Back to resultsEffectiveness of Oral Nutritional Supplements (ONS) in a Meals-on-Wheels Population
Primary Purpose
Elderly, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ensure Plus
Meals on Wheels
Sponsored by
About this trial
This is an interventional treatment trial for Elderly focused on measuring Elderly, Malnutrition, Oral Nutrition Supplement, Meals on Wheels
Eligibility Criteria
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.
Sites / Locations
- Meals on Wheels, Inc. of Tarrant County
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Meals on Wheels
Meals on Wheels + Ensure Plus supplement
Arm Description
Participants will receive two meals daily from Meals on Wheels.
Participants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00933153
First Posted
July 2, 2009
Last Updated
June 12, 2014
Sponsor
Texas Christian University
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00933153
Brief Title
Effectiveness of Oral Nutritional Supplements (ONS) in a Meals-on-Wheels Population
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Christian University
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Malnutrition
Keywords
Elderly, Malnutrition, Oral Nutrition Supplement, Meals on Wheels
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meals on Wheels
Arm Type
Active Comparator
Arm Description
Participants will receive two meals daily from Meals on Wheels.
Arm Title
Meals on Wheels + Ensure Plus supplement
Arm Type
Experimental
Arm Description
Participants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Plus
Intervention Description
Ensure plus supplement with meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Meals on Wheels
Intervention Description
Two Meals on Wheels twice daily
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina J Hill, PhD
Organizational Affiliation
Texas Christian University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherry Simon, BS
Organizational Affiliation
Meals on Wheels Inc. of Tarrant County
Official's Role
Study Director
Facility Information:
Facility Name
Meals on Wheels, Inc. of Tarrant County
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.tcu.edu
Description
Texas Christian University
URL
http://www.mealsonwheels.org
Description
Meals on Wheels Inc. Tarrant County
Learn more about this trial
Effectiveness of Oral Nutritional Supplements (ONS) in a Meals-on-Wheels Population
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