Pre/Post Evaluation of Living Green and Healthy for Teens (LiGHT)

NCT ID: NCT03445325

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-12-23

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.

Detailed Description

Living Green, Healthy for Teens (LiGHT v2) is an engaging online, individualized, gamified lifestyle management program for youth 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 three areas: physical activity, nutrition and sedentary behaviour. The program aims both to treat and prevent childhood obesity, as well as to mitigate increased risk for metabolic and non-metabolic complications associated with obesity in the short and long-term.

Because parents have been shown to be of primary importance in treating childhood obesity, LiGHT v2 will educate 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 software that facilitates peer-to-peer conversations with teen users (forums), but the channels will be gated, so teens and parents each have their own space. LiGHT v2's social features will help parents strategize and empathize with other families facing similar challenges.

The program will be evaluated using three separate study groups. This protocol describes the first of the three.

A sample of 1400 families (one parent and one child) recruited by an online web panel will be screened for eligibility (i.e., children aged 13-17 and their parents). Of these, it is expected that approximately 500 will meet our eligibility criteria and express an interest in enrolling in the study, and of these, about 50% will actually enroll in the study. This evaluation will use a prospective design that integrates pre- and post-evaluations. All families will be given access to LiGHT v2.1 to use from their home computer and prospectively followed for 4.5 months.

Parents will complete questionnaires at baseline and after 4.5 months, which assess behaviours, sociodemographics, mediators of behaviour change, and satisfaction with the app. Teens will complete questionnaires at baseline, and after 1 and 4.5 months, which assess behaviours, satisfaction with the app, mediators of behaviour change, and knowledge for recommendations for healthy behaviours.

Parent/child usage will also be monitored using web-analytic tools in order to understand how users interact with LiGHT.

Conditions

Obesity, Pediatric

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

LiGHT v2.1

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).

Group Type: EXPERIMENTAL

LiGHT v2.1

Intervention Type: BEHAVIORAL

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.

Interventions

LiGHT v2.1

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Childhood Obesity Foundation

OTHER

Sponsor Role: collaborator

Ayogo Health Inc.

OTHER

Sponsor Role: collaborator

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role: collaborator

Merck Canada Inc.

INDUSTRY

Sponsor Role: collaborator

Pacific Blue Cross

UNKNOWN

Sponsor Role: collaborator

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Louise Masse

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise C Masse, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia School of Population and Public Health

Locations

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H16-03090-a

Identifier Type: -

Identifier Source: org_study_id