The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia

November 13, 2019 updated by: Pei-Hsin Yang
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Pei-Hsin Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years to 99 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: individualized nutritional intervention programs (iNIPs)
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.
Other: Assigned 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.
Other Names:
  • The SC group was only provided standard nutritional supplements , and patients' family members were not provided dietary advice.
No Intervention: standard care (SC) group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 6 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pei-Hsin Yang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

May 24, 2018

Study Completion (Actual)

May 24, 2018

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201700126B0C501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently in the submission stage, and then share with other researchers after publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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