Project LiGHT (Living Green and Healthy for Teens): A Novel Weight Management Program That Emphasizes the Benefits of a Healthy Lifestyle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Change in screen behaviour (youth)
研究概览
简要总结
This study is the second of three sub-studies aimed at evaluating the outcomes of the Living Green and Healthy for Teens (LiGHT) program, delivered through the Aim2Be app (v2.2). Aim2Be is an app for 10 to 17 year olds and their families that is intended to help them shift from an healthy lifestyle toward better health habits in four areas: nutrition, physical activity, recreational screen time, and sleep. This second evaluation has the following aims to: 1) describe reach; 2) assess change in knowledge of Canadian health recommendations; and 3) assess change in lifestyle behaviours and weight outcomes and whether these changes are moderated by involvement in the app. This study uses a two-group parallel/crossover randomized controlled trial design following N=200 families for six months.
详细描述
Living Green and Healthy for Teens (LiGHT v2) is an engaging online, individualized, gamified lifestyle management program for youth, delivered through the Aim2Be app. LiGHT v2 is focused on initiating long-term behaviour change in youth and their families in order to help them shift from an unhealthy lifestyle toward better health habits in four areas: nutrition, physical activity, recreational screen time, and sleep. The program aims to support healthy lifestyles of 10- to 17-year-old children and adolescents, as well as to mitigate increased risk for metabolic and non-metabolic complications associated with obesity in the short and long term.
The app includes content that involve the family, and focus on behavioural therapy as well as dietary and physical activity patterns. Aim2Be is intended to be engaging and fun, provide virtual and tangible rewards, interact with participants multiple times per day, and provide a mobile social support network.
Pre-teens (10-13) and teens (14-17) will each have their own unique versions of Aim2Be. Content will be tailored specifically to the developmental stage and needs of each age group. The content will be delivered in such a way that it facilitates education, peer-to-peer conversation, and self-regulation in an engaging platform.
Because parents have been shown to be of primary importance in supporting healthy lifestyles of children, LiGHT v2 will educated and engage parents as well as youth. Parents will receive separate, but complementary content, intended to guide them as they shop for and prepare food and make behavioural changes within their families. The content for parents will be delivered using the same social aspects of Aim2Be as the pre-teens and teens, but the channels will be gated, so teens and parents each have their own space. Aim2Be's social features will help parents strategize and empathize with other families who wish to adopt healthy lifestyles.
The program will be evaluated using three separate study groups. This protocol describes the second of the three.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child must be between 10 and 17 years old
- •Child and at least one of their parents must be able to read at the grade 5 level or above
- •Parent participant must be the caregiver with whom the child primarily lives
- •Families must have a computer or mobile device and internet access at home
- •Child participants must be either overweight or obese, as defined by the age and gender specific WHO cut-offs for children and adolescents aged 5 to 19
排除标准
- •Diagnosis of any musculoskeletal, cardiovascular, pulmonary, or orthopedic problems or disabilities precluding the participant from being physically active
- •Any other physical condition that precludes the participant from being physically active
- •Diagnosis of anorexia nervosa or bulimia nervosa
- •Diagnosis of Type I diabetes
- •Dietary restrictions or special diets that limit a participant's ability to eat a variety of foods
- •Simultaneous participation in another physical activity, nutrition, or weight management study/program
- •Use of medication, nutritional supplements, or herbal preparations to help lose weight
- •Pregnancy
- •A history of psychiatric problems or substance abuse which would interfere with adherence to the study protocol
研究组 & 干预措施
Aim2Be Live Coach
Aim2Be app with Live Coach + Fitbit + BMI tracking tools
干预措施: Aim2Be app with Live Coach + Fitbit + BMI tracking tools (Behavioral)
Aim2Be Waitlist
Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools for three months, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools
干预措施: Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools (Behavioral)
结局指标
主要结局
Change in screen behaviour (youth)
时间窗: Baseline, 3 months, 6 months
Survey questions will assess adolescents' recreational screen time use (using the Take Action survey), and will be reported as the number of self-reported hours of recreational screen time per day.
Change in objective dietary behaviour (youth)
时间窗: Baseline, 3 months, 6 months
Change in mean daily servings of fruits and vegetables and sugar-sweetened beverages consumed over three consecutive 24-hour dietary recalls.
Change in number of daily steps (youth)
时间窗: Baseline, 3 months, 6 months
Change in mean daily steps over a 14-day period at each assessment point, as measured using a Fitbit activity monitor.
Change in Body Mass Index z-score (youth)
时间窗: Baseline, 3 months, 6 months
Change in BMI z-scores will be computed from measured height and weight using World Health Organization (WHO) cut-offs
Change in health behaviour knowledge (youth)
时间窗: Baseline, 3 months, 6 months
Survey questions (using a LiGHT-specific tool) will assess teens' knowledge of Canadian recommendations for healthy eating, physical activity, and sedentary behaviours. Knowledge will be reported as an aggregate knowledge score from 0 to 8 (a score of 0 indicates low knowledge and a score of 8 indicates high knowledge), as well as sub-score for each of the knowledge areas (nutrition, physical activity, recreational screen time, sleep).
次要结局
- Adherence(3 months, 6 months)
- Change in self-reported dietary behaviour (youth)(Baseline, 3 months, 6 months)
- Change in screen behaviour (parents)(Baseline, 3 months, 6 months)
- Reach(Baseline)
- Change in Healthy Eating Index score (youth)(Baseline, 3 months, 6 months)
- Change in self-reported physical activity behaviour (parents)(Baseline, 3 months, 6 months)
- Change in self-reported physical activity behaviour (youth)(Baseline, 3 months, 6 months)
- Change in self-reported dietary behaviour (parents)(Baseline, 3 months, 6 months)
- Change in mediators of behaviour change(Baseline, 3 months, 6 months)
研究者
Louise Masse
Professor
University of British Columbia