Pilot RCT of E4W App in Adolescents

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548868
• Other study ID #: 1000079525
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: March 2023

Study information

• Verified date: September 2022
• Source: The Hospital for Sick Children
• Contact: Jill Hamilton, MD, MSc
• Phone: 416-813-7654
• Email: jill.hamilton[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Canada	SickKids	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Implementation - Accrual Rate	Accrual rate (number of patients who completed the trial) will be tracked to determine feasibility of implementation	Week 4
Primary	Feasibility of Implementation - Technical difficulties	Technical difficulties (total number of technical difficulties encountered) will be tracked to determine feasibility of implementation	Week 4
Primary	Feasibility of Implementation - Patient Satisfaction	Patient Satisfaction (measured using Acceptability E-Scale)	Week 4
Secondary	Change in dietary intake	To examine preliminary effectiveness of E4W, overall change in dietary intake and achievement of goals will be assessed	Week 4