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

NCT ID: NCT00933153

Last Updated: 2014-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-10-31

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.

Conditions

Elderly; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meals on Wheels

Participants will receive two meals daily from Meals on Wheels.

Group Type: ACTIVE_COMPARATOR

Meals on Wheels

Intervention Type: DIETARY_SUPPLEMENT

Two Meals on Wheels twice daily

Meals on Wheels + Ensure Plus supplement

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

Group Type: EXPERIMENTAL

Ensure Plus

Intervention Type: DIETARY_SUPPLEMENT

Ensure plus supplement with meals

Meals on Wheels

Intervention Type: DIETARY_SUPPLEMENT

Two Meals on Wheels twice daily

Interventions

Ensure Plus

Ensure plus supplement with meals

Intervention Type: DIETARY_SUPPLEMENT

Meals on Wheels

Two Meals on Wheels twice daily

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Texas Christian University

OTHER

Sponsor Role: lead

Responsible Party

Gina Hill

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gina J Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Christian University

Sherry Simon, BS

Role: STUDY_DIRECTOR

Meals on Wheels Inc. of Tarrant County

Locations

Meals on Wheels, Inc. of Tarrant County

Fort Worth, Texas, United States

Countries

United States

Related Links

http://www.tcu.edu

Texas Christian University

http://www.mealsonwheels.org

Meals on Wheels Inc. Tarrant County

Other Identifiers

TCUMOW1

Identifier Type: -

Identifier Source: org_study_id