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

Sponsor
Universiti Putra Malaysia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04643626
Collaborator
National Cancer Institute, Malaysia (Other)
70
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Multi-center prospective pilot trial study

Condition or Disease Intervention/Treatment Phase
  • Device: artificial intelligence dietary android mobile application
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multi-center prospective pilot trial studyMulti-center prospective pilot trial study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. weight changes [one month]

      compare weight before intervention and after intervention

    2. daily energy intake [one month]

      compare daily energy intake before intervention and after intervention

    3. daily protein intake [one month]

      compare daily protein intake before intervention and after intervention

    Secondary Outcome Measures

    1. PG-SGA score [one month]

      compare PG-SGA score (numerical data) before intervention and after intervention

    2. Nutrition Impact Symptoms (NIS) [one month]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Institute Putrajaya Wilayah Persekutuan Putrajaya Malaysia 62250

    Sponsors and Collaborators

    • Universiti Putra Malaysia
    • National Cancer Institute, Malaysia

    Investigators

    • Principal Investigator: Chiou Yi Ho, National Cancer Insitute, Malaysia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HO CHIOU YI, Principal Investigator, National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04643626
    Other Study ID Numbers:
    • NMRR-19-2948-51031
    First Posted:
    Nov 25, 2020
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by HO CHIOU YI, Principal Investigator, National Cancer Institute (NCI)
    artificial intelligence dietary application
    weight
    oral intake
    Additional relevant MeSH terms:
    Malnutrition
    Kwashiorkor
    Body Weight Changes

    Study Results

    No Results Posted as of Apr 28, 2021