MalnutritionSPOONfulNCT05810753
Oral Nutritional Supplementation and Community-dwelling Older Adults: a Feasibility Study
A study testing SPOONful in people with Malnutrition and Healthy Aging, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The goal of this study is to assess the feasibility and acceptability to community-dwelling older adults of implementing a precise prescription of oral nutritional supplementation (the SPOONful intervention). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Healthy Aging
- What is being tested?
- SPOONful
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2023to 31 Jan 2024
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be aged ≥70 years.
- Be living independently in the community.
- Be able to self-feed.
- Score >12 on The Montreal Cognitive Assessment (5-minute telephone version).
- Not be classified as High Risk of Malnutrition as assessed by the Malnutrition Universal Screening Tool
- Not have a BMI ≥40.
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- Not have diabetes, a diagnosed eating disorder, a history of gastric/digestive/metabolic/cardiovascular/anosmia/renal disease, galactosaemia or another issue negatively impacting eating.
- Not have an allergy/intolerance/dislike or previous experience of regularly taking ONS.
- Regularly eat breakfast and lunch (≥5 times per week).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: SPOONful: a Structured Prescription Of Oral Nutritional Supplementation for Community-dwelling Older Adults - a Feasibility Study
The goal of this study is to assess the feasibility and acceptability to community-dwelling older adults of implementing a precise prescription of oral nutritional supplementation (the SPOONful intervention).
Read the detailed description
Oral nutritional supplementation (ONS) can treat and prevent malnutrition in older adults (aged ≥70 years). However, older adults' adherence to ONS is poor (~ 37%). One specific influence that may impact adherence is how effectively ONS prescription corresponds with older-adults' typical daily eating patterns (i.e., eating three meals daily and snacking infrequently). Currently, prescription instructions for ONS provided by the UK's National Health Service/National Institute for Health and Care Excellent lack precision within daily eating patterns and place the onus on healthcare practitioners to determine effective implementation. Poor ONS adherence could be caused, in part, by this imprecise prescription.
This hypothesis is founded on research demonstrating the importance of behavioural habit strength in promoting health-behaviour engagement/maintenance. Medical research suggests that forming medication-taking routines/habits through 'piggybacking' (combining a new behaviour with an existing habit/routine) can improve long-term adherence by reducing novel, deliberative behaviours requiring additional cognitive and self-regulatory resources - this is particularly salient for older adults where cognitive decline is widely experienced and a clear barrier to engaging in novel behaviours. Piggybacking with medical care is a key, under explored and relevant direction of enquiry to improve ONS adherence.To explore the idea that a more precise prescription may increase adherence to ONS, a feasibility and acceptability study will be undertaken to provide an initial evaluation of the SPOONful intervention.
Consent will be sought from community-dwelling older adults who will be asked to take part in a two-day familiarisation phase to ensure they understand the protocol and do not dislike or have an adverse reaction to the ONS. They will then be randomised into the intervention or control group. In the intervention group, participants will be asked to consume two ONS at particular times of day for three weeks. In the control group, participants will engage in usual care for ONS, i.e., they will be asked to consume two ONS daily but without specific instruction as to when this should be. All participants will subsequently engage in a follow-up phase comprising interviews with participants. Participants will complete all phases at home. The data gathered will be used to inform the feasibility and acceptability of a later trial.
- Conditions
- Malnutrition, Healthy Aging
- Being tested
- SPOONful
- Keywords
- Oral nutritional supplementation, Older adults, Prescription
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPOONfulBehavioural
Participants will be asked to consume two ONS daily, in addition to their regular diet, for three weeks. Participants will be asked to consume one ONS with their breakfast, and one with lunch.
| Study group | Role | What they receive |
|---|---|---|
| SPOONful | Experimental | Participants will be asked to consume one ONS with their breakfast, and one with their lunch, daily for three weeks. Receives: Behavioral: SPOONful |
| Control | No intervention | Participants will be asked to consume two ONS daily, in addition to their regular diet, for three weeks without any precise instruction regarding when to consume the ONS during the day (standard care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition rate
The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of attrition rate which will be derived by dividing the number of withdrawn participants (calculated as the number of people retained to the end of the intervention/control period subtracted from the total number randomised) by the number originally randomised.
Measured: From randomisation (post-familiarisation) to end of intervention week 3.
Completion of self-report data-collection booklet denoting ONS consumption
The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of participants' ability to complete the self-report data-collection booklet denoting their ONS consumption. Completion of data-collection booklet with times of ONS intake will be calculated as the percentage of blank/incomplete data cells.
Measured: From start of week 1 to end of week 3
Daily consumption of Oral Nutritional Supplementation as per prescription.
The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of daily consumption of ONS as prescribed will be measured as the percentage of instances where participants did not adhere to the prescription.
Measured: From start of week 1 to end of week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start20 May 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, Aston University, Food4Years Ageing Network
- Responsible party
- Principal investigator, Chris McLeod, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810753
- Sponsor's protocol ID
- SPOONful_13002
- Acronym
- SPOONful
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request once the study findings have been published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPOONful: a Structured Prescription Of Oral Nutritional Supplementation for Community-dwelling Older Adults - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05810753
- Acronym / sponsor ID
- SPOONful / SPOONful_13002
- Conditions
- Malnutrition, Healthy Aging
- Keywords
- Oral nutritional supplementation, Older adults, Prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University of Leeds, Aston University, Food4Years Ageing Network
- Study start
- 20 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Apr 2023 (actual)
- 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.
The goal of this study is to assess the feasibility and acceptability to community-dwelling older adults of implementing a precise prescription of oral nutritional supplementation (the SPOONful intervention).
Detailed description
Oral nutritional supplementation (ONS) can treat and prevent malnutrition in older adults (aged ≥70 years). However, older adults' adherence to ONS is poor (~ 37%). One specific influence that may impact adherence is how effectively ONS prescription corresponds with older-adults' typical daily eating patterns (i.e., eating three meals daily and snacking infrequently). Currently, prescription instructions for ONS provided by the UK's National Health Service/National Institute for Health and Care Excellent lack precision within daily eating patterns and place the onus on healthcare practitioners to determine effective implementation. Poor ONS adherence could be caused, in part, by this imprecise prescription.
This hypothesis is founded on research demonstrating the importance of behavioural habit strength in promoting health-behaviour engagement/maintenance. Medical research suggests that forming medication-taking routines/habits through 'piggybacking' (combining a new behaviour with an existing habit/routine) can improve long-term adherence by reducing novel, deliberative behaviours requiring additional cognitive and self-regulatory resources - this is particularly salient for older adults where cognitive decline is widely experienced and a clear barrier to engaging in novel behaviours. Piggybacking with medical care is a key, under explored and relevant direction of enquiry to improve ONS adherence.To explore the idea that a more precise prescription may increase adherence to ONS, a feasibility and acceptability study will be undertaken to provide an initial evaluation of the SPOONful intervention.
Consent will be sought from community-dwelling older adults who will be asked to take part in a two-day familiarisation phase to ensure they understand the protocol and do not dislike or have an adverse reaction to the ONS. They will then be randomised into the intervention or control group. In the intervention group, participants will be asked to consume two ONS at particular times of day for three weeks. In the control group, participants will engage in usual care for ONS, i.e., they will be asked to consume two ONS daily but without specific instruction as to when this should be. All participants will subsequently engage in a follow-up phase comprising interviews with participants. Participants will complete all phases at home. The data gathered will be used to inform the feasibility and acceptability of a later trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPOONful | Experimental | Behavioral: SPOONfulParticipants will be asked to consume one ONS with their breakfast, and one with their lunch, daily for three weeks. |
| Control | No intervention | –Participants will be asked to consume two ONS daily, in addition to their regular diet, for three weeks without any precise instruction regarding when to consume the ONS during the day (standard care). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Be aged ≥70 years.
- Be living independently in the community.
- Be able to self-feed.
- Score >12 on The Montreal Cognitive Assessment (5-minute telephone version).
- Not be classified as High Risk of Malnutrition as assessed by the Malnutrition Universal Screening Tool
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SPOONfulParticipants will be asked to consume two ONS daily, in addition to their regular diet, for three weeks. Participants will be asked to consume one ONS with their breakfast, and one with lunch. | Behavioural | SPOONful |
Primary outcome
Attrition rate
Time frame: From randomisation (post-familiarisation) to end of intervention week 3.
The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of attrition rate which will be derived by dividing the number of withdrawn participants (calculated as the number of people retained to the end of the intervention/control period subtracted from the total number randomised) by the number originally randomised.
Completion of self-report data-collection booklet denoting ONS consumption
Time frame: From start of week 1 to end of week 3
The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of participants' ability to complete the self-report data-collection booklet denoting their ONS consumption. Completion of data-collection booklet with times of ONS intake will be calculated as the percentage of blank/incomplete data cells.
Daily consumption of Oral Nutritional Supplementation as per prescription.
Time frame: From start of week 1 to end of week 3
The primary outcome is the feasibility and acceptability of the SPOONful intervention which includes an assessment of daily consumption of ONS as prescribed will be measured as the percentage of instances where participants did not adhere to the prescription.
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 15 Mar 2024.
- Individual participant dataSharing planned: Yes. Available upon request once the study findings have been published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPOONful in people with Malnutrition and Healthy Aging, run by Loughborough University at 1 site in United Kingdom.
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 9 inclusion and 0 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 15 Mar 2024. 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 Kingdom. 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.
What does the primary outcome measure?
Attrition rate (time frame: From randomisation (post-familiarisation) to end of intervention week 3.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 15 Mar 2024.