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

Loughborough University

Status: Completed

Conditions: Malnutrition; Healthy Aging

Treatments: Behavioral: SPOONful

Study type: Interventional

Funder types: Other

Identifiers

NCT05810753

SPOONful_13002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.
• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

SPOONful

Experimental group

Description:

Participants will be asked to consume one ONS with their breakfast, and one with their lunch, daily for three weeks.

Treatment:

Behavioral: SPOONful

Control

No Intervention group

Description:

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).