Pilot RCT of E4W App in Adolescents

NCT05548868 | Unknown

• 1 other identifier: 1000079525
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Pediatric Obesity; Weight management; Dietary Assessment; Digital health applications; Adolescents; Mobile health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in dietary intake

  Week 4

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Patients will receive standard dietary counselling and use of E4W mobile app

Device: E4W mobile app; Behavioral: Standard Care

Control Arm

ACTIVE COMPARATOR

Patients will receive standard dietary counselling. No use of E4W.

Behavioral: Standard Care

Interventions

E4W mobile app DEVICE

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.

Experimental Arm

Standard Care BEHAVIORAL

Patients will receive standard dietary counselling as part of the weight management program.

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

SickKids

Toronto, Ontario, M5G1X8, Canada

RECRUITING

Related Publications (1)

• Oei K, Choi EE, Bar-Dayan A, Stinson JN, Palmert MR, Alfonsi JE, Hamilton J. An Image-Recognition Dietary Assessment App for Adolescents With Obesity: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Dec 2;8:e58682. doi: 10.2196/58682.

  PMID: 39621405 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jill Hamilton, MD, MSc

  Division Head of Endocrinology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Hamilton, MD, MSc

CONTACT

416-813-7654; jill.hamilton@sickkids.ca

Rebecca Noseworthy, RD, MPH

CONTACT

416-813-7654; rebecca.noseworthy@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Endocrinology

Model Details: Open-label, parallel groups, pilot randomized controlled trial

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 22, 2022
• Study Start: August 5, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)