A Digital Intervention (KOKU-Nut) to Improve Nutrition in Older Adults: Protocol for a Feasibility Randomised Controlled Trial

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Abstract

Background: Digital health tools can support behaviour change and allow interventions to be scalable at a minimal cost. Keep-on-Keep-up Nutrition (KOKU-Nut) is a free, tablet-based app that focuses on increasing physical activity and improving the dietary intake of older adults based on UK guidelines. The intervention targets an important research area identified as a research priority reported by the James Lind Alliance priority setting partnership for malnutrition.

Objective: The aim of this study is to assess the feasibility of using the digital health tool KOKU-Nut amongst community-dwelling older adults to inform a future randomised controlled trial. Secondary aims are to determine the acceptability, usability, preliminary effect sizes and safety of the study and the intervention (KOKU-Nut).

Methods: This is a feasibility randomised controlled trial. We plan to recruit a total of 36 community-dwelling older adults using purposive sampling. Participants will be randomised in a 1:1 ratio to either the intervention or the control group. The intervention group will be asked to engage with KOKU-Nut three times a week for 12 weeks. Participants in the control group will receive a leaflet promoting a healthy lifestyle. All study participants will complete questionnaires at baseline and at the end of the 12 weeks. A sample of participants will be asked to participate in an optional interview. The study will collect a range of data including anthropometry (height, weight), dietary intake (3-day food diary), physical function (grip strength, 5-times sit-to-stand), perceived quality of life (EuroQol-5 Dimension (EQ-5D-5L)), usability (system usability scale) and safety (adverse events).

Results: We anticipate data collection will commence in March 2023 with results ready for publication by January 2025. Feasibility will consider participants self-reported engagement with the intervention and recruitment and retention rates and will be summarised descriptively. We will also consider the amounts of missing data and assess how outcomes related to group assignment. Acceptability will be measured using the modified treatment evaluation inventory (TEI) and one-to-one semi-structured interviews. Transcripts from the interviews will be analysed on NVivo 12 software using framework analysis to understand any barriers to the recruitment process, the suitability of the assessment measures and acceptability of the intervention and study design.

Conclusions: The study aligns with guidelines developed by the Medical Research Council for developing a complex intervention by employing qualitative and quantitative research to examine the barriers of the intervention and to identify potential challenges around recruitment and retention. We anticipate these results will inform the development of a future powered randomised controlled design trial to test the true effectiveness of KOKU-Nut.
Original languageEnglish
JournalJMIR research protocols
Volume30
DOIs
Publication statusPublished - 30 Apr 2024

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