NCT04643626

Brief Summary

Multi-center prospective pilot trial study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

November 3, 2020

Last Update Submit

November 1, 2022

Conditions

Keywords

artificial intelligence dietary applicationweightoral intake

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • PG-SGA score

    one month

  • Nutrition Impact Symptoms (NIS)

    one month

Study Arms (2)

IG

EXPERIMENTAL

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

CG

NO INTERVENTION

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

Interventions

subjects use artificial intelligence dietary mobile application to monitor dietary intake

Also known as: iDSA
IG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Putrajaya, Putrajaya, 62250, Malaysia

Location

MeSH Terms

Conditions

MalnutritionKwashiorkorBody Weight ChangesBody Weight

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSevere Acute MalnutritionSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chiou Yi Ho

    National Cancer Insitute, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Multi-center prospective pilot trial study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 25, 2020

Study Start

May 1, 2021

Primary Completion

January 1, 2022

Study Completion

March 31, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations