Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigating the Efficacy of a Mobile App Intervention to Change Youth and Their Families' Health Behaviours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651284
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : April 22, 2019
Sponsor:
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
Information provided by (Responsible Party):
Louise Masse, University of British Columbia

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Obesity, Pediatric Behavioral: Aim2Be app with Live Coach + Fitbit + BMI tracking tools Behavioral: Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Project LiGHT (Living Green and Healthy for Teens): A Novel Weight Management Program That Emphasizes the Benefits of a Healthy Lifestyle
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: Aim2Be Live Coach
Aim2Be app with Live Coach + Fitbit + BMI tracking tools
Behavioral: Aim2Be app with Live Coach + Fitbit + BMI tracking tools
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 Waitlist
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
Behavioral: Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools
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.




Primary Outcome Measures :
  1. 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

  2. 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).

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Adherence [ Time Frame: 3 months, 6 months ]
    App analytics will be used assess participants' adherence to the intervention

  2. Reach [ Time Frame: Baseline ]
    Survey questions will assess socio-demographic characteristics of families and will be compared against families who typically register for weight-management centres in Canada.

  3. Change in Healthy Eating Index score (youth) [ Time Frame: Baseline, 3 months, 6 months ]

    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]


  4. Change in self-reported dietary behaviour (youth) [ Time Frame: Baseline, 3 months, 6 months ]
    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.

  5. Change in self-reported physical activity behaviour (youth) [ Time Frame: Baseline, 3 months, 6 months ]
    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.

  6. Change in self-reported dietary behaviour (parents) [ Time Frame: Baseline, 3 months, 6 months ]
    Survey questions will assess parents' dietary behaviours, and be reported as average number of fruits and vegetables and sugar-sweetened beverages per day.

  7. Change in self-reported physical activity behaviour (parents) [ Time Frame: Baseline, 3 months, 6 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 and vigorous physical activity.

  8. Change in screen behaviour (parents) [ Time Frame: Baseline, 3 months, 6 months ]
    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.

  9. Change in mediators of behaviour change [ Time Frame: Baseline, 3 months, 6 months ]
    Survey questions will assess adolescents' self-efficacy and motivation in changing the health behaviours targeted by LiGHT.


Other Outcome Measures:
  1. Functionality [ Time Frame: 3 months, 6 months ]
    Survey questions will assess whether users like the program (i.e. was Aim2Be fun, easy to use and intuitive, did it offer content to which they could relate and features they like).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651284


Contacts
Layout table for location contacts
Contact: Janae Vlaar, MSc 604-875-2000 ext 6393 jvlaar@bcchr.ubc.ca

Locations
Layout table for location information
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Heidi Virtanen       heidi.virtanen@albertahealthservices.ca   
Principal Investigator: Josephine Ho, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Nicole Gehring       ngehring@ualberta.ca   
Principal Investigator: Geoff Ball, PhD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Janae Vlaar, MSc    6048752000 ext 6393    jvlaar@bcchr.ubc.ca   
Principal Investigator: Louise C Masse, PhD         
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Elizabeth Gunn       gunne@mcmaster.ca   
Principal Investigator: Katherine Morrison, MD         
Children's Hospital of Eastern Ontario Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Charmaine Mohipp       cmohipp@cheo.on.ca   
Principal Investigator: Annick Buchholz, PhD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Rebecca Noseworthy       rebecca.noseworthy@sickkids.ca   
Principal Investigator: Jill Hamilton, MD         
Sponsors and Collaborators
University of British Columbia
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
Investigators
Layout table for investigator information
Principal Investigator: Louise C Masse, PhD University of British Columbia, BC Children's Hospital Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Louise Masse, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03651284    
Other Study ID Numbers: H16-03090-b
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Louise Masse, University of British Columbia:
obesity
physical activity
nutrition
adolescents
gamification
video game
sedentary activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight