ElderlyNCT00933153
Effectiveness of Oral Nutritional Supplements (ONS) in a Meals-on-Wheels Population
A study testing Ensure Plus and Meals on Wheels in people with Elderly and Malnutrition, run by Texas Christian University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly, Malnutrition
- What is being tested?
- Ensure Plus and Meals on Wheels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Meals on Wheels, Inc. of Tarrant County
Fort Worth, Texas, 76104
About this study
Official 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
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.
Read the 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
- Being tested
- Ensure Plus, Meals on Wheels
- Keywords
- Elderly, Malnutrition, Oral Nutrition Supplement, Meals on Wheels
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure PlusDietary supplement
Ensure plus supplement with meals
Meals on WheelsDietary supplement
Two Meals on Wheels twice daily
| Study group | Role | What they receive |
|---|---|---|
| Meals on Wheels | Active comparator | Participants will receive two meals daily from Meals on Wheels. Receives: 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. Receives: Dietary Supplement: Ensure Plus; Dietary Supplement: Meals on Wheels |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Gina Hill, Texas Christian University
- Investigators
- Gina J Hill, PhD, Principal investigator, Texas Christian UniversitySherry Simon, BS, Study director, Meals on Wheels Inc. of Tarrant County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933153
- Sponsor's protocol ID
- TCUMOW1
- Status last verified
- Jun 2014
- First submitted
- 2 Jul 2009
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00933153
- Acronym / sponsor ID
- TCUMOW1
- Conditions
- Elderly, Malnutrition
- Keywords
- Elderly, Malnutrition, Oral Nutrition Supplement, Meals on Wheels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meals on Wheels | Active comparator | Dietary Supplement: Meals on WheelsParticipants will receive two meals daily from Meals on Wheels. |
| Meals on Wheels + Ensure Plus supplement | Experimental | Dietary Supplement: Ensure Plus, Dietary Supplement: Meals on WheelsParticipants will receive two meals from Meals on Wheels daily plus Ensure Plus supplements with meals. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient cannot safely consume an oral nutritional supplement (ONS).
- Patient has Diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure PlusEnsure plus supplement with meals | Dietary supplement | Meals on Wheels + Ensure Plus supplement |
| Meals on WheelsTwo Meals on Wheels twice daily | Dietary supplement | Meals on Wheels, Meals on Wheels + Ensure Plus supplement |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
- Texas Christian UniversityLink provided by the sponsor.
- Meals on Wheels Inc. Tarrant CountyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina J Hill, PhD principal investigator
Texas Christian University
Sherry Simon, BS study director
Meals on Wheels Inc. of Tarrant County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Plus and Meals on Wheels in people with Elderly and Malnutrition, run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.