Obesity, PediatricNCT03651284
Investigating the Efficacy of a Mobile App Intervention to Change Youth and Their Families' Health Behaviours
A study testing Aim2Be app with Live Coach + Fitbit + BMI tracking tools and Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools in people with Obesity, Pediatric, run by University of British Columbia at 6 sites in Canada.
Trial summary
This study is the second of three sub-studies aimed at evaluating the outcomes of the Living Green and Healthy for Teens (LiGHT) program, delivered through the Aim2Be app (v2.2). Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Obesity, Pediatric
- What is being tested?
- Aim2Be app with Live Coach + Fitbit + BMI tracking tools and Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesCanada
- Study dates
- 1 Nov 2018to 23 Jun 2022
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child must be between 10 and 17 years old
- Child and at least one of their parents must be able to read at the grade 5 level or above
- Parent participant must be the caregiver with whom the child primarily lives
- Families must have a computer or mobile device and internet access at home
- Child participants must be either overweight or obese, as defined by the age and gender specific WHO cut-offs for children and adolescents aged 5 to 19
Who cannot join
- Diagnosis of any musculoskeletal, cardiovascular, pulmonary, or orthopedic problems or disabilities precluding the participant from being physically active
- Any other physical condition that precludes the participant from being physically active
- Diagnosis of anorexia nervosa or bulimia nervosa
- Diagnosis of Type I diabetes
- Dietary restrictions or special diets that limit a participant's ability to eat a variety of foods
- Simultaneous participation in another physical activity, nutrition, or weight management study/program
Show all 9Show fewer
- Use of medication, nutritional supplements, or herbal preparations to help lose weight
- Pregnancy
- A history of psychiatric problems or substance abuse which would interfere with adherence to the study protocol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
University of Alberta
Edmonton, Alberta, T6G 2R3
McMaster University
Hamilton, Ontario, L8S 4K1
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
University of British Columbia
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 second of three sub-studies aimed at evaluating the outcomes of the Living Green and Healthy for Teens (LiGHT) program, delivered through the Aim2Be app (v2.2). Aim2Be is an app for 10 to 17 year olds and their families that is intended to help them shift from an healthy lifestyle toward better health habits in four areas: nutrition, physical activity, recreational screen time, and sleep. This second evaluation has the following aims to: 1) describe reach; 2) assess change in knowledge of Canadian health recommendations; and 3) assess change in lifestyle behaviours and weight outcomes and whether these changes are moderated by involvement in the app. This study uses a two-group parallel/crossover randomized controlled trial design following N=200 families for six months.
Read the detailed description
Living Green and Healthy for Teens (LiGHT v2) is an engaging online, individualized, gamified lifestyle management program for youth, delivered through the Aim2Be app. LiGHT v2 is 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 four areas: nutrition, physical activity, recreational screen time, and sleep. The program aims to support healthy lifestyles of 10- to 17-year-old children and adolescents, as well as to mitigate increased risk for metabolic and non-metabolic complications associated with obesity in the short and long term.
The app includes content that involve the family, and focus on behavioural therapy as well as dietary and physical activity patterns. Aim2Be is intended to be engaging and fun, provide virtual and tangible rewards, interact with participants multiple times per day, and provide a mobile social support network.
Pre-teens (10-13) and teens (14-17) will each have their own unique versions of Aim2Be. Content will be tailored specifically to the developmental stage and needs of each age group. The content will be delivered in such a way that it facilitates education, peer-to-peer conversation, and self-regulation in an engaging platform.
Because parents have been shown to be of primary importance in supporting healthy lifestyles of children, LiGHT v2 will educated 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 aspects of Aim2Be as the pre-teens and teens, but the channels will be gated, so teens and parents each have their own space. Aim2Be's social features will help parents strategize and empathize with other families who wish to adopt healthy lifestyles.
The program will be evaluated using three separate study groups. This protocol describes the second of the three.
Families (one parent and one child) will be recruited through advertising on social media and through active referral from six Canadian Pediatric Weight Management Registry (CANPWR) sites (Children's Hospital of Eastern Ontario, SickKids, McMaster Children's Hospital, Stollery Children's Hospital, Alberta Children's Hospital, and British Columbia Children's Hospital). Approximately 350 families will be recruited and a total of 200 families will be enrolled into the study and randomized into two groups. This study uses a two-group parallel/crossover randomized controlled trial design. All families will be given access to Aim2Be v2.2 to use from their mobile device or home computer. Participants will be prospectively followed for six months.
Once participants are deemed eligible to participate in the study and complete their baseline assessments, they are allocated to one of two conditions: 1) Live Coach; or 3) waitlist control group given standard of care. Participants in the Live Coach group will be given access to Aim2Be for six months with a live coach who has expertise in supporting lifestyle modification and will help youth and parents set goals and achieve these goals using principles from motivational interviewing. Participants in the control group will be wait listed for enrollment in the app for three months and will be given access to the Virtual Coach version of the app after they complete the three month evaluation. The Virtual Coach group version provides automated guidance from a virtual coach instead of a live person, but that is programmed using the same motivational interviewing principles.
Evaluation at baseline, three months, and six months will be used to compare whether those assigned to the different coach conditions have better health outcomes than those assigned to the waitlist control group. Parents will complete questionnaires at baseline, three months, and six months, which assess sociodemographics, behaviours, and mediators of behaviour change. Youth will complete questionnaires at baseline, three months, and six months, which assess health behaviours, mediators of behaviour change, and knowledge of Canadian recommendations for healthy behaviours. Questionnaire data will be collected and managed using REDCap.
Families will be provided with a Fitbit, scale, and measuring tape when they enroll in the study. At each assessment point (baseline, three months, and six months), parents will provide youth's height and weight, and youth will complete three 24-hour dietary recalls and wear the Fitbit for the duration of the study.
Honoraria will be paid at each time point to compensate participation.
Participants will be randomly allocated to each of the two groups and have equal likelihood of assignment to each condition. Participants will not be blinded as the design of the intervention does not facilitate this. Participants will be informed of their allocation after completing all baseline measures. Evaluators and researchers will be blinded to allocation during data analysis.
The aims of this study are to: 1) determine reach/ who participates in this study (short term outcome); 2) determine whether participation in the program increases adolescents' knowledge of Canadian health recommendations related to dietary habits, physical activity, and sedentary behaviour (medium term outcome); and 3) assess the impact of Aim2Be on changes in dietary habits, physical activity, and sedentary behaviours as well as Body Mass Index (BMI) and whether the impact is moderated by involvement in the app (long term outcome).
- Conditions
- Obesity, Pediatric
- Being tested
- Aim2Be app with Live Coach + Fitbit + BMI tracking tools, Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools
- Keywords
- obesity, physical activity, nutrition, adolescents, gamification, video game, 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.
Aim2Be app with Live Coach + Fitbit + BMI tracking toolsBehavioural
Participants will spend six months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. They will also complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Live Coach and the Virtual Coach. The Live Coach has specialized training in lifestyle and motivational interviewing and will support families in changing their health behaviours through in-app messaging and phone calls. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory.
Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking toolsBehavioural
Participants in this condition will be waitlisted for three months while they receive standard of care (Canadian Health Recommendations for physical activity, dietary habits, screen behaviours, and sleep). Participants will gain access to the Aim2Be app with Virtual Coach after the three month assessment. Participants will then spend three months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. For the whole six months, participants will complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Virtual Coach only. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory.
| Study group | Role | What they receive |
|---|---|---|
| Aim2Be Live Coach | Experimental | Aim2Be app with Live Coach + Fitbit + BMI tracking tools Receives: Behavioral: Aim2Be app with Live Coach + Fitbit + BMI tracking tools |
| Aim2Be Waitlist | Other | Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools for three months, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools Receives: Behavioral: Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index z-score (youth)
Change in BMI z-scores will be computed from measured height and weight using World Health Organization (WHO) cut-offs
Measured: Baseline, 3 months, 6 months
Change in health behaviour knowledge (youth)
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 8 (a score of 0 indicates low knowledge and a score of 8 indicates high knowledge), as well as sub-score for each of the knowledge areas (nutrition, physical activity, recreational screen time, sleep).
Measured: Baseline, 3 months, 6 months
Change in objective dietary behaviour (youth)
Change in mean daily servings of fruits and vegetables and sugar-sweetened beverages consumed over three consecutive 24-hour dietary recalls.
Measured: Baseline, 3 months, 6 months
Change in number of daily steps (youth)
Change in mean daily steps over a 14-day period at each assessment point, as measured using a Fitbit activity monitor.
Measured: Baseline, 3 months, 6 months
Change in screen behaviour (youth)
Survey questions will assess adolescents' 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, 3 months, 6 months
Secondary outcomes (9)
Adherence
App analytics will be used assess participants' adherence to the intervention
Measured: 3 months, 6 months
Reach
Survey questions will assess socio-demographic characteristics of families and will be compared against families who typically register for weight-management centres in Canada.
Measured: Baseline
Change in Healthy Eating Index score (youth)
Change in score of dietary quality, as measured using three consecutive 24-hour dietary recalls and scored on the Healthy Eating Index (adapted for the Canadian recommendations).
Total score: [0-100] (sum of all subscale scores; high scores represent better outcomes)
Adequacy (high score=high consumption) Total fruits: [0-5] Whole fruits: [0-5] Total vegetables: [0-5] Greens and beans: [0-5] Whole grains: [0-10] Dairy: [0-10] Total protein foods: [0-5] Seafood and plant proteins: [0-5] Fatty acids: [0-10]
Moderation (high score=low consumption) Refined grains: [0-10] Sodium: [0-10] Added sugars: [0-10] Saturated fats: [0-10]
Measured: Baseline, 3 months, 6 months
Change in self-reported dietary behaviour (youth)
Survey questions will assess adolescents' dietary behaviours, and be reported as average number of servings of fruits and vegetables and consumption of sugar-sweetened beverages per day.
Measured: Baseline, 3 months, 6 months
Change in self-reported physical activity behaviour (youth)
Survey questions will assess adolescents' physical activity behaviours, and change in physical activity will be reported as average number of days they were active for at least 60 minutes. Adolescent physical activity will be assessed using a modified version of the International Physical Activity and the Environment Network Adolescent Survey for Children.
Measured: Baseline, 3 months, 6 months
Change in self-reported dietary behaviour (parents)
Survey questions will assess parents' dietary behaviours, and be reported as average number of fruits and vegetables and sugar-sweetened beverages per day.
Measured: Baseline, 3 months, 6 months
Change in self-reported physical activity behaviour (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 and vigorous physical activity.
Measured: Baseline, 3 months, 6 months
Change in screen behaviour (parents)
Survey questions will assess 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, 3 months, 6 months
Change in mediators of behaviour change
Survey questions will assess adolescents' self-efficacy and motivation in changing the health behaviours targeted by LiGHT.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Nov 2018
- Primary completion30 Mar 2020
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 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, David Suzuki Foundation, Craving Change, Diabetes Canada, Canadian Institutes of Health Research (CIHR), British Columbia Children's Hospital, Children's Hospital of Eastern Ontario Research Institute, The Hospital for Sick Children, Hamilton Health Sciences Corporation, Alberta Health services, The Governors of the University of Alberta, University of Alberta, Alberta Innovates Health Solutions, Women and Children's Health Research Institute, Canada, Canadian Obesity Network, Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Louise Masse, University of British Columbia
- Investigators
- Louise C Masse, PhD, Principal investigator, University of British Columbia, BC Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651284
- Sponsor's protocol ID
- H16-03090-b
- Status last verified
- Jun 2022
- First submitted
- 27 Aug 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
Publications
Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
PubMed 38375882Tugault-Lafleur CN, De-Jongh Gonzalez O, Macdonald J, Bradbury J, Warshawski T, Ball GDC, Morrison K, Ho J, Hamilton J, Buchholz A, Masse L. Efficacy of the Aim2Be Intervention in Changing Lifestyle Behaviors Among Adolescents With Overweight and Obesity: Randomized Controlled Trial. J Med Internet Res. 2023 Apr 25;25:e38545. doi: 10.2196/38545.
PubMed 37097726Deslippe AL, Gonzalez OD, Buckler EJ, Ball GDC, Ho J, Bucholz A, Morrison KM, Masse LC. Do Individual Characteristics and Social Support Increase Children's Use of an MHealth Intervention? Findings from the Evaluation of a Behavior Change MHealth App, Aim2Be. Child Obes. 2023 Oct;19(7):435-442. doi: 10.1089/chi.2022.0055. Epub 2022 Dec 22.
PubMed 36576875De-Jongh Gonzalez O, Tugault-Lafleur CN, Buckler EJ, Hamilton J, Ho J, Buchholz A, Morrison KM, Ball GD, Masse LC. The Aim2Be mHealth Intervention for Children With Overweight or Obesity and Their Parents: Person-Centered Analyses to Uncover Digital Phenotypes. J Med Internet Res. 2022 Jun 22;24(6):e35285. doi: 10.2196/35285.
PubMed 35731547Masse LC, Vlaar J, Macdonald J, Bradbury J, Warshawski T, Buckler EJ, Hamilton J, Ho J, Buchholz A, Morrison KM, Ball GDC. Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial. Trials. 2020 Feb 3;21(1):132. doi: 10.1186/s13063-020-4080-2.
PubMed 32014057
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
- NCT03651284
- Acronym / sponsor ID
- H16-03090-b
- Conditions
- Obesity, Pediatric
- Keywords
- obesity, physical activity, nutrition, adolescents, gamification, video game, sedentary activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 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, David Suzuki Foundation, Craving Change, Diabetes Canada, Canadian Institutes of Health Research (CIHR), British Columbia Children's Hospital, Children's Hospital of Eastern Ontario Research Institute, The Hospital for Sick Children, Hamilton Health Sciences Corporation, Alberta Health services, The Governors of the University of Alberta, University of Alberta, Alberta Innovates Health Solutions, Women and Children's Health Research Institute, Canada, Canadian Obesity Network, Ontario Ministry of Health and Long Term Care
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 29 Aug 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 second of three sub-studies aimed at evaluating the outcomes of the Living Green and Healthy for Teens (LiGHT) program, delivered through the Aim2Be app (v2.2). Aim2Be is an app for 10 to 17 year olds and their families that is intended to help them shift from an healthy lifestyle toward better health habits in four areas: nutrition, physical activity, recreational screen time, and sleep. This second evaluation has the following aims to: 1) describe reach; 2) assess change in knowledge of Canadian health recommendations; and 3) assess change in lifestyle behaviours and weight outcomes and whether these changes are moderated by involvement in the app. This study uses a two-group parallel/crossover randomized controlled trial design following N=200 families for six months.
Detailed description
Living Green and Healthy for Teens (LiGHT v2) is an engaging online, individualized, gamified lifestyle management program for youth, delivered through the Aim2Be app. LiGHT v2 is 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 four areas: nutrition, physical activity, recreational screen time, and sleep. The program aims to support healthy lifestyles of 10- to 17-year-old children and adolescents, as well as to mitigate increased risk for metabolic and non-metabolic complications associated with obesity in the short and long term.
The app includes content that involve the family, and focus on behavioural therapy as well as dietary and physical activity patterns. Aim2Be is intended to be engaging and fun, provide virtual and tangible rewards, interact with participants multiple times per day, and provide a mobile social support network.
Pre-teens (10-13) and teens (14-17) will each have their own unique versions of Aim2Be. Content will be tailored specifically to the developmental stage and needs of each age group. The content will be delivered in such a way that it facilitates education, peer-to-peer conversation, and self-regulation in an engaging platform.
Because parents have been shown to be of primary importance in supporting healthy lifestyles of children, LiGHT v2 will educated 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 aspects of Aim2Be as the pre-teens and teens, but the channels will be gated, so teens and parents each have their own space. Aim2Be's social features will help parents strategize and empathize with other families who wish to adopt healthy lifestyles.
The program will be evaluated using three separate study groups. This protocol describes the second of the three.
Families (one parent and one child) will be recruited through advertising on social media and through active referral from six Canadian Pediatric Weight Management Registry (CANPWR) sites (Children's Hospital of Eastern Ontario, SickKids, McMaster Children's Hospital, Stollery Children's Hospital, Alberta Children's Hospital, and British Columbia Children's Hospital). Approximately 350 families will be recruited and a total of 200 families will be enrolled into the study and randomized into two groups. This study uses a two-group parallel/crossover randomized controlled trial design. All families will be given access to Aim2Be v2.2 to use from their mobile device or home computer. Participants will be prospectively followed for six months.
Once participants are deemed eligible to participate in the study and complete their baseline assessments, they are allocated to one of two conditions: 1) Live Coach; or 3) waitlist control group given standard of care. Participants in the Live Coach group will be given access to Aim2Be for six months with a live coach who has expertise in supporting lifestyle modification and will help youth and parents set goals and achieve these goals using principles from motivational interviewing. Participants in the control group will be wait listed for enrollment in the app for three months and will be given access to the Virtual Coach version of the app after they complete the three month evaluation. The Virtual Coach group version provides automated guidance from a virtual coach instead of a live person, but that is programmed using the same motivational interviewing principles.
Evaluation at baseline, three months, and six months will be used to compare whether those assigned to the different coach conditions have better health outcomes than those assigned to the waitlist control group. Parents will complete questionnaires at baseline, three months, and six months, which assess sociodemographics, behaviours, and mediators of behaviour change. Youth will complete questionnaires at baseline, three months, and six months, which assess health behaviours, mediators of behaviour change, and knowledge of Canadian recommendations for healthy behaviours. Questionnaire data will be collected and managed using REDCap.
Families will be provided with a Fitbit, scale, and measuring tape when they enroll in the study. At each assessment point (baseline, three months, and six months), parents will provide youth's height and weight, and youth will complete three 24-hour dietary recalls and wear the Fitbit for the duration of the study.
Honoraria will be paid at each time point to compensate participation.
Participants will be randomly allocated to each of the two groups and have equal likelihood of assignment to each condition. Participants will not be blinded as the design of the intervention does not facilitate this. Participants will be informed of their allocation after completing all baseline measures. Evaluators and researchers will be blinded to allocation during data analysis.
The aims of this study are to: 1) determine reach/ who participates in this study (short term outcome); 2) determine whether participation in the program increases adolescents' knowledge of Canadian health recommendations related to dietary habits, physical activity, and sedentary behaviour (medium term outcome); and 3) assess the impact of Aim2Be on changes in dietary habits, physical activity, and sedentary behaviours as well as Body Mass Index (BMI) and whether the impact is moderated by involvement in the app (long term outcome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim2Be Live Coach | Experimental | Behavioral: Aim2Be app with Live Coach + Fitbit + BMI tracking toolsAim2Be app with Live Coach + Fitbit + BMI tracking tools |
| Aim2Be Waitlist | Other | Behavioral: Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking toolsAim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools for three months, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child must be between 10 and 17 years old
- Child and at least one of their parents must be able to read at the grade 5 level or above
- Parent participant must be the caregiver with whom the child primarily lives
- Families must have a computer or mobile device and internet access at home
- Child participants must be either overweight or obese, as defined by the age and gender specific WHO cut-offs for children and adolescents aged 5 to 19
Key exclusion criteria (9 listed)
- Diagnosis of any musculoskeletal, cardiovascular, pulmonary, or orthopedic problems or disabilities precluding the participant from being physically active
- Any other physical condition that precludes the participant from being physically active
- Diagnosis of anorexia nervosa or bulimia nervosa
- Diagnosis of Type I diabetes
- Dietary restrictions or special diets that limit a participant's ability to eat a variety of foods
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 |
|---|---|---|
| Aim2Be app with Live Coach + Fitbit + BMI tracking toolsParticipants will spend six months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. They will also complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Live Coach and the Virtual Coach. The Live Coach has specialized training in lifestyle and motivational interviewing and will support families in changing their health behaviours through in-app messaging and phone calls. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory. | Behavioural | Aim2Be Live Coach |
| Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking toolsParticipants in this condition will be waitlisted for three months while they receive standard of care (Canadian Health Recommendations for physical activity, dietary habits, screen behaviours, and sleep). Participants will gain access to the Aim2Be app with Virtual Coach after the three month assessment. Participants will then spend three months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. For the whole six months, participants will complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Virtual Coach only. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory. | Behavioural | Aim2Be Waitlist |
Primary outcome
Change in Body Mass Index z-score (youth)
Time frame: Baseline, 3 months, 6 months
Change in BMI z-scores will be computed from measured height and weight using World Health Organization (WHO) cut-offs
Change in health behaviour knowledge (youth)
Time frame: Baseline, 3 months, 6 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 8 (a score of 0 indicates low knowledge and a score of 8 indicates high knowledge), as well as sub-score for each of the knowledge areas (nutrition, physical activity, recreational screen time, sleep).
Change in objective dietary behaviour (youth)
Time frame: Baseline, 3 months, 6 months
Change in mean daily servings of fruits and vegetables and sugar-sweetened beverages consumed over three consecutive 24-hour dietary recalls.
Change in number of daily steps (youth)
Time frame: Baseline, 3 months, 6 months
Change in mean daily steps over a 14-day period at each assessment point, as measured using a Fitbit activity monitor.
Change in screen behaviour (youth)
Time frame: Baseline, 3 months, 6 months
Survey questions will assess adolescents' 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.
9 secondary outcomes
Adherence
Time frame: 3 months, 6 months
Reach
Time frame: Baseline
Change in Healthy Eating Index score (youth)
Time frame: Baseline, 3 months, 6 months
Change in self-reported dietary behaviour (youth)
Time frame: Baseline, 3 months, 6 months
Change in self-reported physical activity behaviour (youth)
Time frame: Baseline, 3 months, 6 months
Change in self-reported dietary behaviour (parents)
Time frame: Baseline, 3 months, 6 months
Change in self-reported physical activity behaviour (parents)
Time frame: Baseline, 3 months, 6 months
Change in screen behaviour (parents)
Time frame: Baseline, 3 months, 6 months
Change in mediators of behaviour change
Time frame: Baseline, 3 months, 6 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.
- Derived from this study: PubMed 38375882Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
- Derived from this study: PubMed 37097726Tugault-Lafleur CN, De-Jongh Gonzalez O, Macdonald J, Bradbury J, Warshawski T, Ball GDC, Morrison K, Ho J, Hamilton J, Buchholz A, Masse L. Efficacy of the Aim2Be Intervention in Changing Lifestyle Behaviors Among Adolescents With Overweight and Obesity: Randomized Controlled Trial. J Med Internet Res. 2023 Apr 25;25:e38545. doi: 10.2196/38545.
- Derived from this study: PubMed 36576875Deslippe AL, Gonzalez OD, Buckler EJ, Ball GDC, Ho J, Bucholz A, Morrison KM, Masse LC. Do Individual Characteristics and Social Support Increase Children's Use of an MHealth Intervention? Findings from the Evaluation of a Behavior Change MHealth App, Aim2Be. Child Obes. 2023 Oct;19(7):435-442. doi: 10.1089/chi.2022.0055. Epub 2022 Dec 22.
- Derived from this study: PubMed 35731547De-Jongh Gonzalez O, Tugault-Lafleur CN, Buckler EJ, Hamilton J, Ho J, Buchholz A, Morrison KM, Ball GD, Masse LC. The Aim2Be mHealth Intervention for Children With Overweight or Obesity and Their Parents: Person-Centered Analyses to Uncover Digital Phenotypes. J Med Internet Res. 2022 Jun 22;24(6):e35285. doi: 10.2196/35285.
- Derived from this study: PubMed 32014057Masse LC, Vlaar J, Macdonald J, Bradbury J, Warshawski T, Buckler EJ, Hamilton J, Ho J, Buchholz A, Morrison KM, Ball GDC. Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial. Trials. 2020 Feb 3;21(1):132. doi: 10.1186/s13063-020-4080-2.
- Individual participant dataSharing planned: No
Related trials for Obesity, Pediatric
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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, BC Children's Hospital Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aim2Be app with Live Coach + Fitbit + BMI tracking tools and Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools in people with Obesity, Pediatric, run by University of British Columbia at 6 sites 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 9 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 6 sites 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?
Change in Body Mass Index z-score (youth) (time frame: Baseline, 3 months, 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03651284, which also lists 5 linked publications.
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.