The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
1 other identifier
interventional
82
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2018
CompletedFirst Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedNovember 14, 2019
November 1, 2019
1.2 years
November 7, 2019
November 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 6 months of intervention
Study Arms (2)
individualized nutritional intervention programs (iNIPs)
EXPERIMENTALParticipants 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 INTERVENTIONSC 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Renal insufficiency (glomerular filtration rate \[GFR\] \<60 mL/min/1.73 m2 or GFR staging of G3b-G5)
- Cancer
- Hospital stay \<7 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pei-Hsin Yanglead
Study Sites (1)
Pei-Hsin Yang
Kaohsiung City, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- investigator
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 13, 2019
Study Start
March 1, 2017
Primary Completion
May 24, 2018
Study Completion
May 24, 2018
Last Updated
November 14, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share
Currently in the submission stage, and then share with other researchers after publication.