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临床试验/NCT04759716
NCT04759716已完成不适用

The Effectiveness of Health Literacy-based Weight Control Intervention Via Mobile Health Application for Overweight and Obese Adolescent: A Longitudinal Panel Study

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
2
主要终点
BMI(body mass index)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Severe diseases;
  • Participate in other weight control program.

结局指标

主要结局

BMI(body mass index)

时间窗: Change from baseline body mass index at 3 months, 9 months, 15 months, and 21 months.

BMI = weight / height².

次要结局

  • WHR(waist-to-hip ratio )(Change from baseline waist-to-hip ratio at 3 months, 9 months, 15 months, and 21 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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