Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery

Nutritional Deficiency Clinical Trial

Official title:

Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091165
• Other study ID #: MCC-19978
• Status: Completed
• Start date: September 23, 2019
• Est. completion date: January 7, 2022

Study information

• Verified date: April 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 7, 2022
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GI Cancer
• Malnutrition
• Nutritional Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	H Lee Moffitt Cancer & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of Smart Phone Application	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.	Up to 3 months
Primary	Acceptability of Smart Phone Application	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.	Up to 3 months
Secondary	Adherence to Recommended Nutritional Plan	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.	Up to 3 months

External Links

•   Moffitt Cancer Center Clinical Trials website