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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

July 2, 2009
June 12, 2014
October 2009
October 2011   (final data collection date for primary outcome measure)
Not Provided
Weight [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00933153 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
 
Effectiveness of Oral Nutritional Supplements (ONS) in a Meals-on-Wheels Population
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Elderly
  • Malnutrition
  • Dietary Supplement: Ensure Plus
    Ensure plus supplement with meals
  • Dietary Supplement: Meals on Wheels
    Two Meals on Wheels twice daily
  • Active Comparator: Meals on Wheels
    Participants will receive two meals daily from Meals on Wheels.
    Intervention: Dietary Supplement: Meals on Wheels
  • Experimental: Meals on Wheels + Ensure Plus supplement
    Participants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals.
    Interventions:
    • Dietary Supplement: Ensure Plus
    • Dietary Supplement: Meals on Wheels
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00933153
TCUMOW1
Yes
Gina Hill, Texas Christian University
Texas Christian University
Abbott
Principal Investigator: Gina J Hill, PhD Texas Christian University
Study Director: Sherry Simon, BS Meals on Wheels Inc. of Tarrant County
Texas Christian University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP