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Completed

NCT Number: NCT00933153

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meals on Wheels, Inc. of Tarrant County

Fort Worth, Texas, 76104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ensure plus

Dietary Supplement

Ensure plus supplement with meals

Meals on Wheels

Dietary Supplement

Two Meals on Wheels twice daily

Sponsors and collaborators

Lead sponsor

Texas Christian University

Other

Collaborators

  • Abbott

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 7, 2009
Registry last updated
Jun 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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