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Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)

2019年9月4日 更新者:Semra Ozdemir、Duke-NUS Graduate Medical School

Randomized Controlled Trial of a Physical Activity Program for Teenagers (FIT-TEEN)

The study aims:

  1. To test the effect of providing social comparison information on increasing physical activity among Singaporean adolescents.
  2. To test whether providing social comparison information increases physical activity more when it is provided publicly compared to when it is provided anonymously.

研究概览

详细说明

Childhood and adolescent obesity represents a major public health challenge worldwide. Singapore is no exception as the prevalence of obesity among children was estimated at 12%. Overweight and obese children are more likely to become obese adults, to develop non-communicable diseases at a younger age, and to have a shorter life expectancy. One of the main reasons behind the growing obesity epidemic is low levels of physical activity. Previous literature shows evidence of a steep decline in physical activity among boys after the primary school years and low levels of activity among girls throughout the primary and high school years in Singapore. Daily step counts are found to be up to 35% short of the recommended daily steps for adolescents. Low levels of physical activity are also associated with lower psychological well-being among adolescents. Thus, it is important that interventions aimed at increasing physical activity target adolescent years.

In this study, the investigators propose to test the effectiveness of providing social comparison information on increasing physical activity among adolescents. Participating adolescents will be randomized into a group and groups will be randomized into one of two study arms in a 4-month walking program:

Private arm: At the end of each week, participants will be provided with the number of steps logged by the participants in their group. The number of steps will be ranked from highest to the lowest without any identifiable information about the participants.

Public arm: At the end of each week, participants in this arm will be provided with the same information as in the other arm plus the names of the participants corresponding to the number of steps logged.

Social comparison information will be provided to the study participants via SMS. We will conduct a 4-month two-arm RCT to test whether social comparison information increases physical activity more when it is disclosed publicly compared to when it is provided anonymously. The primary outcome is the average number of steps taken per week by participants. Study outcomes relating to physical activity and health-related quality of life for participants will be evaluated at baseline and 4 months. Step activity will be tracked in real time via Fitbit wireless pedometers throughout the study.

研究类型

介入性

注册 (实际的)

311

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡、169857
        • Duke-NUS Medical School

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 16年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • The study's target population is adolescents aged 13-16 years. Participants should be Singaporean citizens or permanent residents. Participants should be English-speaking. Participants should be willing to wear a pedometer for 4 months. Only participants who provide at least 8 (out of 14 days) valid days of pedometer data including at least 2 days of the weekend at baseline will be included.

Exclusion Criteria:

  • Participants will be asked to complete a short screener questionnaire to ensure that they are healthy enough to participate. Participants reporting the following will be excluded:
  • Having any medical condition that may limit their ability to walk as a means of physical activity
  • Are unwilling to wear a wireless pedometer for 4 months

Participants will also be screened with a Physical Activity Readiness Questionnaire (PAR-Q). Those who answer 'YES' to any PAR-Q question will be permitted to enroll only if they provide written approval from a medical doctor.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Private Arm
At the end of each week, participants will be provided with the number of steps logged by the participants in their group. The number of steps will be ranked from highest to the lowest without any identifiable information about the participants.
Social comparison information will be provided to the study participants weekly via SMS
Fitbit is a wireless pedometer that tracks steps of participants and will be offered in conjunction with a tailored website with customised information for participants.
其他名称:
  • Fitbit Flex, wireless pedometer, physical activity tracker
实验性的:Public Arm
At the end of each week, participants will be provided with the number of steps logged by the participants in their group. The number of steps will be ranked from highest to the lowest with the full names of the participants corresponding to the number of steps.
Social comparison information will be provided to the study participants weekly via SMS
Fitbit is a wireless pedometer that tracks steps of participants and will be offered in conjunction with a tailored website with customised information for participants.
其他名称:
  • Fitbit Flex, wireless pedometer, physical activity tracker

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The average number of steps taken per week by participants
大体时间:4 months
These will be assessed through Fitbit pedometers at baseline and at the last 2 weeks of the trial. All participants will be issued a step counter, the Fitbit Flex™ for use during the entire 4-month RCT.
4 months

次要结果测量

结果测量
措施说明
大体时间
Health Outcomes: Quality of life index
大体时间:4 months
The quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) for adolescents. These measures will be taken twice; at baseline and at the end of the study.
4 months
Health Outcomes: Depression
大体时间:4 months
Depression will be measured using Asian Adolescent Depression Scale (AADS) which is validated for Singaporean adolescents.These measures will be taken twice; at baseline and at the end of the study.
4 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Semra Ozdemir, PhD、Duke-NUS Graduate Medical School

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年12月1日

初级完成 (实际的)

2018年8月1日

研究完成 (实际的)

2018年12月1日

研究注册日期

首次提交

2017年3月9日

首先提交符合 QC 标准的

2017年3月9日

首次发布 (实际的)

2017年3月15日

研究记录更新

最后更新发布 (实际的)

2019年9月6日

上次提交的符合 QC 标准的更新

2019年9月4日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • HSRNIG13nov007

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Upon request from the principal investigator, individual participant data will be available to other researchers for secondary analysis purposes, such as meta-analyses, reanalysis or replication of results. Any data that will be shared will be de-identified so privacy of the participants will be protected.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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