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A Need-based Nutritional Intervention in Nursing Home Residents

Primary Purpose

Malnutrition

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Nutritional supplement

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Nutritional supplement, Nutritional status, Physical functional activity, Nursing home elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 65 years of age
BMI ≤ 25 (kg/m2)
≥1 month of residency
Able to self-feed or receive oral-feeding
Non-bed-ridden
Cognitively able to answer the questionnaire

Exclusion Criteria:

1.Hospitalized or having acute infection/diseases

Sites / Locations

Asia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Received nutrition supplement as needed

Arm Description

No intervention was given. All subjects received routine care

Subjects in this group received 50 g/day soy protein-based nutritional supplement (containing 9.5 g protein, 250 kcal energy and all essential micro-nutrients) whenever subjects BMI is below 24 and MNA score also below 24.

Outcomes

Primary Outcome Measures

Assessment of nutritional status with the Mini nutritional Assessment (MNA)

Change from baseline in MNA score at 4, 8, 12, 16, 20 and 24 weeks

Secondary Outcome Measures

Biochemical indicators

Change from baseline in serum albumin and cholesterol concentrations, and hemoglobin, hematocrit and lymphocyte count status at 12, and 24 weeks.

Full Information

NCT ID

NCT01741870

First Posted

November 29, 2012

Last Updated

December 3, 2012

Sponsor

Asia University

1. Study Identification

Unique Protocol Identification Number

NCT01741870

Brief Title

A Need-based Nutritional Intervention in Nursing Home Residents

Official Title

The Effectiveness of a Need-based Nutritional Intervention Strategy to Improve the Nutritional Status of Elderly Nursing Home Residents

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To examine the effectiveness of a "need-based nutritional intervention" strategy in improving the nutritional and physical functional status of nursing home elderly.

Detailed Description

Ninety-two nursing home residents aged 65 years or older and BMI <25 were randomly assigned to the intervention or control groups. Subjects in the treatment group received a soy-protein-based nutritional supplement, if his/her BMI was <24kg/m2 and nutritional score was <24 according to the Mini Nutritional Assessment. The supplementation would be suspended if both conditions were not met. At baseline and every 4 weeks up to 24 weeks, thereafter, all subjects were measured for anthropometric parameters. At baseline, 12 weeks and 24 weeks subjects were measured for blood biochemical indicators, handgrip strength and Barthel's index.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition

Keywords

Nutritional supplement, Nutritional status, Physical functional activity, Nursing home elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

No intervention was given. All subjects received routine care

Arm Title

Received nutrition supplement as needed

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Nutritional supplement

Intervention Description

Subjects will receive 50 g/day of a soy protein-based nutritional supplement containing 9.5 g protein, 250 kcal energy and all essential micronutrients

Primary Outcome Measure Information:

Title

Assessment of nutritional status with the Mini nutritional Assessment (MNA)

Description

Change from baseline in MNA score at 4, 8, 12, 16, 20 and 24 weeks

Time Frame

Baseline and every 4 weeks, up to 24 weeks

Secondary Outcome Measure Information:

Title

Biochemical indicators

Description

Change from baseline in serum albumin and cholesterol concentrations, and hemoglobin, hematocrit and lymphocyte count status at 12, and 24 weeks.

Time Frame

Baseline, 12, and 24 weeks

Other Pre-specified Outcome Measures:

Title

Physical functional status

Description

Change from baseline in Barthel's index and handgrip strength at 12 and 24 weeks

Time Frame

Baseline, 12 and 24 weeks

Title

Hospital admissions

Description

Frequency of outpatient visits, emergency visits and hospital admission (length of stay) during the study

Time Frame

Baseline, and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 65 years of age BMI ≤ 25 (kg/m2) ≥1 month of residency Able to self-feed or receive oral-feeding Non-bed-ridden Cognitively able to answer the questionnaire Exclusion Criteria: 1.Hospitalized or having acute infection/diseases

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan C Tsai, PhD

Organizational Affiliation

Professor, Dept. of Healthcare Adm., Asia University, 500 liufeng Road, Wufeng, Taichung, Taiwan 41354

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asia University

City

Taichung

ZIP/Postal Code

41354

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

11322680

Citation

Weatherall M. Protein-energy oral supplementation in malnourished nursing-home residents. Age Ageing. 2001 Jan;30(1):85. doi: 10.1093/ageing/30.1.85. No abstract available.

Results Reference

background

PubMed Identifier

23648392

Citation

Lee LC, Tsai AC, Wang JY, Hurng BS, Hsu HC, Tsai HJ. Need-based intervention is an effective strategy for improving the nutritional status of older people living in a nursing home: a randomized controlled trial. Int J Nurs Stud. 2013 Dec;50(12):1580-8. doi: 10.1016/j.ijnurstu.2013.04.004. Epub 2013 May 3.

Results Reference

derived

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A Need-based Nutritional Intervention in Nursing Home Residents

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