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Weight LossNCT02567526

Cost Effectiveness of Nutrition Intervention in Long Term Care

A study testing Between-Meal Intervention Group in people with Weight Loss, run by Vanderbilt University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Inadequate food and fluid intake is a common problem among nursing home (NH) residents and one that can lead to under-nutrition, dehydration, weight loss, hospitalization, and even death. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Weight Loss
What is being tested?
Between-Meal Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
No sites listed yet
Study dates
Aug 2011to Jul 2016
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Long-stay nursing home residents
  • Capable of oral food and fluid intake
  • Physician or dietitian order for caloric supplementation

Who cannot join

  • Short-stay (rehabilitation only)
  • Feeding tube
  • Hospice care
  • History of Aspiration

About this study

Inadequate food and fluid intake is a common problem among nursing home (NH) residents and one that can lead to under-nutrition, dehydration, weight loss, hospitalization, and even death. The most common nutrition intervention for at-risk NH residents is oral liquid nutrition supplementation, although, there is limited controlled evidence of the efficacy of supplements in promoting weight gain in NH residents. Moreover, studies show that supplements are not provided consistent with orders and residents receive little to no staff assistance to promote consumption in daily NH care practice. The result is that nutritionally at-risk NH residents with supplement orders receive few additional daily calories from supplements. Recent evidence strongly suggests that offering residents a choice among a variety of foods and fluids multiple times per day between meals coupled with assistance is effective in increasing daily caloric intake and promoting weight gain. However, the provision of the between-meal choice intervention requires significantly more staff time relative to the amount of time NH staff currently spend on between-meal nutritional care provision.

A new federal regulation allows NHs to train non-nursing staff to provide feeding assistance care. Preliminary research has demonstrated that non-nursing staff trained as "feeding assistants" provide mealtime feeding assistance care that is comparable to or better than their indigenous nurse aide counterparts. Moreover, a recent demonstration project showed that these staff can be used to effectively augment nurse aide staff for mealtime feeding assistance care provision in daily care practice. The proposed translational study will utilize the federal regulation to train non-nursing staff for between-meal nutritional care delivery. Specifically, the proposed study will use a controlled, intervention design to determine the cost-effectiveness of the between-meal choice intervention relative to a usual care control group in a group of 200 residents across 4 NH sites. Residents with an order for caloric supplementation will be included in this study and randomized into either a usual care control group or a choice intervention group (100 residents per group). The usual care control group will continue to receive standard NH care for supplement or snack delivery between meals, as provided by indigenous nurse aide staff. Non-nursing staff trained as "feeding assistants" will offer residents in the intervention group a choice between supplements and other snack foods and fluids twice daily, five days per week, for 24 weeks while also providing a standardized prompting protocol to enhance intake and independence in eating. Research staff will independently document the costs of intervention implementation and compare these costs to effectiveness measures which include improvements in caloric intake, weight and quality of life. These outcomes will be independently monitored for both groups across 24 study weeks by trained research staff using standardized, validated protocols. This translational research effort will provide critical information to improve care practices in nursing homes for nutritionally at risk residents.

Conditions
Weight Loss
Being tested
Between-Meal Intervention Group
Keywords
food and fluid intake, nursing home residents, staffing
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Between-Meal Intervention GroupBehavioural

    Non-nursing staff trained as Feeding Assistants were responsible for supplement and snack delivery in the mornings and afternoons between meals supervised by research staff

Study groups in NCT02567526
Study groupRoleWhat they receive
Usual Care Control GroupNo interventionEligible, consented residents continued to receive usual care from nursing home staff and were monitored by trained research staff.
Between-meal Intervention GroupExperimentalNon-nursing staff trained as Feeding Assistants were utilized to deliver supplements and snacks twice per day, between meals for 24 study weeks.
Receives: Behavioral: Between-Meal Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total caloric intake during and between meals

    Weighed intake methods were used to determine total caloric intake during and between meals before and after intervention

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2015 (estimated)
  2. Study startAug 2011
  3. Primary completionJan 2016
  4. Study completionJul 2016

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02567526
Sponsor's protocol ID
111645
Other IDs
5R01AG033828
Status last verified
Oct 2016
First submitted
1 Oct 2015
Last updated
1 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Hollingsworth EK, Long EA, Simmons SF. Comparison Between Quality of Care Provided by Trained Feeding Assistants and Certified Nursing Assistants During Between-Meal Supplementation in Long-Term Care Settings. J Appl Gerontol. 2018 Nov;37(11):1391-1410. doi: 10.1177/0733464816669806. Epub 2016 Sep 22.

    PubMed 27664171

Questions about this trial

What is this clinical trial studying?

A study testing Between-Meal Intervention Group in people with Weight Loss, run by Vanderbilt University.

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 3 inclusion and 4 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

What does the primary outcome measure?

total caloric intake during and between meals (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02567526, which also lists 1 linked publication.

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 1 Nov 2016.

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