Mobile APP Utilization for Enhanced Post-Operative Nutritional Recovery

NCT04091165 | Completed

• 1 other identifier: MCC-19978
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

GI Cancer; Nutritional Deficiency

Keywords

food diary; malnutrition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Adherence to Recommended Nutritional Plan

  Up to 3 months

Study Arms (1)

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

Interventions

My Plate Calorie Tracker OTHER

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.

Also known as: mobile application

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for surgery in the Moffitt GI Clinic

You may qualify if:

• 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

You may not qualify if:

• Participants with tube feeds and/or need for parenteral/enteral nutrition
• Participants not willing to download or utilize the commercially available weight monitoring application

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H Lee Moffitt Cancer & Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Allenson K, Turner K, Gonzalez BD, Gurd E, Zhu S, Misner N, Chin A, Adams M, Cooper L, Nguyen D, Naffouje S, Castillo DL, Kocab M, James B, Denbo J, Pimiento JM, Malafa M, Powers BD, Fleming JB, Anaya DA, Hodul PJ. Pilot trial of remote monitoring to prevent malnutrition after hepatopancreatobiliary surgery. BMC Nutr. 2021 Dec 9;7(1):82. doi: 10.1186/s40795-021-00487-3.

  PMID: 34886909 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Pamela Hodul, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: September 23, 2019
• Primary Completion: July 23, 2020
• Study Completion: January 7, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

US (1)