Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
125 participants
INTERVENTIONAL
2021-03-09
2023-11-18
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Health Literacy-based Weight Control Intervention arm
intervention arm will receive weight control program
Health Literacy-based Weight Control Intervention
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
control arm
routine care
No interventions assigned to this group
Interventions
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Health Literacy-based Weight Control Intervention
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Participate in other weight control program.
13 Years
19 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Bih-Shya Gau
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University, College of Medicine
Locations
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National Taiwan University
Taipei, , Taiwan
Countries
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References
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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.
Other Identifiers
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201912048RIND
Identifier Type: -
Identifier Source: org_study_id