Effectiveness of Oral Nutritional Supplements (ONS) in a Meals-on-Wheels Population

Malnutrition Clinical Trial

Official title:

Validation of the Malnutrition Screening Tool (MST) and Effectiveness of Oral Nutritional Supplements (ONS) on Weight, Nutritional Status and Quality of Life in a Meals-on-Wheels Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933153
• Other study ID #: TCUMOW1
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: June 12, 2014
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• Source: Texas Christian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Researchers will measure weight, height, hand grip strength and quality of life information of Meals on Wheels (MOW) clients who are considered to have nutrition problems. Participants will randomly be put into a group that receives either typical meals from Meals on Wheels or Ensure Plus supplements with their meals. Three months later the same data will be collected again. The objective of this study is to demonstrate the effectiveness of providing oral nutritional supplements (ONS) to MOW clients with or at risk of malnutrition on nutritional status over a 3-month period.

Description:

While it is well known that older adults are at increased nutritional risk and that nutrition intervention, such as oral nutritional supplementation (ONS) is beneficial in this population, there is limited research on the effect of oral nutritional supplements (ONS) in the Meals on Wheels population. This prospective randomized controlled trial will determine the effectiveness of oral nutritional supplements (ONS) in addition to daily meals from Meals on Wheels on weight status, hand grip strength, quality of life, and malnutrition screening scores in MOW clients with or at-risk of malnutrition over a 3-month study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Participant is Meals on Wheels Inc. of Tarrant County client.

• Participant is 60 years of age or older.

• Participant is identified as medium or high risk of malnutrition as defined by the MST (Medium Risk MST score =2-3 or High Risk MST score =4-5).

• Participant is willing and/or able to consume oral nutritional supplements (ONS).

• Participant provides written informed consent to participate in the study.

• Participant provides authorization to use and/or disclose personal and/or health data.

Exclusion Criteria:

• Patient cannot safely consume an oral nutritional supplement (ONS).

• Example Patient has active gastrointestinal disease (e.g., intestinal obstruction, inflammatory bowel disease, ischemic colitis, diverticulitis, irritable bowel disease, pancreatitis).

• Patient has Diabetes mellitus.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly
• Malnutrition

Intervention

Dietary Supplement:
• Ensure Plus
Ensure plus supplement with meals
• Meals on Wheels
Two Meals on Wheels twice daily

Locations

Country	Name	City	State
United States	Meals on Wheels, Inc. of Tarrant County	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Christian University	Abbott

Country where clinical trial is conducted

United States, 

External Links

•   Meals on Wheels Inc. Tarrant County
•   Texas Christian University