Oral Nutritional Supplementation and Community-dwelling Older Adults: a Feasibility Study
NCT ID: NCT05810753
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2023-05-20
2024-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SPOONful
Participants will be asked to consume one ONS with their breakfast, and one with their lunch, daily for three weeks.
SPOONful
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.
Control
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).
No interventions assigned to this group
Interventions
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SPOONful
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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).
70 Years
ALL
Yes
Sponsors
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University of Leeds
OTHER
Aston University
OTHER
Food4Years Ageing Network
UNKNOWN
Loughborough University
OTHER
Responsible Party
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Chris McLeod
Lecturer
Locations
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Loughborough University
Loughborough, Leicestershire, United Kingdom
Countries
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Other Identifiers
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SPOONful_13002
Identifier Type: -
Identifier Source: org_study_id
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