Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05810753
Study type Interventional
Source Loughborough University
Contact
Status Completed
Phase N/A
Start date May 20, 2023
Completion date January 31, 2024

See also
  Status Clinical Trial Phase
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03268902 - Early Life Interventions for Childhood Growth and Development In Tanzania Phase 2/Phase 3
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT04608656 - Livestock for Health Project N/A
Completed NCT06009198 - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting NCT05257980 - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03628196 - A Nutrition-Focused QIP in Outpatient Clinics
Enrolling by invitation NCT04675229 - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Not yet recruiting NCT06047054 - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT03150927 - Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children N/A
Recruiting NCT03408067 - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients N/A
Recruiting NCT02833740 - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition N/A
Completed NCT02938234 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake N/A
Completed NCT02938247 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake N/A