The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients

Multi-center prospective pilot trial study

Study Overview

• Status: Completed
• Conditions: Weight Change, Body; Malnutrition, Calorie; Malnutrition; Protein
• Intervention / Treatment: Device: artificial intelligence dietary android mobile application

Detailed Description

This is a clinical study to evaluate impact of dietary smartphone application on nutritional status among cancer patients. the study hypotheses there is improvement in nutritional outcome in intervention group if compare with control group. the eligible subjects will be screened according to inclusion criteria and approached individually to participate in this study. The consented subjects will be divided randomly into two groups, intervention and conventional groups. Conventional dietitian care will be given to conventional group (CG) while intervention group (IG) will received innovated dietitian care where they will be introduced with iDSA apps and installed in consented subjects' smartphone. All subjects will be reviewed again by dietitian in 1-month time to assess nutritional status (weight and energy protein intake) as well as nutrition impact symptoms.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Putrajaya
    • Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
      • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Possessing smartphone and is willing to use smartphone application
• Been referred to dietitian in outpatient clinic
• At least 18 years of age
• Malaysian

Exclusion Criteria:

• Inability to use the smartphone application (eg. due to vision problems)
• Not been referred to dietitian in outpatient clinic
• Patients who participate in other study at the same time
• On nutrition support (enteral / intra-venous)
• Vulnerable subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IG; artificial intelligence dietary application, iDSA, will be introduced and installed. Explanation on the function and application of iDSA will be given. Daily energy and macro-nutrients requirement target will bed set. The daily energy and macronutrients requirement target is secured by password. Subjects will record their daily dietary intake (food with cooking method and portion size) and nutrition impact symptoms via smartphone application at least 3 times a week. Subjects able to keep track their intake at home. During follow up session, subjects show the iDSA diet intake summary records to Researcher for further assessment.	Device: artificial intelligence dietary android mobile application; subjects use artificial intelligence dietary mobile application to monitor dietary intake; Other Names: iDSA
No Intervention: CG; CG will receive conventional dietitian care includes nutrition care process using conventional 24 hours diet recall method for dietary assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight changes	compare weight before intervention and after intervention	one month
daily energy intake	compare daily energy intake before intervention and after intervention	one month
daily protein intake	compare daily protein intake before intervention and after intervention	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PG-SGA score	compare PG-SGA score (numerical data) before intervention and after intervention	one month
Nutrition Impact Symptoms (NIS)	compare NIS score (scale data) before intervention and after intervention. The score range from 1 to 5 where score 1 is better while score 5 is worst	one month

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: National Cancer Institute, Malaysia
• Investigators: Principal Investigator: Chiou Yi Ho, National Cancer Insitute, Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: weight; oral intake; artificial intelligence dietary application
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Severe Acute Malnutrition; Malnutrition; Body Weight Changes; Kwashiorkor
• Other Study ID Numbers: NMRR-19-2948-51031

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