NCT03996109

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
2.5 years until next milestone

Study Start

First participant enrolled

December 11, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

June 19, 2019

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Healthy living behaviours

    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.

    6 months

Secondary Outcomes (3)

  • BMI Z-score

    6 months

  • MVPA

    6 months, 1 year

  • Diet quality biomarker

    6 months

Other Outcomes (8)

  • Change in number of health behaviours

    6 months, (1 year exploratory)

  • Cardiorespiratory fitness

    6 months

  • Health related quality of life

    6 months, (1 year exploratory)

  • +5 more other outcomes

Study Arms (2)

Aim2Be

EXPERIMENTAL

Youth-parent dyads randomized to Aim2Be

Behavioral: Aim2Be smartphone app system

BnLt

ACTIVE COMPARATOR

Youth-parent dyads randomized to BnLt

Behavioral: BnLt smartphone app

Interventions

Youth-parent dyads will receive the LiGHT program (addressing healthy eating, physical activity, screen time and sleep) via the Aim2Be smartphone app for 6 months. 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.

Aim2Be

Youth-parent dyads will receive a simple app called BnLt for 6 months. 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.

BnLt

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Zubin Punthakee, MD, MSc

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 24, 2019

Study Start

December 11, 2021

Primary Completion

September 30, 2024

Study Completion

December 31, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations