- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04091165
Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery
April 10, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute
This study is to assess the usability and acceptability of a digital food consumption diary as part of the perioperative management of gastrointestinal oncology patients and to evaluate the impact of a digital food diary on adherence to dietician-recommended plan and on quality recovery, using a commercially available smart phone application.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
23
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Tampa, Florida, United States, 33612
- H Lee Moffitt Cancer & Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for surgery in the Moffitt GI Clinic
Description
Inclusion Criteria:
- Diagnosis of gastrointestinal (GI) cancers confirmed by tissue diagnosis and/or clinical presentation as judged by the treating physician
- Candidate for curative-intent surgery
- Participants will be eligible for participation regardless of degree of malnutrition (as determined at pre-operative dietary consultation)
- Own a smartphone with iOS or Android operating systems with WiFi or 3G/4G connection
- Willingness to download the Livestrong.com MyPlate Calorie Tracker onto a personal smart phone with assumption and responsibility for individual data usage, and creation of login for website data extraction
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Sufficient English language proficiency to execute study tasks
Exclusion Criteria:
- Participants with tube feeds and/or need for parenteral/enteral nutrition
- Participants not willing to download or utilize the commercially available weight monitoring application
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
Participants will be identified for inclusion by leaders of the GI Clinic after GI surgery has been scheduled.
Upon consenting, participants will be instructed how to download and use the mobile phone application "My Plate Calorie Counter".
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My Plate Calorie Tracker is a user-friendly weight management, calorie record application, available for smart phone devices.
Users have the option to input items manually (i.e., calories, carbohydrates, fats, and proteins), select from a list of popular food items, or scan barcodes on the food packaging.
In addition to food entries, users can also enter daily water intake and physical activities.
Once an account is created, data entered into the mobile application can be sync'd to the "My Plate Calorie Tracker" website.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability of Smart Phone Application
Time Frame: Up to 3 months
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Usability of smart phone application will be captured by (1) number of days that entries have been made by the study participants and recorded as a percentage of the total number of days after discharge from the hospital (obtained from mobile application (2) number of meals recorded in the application per day (obtained from mobile application) and (3) Exit Questionnaire (6 questions of 12).
The Exit Questionnaire includes a mixture of 5-point Likert-scale, yes or no, and open-ended items to assess usability.
Questions on the 5 point scale use 1 as an indication of difficulty in using application and 5 would be ease of use.
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Up to 3 months
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Acceptability of Smart Phone Application
Time Frame: Up to 3 months
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Patient's acceptability of the mobile application to assist with postoperative nutrition goals will be captured by the Exit Questionnaire (6 questions of 12).
The Exit Questionnaire includes a mixture of 5-point Likert-scale, yes or no, and open-ended items to assess acceptability.
Questions on the 5 point scale use 1 as an indication of acceptability issues of the application and 5 would be acceptability.
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Up to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to Recommended Nutritional Plan
Time Frame: Up to 3 months
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Adherence to the participant's recommended nutritional plan will be calculated by participant's energy (caloric) intake over time, as recorded in the digital food diary, and compared to estimates of the optimum energy needs established by the dietician.
Adherence will be reported as a percentage of estimated energy requirements.
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Up to 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pamela Hodul, MD, H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2019
Primary Completion (Actual)
July 23, 2020
Study Completion (Actual)
January 7, 2022
Study Registration Dates
First Submitted
September 12, 2019
First Submitted That Met QC Criteria
September 13, 2019
First Posted (Actual)
September 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 11, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-19978
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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