The purposes of this study will to understand the relationship between health literacy, weight control behavior and weight control health outcome.
Read the detailed description
According to the definition of Health Literacy, health literacy means that a person can apply his or her reading, writing, and computing abilities to health-related information and activities. WHO consider Health Literacy is the cognitive and social skills which determine the motivation and ability of individuals to gain access, to understand and use information.
The purposes of this study will to understand the relationship between health literacy, weight control behavior and weight control health outcome.
According to the purpose, the study will be multi wave longitudinal panel study. The study will apply mobile phone applications and smart watches to understand the relationship between weight control behaviors and weight control health outcome in adolescent.
There are two blocks in the mobile phone applications: questionnaire block and Weight status block will be design for the study. Questionnaire block include demography, and health literacy scales and diet diary. Weight status block include height, weight, waist circumference, and hip circumference. After the participant key-in the height and weight, the system will automatically calculate the BMI, also show the results of the BMI. The standard for BMI interpretation was by Dr. Chang's research about New Growth Charts for Taiwanese Adolescents.
The data of smart watches will be upload into the NTUH health cloud system (named NTU MED GOD). This is the NTUH health cloud, different kinds of medical materials and data could be sent to the system, such as mobile phone and smart watches data.
- Conditions
- Adolescent Obesity
- Being tested
- smart devices in adolescent weight control
- Keywords
- Adolescent, smart devices, weight control, health literacy
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart devices in adolescent weight controlBehavioural
The study will apply mobile phone applications and smart watches to understand the relationship between weight control behaviors and weight control health outcome in adolescent.
| Study group | Role | What they receive |
|---|---|---|
| study group | smart devices in adolescent Receives: Behavioral: smart devices in adolescent weight control |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI(body mass index)
Body mass index (BMI) is a measure of body fat based on height and weight.
Measured: Change from baseline body mass index at 3 months, 6 months, 9 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start17 Jun 2020
- Primary completion31 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsia Chen, Principal investigator, National Taiwan University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760587
- Sponsor's protocol ID
- 202005008RIND
- Status last verified
- Apr 2022
- First submitted
- 17 Feb 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Smart Devices in Adolescent Weight Control: A Longitudinal Panel Study
- ClinicalTrials.gov ID
- NCT04760587
- Acronym / sponsor ID
- 202005008RIND
- Conditions
- Adolescent Obesity
- Keywords
- Adolescent, smart devices, weight control, health literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 Feb 2021 (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.
According to the definition of Health Literacy, health literacy means that a person can apply his or her reading, writing, and computing abilities to health-related information and activities. WHO consider Health Literacy is the cognitive and social skills which determine the motivation and ability of individuals to gain access, to understand and use information.
The purposes of this study will to understand the relationship between health literacy, weight control behavior and weight control health outcome.
Detailed description
According to the definition of Health Literacy, health literacy means that a person can apply his or her reading, writing, and computing abilities to health-related information and activities. WHO consider Health Literacy is the cognitive and social skills which determine the motivation and ability of individuals to gain access, to understand and use information.
The purposes of this study will to understand the relationship between health literacy, weight control behavior and weight control health outcome.
According to the purpose, the study will be multi wave longitudinal panel study. The study will apply mobile phone applications and smart watches to understand the relationship between weight control behaviors and weight control health outcome in adolescent.
There are two blocks in the mobile phone applications: questionnaire block and Weight status block will be design for the study. Questionnaire block include demography, and health literacy scales and diet diary. Weight status block include height, weight, waist circumference, and hip circumference. After the participant key-in the height and weight, the system will automatically calculate the BMI, also show the results of the BMI. The standard for BMI interpretation was by Dr. Chang's research about New Growth Charts for Taiwanese Adolescents.
The data of smart watches will be upload into the NTUH health cloud system (named NTU MED GOD). This is the NTUH health cloud, different kinds of medical materials and data could be sent to the system, such as mobile phone and smart watches data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Behavioral: smart devices in adolescent weight controlsmart devices in adolescent |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The study in this study will be 13-19 years old adolescents.
Key inclusion criteria (3 listed)
- 13-19 years old adolescents;
- Could use their mobile phones to upload diet records and fill out the questionnaire;
- Adolescents and their parents agree to involve in the study and sign the consent form.
Key exclusion criteria (2 listed)
- Severe diseases;
- Participate in other weight control program.
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 |
|---|---|---|
| smart devices in adolescent weight controlThe study will apply mobile phone applications and smart watches to understand the relationship between weight control behaviors and weight control health outcome in adolescent. | Behavioural | study group |
Primary outcome
BMI(body mass index)
Time frame: Change from baseline body mass index at 3 months, 6 months, 9 months, and 12 months.
Body mass index (BMI) is a measure of body fat based on height and weight.
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 23 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Yu-Hsia Chen principal investigator
National Taiwan University, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Obesity, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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 23 Jan 2023. 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 Taiwan. 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?
BMI(body mass index) (time frame: Change from baseline body mass index at 3 months, 6 months, 9 months, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2023.