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

March 13, 2024 updated by: Chris McLeod, Loughborough University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Loughborough, Leicestershire, United Kingdom, LE11 3TU
        • Loughborough University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPOONful
Participants will be asked to consume one ONS with their breakfast, and one with their lunch, daily for three weeks.
Behavioral: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomisation (post-familiarisation) to end of intervention week 3.
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.
From start of week 1 to end of week 3
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.
From start of week 1 to end of week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loughborough University

Collaborators

University of Leeds
Aston University
Food4Years Ageing Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPOONful_13002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available upon request once the study findings have been published.

IPD Sharing Time Frame

Intention to publish date 1/12/2024

IPD Sharing Access Criteria

Anonymous data will be shared with all who request access via email for novel analyses or re-analysis of the study outcomes. This will be administered by Dr Chris McLeod.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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