Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery
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|ClinicalTrials.gov Identifier: NCT04091165|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : November 3, 2022
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|Condition or disease||Intervention/treatment|
|GI Cancer Nutritional Deficiency||Other: My Plate Calorie Tracker|
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|Official Title:||Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery|
|Actual Study Start Date :||September 23, 2019|
|Actual Primary Completion Date :||July 23, 2020|
|Estimated Study Completion Date :||September 11, 2023|
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".
Other: My Plate Calorie Tracker
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 Name: mobile application
- Usability of Smart Phone Application [ Time Frame: Up to 3 months ]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.
- Acceptability of Smart Phone Application [ Time Frame: Up to 3 months ]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.
- Adherence to Recommended Nutritional Plan [ Time Frame: Up to 3 months ]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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- Participants with tube feeds and/or need for parenteral/enteral nutrition
- Participants not willing to download or utilize the commercially available weight monitoring application
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091165
|United States, Florida|
|H Lee Moffitt Cancer & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Pamela Hodul, MD||H. Lee Moffitt Cancer Center and Research Institute|
Documents provided by H. Lee Moffitt Cancer Center and Research Institute:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||H. Lee Moffitt Cancer Center and Research Institute|
|Other Study ID Numbers:||
|First Posted:||September 16, 2019 Key Record Dates|
|Last Update Posted:||November 3, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|