Malnutrition, CalorieNCT04643626
The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients
A study testing artificial intelligence dietary android mobile application in people with Malnutrition, Calorie and Malnutrition; Protein, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
Multi-center prospective pilot trial study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Calorie, Malnutrition; Protein, Weight Change, Body
- What is being tested?
- artificial intelligence dietary android mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Possessing smartphone and is willing to use smartphone application
- Been referred to dietitian in outpatient clinic
- At least 18 years of age
- Malaysian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Multi-center prospective pilot trial study
Read the 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.
- Being tested
- artificial intelligence dietary android mobile application
- Keywords
- artificial intelligence dietary application, weight, oral intake
- Medical subject headings
- Malnutrition, Kwashiorkor, Body Weight Changes, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligence dietary android mobile applicationDevice
Also called iDSA
subjects use artificial intelligence dietary mobile application to monitor dietary intake
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight changes
compare weight before intervention and after intervention
Measured: one month
daily energy intake
compare daily energy intake before intervention and after intervention
Measured: one month
daily protein intake
compare daily protein intake before intervention and after intervention
Measured: one month
Secondary outcomes (2)
PG-SGA score
compare PG-SGA score (numerical data) before intervention and after intervention
Measured: 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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 May 2021
- Primary completion1 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, CalorieStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center prospective pilot trial study
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Malaysia
- Responsible party
- Principal investigator, HO CHIOU YI, National Cancer Institute (NCI)
- Investigators
- Chiou Yi Ho, Principal investigator, National Cancer Insitute, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643626
- Sponsor's protocol ID
- NMRR-19-2948-51031
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients
- ClinicalTrials.gov ID
- NCT04643626
- Acronym / sponsor ID
- NMRR-19-2948-51031
- Keywords
- artificial intelligence dietary application, weight, oral intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- National Cancer Institute, Malaysia
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center prospective pilot trial study
| Arm | Type | Receives |
|---|---|---|
| IG | Experimental | Device: artificial intelligence dietary android mobile applicationartificial 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 | No intervention | –CG will receive conventional dietitian care includes nutrition care process using conventional 24 hours diet recall method for dietary assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Possessing smartphone and is willing to use smartphone application
- Been referred to dietitian in outpatient clinic
- At least 18 years of age
- Malaysian
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| artificial intelligence dietary android mobile applicationAlso: iDSAsubjects use artificial intelligence dietary mobile application to monitor dietary intake | Device | IG |
Primary outcome
weight changes
Time frame: one month
compare weight before intervention and after intervention
daily energy intake
Time frame: one month
compare daily energy intake before intervention and after intervention
daily protein intake
Time frame: one month
compare daily protein intake before intervention and after intervention
2 secondary outcomes
PG-SGA score
Time frame: one month
Nutrition Impact Symptoms (NIS)
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiou Yi Ho principal investigator
National Cancer Insitute, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificial intelligence dietary android mobile application in people with Malnutrition, Calorie and Malnutrition; Protein, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight changes (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.