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

• Hand grip strength [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]
• Quality of Life [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]
• Malnutrition Screening Tool score [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]
• DETERMINE screen score [ Time Frame: Day 1, Day 90 ] [ Designated as safety issue: No ]

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.

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.

• Elderly
• Malnutrition

• Dietary Supplement: Ensure Plus
  Ensure plus supplement with meals
• Dietary Supplement: Meals on Wheels
  Two Meals on Wheels twice daily

• Active Comparator: Meals on Wheels
  Participants will receive two meals daily from Meals on Wheels.
  Intervention: Dietary Supplement: Meals on Wheels
• Experimental: Meals on Wheels + Ensure Plus supplement
  Participants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals.
  Interventions:

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

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.