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NCT04160819 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04160819
Other study ID # 201700126B0C501
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date May 24, 2018

Study information
Verified date November 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date May 24, 2018
Est. primary completion date May 24, 2018
Accepts healthy volunteers No
Gender All
Age group 66 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Taiwan Pei-Hsin Yang Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Pei-Hsin Yang

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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