Pilot RCT of E4W App in Adolescents

Feasibility Testing and Pilot RCT of Eating for Wellness (E4W) - An Image-Recognition Dietary Assessment App for Use in Adolescents With Obesity

Recommendations for weight management in adolescents with obesity include setting small goals to improve eating behaviours. This frequently includes manually recording food intake over a few days. This is particularly challenging for adolescents as they do not enjoy writing down what they eat, leading to incomplete records. To address this, mobile applications (apps) can easily capture what is eaten through photos. Eating for wellness (E4W) is an app that analyzes photos of meals taken by the user and determines the nutritional profile. The investigators will conduct a pilot randomized controlled trial to determine whether E4W can be implemented successfully and its preliminary effectiveness and impact on dietary intake in adolescents with obesity participating in SickKids' weight management program.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Obesity
• Intervention / Treatment: Device: E4W mobile app; Behavioral: Standard Care

Detailed Description

Adolescents are at increased susceptibility for developing obesity-related health issues, with poor eating patterns and increased sedentary behaviours. Recommendations for pediatric obesity management include frequent dietary assessments with health care providers. However, youth often avoid logging their dietary intake through traditional methods. To address this need, image-based mobile applications (apps) are emerging as tools for assessing intake and enhancing participant engagement in weight management programs. However, limited research has been done to characterize eating patterns and diet quality using nutrition smartphone apps in this population. In this study, the investigators will use Eating for Wellness (E4W), an app that analyzes photos of meals taken by the user and determines the nutritional profile. Nutritional content is directly transmitted to the dietitian and remains invisible to the user. E4W provides adolescents with feedback, goal-setting, and tailored support from their dietitian.

The objective of this proposal is to determine whether E4W can be implemented successfully and its preliminary effectiveness and impact on dietary intake in adolescents with obesity participating in a weight management program. The study population will consist of adolescents in the weight management program without an eating disorder, who have the ability to use a smartphone.

Adolescents will be randomly placed in a control (standard care plus logging with default phone camera app only) or experimental group (standard care plus E4W) for 4 weeks. The investigators will assess feasibility and preliminary effectiveness of E4W in improving dietary intake in adolescents with obesity.

Ultimately, our results will inform the design of a larger randomized controlled trial to assess E4W's suitability in replacing current tools for dietary assessment in adolescents with obesity and other populations of children where dietary assessment is important.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Hamilton, MD, MSc; Phone Number: 205115 416-813-7654; Email: jill.hamilton@sickkids.ca
• Study Contact Backup: Name: Rebecca Noseworthy, RD, MPH; Phone Number: 201915 416-813-7654; Email: rebecca.noseworthy@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • Recruiting
      • SickKids
      • Contact: Jill Hamilton, MD, MSc; Phone Number: 205115 416-813-7654; Email: jill.hamilton@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrolled in pediatric weight management program
• BMI > or equal to 97th percentile for age and sex
• English-speaking
• Own a smartphone

Exclusion Criteria:

• Non-English speaking
• Severe cognitive impairments that could preclude assessment
• Undergone bariatric surgery
• Diagnosed eating disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Arm; Patients will receive standard dietary counselling and use of E4W mobile app	Device: E4W mobile app; Eating for Wellness (E4W) is a mobile application that analyzes photos of meals taken by the user and determines the nutritional profile. Nutritional content is then directly transmitted to the dietitian.; Behavioral: Standard Care; Patients will receive standard dietary counselling as part of the weight management program.
ACTIVE_COMPARATOR: Control Arm; Patients will receive standard dietary counselling. No use of E4W.	Behavioral: Standard Care; Patients will receive standard dietary counselling as part of the weight management program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Implementation - Accrual Rate	Accrual rate (number of patients who completed the trial) will be tracked to determine feasibility of implementation	Week 4
Feasibility of Implementation - Technical difficulties	Technical difficulties (total number of technical difficulties encountered) will be tracked to determine feasibility of implementation	Week 4
Feasibility of Implementation - Patient Satisfaction	Patient Satisfaction (measured using Acceptability E-Scale)	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dietary intake	To examine preliminary effectiveness of E4W, overall change in dietary intake and achievement of goals will be assessed	Week 4

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Jill Hamilton, MD, MSc, Division Head of Endocrinology

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 5, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (ACTUAL): September 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Adolescents; Mobile health; Pediatric Obesity; Weight management; Dietary Assessment; Digital health applications
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 1000079525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No