ObesityNCT04759716
Health Literacy-based Weight Control Intervention
A study of Obesity and Overweight, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This research will be a continuation of 2015-2017 research projects of smart phone APP research granted by Ministry of Science and Technology. First of all, a four-wave-cross-sectional survey by cluster sampling is used to recruit 90 adolescents aged 13-19 from high school, vocational schools or colleges to test the… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Mar 2021to 18 Nov 2023
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-19 years old adolescents;
- Could use their mobile phones to upload diet records and photos;
- Adolescents and their parents or legal representatives agree to involve in the study and sign the consent.
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: The Effectiveness of Health Literacy-based Weight Control Intervention Via Mobile Health Application for Overweight and Obese Adolescent: A Longitudinal Panel Study
This research will be a continuation of 2015-2017 research projects of smart phone APP research granted by Ministry of Science and Technology. First of all, a four-wave-cross-sectional survey by cluster sampling is used to recruit 90 adolescents aged 13-19 from high school, vocational schools or colleges to test the feasibility of the health literacy-based weight-control program. In the second stage, a two-arm randomized controlled trial (RCT) will be applied to recruit 240 overweight or obese teenagers to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program. Based on the previous research evidences, the outcome follow up will be scheduled on 3 months, 9 months, 15 months, and 21 months after the mobile Health Apps intervention. Short-term outcome indicators include health literacy, diet pattern, and dietary behaviors; long-term outcome indicators include BMI z-score, waist circumference. Intention-to-treat analysis, generalized linear mixed models with repeated measures, multiple regression analysis model, and counterfactual causal Inference will be applied to analyze the effectiveness of the interventions.
Read the detailed description
Adolescent overweight and obesity are major health issues and challenges worldwide. According to the estimate of World Health Organization, the number of obese people in the world has tripled since 1975. Overweight and obese children and adolescents increased from 124 million in 1975 to 340 million in 2016. The obese young children will have a negative impact on the physical, psychological and social health, and will increase the risk of obesity in adulthood.
This study is a continuing project of the research funded by the Ministry of Science and Technology to explore the smartphone app, health literacy. Purposes of this study are to (1) validate the Health literacy based mobile Health Apps Interventions, (2) conduct the mobile health apps and smart sports watches to intervene in 12 months and evaluate the effectiveness by follow-up repeated measures.
Eligibility criteria. The inclusion criteria are 13-19 years old adolescents; Could use their mobile phones to upload diet records and photos; and Adolescents and their parents agree to involve in the study and sign the consent form.
Exclusion conditions are the adolescent who with severe diseases (such as tumors and other diseases); and they already participate in other weight control program.
Methods This research will be a continuation of 2015-2017 research projects of smart phone APP research granted by Ministry of Science and Technology. First of all, a four-wave-cross-sectional survey by cluster sampling is used to recruit 90 adolescents aged 13-19 from high school, vocational schools or colleges to test the feasibility of the health literacy-based weight-control program. In the second stage, a two-arm randomized controlled trial (RCT) will be applied to recruit 240 overweight or obese teenagers to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program. Based on the previous research evidences, the outcome follow up will be scheduled on 3 months, 9 months, 15 months, and 21 months after the mobile Health Apps intervention. Short-term outcome indicators include health literacy, diet pattern, and dietary behaviors; long-term outcome indicators include BMI z-score, waist circumference. Intention-to-treat analysis, generalized linear mixed models with repeated measures, multiple regression analysis model, and counterfactual causal Inference will be applied to analyze the effectiveness of the interventions.
Expected outcomes This study applies health literacy-based mobile Health Apps weight control program for the overweight and obese adolescents. By strengthening healthy lifestyle of healthy dietary pattern and physical activity for adolescents, we hope to effectively prevent adolescent obesity, so as to reduce the impacts of obesity to social, medical and economic burdens.
- Conditions
- Obesity, Overweight
- Being tested
- Health Literacy-based Weight Control Intervention
- Keywords
- weight control, Adolescents, overweight, obesity, Mobile health
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Literacy-based Weight Control InterventionOther
intervention arm will be applied to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program
| Study group | Role | What they receive |
|---|---|---|
| Health Literacy-based Weight Control Intervention arm | Experimental | intervention arm will receive weight control program Receives: Other: Health Literacy-based Weight Control Intervention |
| control arm | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI(body mass index)
BMI = weight / height².
Measured: Change from baseline body mass index at 3 months, 9 months, 15 months, and 21 months.
Secondary outcomes (1)
WHR(waist-to-hip ratio )
waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W⁄H).
Measured: Change from baseline waist-to-hip ratio at 3 months, 9 months, 15 months, and 21 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 start9 Mar 2021
- Primary completion30 Oct 2023
- Study completion18 Nov 2023
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bih-Shya Gau, Principal investigator, National Taiwan University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759716
- Sponsor's protocol ID
- 201912048RIND
- Status last verified
- Apr 2022
- First submitted
- 10 Feb 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen YH, Tzeng YF, Gau BS. Mobile Health-Based Health Literacy Weight Management Intervention Using Smart Devices for Adolescents: A Convergent Mixed-Methods Pilot Study. Nurs Health Sci. 2024 Dec;26(4):e13172. doi: 10.1111/nhs.13172.
PubMed 39428322
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Health Literacy-based Weight Control Intervention Via Mobile Health Application for Overweight and Obese Adolescent: A Longitudinal Panel Study
- ClinicalTrials.gov ID
- NCT04759716
- Acronym / sponsor ID
- 201912048RIND
- Conditions
- Obesity, Overweight
- Keywords
- weight control, Adolescents, overweight, obesity, Mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 18 Nov 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.
This research will be a continuation of 2015-2017 research projects of smart phone APP research granted by Ministry of Science and Technology. First of all, a four-wave-cross-sectional survey by cluster sampling is used to recruit 90 adolescents aged 13-19 from high school, vocational schools or colleges to test the feasibility of the health literacy-based weight-control program. In the second stage, a two-arm randomized controlled trial (RCT) will be applied to recruit 240 overweight or obese teenagers to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program. Based on the previous research evidences, the outcome follow up will be scheduled on 3 months, 9 months, 15 months, and 21 months after the mobile Health Apps intervention. Short-term outcome indicators include health literacy, diet pattern, and dietary behaviors; long-term outcome indicators include BMI z-score, waist circumference. Intention-to-treat analysis, generalized linear mixed models with repeated measures, multiple regression analysis model, and counterfactual causal Inference will be applied to analyze the effectiveness of the interventions.
Detailed description
Adolescent overweight and obesity are major health issues and challenges worldwide. According to the estimate of World Health Organization, the number of obese people in the world has tripled since 1975. Overweight and obese children and adolescents increased from 124 million in 1975 to 340 million in 2016. The obese young children will have a negative impact on the physical, psychological and social health, and will increase the risk of obesity in adulthood.
This study is a continuing project of the research funded by the Ministry of Science and Technology to explore the smartphone app, health literacy. Purposes of this study are to (1) validate the Health literacy based mobile Health Apps Interventions, (2) conduct the mobile health apps and smart sports watches to intervene in 12 months and evaluate the effectiveness by follow-up repeated measures.
Eligibility criteria. The inclusion criteria are 13-19 years old adolescents; Could use their mobile phones to upload diet records and photos; and Adolescents and their parents agree to involve in the study and sign the consent form.
Exclusion conditions are the adolescent who with severe diseases (such as tumors and other diseases); and they already participate in other weight control program.
Methods This research will be a continuation of 2015-2017 research projects of smart phone APP research granted by Ministry of Science and Technology. First of all, a four-wave-cross-sectional survey by cluster sampling is used to recruit 90 adolescents aged 13-19 from high school, vocational schools or colleges to test the feasibility of the health literacy-based weight-control program. In the second stage, a two-arm randomized controlled trial (RCT) will be applied to recruit 240 overweight or obese teenagers to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program. Based on the previous research evidences, the outcome follow up will be scheduled on 3 months, 9 months, 15 months, and 21 months after the mobile Health Apps intervention. Short-term outcome indicators include health literacy, diet pattern, and dietary behaviors; long-term outcome indicators include BMI z-score, waist circumference. Intention-to-treat analysis, generalized linear mixed models with repeated measures, multiple regression analysis model, and counterfactual causal Inference will be applied to analyze the effectiveness of the interventions.
Expected outcomes This study applies health literacy-based mobile Health Apps weight control program for the overweight and obese adolescents. By strengthening healthy lifestyle of healthy dietary pattern and physical activity for adolescents, we hope to effectively prevent adolescent obesity, so as to reduce the impacts of obesity to social, medical and economic burdens.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Literacy-based Weight Control Intervention arm | Experimental | Other: Health Literacy-based Weight Control Interventionintervention arm will receive weight control program |
| control arm | No intervention | –routine care |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 13-19 years old adolescents;
- Could use their mobile phones to upload diet records and photos;
- Adolescents and their parents or legal representatives agree to involve in the study and sign the consent.
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 |
|---|---|---|
| Health Literacy-based Weight Control Interventionintervention arm will be applied to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program | Other | Health Literacy-based Weight Control Intervention arm |
Primary outcome
BMI(body mass index)
Time frame: Change from baseline body mass index at 3 months, 9 months, 15 months, and 21 months.
BMI = weight / height².
1 secondary outcome
WHR(waist-to-hip ratio )
Time frame: Change from baseline waist-to-hip ratio at 3 months, 9 months, 15 months, and 21 months.
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 22 Nov 2023.
- Derived from this study: PubMed 39428322Chen YH, Tzeng YF, Gau BS. Mobile Health-Based Health Literacy Weight Management Intervention Using Smart Devices for Adolescents: A Convergent Mixed-Methods Pilot Study. Nurs Health Sci. 2024 Dec;26(4):e13172. doi: 10.1111/nhs.13172.
- 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.
Bih-Shya Gau 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?
A study of Obesity and Overweight, 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 22 Nov 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, 9 months, 15 months, and 21 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 NCT04759716, 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 22 Nov 2023.