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临床试验/NCT05123235
NCT05123235暂停不适用

The Effectiveness of a Telehealth-Based Physical Activity Intervention in Adolescents Receiving Treatment for Obesity

East Carolina University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
24
试验地点
2
主要终点
Change in BMI percentile

研究概览

简要总结

This study is a 11 week telehealth intervention focusing on increasing physical activity in adolescents who are receiving medical care for obesity. The participants will be randomized into two groups: control and intervention. During the 11 weeks both groups will be contacted once a week for a video call. The control group will report their past week physical activity levels and the intervention group will review the material in weekly newsletters on behavior changes related to physical activity. Physical activity levels will be measures before and after the intervention.

详细描述

The purpose of this study is to determine if a physical activity telehealth intervention will increase the amount of moderate-to-vigorous physical activity among 14-17 year olds who are receiving obesity treatment. A secondary purpose is to determine if a telehealth physical activity intervention will impact the adolescents' body mass index (BMI) z-score who are receiving treatment for obesity. The participants will complete questionnaires to measure current physical activity levels, physical activity enjoyment, motivation, and strategies to be active. The study investigators will also review the participants medical records to get BMI. Participants will be randomized into either an intervention or standard care control group at a 1:1 ratio (intervention-control). A computer-generated randomization list will be created by an individual not associated with the study. The intervention will last 11 weeks, and participants in the intervention group receive standard medical care and will have individual weekly web-meeting using a video conferencing platform, Microsoft Teams. The weekly meeting is expected to last approximately 30 minutes. During this meeting, participants will report on the past week's physical activity goals, failures and successes, set goals for the next week, discuss that week's behavioral strategy to promote physical activity for that week, and engage around 5 minutes of physical activity. The topics that will be discussed in the newsletters and weekly meetings will include behavioral strategies for physical activity changes. Those in the control group will also receive standard medical care and be contacted weekly for 11 weeks and will be asked about their physical activity levels for the past week. These meetings will also occur using video conferencing and last 5 minutes. After a regular visit to the medical clinic (6 weeks from the 1st study visit) the study investigators will review medical records from all participants for height, weight, and BMI. About 12 weeks after the 1st study visit, during a regular clinic visit all participants will complete questionnaires to measure current physical activity levels, physical activity enjoyment, motivation, and strategies to be active. The study investigators will also review the participants medical records to get height, weight and BMI.

研究设计

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

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 14-17 years of age
  • receiving treatment for obesity
  • have a smart device for video conferencing

排除标准

  • under 14 years of age
  • Type 1 or Type 2 Diabetes
  • Neuromuscular disease that impacts moving
  • Parent or child unable to speak or write in English.

结局指标

主要结局

Change in BMI percentile

时间窗: weeks 1, 6, and 12

BMI percentile will be calculated from BMI and CDC normative data

Change in physical activity participation

时间窗: weeks 1 and 12

minutes spent in physical activity

Change in BMI z-score

时间窗: weeks 1, 6, and 12

BMI z-score will be calculated from BMI and CDC normative data

次要结局

  • Change in physical activity enjoyment(weeks 1 and 12)
  • Change in physical activity motivation(weeks 1 and 12)
  • Change in physical activity strategies(weeks 1 and 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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