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Completed

NCT Number: NCT04160819

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

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.

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Key information

Age range

66 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pei-Hsin Yang

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assigned Interventions

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pei-Hsin Yang

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2019
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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