Investigating the Efficacy of a Mobile App Intervention to Change Youth and Their Families' Health Behaviours
Condition: Obesity, Pediatric
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Families (one parent and one child) will be recruited through advertising on social media and
      through active referral from six Canadian Pediatric Weight Management Registry (CANPWR) sites
      (Children's Hospital of Eastern Ontario, SickKids, McMaster Children's Hospital, Stollery
      Children's Hospital, Alberta Children's Hospital, and British Columbia Children's Hospital).
      Approximately 350 families will be recruited and a total of 200 families will be enrolled
      into the study and randomized into two groups. This study uses a two-group parallel/crossover
      randomized controlled trial design. All families will be given access to Aim2Be v2.2 to use
      from their mobile device or home computer. Participants will be prospectively followed for
      six months.

      Once participants are deemed eligible to participate in the study and complete their baseline
      assessments, they are allocated to one of two conditions: 1) Live Coach; or 3) waitlist
      control group given standard of care. Participants in the Live Coach group will be given
      access to Aim2Be for six months with a live coach who has expertise in supporting lifestyle
      modification and will help youth and parents set goals and achieve these goals using
      principles from motivational interviewing. Participants in the control group will be wait
      listed for enrollment in the app for three months and will be given access to the Virtual
      Coach version of the app after they complete the three month evaluation. The Virtual Coach
      group version provides automated guidance from a virtual coach instead of a live person, but
      that is programmed using the same motivational interviewing principles.

      Evaluation at baseline, three months, and six months will be used to compare whether those
      assigned to the different coach conditions have better health outcomes than those assigned to
      the waitlist control group. Parents will complete questionnaires at baseline, three months,
      and six months, which assess sociodemographics, behaviours, and mediators of behaviour
      change. Youth will complete questionnaires at baseline, three months, and six months, which
      assess health behaviours, mediators of behaviour change, and knowledge of Canadian
      recommendations for healthy behaviours. Questionnaire data will be collected and managed
      using REDCap.

      Families will be provided with a Fitbit, scale, and measuring tape when they enroll in the
      study. At each assessment point (baseline, three months, and six months), parents will
      provide youth's height and weight, and youth will complete three 24-hour dietary recalls and
      wear the Fitbit for the duration of the study.

      Honoraria will be paid at each time point to compensate participation.

      Participants will be randomly allocated to each of the two groups and have equal likelihood
      of assignment to each condition. Participants will not be blinded as the design of the
      intervention does not facilitate this. Participants will be informed of their allocation
      after completing all baseline measures. Evaluators and researchers will be blinded to
      allocation during data analysis.

      The aims of this study are to: 1) determine reach/ who participates in this study (short term
      outcome); 2) determine whether participation in the program increases adolescents' knowledge
      of Canadian health recommendations related to dietary habits, physical activity, and
      sedentary behaviour (medium term outcome); and 3) assess the impact of Aim2Be on changes in
      dietary habits, physical activity, and sedentary behaviours as well as Body Mass Index (BMI)
      and whether the impact is moderated by involvement in the app (long term outcome).
    

Intervention name(s): Aim2Be app with Live Coach + Fitbit + BMI tracking tools; Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will spend six months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. They will also complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Live Coach and the Virtual Coach. The Live Coach has specialized training in lifestyle and motivational interviewing and will support families in changing their health behaviours through in-app messaging and phone calls. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory.; Participants in this condition will be waitlisted for three months while they receive standard of care (Canadian Health Recommendations for physical activity, dietary habits, screen behaviours, and sleep). Participants will gain access to the Aim2Be app with Virtual Coach after the three month assessment. Participants will then spend three months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. For the whole six months, participants will complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Virtual Coach only. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; physical activity; nutrition; adolescents; gamification; video game; sedentary activity