Pilot RCT of E4W App in Adolescents
Primary Purpose
Pediatric Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
E4W mobile app
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric Obesity, Weight management, Dietary Assessment, Digital health applications, Adolescents, Mobile health
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
Sites / Locations
- SickKidsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Arm
Control Arm
Arm Description
Patients will receive standard dietary counselling and use of E4W mobile app
Patients will receive standard dietary counselling. No use of E4W.
Outcomes
Primary Outcome Measures
Feasibility of Implementation - Accrual Rate
Accrual rate (number of patients who completed the trial) will be tracked to determine feasibility of implementation
Feasibility of Implementation - Technical difficulties
Technical difficulties (total number of technical difficulties encountered) will be tracked to determine feasibility of implementation
Feasibility of Implementation - Patient Satisfaction
Patient Satisfaction (measured using Acceptability E-Scale)
Secondary Outcome Measures
Change in dietary intake
To examine preliminary effectiveness of E4W, overall change in dietary intake and achievement of goals will be assessed
Full Information
NCT ID
NCT05548868
First Posted
September 12, 2022
Last Updated
September 16, 2022
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT05548868
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Pediatric Obesity, Weight management, Dietary Assessment, Digital health applications, Adolescents, Mobile health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label, parallel groups, pilot randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Patients will receive standard dietary counselling and use of E4W mobile app
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Patients will receive standard dietary counselling. No use of E4W.
Intervention Type
Device
Intervention Name(s)
E4W mobile app
Intervention Description
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
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Patients will receive standard dietary counselling as part of the weight management program.
Primary Outcome Measure Information:
Title
Feasibility of Implementation - Accrual Rate
Description
Accrual rate (number of patients who completed the trial) will be tracked to determine feasibility of implementation
Time Frame
Week 4
Title
Feasibility of Implementation - Technical difficulties
Description
Technical difficulties (total number of technical difficulties encountered) will be tracked to determine feasibility of implementation
Time Frame
Week 4
Title
Feasibility of Implementation - Patient Satisfaction
Description
Patient Satisfaction (measured using Acceptability E-Scale)
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change in dietary intake
Description
To examine preliminary effectiveness of E4W, overall change in dietary intake and achievement of goals will be assessed
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Hamilton, MD, MSc
Phone
416-813-7654
Ext
205115
Email
jill.hamilton@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Noseworthy, RD, MPH
Phone
416-813-7654
Ext
201915
Email
rebecca.noseworthy@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Hamilton, MD, MSc
Organizational Affiliation
Division Head of Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
SickKids
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Hamilton, MD, MSc
Phone
416-813-7654
Ext
205115
Email
jill.hamilton@sickkids.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot RCT of E4W App in Adolescents
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