Clinical Trials Directory

Trials / Completed

CompletedNCT05810753

Oral Nutritional Supplementation and Community-dwelling Older Adults: a Feasibility Study

SPOONful: a Structured Prescription Of Oral Nutritional Supplementation for Community-dwelling Older Adults - a Feasibility Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Loughborough University · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Accepted

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).

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

Interventions

TypeNameDescription
BEHAVIORALSPOONfulParticipants 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.

Timeline

Start date
2023-05-20
Primary completion
2024-01-31
Completion
2024-01-31
First posted
2023-04-12
Last updated
2024-03-15

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05810753. Inclusion in this directory is not an endorsement.