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

Primary Purpose

Malnutrition, Healthy Aging

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SPOONful
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Oral nutritional supplementation, Older adults, Prescription

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Lonsdale Mews Care Home
  • Cedar Residental Care HomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SPOONful

Control

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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SPOONful intervention which includes an assessment of attrition rate which will be derived by dividing the number of withdrawn participants (calculated as the number of people retained to the end of the intervention/control period subtracted from the total number randomised) by the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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2023
Last Updated
October 2, 2023
Sponsor
Loughborough University
Collaborators
University of Leeds, Aston University, Food4Years Ageing Network
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1. Study Identification

Unique Protocol Identification Number
NCT05810753
Brief Title
Oral Nutritional Supplementation and Community-dwelling Older Adults: a Feasibility Study
Acronym
SPOONful
Official Title
SPOONful: a Structured Prescription Of Oral Nutritional Supplementation for Community-dwelling Older Adults - a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
University of Leeds, Aston University, Food4Years Ageing Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Healthy Aging
Keywords
Oral nutritional supplementation, Older adults, Prescription

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPOONful
Arm Type
Experimental
Arm Description
Participants will be asked to consume one ONS with their breakfast, and one with their lunch, daily for three weeks.
Arm Title
Control
Arm Type
No Intervention
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
SPOONful
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attrition rate
Description
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.
Time Frame
From randomisation (post-familiarisation) to end of intervention week 3.
Title
Completion of self-report data-collection booklet denoting ONS consumption
Description
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.
Time Frame
From start of week 1 to end of week 3
Title
Daily consumption of Oral Nutritional Supplementation as per prescription.
Description
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.
Time Frame
From start of week 1 to end of week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chris J McLeod, PhD
Phone
01509 226578
Email
c.mcleod@lboro.ac.uk
Facility Information:
Facility Name
Lonsdale Mews Care Home
City
Loughborough
State/Province
Leicestershire
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Cedar Residental Care Home
City
Rothley
State/Province
Leicestershire
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Renshaw

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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