Clinical trial NCT05548868: Pilot RCT of E4W App in Adolescents
Official title: Feasibility Testing and Pilot RCT of Eating for Wellness (E4W) - An Image-Recognition Dietary Assessment App for Use in Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Keywords: Pediatric Obesity
Weight management
Dietary Assessment
Digital health applications
Adolescents
Mobile health
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, parallel groups, pilot randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Implementation - Accrual Rate
timeFrame: Week 4
measure: Feasibility of Implementation - Technical difficulties
timeFrame: Week 4
measure: Feasibility of Implementation - Patient Satisfaction
timeFrame: Week 4
Secondary outcomes:
measure: Change in dietary intake
timeFrame: Week 4
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: SickKids
state: Ontario
Study officials:
affiliation: Division Head of Endocrinology
name: Jill Hamilton, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: