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

NCT ID: NCT04160819

Last Updated: 2019-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-05-24

Brief Summary

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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

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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

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Assigned Interventions

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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The SC group was only provided standard nutritional supplements , and patients' family members were not provided dietary advice.

Eligibility Criteria

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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
Minimum Eligible Age

66 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pei-Hsin Yang

OTHER

Sponsor Role lead

Responsible Party

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Pei-Hsin Yang

investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Pei-Hsin Yang

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201700126B0C501

Identifier Type: -

Identifier Source: org_study_id

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