NCT03445325

Brief Summary

This study is the first of three sub-studies aimed at evaluating the outcomes of Living Green, Healthy for Teens (LiGHT v2.1), an app for 13 to 17 year -olds and their families that is intended to help them shift from an unhealthy lifestyle toward better health habits in three areas: physical activity, nutrition and sedentary behaviours. This first evaluation has the following aims to: 1) describe reach; 2) determine utilization/adherence to strategies implemented in the app and predictors of utilization/adherence; 3) assess change in knowledge and lifestyles behaviours associated with obesity as well as assess mediators of behaviour change. As this is a formative evaluation, it will prospectively follow 500 families for 4.5 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 6, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

February 6, 2018

Last Update Submit

June 23, 2022

Conditions

Keywords

obesityphysical activitynutritionadolescentsgamificationsedentary activity

Outcome Measures

Primary Outcomes (7)

  • Reach

    Survey questions will assess socio-demographic characteristics of families and will be compared against those who were invited to participate in the study (from a web-based panel) and families who typically register for weight-management centres in Canada.

    Baseline

  • Adherence

    Web-analytic tools will track utilization of LiGHT components and all interactions with the program. Adherence will be calculated as cumulative number of feature-specific interactions per week (e.g., number of interactions with articles, number of interactions with social wall, etc.).

    Ongoing for 4.5 months

  • Change in health behaviour knowledge

    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 13 (a score of 0 indicates low knowledge and a score of 13 indicates high knowledge), as well as sub-score for each of the knowledge area (healthy eating, physical activity, and sedentary behaviours).

    Baseline and 4.5 months

  • Change in physical activity behavior (teens)

    Survey questions will assess teens' physical activity behaviours, and change in physical activity will be computed based on a composite physical activity score. Teen physical activity will be assessed using a modified version of the Physical Activity Questionnaire for Children (PAC-Q), and scored as average minutes per day of moderate-vigorous physical activity.

    Baseline and 4.5 months

  • Change in physical activity behavior (parents)

    Survey questions will assess parents' physical activity behaviours, and change in physical activity will be computed based on a composite physical activity score. Parent physical activity will be assessed using a modified version of the International Physical Activity Questionnaire Short Form (IPAQ-SF), and scored as average minutes per day of moderate-vigorous physical activity.

    Baseline and 4.5 months

  • Change in sedentary behaviour

    Survey questions will assess teens' and parents' 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.

    Baseline and 4.5 months

  • Change in dietary behaviour

    Survey questions will assess teens' and parents' dietary behaviours, and be reported as average number of fruits and vegetables and sugar-sweetened beverages per day.

    Baseline and 4.5 months

Secondary Outcomes (1)

  • Change in mediators of behaviour change

    Baseline, 1 month, and 4.5 months

Other Outcomes (1)

  • Functionality

    4.5 months

Study Arms (1)

LiGHT v2.1

EXPERIMENTAL

Participants will be assigned the intervention (use of the parent or teen app for 4.5 months) and asked to use throughout the intervention period (all participants are assigned to the intervention arm and results will be analyzed pre- and post-intervention).

Behavioral: LiGHT v2.1

Interventions

LiGHT v2.1BEHAVIORAL

The LiGHT mobile program strives to support youth and their families to adopt lifelong healthy behaviours in four areas - eating, physical activity, recreational screen time and sleep - to foster healthy growth and development, to prevent chronic diseases and manage unhealthy weights. The program includes content that involve the family, and focus on behavioural therapy as well as dietary and physical activity patterns. LiGHT is intended to be engaging and fun, provide virtual and tangible rewards, and interact with participants multiple times per day. In addition, it will feature a mobile social support network and interaction with a live coach with specialized training in motivational interviewing to support youth/families in changing their health behaviours through messaging and phone calls.

LiGHT v2.1

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Youth participants must be between the ages of 13 and 17
  • Youth participants and at least one of their parents must be literate in English
  • Youth participants and at least one of their parents must be able to read at the grade 5 level or above
  • Parent participants must have primary custody of the child participant
  • Families must have a computer or mobile device and internet access at home

You may not qualify if:

  • Youth participants must not have any health condition that restricts the amount or type of activity the participant can do
  • Youth participants must not have any health condition that severely restricts the types of food the participant can eat
  • Youth participants must not have a diagnosis of type I diabetes
  • Youth participants must not have any reason (including cognitive, psychological, or physical limitations) that preclude them from being able to spend 20-30 minutes using a computer program that is written at a 5th grade reading level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Pediatric ObesityObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Louise C Masse, PhD

    University of British Columbia School of Population and Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 26, 2018

Study Start

March 1, 2018

Primary Completion

November 30, 2018

Study Completion

December 23, 2019

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations