Obesity, PediatricNCT03445325
Pre/Post Evaluation of Living Green and Healthy for Teens (LiGHT)
A study testing LiGHT v2.1 in people with Obesity, Pediatric, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Obesity, Pediatric
- What is being tested?
- LiGHT v2.1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Project LiGHT (Living Green and Healthy for Teens): A Novel Weight Management Program That Emphasizes the Benefits of a Healthy Lifestyle
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.
Read the 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
- Being tested
- LiGHT v2.1
- Keywords
- obesity, physical activity, nutrition, adolescents, gamification, sedentary activity
- Medical subject headings
- Pediatric Obesity, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiGHT v2.1Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: LiGHT v2.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4.5 months
Secondary outcomes (1)
Change in mediators of behaviour change
Survey questions will assess teens' self-efficacy and motivation in changing the health behaviours targeted by LiGHT
Measured: Baseline, 1 month, and 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Nov 2018
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, PediatricStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Childhood Obesity Foundation, Ayogo Health Inc., Public Health Agency of Canada (PHAC), Merck Canada Inc., Pacific Blue Cross, Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Louise Masse, University of British Columbia
- Investigators
- Louise C Masse, PhD, Principal investigator, University of British Columbia School of Population and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445325
- Sponsor's protocol ID
- H16-03090-a
- Status last verified
- Jun 2022
- First submitted
- 6 Feb 2018
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project LiGHT (Living Green and Healthy for Teens): A Novel Weight Management Program That Emphasizes the Benefits of a Healthy Lifestyle
- ClinicalTrials.gov ID
- NCT03445325
- Acronym / sponsor ID
- H16-03090-a
- Conditions
- Obesity, Pediatric
- Keywords
- obesity, physical activity, nutrition, adolescents, gamification, sedentary activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Childhood Obesity Foundation, Ayogo Health Inc., Public Health Agency of Canada (PHAC), Merck Canada Inc., Pacific Blue Cross, Heart and Stroke Foundation of Canada
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LiGHT v2.1 | Experimental | Behavioral: LiGHT v2.1Participants 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). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiGHT v2.1The 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. | Behavioural | LiGHT v2.1 |
Primary outcome
Reach
Time frame: Baseline
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.
Adherence
Time frame: Ongoing for 4.5 months
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.).
Change in health behaviour knowledge
Time frame: Baseline and 4.5 months
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).
Change in physical activity behavior (teens)
Time frame: Baseline and 4.5 months
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.
Change in physical activity behavior (parents)
Time frame: Baseline and 4.5 months
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.
Change in sedentary behaviour
Time frame: Baseline and 4.5 months
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.
Change in dietary behaviour
Time frame: Baseline and 4.5 months
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.
1 secondary outcome
Change in mediators of behaviour change
Time frame: Baseline, 1 month, and 4.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise C Masse, PhD principal investigator
University of British Columbia School of Population and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiGHT v2.1 in people with Obesity, Pediatric, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.