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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Gina Hill, Texas Christian University
ClinicalTrials.gov Identifier:
NCT00933153
First received: July 2, 2009
Last updated: June 12, 2014
Last verified: June 2014
  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:


Further study details as provided by Texas Christian University:

Enrollment: 91
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00933153

Locations
United States, Texas
Meals on Wheels, Inc. of Tarrant County
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Texas Christian University
Abbott
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:
No publications provided

Responsible Party: Gina Hill, Associate Professor, Texas Christian University
ClinicalTrials.gov Identifier: NCT00933153     History of Changes
Other Study ID Numbers: TCUMOW1
Study First Received: July 2, 2009
Last Updated: June 12, 2014
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 October 19, 2014