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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Texas Christian University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Texas Christian University
ClinicalTrials.gov Identifier:
NCT00933153
First received: July 2, 2009
Last updated: July 6, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Elderly
Malnutrition
 Dietary Supplement: Ensure Plus
Dietary Supplement: Meals on Wheels

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Texas Christian University:

Primary Outcome Measures:
  • Weight [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hand grip strength [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]
  • Malnutrition Screening Tool score [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]
  • DETERMINE screen score [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Meals on Wheels
Participants will receive two meals daily from Meals on Wheels.
 Dietary Supplement: Meals on Wheels
Two Meals on Wheels twice daily
Experimental: Meals on Wheels + Ensure Plus supplement
Participants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals.
 Dietary Supplement: Ensure Plus
Ensure plus supplement with meals
Dietary Supplement: Meals on Wheels
Two Meals on Wheels twice daily

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933153

Contacts
Contact: Gina J Hill, PhD 817-257-6320 g.jarman@tcu.edu

Locations
United States, Texas
Meals on Wheels, Inc. of Tarrant County Not yet recruiting
Fort Worth, Texas, United States, 76104
Contact: Sherry Simon, BS     817-336-0912     ssimon@mealsonwheels.org    
Sponsors and Collaborators
Texas Christian University
Investigators
Principal Investigator: Gina J Hill, PhD Texas Christian University
Study Director: Sherry Simon, BS Meals on Wheels Inc. of Tarrant County
  More Information

Additional Information:
Texas Christian University  This link exits the ClinicalTrials.gov site
Meals on Wheels Inc. Tarrant County  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gina Jarman Hill, PhD, RD, LD, Texas Christian University
ClinicalTrials.gov Identifier: NCT00933153     History of Changes
Other Study ID Numbers: TCUMOW1
Study First Received: July 2, 2009
Last Updated: July 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Christian University:
Elderly
Malnutrition
Oral Nutrition Supplement
Meals on Wheels

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 19, 2013