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

Obesity, Pediatric Clinical Trial

Official title:

Project LiGHT (Living Green and Healthy for Teens): A Novel Weight Management Program That Emphasizes the Benefits of a Healthy Lifestyle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651284
• Other study ID #: H16-03090-b
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 23, 2022

Study information

• Verified date: June 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 23, 2022
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Pediatric
• Pediatric Obesity

Intervention

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 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	Children's Hospital of Eastern Ontario Research Institute	Ottawa	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (22)

Lead Sponsor

Collaborator

University of British Columbia

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functionality	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).	3 months, 6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Adherence	App analytics will be used assess participants' adherence to the intervention	3 months, 6 months
Secondary	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.	Baseline
Secondary	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]	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	Change in mediators of behaviour change	Survey questions will assess adolescents' self-efficacy and motivation in changing the health behaviours targeted by LiGHT.	Baseline, 3 months, 6 months