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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malnutrition, Healthy Aging

Intervention / Treatment
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* Behavioral: SPOONful


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPOONful<br>Participants will be asked to consume one ONS with their breakfast, and one with their lunch, daily for three weeks. | Behavioral: SPOONful<br>* 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.<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutritional supplementation, Older adults, Prescription