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

Primary Purpose

Malnutrition, Calorie, Malnutrition; Protein, Weight Change, Body

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

artificial intelligence dietary android mobile application

About this trial

This is an interventional supportive care trial for Malnutrition, Calorie focused on measuring artificial intelligence dietary application, weight, oral intake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

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.

CG will receive conventional dietitian care includes nutrition care process using conventional 24 hours diet recall method for dietary assessment

Outcomes

Primary Outcome Measures

weight changes

compare weight before intervention and after intervention

daily energy intake

compare daily energy intake before intervention and after intervention

daily protein intake

compare daily protein intake before intervention and after intervention

Secondary Outcome Measures

PG-SGA score

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

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

Full Information

NCT ID

NCT04643626

First Posted

November 3, 2020

Last Updated

November 1, 2022

Sponsor

Universiti Putra Malaysia

Collaborators

National Cancer Institute, Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT04643626

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

January 1, 2022 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Putra Malaysia

Collaborators

National Cancer Institute, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Multi-center prospective pilot trial study

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition, Calorie, Malnutrition; Protein, Weight Change, Body

Keywords

artificial intelligence dietary application, weight, oral intake

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Multi-center prospective pilot trial study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

No Intervention

Arm Description

CG will receive conventional dietitian care includes nutrition care process using conventional 24 hours diet recall method for dietary assessment

Intervention Type

Device

Intervention Name(s)

artificial intelligence dietary android mobile application

Other Intervention Name(s)

iDSA

Intervention Description

subjects use artificial intelligence dietary mobile application to monitor dietary intake

Primary Outcome Measure Information:

Title

weight changes

Description

compare weight before intervention and after intervention

Time Frame

one month

Title

daily energy intake

Description

compare daily energy intake before intervention and after intervention

Time Frame

one month

Title

daily protein intake

Description

compare daily protein intake before intervention and after intervention

Time Frame

one month

Secondary Outcome Measure Information:

Title

PG-SGA score

Description

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

Time Frame

one month

Title

Nutrition Impact Symptoms (NIS)

Description

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

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chiou Yi Ho

Organizational Affiliation

National Cancer Insitute, Malaysia

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Institute

City

Putrajaya

State/Province

Wilayah Persekutuan Putrajaya

ZIP/Postal Code

62250

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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