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

NCT03651284 | Completed

• 1 other identifier: H16-03090-b
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Obesity, Pediatric

Keywords

obesity; physical activity; nutrition; adolescents; gamification; video game; sedentary activity

Outcome Measures

Primary Outcomes (5)

• 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

  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).

  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.

  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.

  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.

  Baseline, 3 months, 6 months

Secondary Outcomes (9)

• Adherence

  3 months, 6 months

• Reach

  Baseline

• Change in Healthy Eating Index score (youth)

  Baseline, 3 months, 6 months

• Change in self-reported dietary behaviour (youth)

  Baseline, 3 months, 6 months

• Change in self-reported physical activity behaviour (youth)

  Baseline, 3 months, 6 months

Other Outcomes (1)

• Functionality

  3 months, 6 months

Study Arms (2)

Aim2Be Live Coach

EXPERIMENTAL

Aim2Be app with Live Coach + Fitbit + BMI tracking tools

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

Behavioral: Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools

Interventions

Aim2Be app with Live Coach + Fitbit + BMI tracking tools BEHAVIORAL

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 Live Coach

Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools BEHAVIORAL

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.

Aim2Be Waitlist

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Childhood Obesity Foundation: collaborator
• Ayogo Health Inc.: collaborator
• Public Health Agency of Canada (PHAC): collaborator
• Merck Canada Inc.: collaborator
• Pacific Blue Cross: collaborator
• Heart and Stroke Foundation of Canada: collaborator
• David Suzuki Foundation: collaborator
• Craving Change: collaborator
• Diabetes Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• British Columbia Children's Hospital: collaborator
• Children's Hospital of Eastern Ontario Research Institute: collaborator
• The Hospital for Sick Children: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Alberta Health services: collaborator
• The Governors of the University of Alberta: collaborator
• University of Alberta: collaborator
• Alberta Innovates Health Solutions: collaborator
• Women and Children's Health Research Institute, Canada: collaborator
• Canadian Obesity Network: collaborator
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (6)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Children's Hospital of Eastern Ontario Research Institute

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (5)

• 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.

  PMID: 38375882 DERIVED

• Tugault-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.

  PMID: 37097726 DERIVED

• Deslippe 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.

  PMID: 36576875 DERIVED

• De-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.

  PMID: 35731547 DERIVED

• Masse 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.

  PMID: 32014057 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Louise C Masse, PhD

  University of British Columbia, BC Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: November 1, 2018
• Primary Completion: March 30, 2020
• Study Completion: June 23, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)