Clinical trial NCT00933153: 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
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Malnutrition
Keywords: Elderly
Malnutrition
Oral Nutrition Supplement
Meals on Wheels
Lead sponsor: Texas Christian University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2009-07-07
Enrollment: 91
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Meals on Wheels, Inc. of Tarrant County
state: Texas
Study officials:
affiliation: Texas Christian University
name: Gina J Hill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meals on Wheels Inc. of Tarrant County
name: Sherry Simon, BS
role: STUDY_DIRECTOR
References: