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

Texas Christian University

Status: Completed

Conditions: Malnutrition; Elderly

Treatments: Dietary Supplement: Ensure Plus; Dietary Supplement: Meals on Wheels

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00933153

TCUMOW1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Meals on Wheels

Active Comparator group

Description:

Participants will receive two meals daily from Meals on Wheels.

Treatment:

Dietary Supplement: Meals on Wheels

Meals on Wheels + Ensure Plus supplement

Experimental group

Description:

Participants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals.

Treatment:

Dietary Supplement: Meals on Wheels

Dietary Supplement: Ensure Plus