An interventional study of LiGHT v2.1 in Obesity, Pediatric, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-06-27.
Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention
Among 51 studies in Pediatric Obesity with a site in Canada — 7 open to participants now, 9 under way, 1 of them phase 3. Pediatric Obesity · Canada.
Among the 51 studies in Pediatric Obesity with a site in Canada, this one is the 7th largest by enrollment of the 40 interventional ones that give a count, is one of 5 that started in 2018, is one of 37 with no phase, and was the 26th registered.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
Browse Pediatric Obesity studies →7 of the 51 studies in Pediatric Obesity with a site in Canada are open now. Recruiting first, the newest first:
Hamilton Health Sciences Corporation · Sites in Canada
University of Victoria · Sites in Canada
University of Alberta · Sites in Canada
St. Justine's Hospital · Sites in Canada
The Hospital for Sick Children · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.
This study: 13 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 5 started in 2018.
This study's enrollment of 500 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Median enrollment 73 across the 40 interventional studies, 54 across the 11 observational. Of the 36 that completed or were terminated, 2 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 51 has an industry lead sponsor. The 10 most frequent:
University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
University of British Columbia has 3 studies filed under Pediatric Obesity — fewer than ten, so there is no comparison to draw.
3 of the studies in Pediatric Obesity with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04578652Phase 3University of AlbertaFiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance | 2027-02 |
| NCT05534711University of GuelphThe Family Stress Study - Chronic Stress and Child Adiposity: Testing a Bio-behavioural Model | 2027-05-30 |
| NCT06844786Hamilton Health Sciences CorporationSCORE! ACTIVE Trial | 2027-08-15 |
Among the 51 studies in Pediatric Obesity with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
Time frame: 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.).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4.5 months
Change in mediators of behaviour change
Survey questions will assess teens' self-efficacy and motivation in changing the health behaviours targeted by LiGHT
Time frame: Baseline, 1 month, and 4.5 months
Functionality
Monthly satisfaction surveys will assess whether users like the program (e.g. was LiGHT fun, easy to use and intuitive, did it offer content to which they could relate and features they like) and whether they have suggestions for improvement
Time frame: 4.5 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Nov 2018, 8 months.
Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 8 months is below that.
Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of British Columbia →