Pilot RCT of E4W App in Adolescents

NCT ID: NCT05548868

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-05

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, parallel groups, pilot randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Arm

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

Group Type EXPERIMENTAL

E4W mobile app

Intervention Type 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.

Standard Care

Intervention Type BEHAVIORAL

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

Control Arm

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

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DEVICE

Standard Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Jill Hamilton

Division Head, Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill Hamilton, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Division Head of Endocrinology

Locations

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SickKids

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jill Hamilton, MD, MSc

Role: CONTACT

416-813-7654 ext. 205115

Rebecca Noseworthy, RD, MPH

Role: CONTACT

416-813-7654 ext. 201915

Facility Contacts

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Jill Hamilton, MD, MSc

Role: primary

416-813-7654 ext. 205115

References

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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.

Reference Type DERIVED
PMID: 39621405 (View on PubMed)

Other Identifiers

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1000079525

Identifier Type: -

Identifier Source: org_study_id

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