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Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091165
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
GI Cancer Nutritional Deficiency Other: My Plate Calorie Tracker

Study Design
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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Groups and Cohorts
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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".
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Study Population
Patients scheduled for surgery in the Moffitt GI Clinic
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Florida
H Lee Moffitt Cancer & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Pamela Hodul, MD H. Lee Moffitt Cancer Center and Research Institute
  Study Documents (Full-Text)

Documents provided by H. Lee Moffitt Cancer Center and Research Institute:
Informed Consent Form  [PDF] June 14, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04091165    
Other Study ID Numbers: MCC-19978
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
food diary
malnutrition
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders