A Need-based Nutritional Intervention in Nursing Home Residents

NCT01741870 | Completed DMC

• 1 other identifier: tsai1943
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and every 4 weeks, up to 24 weeks

Secondary Outcomes (1)

• Biochemical indicators

  Baseline, 12, and 24 weeks

Other Outcomes (2)

• Physical functional status

  Baseline, 12 and 24 weeks

• Hospital admissions

  Baseline, and 24 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

No intervention was given. All subjects received routine care

Other: Treatment as usual

Received nutrition supplement as needed

ACTIVE COMPARATOR

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.

Dietary Supplement: Nutritional supplement; Other: Treatment as usual

Interventions

Nutritional supplement DIETARY_SUPPLEMENT

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

Received nutrition supplement as needed

Treatment as usual OTHER

routine care

Control; Received nutrition supplement as needed

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• Hospitalized or having acute infection/diseases

Sponsors & Collaborators

• Asia University: lead

Study Sites (1)

Asia University

Taichung, 41354, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 11322680 BACKGROUND

• 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.

  PMID: 23648392 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements; Therapeutics

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alan C Tsai, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 5, 2012
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

TW (1)