Pediatric ObesityNCT05548868
Pilot RCT of E4W App in Adolescents
A study testing E4W mobile app in people with Pediatric Obesity, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- E4W mobile app
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled in pediatric weight management program
- BMI > or equal to 97th percentile for age and sex
- English-speaking
- Own a smartphone
Who cannot join
- Non-English speaking
- Severe cognitive impairments that could preclude assessment
- Undergone bariatric surgery
- Diagnosed eating disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
SickKids
Toronto, Ontario, M5G1X8
Jill Hamilton, MD, MSc, 416-813-7654 ext. 205115, jill.hamilton@sickkids.ca
About this study
Official title: Feasibility Testing and Pilot RCT of Eating for Wellness (E4W) - An Image-Recognition Dietary Assessment App for Use in Adolescents With Obesity
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- E4W mobile app, Standard Care
- Keywords
- Pediatric Obesity, Weight management, Dietary Assessment, Digital health applications, Adolescents, Mobile health
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E4W mobile appDevice
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 CareBehavioural
Patients will receive standard dietary counselling as part of the weight management program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Patients will receive standard dietary counselling and use of E4W mobile app Receives: Device: E4W mobile app; Behavioral: Standard Care |
| Control Arm | Active comparator | Patients will receive standard dietary counselling. No use of E4W. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Implementation - Accrual Rate
Accrual rate (number of patients who completed the trial) will be tracked to determine feasibility of implementation
Measured: Week 4
Feasibility of Implementation - Technical difficulties
Technical difficulties (total number of technical difficulties encountered) will be tracked to determine feasibility of implementation
Measured: Week 4
Feasibility of Implementation - Patient Satisfaction
Patient Satisfaction (measured using Acceptability E-Scale)
Measured: Week 4
Secondary outcomes (1)
Change in dietary intake
To examine preliminary effectiveness of E4W, overall change in dietary intake and achievement of goals will be assessed
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start5 Aug 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, parallel groups, pilot randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Hamilton, The Hospital for Sick Children
- Investigators
- Jill Hamilton, MD, MSc, Principal investigator, Division Head of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548868
- Sponsor's protocol ID
- 1000079525
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39621405
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing and Pilot RCT of Eating for Wellness (E4W) - An Image-Recognition Dietary Assessment App for Use in Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT05548868
- Acronym / sponsor ID
- 1000079525
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric Obesity, Weight management, Dietary Assessment, Digital health applications, Adolescents, Mobile health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, parallel groups, pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: E4W mobile app, Behavioral: Standard CarePatients will receive standard dietary counselling and use of E4W mobile app |
| Control Arm | Active comparator | Behavioral: Standard CarePatients will receive standard dietary counselling. No use of E4W. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Enrolled in pediatric weight management program
- BMI > or equal to 97th percentile for age and sex
- English-speaking
- Own a smartphone
Key exclusion criteria (4 listed)
- Non-English speaking
- Severe cognitive impairments that could preclude assessment
- Undergone bariatric surgery
- Diagnosed eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E4W mobile appEating 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. | Device | Experimental Arm |
| Standard CarePatients will receive standard dietary counselling as part of the weight management program. | Behavioural | Control Arm, Experimental Arm |
Primary outcome
Feasibility of Implementation - Accrual Rate
Time frame: Week 4
Accrual rate (number of patients who completed the trial) will be tracked to determine feasibility of implementation
Feasibility of Implementation - Technical difficulties
Time frame: Week 4
Technical difficulties (total number of technical difficulties encountered) will be tracked to determine feasibility of implementation
Feasibility of Implementation - Patient Satisfaction
Time frame: Week 4
Patient Satisfaction (measured using Acceptability E-Scale)
1 secondary outcome
Change in dietary intake
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Derived from this study: PubMed 39621405Oei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Hamilton, MD, MSc principal investigator
Division Head of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E4W mobile app in people with Pediatric Obesity, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jill Hamilton, MD, MSc (416-813-7654 ext. 205115, jill.hamilton@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Implementation - Accrual Rate (time frame: Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05548868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.