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

NCT00933153 | Completed DMC

• 1 other identifier: TCUMOW1
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Malnutrition

Keywords

Elderly; Malnutrition; Oral Nutrition Supplement; Meals on Wheels

Study Arms (2)

Meals on Wheels

ACTIVE COMPARATOR

Participants will receive two meals daily from Meals on Wheels.

Dietary Supplement: Meals on Wheels

Meals on Wheels + Ensure Plus supplement

EXPERIMENTAL

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

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

Interventions

Ensure Plus DIETARY_SUPPLEMENT

Ensure plus supplement with meals

Meals on Wheels + Ensure Plus supplement

Meals on Wheels DIETARY_SUPPLEMENT

Two Meals on Wheels twice daily

Meals on Wheels; Meals on Wheels + Ensure Plus supplement

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Christian University: lead
• Abbott: collaborator

Study Sites (1)

Meals on Wheels, Inc. of Tarrant County

Fort Worth, Texas, 76104, United States

Location

Related Links

• Texas Christian University
• Meals on Wheels Inc. Tarrant County

MeSH Terms

Conditions

Malnutrition

Interventions

Ensure Plus; Food Services

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food Industry; Industry; Technology, Industry, and Agriculture

Study Officials

• Gina J Hill, PhD

  Texas Christian University

  PRINCIPAL INVESTIGATOR

• Sherry Simon, BS

  Meals on Wheels Inc. of Tarrant County

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

US (1)