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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00933153
Other study ID # TCUMOW1
Secondary ID
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


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, 

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