Back to resultsThe Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Assigned Interventions
Sponsored by
About this trial
This is an interventional prevention trial for Pneumonia focused on measuring nutritional intervention, malnutrition, respiratory disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Renal insufficiency (glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or GFR staging of G3b-G5)
- Cancer
- Hospital stay <7 days
Sites / Locations
- Pei-Hsin Yang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
individualized nutritional intervention programs (iNIPs)
standard care (SC) group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160819
Brief Title
The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
Official Title
The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pei-Hsin Yang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
nutritional intervention, malnutrition, respiratory disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
individualized nutritional intervention programs (iNIPs)
Arm Type
Experimental
Arm Description
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.
Arm Title
standard care (SC) group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Assigned Interventions
Other Intervention Name(s)
The SC group was only provided standard nutritional supplements , and patients' family members were not provided dietary advice.
Intervention Description
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.
Primary Outcome Measure Information:
Title
nutritional status
Description
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.
Time Frame
up to 6 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
66 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Renal insufficiency (glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or GFR staging of G3b-G5)
Cancer
Hospital stay <7 days
Facility Information:
Facility Name
Pei-Hsin Yang
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently in the submission stage, and then share with other researchers after publication.
Learn more about this trial
The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
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