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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04643626
Other study ID # NMRR-19-2948-51031
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date March 31, 2022

Study information

Verified date November 2022
Source Universiti Putra Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multi-center prospective pilot trial study


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date March 31, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
artificial intelligence dietary android mobile application
subjects use artificial intelligence dietary mobile application to monitor dietary intake

Locations

Country Name City State
Malaysia National Cancer Institute Putrajaya Wilayah Persekutuan Putrajaya

Sponsors (2)

Lead Sponsor Collaborator
Universiti Putra Malaysia National Cancer Institute, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary weight changes compare weight before intervention and after intervention one month
Primary daily energy intake compare daily energy intake before intervention and after intervention one month
Primary daily protein intake compare daily protein intake before intervention and after intervention one month
Secondary PG-SGA score compare PG-SGA score (numerical data) before intervention and after intervention one month
Secondary 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
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