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临床试验/NCT03996109
NCT03996109进行中(未招募)不适用

Living Green and Healthy for Teens (LiGHT) - a Randomized Trial Evaluating Behaviour Change Using a Gamified Healthy Living App for Youth and Their Families

Population Health Research Institute1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
74
试验地点
1
主要终点
Healthy living behaviours

研究概览

简要总结

This is a two-group parallel randomized controlled trial testing whether a gamified healthy living smartphone app for youth aged 10-16 representative of the Canadian population and one of their parents is more effective at improving a composite of health behaviours (diet, physical activity, sleep and screen time) than a simple app providing links to healthy living websites.

详细描述

Living Green and Healthy for Teens (LiGHT) is a Canadian smartphone app-based program that combines health promotion (healthy eating, active living, screen time and sleep) with additional novel motivators such as environmental stewardship (e.g. reduce prepackaged foods, walk rather than drive) and cost-savings (e.g., eat at home rather than restaurants), that may further increase the likelihood of behaviour change.

The primary aim of the trial is to determine, among youth aged 10-16 years, if randomization of their family to the use of the interactive gamified Living Green and Healthy for Teens (LiGHT) app over a 6 month period, compared to a control app, increases the number of healthy active living behaviours engaged in by youth. Additional outcomes will include youth anthropometrics, diet quality, fitness, quality of life, and parental health behaviours and cardiovascular risk.

Using a multi-centre randomized, parallel, controlled single-blind design, 376 eligible youth-parent dyads stratified by youth (gender, and age <13.5/≥13.5y) will be allocated 1:1 to receive intervention or control apps that provide information and tips on healthy eating and activity in different ways. Participants will be followed for 1 year, with the primary outcome assessed at 6 months.

Participants will be recruited from the community in Hamilton, Ontario, and Surrey, British Columbia, Canada. The target population is the general population of youth and their families. Therefore, entry criteria will be broad. Youth aged 10-16 years of age who identify a need or potential to improve health behaviours will be included if one parent is willing to attend all study visits and use the app, there is at least one internet enabled device in the household, and there are no contraindications to healthy eating and activity, and no family member is participating in a weight management program or other clinical trial.

Participants will be blinded to treatment group. Both apps have appealing interfaces, and both provide information, tips and interactivity (though to different degrees). Every effort will be made to keep research staff who help participants with the app separate from staff who collect data, and the latter will be trained to avoid discussing the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Living in a home setting with at least one smartphone or tablet and internet access in the household, and
  • One parent or guardian (the "primary parent") who is able to attend all study visits.
  • Youth or parent identifying a need or potential to improve health behaviours

排除标准

  • Inability of the youth and/or primary parent to read English at a grade 5 level
  • A health condition in the youth that precludes eating a variety of foods or engaging in physical activity
  • Current participation of any family member in a weight management program
  • Current participation in another clinical trial
  • Current or prior participation of another member of the household/family in this trial

结局指标

主要结局

Healthy living behaviours

时间窗: 6 months

Number of behaviours engaged in by youth of the following 7 behaviours: a) ≥60 minutes of MVPA daily, b) ≤2 hours of recreational screen time daily, c) 9-11 hours (for those ≤13 years) and 8-10 hours (for those ≥14 years) of nightly sleep, d) ≥5 fruit and vegetable servings per day, e) ≤2 sugary beverages per week, f) breakfast consumption 7 days per week, and g) eating out or ordering in \<1 time per week.

次要结局

  • MVPA(6 months, 1 year)
  • BMI Z-score(6 months)
  • Diet quality biomarker(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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