PneumoniaNCT04160819
The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
A study testing Assigned Interventions in people with Pneumonia, run by Pei-Hsin Yang at 1 site in Taiwan.
Trial summary
To investigate the effects of an individualized nutritional intervention programs (iNIPs) on nutritional status and readmission rate in older adults with pneumonia during hospitalization and 3 and 6 months after discharge. Read more about this study
- Who is it for?
- Ages 66 to 99 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Assigned Interventions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2017to 24 May 2018
- 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 66 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Primary diagnosis of pneumonia by a physician
- Age more than 65 years
- Malnutrition status indicated by body mass index (BMI) <18.5 kg/m2 or Mini-Nutritional Assessment-Short Form (MNA-SF) score≤7
Who cannot join
- Renal insufficiency (glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or GFR staging of G3b-G5)
- Cancer
- Hospital stay <7 days
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effects of an individualized nutritional intervention programs (iNIPs) on nutritional status and readmission rate in older adults with pneumonia during hospitalization and 3 and 6 months after discharge.
Read the detailed description
Method: Eighty-two malnourished older adults with primary diagnosis of pneumonia participated. Patients were randomly allocated to either a nutrition intervention (NI) group or a standard care (SC) group. Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs. Anthropometry (i.e., body mass index, limb circumference, and subcutaneous fat thickness), blood parameters (i.e., albumin and total lymphocyte count), hospital stay, Mini-Nutritional Assessment-Short Form (MNA-SF) score, target daily calorie intake, total calorie intake adherence rate, and three-major-nutrient intake were assessed during hospitalization and 3 and 6 months after discharge. Both groups received regular follow-up through phone calls. Furthermore, the rate of readmission resulting from pneumonia was recorded after discharge.
- Conditions
- Pneumonia
- Being tested
- Assigned Interventions
- Keywords
- nutritional intervention, malnutrition, respiratory disease
- Medical subject headings
- Pneumonia, Malnutrition, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
Also called The SC group was only provided standard nutritional supplements , and patients' family members were not provided dietary advice.
Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs.
| Study group | Role | What they receive |
|---|---|---|
| individualized nutritional intervention programs (iNIPs) | Experimental | Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs. Anthropometry (i.e., body mass index, limb circumference, and subcutaneous fat thickness), blood parameters (i.e., albumin and total lymphocyte count), hospital stay, Mini-Nutritional Assessment-Short Form (MNA-SF) score, target daily calorie intake, total calorie intake adherence rate, and three-major-nutrient intake were assessed during hospitalization and 3 and 6 months after discharge. Both groups received regular follow-up through phone calls. Furthermore, the rate of readmission resulting from pneumonia was recorded after discharge. Receives: Other: Assigned Interventions |
| standard care (SC) group | No intervention | SC group was only provided standard nutritional supplements according to the Kaohsiung Chang Gung Memorial Hospital Nutrition Department, and patients' family members were not provided dietary advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional status
Mini-Nutritional Assessment short-form scores;MNA-SF scores ranging within 0-7, 8-11, and 12-14 indicate malnutrition, risk of malnutrition, and normal nutritional status, respectively.
Measured: up to 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Mar 2017
- Primary completion24 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pei-Hsin Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pei-Hsin Yang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160819
- Sponsor's protocol ID
- 201700126B0C501
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently in the submission stage, and then share with other researchers after publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
- ClinicalTrials.gov ID
- NCT04160819
- Acronym / sponsor ID
- 201700126B0C501
- Conditions
- Pneumonia
- Keywords
- nutritional intervention, malnutrition, respiratory disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Pei-Hsin YangUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 13 Nov 2019 (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.
To investigate the effects of an individualized nutritional intervention programs (iNIPs) on nutritional status and readmission rate in older adults with pneumonia during hospitalization and 3 and 6 months after discharge.
Detailed description
Method: Eighty-two malnourished older adults with primary diagnosis of pneumonia participated. Patients were randomly allocated to either a nutrition intervention (NI) group or a standard care (SC) group. Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs. Anthropometry (i.e., body mass index, limb circumference, and subcutaneous fat thickness), blood parameters (i.e., albumin and total lymphocyte count), hospital stay, Mini-Nutritional Assessment-Short Form (MNA-SF) score, target daily calorie intake, total calorie intake adherence rate, and three-major-nutrient intake were assessed during hospitalization and 3 and 6 months after discharge. Both groups received regular follow-up through phone calls. Furthermore, the rate of readmission resulting from pneumonia was recorded after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individualized nutritional intervention programs (iNIPs) | Experimental | Other: Assigned InterventionsParticipants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs. Anthropometry (i.e., body mass index, limb circumference, and subcutaneous fat thickness), blood parameters (i.e., albumin and total lymphocyte count), hospital stay, Mini-Nutritional Assessment-Short Form (MNA-SF) score, target daily calorie intake, total calorie intake adherence rate, and three-major-nutrient intake were assessed during hospitalization and 3 and 6 months after discharge. Both groups received regular follow-up through phone calls. Furthermore, the rate of readmission resulting from pneumonia was recorded after discharge. |
| standard care (SC) group | No intervention | –SC group was only provided standard nutritional supplements according to the Kaohsiung Chang Gung Memorial Hospital Nutrition Department, and patients' family members were not provided dietary advice. |
Who may qualify
- Ages
- 66 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of pneumonia by a physician
- Age more than 65 years
- Malnutrition status indicated by body mass index (BMI) <18.5 kg/m2 or Mini-Nutritional Assessment-Short Form (MNA-SF) score≤7
Key exclusion criteria (3 listed)
- Renal insufficiency (glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or GFR staging of G3b-G5)
- Cancer
- Hospital stay <7 days
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 |
|---|---|---|
| Assigned InterventionsAlso: The SC group was only provided standard nutritional supplements , and patients' family members were not provided dietary advice.Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs. | Other | individualized nutritional intervention programs (iNIPs) |
Primary outcome
nutritional status
Time frame: up to 6 months of intervention
Mini-Nutritional Assessment short-form scores;MNA-SF scores ranging within 0-7, 8-11, and 12-14 indicate malnutrition, risk of malnutrition, and normal nutritional status, respectively.
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 14 Nov 2019.
- Individual participant dataSharing planned: No. Currently in the submission stage, and then share with other researchers after publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with Pneumonia, run by Pei-Hsin Yang at 1 site in Taiwan.
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 3 inclusion and 3 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 14 Nov 2019. 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 Taiwan. 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?
nutritional status (time frame: up to 6 months of intervention). 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 14 Nov 2019; AzTrials last refreshed its copy on 3 Nov 2026.