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Living Green and Healthy for Teens (LiGHT)

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ClinicalTrials.gov Identifier: NCT03996109
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2022
Sponsor:
Collaborators:
Childhood Obesity Foundation
University of British Columbia
Ayogo Health Inc.
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Lifestyle Adolescent Behavior Behavioral: Aim2Be smartphone app system Behavioral: BnLt smartphone app Not Applicable

Detailed Description:

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 1-year period, compared to a control app, increase the proportion of youth engaging in a composite of healthy active living behaviours. Additional outcomes will include youth anthropometrics, diet quality, fitness, quality of life, and parental health behaviours and cardiovascular risk.

Using a single-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.

Participants will be recruited from the community in Hamilton, Ontario, 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.

Evaluations at baseline, 6 months and 1 year will include a youth questionnaire including questions about food intake , screen time, physical activity, health related quality of life, and resilience, and measurement of height, weight, body fat percentage using bioelectrical impedance assessment, blood pressure, hand grip strength using a dynamometer and leg strength using a standing long jump test, and cardiorespiratory fitness using a step test. They will also provide a urine sample and wear an accelerometer for 7 days. Parents will complete a questionnaire including questions about sociodemographics, their own food intake, screentime, physical activity, parental role modelling and logistic support. Parents will also complete the non-laboratory based INTERHEART risk score questionnaire and have their waist and hip circumference measured. Participants and parents will complete questionnaires about youth experience of online bullying and access to undesirable online content. 18 months after randomization, participants and parents may be invited to complete the same study questionnaires online.

This trial will demonstrate whether a relatively long term use of a rigorously-designed, evidence-based, user-friendly app is able to help families with teenagers improve health behaviours of youth and have any early impact on CV risk factors. Conducting an RCT in the context of the full range of youth in the community has the potential to inform population-scale implementation as a public health tool for sustainable obesity prevention across Canada.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Living Green and Healthy for Teens (LiGHT) - a Randomized Trial Evaluating Behaviour Change Using a Gamified Healthy Living App for Youth and Their Families
Actual Study Start Date : December 11, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Arm Intervention/treatment
Experimental: Aim2Be
Youth-parent dyads randomized to Aim2Be
Behavioral: Aim2Be smartphone app system
Youth-parent dyads will receive the LiGHT program (addressing healthy eating, physical activity, screen time and sleep) via the Aim2Be smartphone app for 1 year. It provides personalization beginning with creation of an avatar and identifying user motivations, offers progressive goal-setting considering readiness, sub-tasks, milestones, self-monitoring tools with feedback and positive reinforcement. It applies behaviour change techniques, provides a knowledge centre, simulation narratives to enable decision making, and separate social exchange platforms for parents and youth to share ideas and challenges with peers. A Virtual Coach has been programmed using motivational interviewing theory. Gamification includes elements of choice, challenge, uncertainty, discovery, and kudos for achieving outcomes in the process of developing motivations, skills and mastery.

Active Comparator: BnLt
Youth-parent dyads randomized to BnLt
Behavioral: BnLt smartphone app
Youth-parent dyads will receive a simple app called BnLt for 1 year. It provides web-links to external websites that provide information and tips on healthy eating and activity, including the Canada Food Guide, Canadian Society of Exercise Physiology recommendations for physical activity, screen time and sleep for youth, and other resources.




Primary Outcome Measures :
  1. Composite of healthy living behaviours [ Time Frame: 1 year ]
    The proportion of youth engaging in at least 4 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.


Secondary Outcome Measures :
  1. BMI Z-score [ Time Frame: 1 year (and 6 months as an exploratory outcome) ]
    Age, and sex specific body mass index Z-scores based on WHO norms

  2. MVPA [ Time Frame: 1 year (and 6 months as an exploratory outcome) ]
    Average daily minutes of moderate to vigorous physical activity measured by accelerometry over 1 week

  3. Diet quality biomarker [ Time Frame: 1 year (and 6 months as an exploratory outcome) ]
    Diet quality assessed by urine sodium-to-potassium concentration ratio


Other Outcome Measures:
  1. Change in number of health behaviours [ Time Frame: 6 months, 1 year ]
    Change from baseline in the number of the 7 measured health behaviours over time

  2. Percent body fat [ Time Frame: 6 months, 1 year ]
    Percent body fat by bioelectrical impedence

  3. Blood pressure [ Time Frame: 6 months, 1 year ]
    Systolic and Diastolic blood pressure Z-scores (based on NHANES norms for those with BMI Z-score <85%ile)

  4. Cardiorespiratory fitness [ Time Frame: 6 months, 1 year ]
    The modified Canadian Aerobic Fitness Test step test (Score range 0-4 with higher scores indicating better fitness)

  5. Health related quality of life [ Time Frame: 6 months, 1 year ]
    Kidscreen-27 Health-Related Quality of Life Questionnaire for Children and Adolescents - Total Score and Subscales(Physical Well-Being, Psychological Well-Being, Autonomy & Parents, Peers & Social Support, and School Environment) - Total and subscales transformed to T scores with mean 50 and standard deviation 10 with higher scores indicating better quality of life

  6. Child and Youth Resilience Measure-12 [ Time Frame: 6 months, 1 year ]
    The Child and Youth Resilience Measure (CYRM) is a questionnaire assessing the resources (individual, relational, communal and cultural) available to individuals that may bolster their resilience. (Score range 12-36 with higher scores indicating better resilience)

  7. Parental support of healthy eating and physical activity [ Time Frame: 6 months, 1 year ]
    Survey questions to asses parental role-modelling and logistic support of their youth's eating and activity behaviours

  8. Changes in parental diet [ Time Frame: 6 months, 1 year ]
    Changes in parental mean frequency of intake of fruits & vegetables, sugary drinks, eating breakfast and restaurant meals from baseline

  9. Changes in parental physical activity [ Time Frame: 6 months, 1 year ]
    Changes in parental metabolic equivalent-minutes (MET-mins) from the International Physical Activity Questionnaire (Score range 0-19278, with higher scores indicating greater physical activity)

  10. Parental cardiovascular risk [ Time Frame: 6 months, 1 year ]
    Parental non-laboratory based Interheart modifiable cardiovascular risk score, including questions about diabetes, hypertension, smoking, stress, family history, diet and physical activity (Score range 0-48, with higher scores indicating greater cardiovascular risk)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996109


Contacts
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Contact: LiGHT Trial study coordinator 905-527-4322 ext 40346 light@phri.ca

Locations
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Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
Contact: LiGHT Trial study coordinator    905-527-4322 ext 40346    light@phri.ca   
Sponsors and Collaborators
Population Health Research Institute
Childhood Obesity Foundation
University of British Columbia
Ayogo Health Inc.
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Zubin Punthakee, MD, MSc Population Health Research Institute
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03996109    
Other Study ID Numbers: LiGHT
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No