Clinical trial NCT03445325: Pre/Post Evaluation of Living Green and Healthy for Teens (LiGHT)
Official title: Project LiGHT (Living Green and Healthy for Teens): A Novel Weight Management Program That Emphasizes the Benefits of a Healthy Lifestyle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Pediatric
Keywords: obesity
physical activity
nutrition
adolescents
gamification
sedentary activity
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Childhood Obesity Foundation
name: Ayogo Health Inc.
name: Public Health Agency of Canada (PHAC)
name: Merck Canada Inc.
name: Pacific Blue Cross
name: Heart and Stroke Foundation of Canada
First posted: 2018-02-26
Enrollment: 500
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Reach
timeFrame: Baseline
measure: Adherence
timeFrame: Ongoing for 4.5 months
measure: Change in health behaviour knowledge
timeFrame: Baseline and 4.5 months
measure: Change in physical activity behavior (teens)
timeFrame: Baseline and 4.5 months
measure: Change in physical activity behavior (parents)
timeFrame: Baseline and 4.5 months
measure: Change in sedentary behaviour
timeFrame: Baseline and 4.5 months
measure: Change in dietary behaviour
timeFrame: Baseline and 4.5 months
Secondary outcomes:
measure: Change in mediators of behaviour change
timeFrame: Baseline, 1 month, and 4.5 months
Other outcomes:
measure: Functionality
timeFrame: 4.5 months
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia School of Population and Public Health
name: Louise C Masse, PhD
role: PRINCIPAL_INVESTIGATOR
References: