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

Not Applicable

Completed

• Conditions: Malnutrition; Elderly
• Interventions: Dietary Supplement: Meals on Wheels; Dietary Supplement: Ensure Plus

• Registration Number: NCT00933153
• Lead Sponsor: Texas Christian University

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.

Study Timeline

• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Study Start: 2009-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-12
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meals on Wheels	Meals on Wheels	Participants will receive two meals daily from Meals on Wheels.
Meals on Wheels + Ensure Plus supplement	Ensure Plus	Participants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals.
Meals on Wheels + Ensure Plus supplement	Meals on Wheels	Participants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals.

Trial Locations

Locations (1)

Meals on Wheels, Inc. of Tarrant County; 🇺🇸 Fort Worth, Texas, United States