Digital Intervention (Keep-On-Keep-Up Nutrition) to Improve Nutrition in Older Adults: Protocol for a Feasibility Randomized Controlled Trial
Authors: French Chloe , Burden Sorrel , Stanmore Emma 
Published: February 2024

Background
Digital health tools can support behavior 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
This study aims to assess the feasibility of using the digital health tool KOKU-Nut among community-dwelling older adults to inform a future randomized controlled trial. The 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 randomized controlled trial. We plan to recruit a total of 36 community-dwelling older adults using purposive sampling. Participants will be randomized 1:1 to either the intervention or the control group. The intervention group will be asked to engage with KOKU-Nut 3 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 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 and weight), dietary intake (3-day food diary), physical function (grip strength and 5-times sit-to-stand), perceived quality of life (EQ-5D), usability (System Usability Scale), and safety (adverse events).

Results
Data collection commenced in March 2024, and the results will be ready for publication by January 2025. Feasibility will be determined on the basis of participants’ self-reported engagement with the intervention, and recruitment and retention rates and will be summarized descriptively. We will also consider the amount of missing data and assess how outcomes are related to group assignment. Acceptability will be measured using the modified treatment evaluation inventory and one-to-one semistructured interviews. Transcripts from the interviews will be analyzed using NVivo (version 12; QSR International) software using framework analysis to understand any barriers to the recruitment process, the suitability of the assessment measures, and the 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 using qualitative and quantitative research to examine the barriers of the intervention and identify potential challenges around recruitment and retention. We anticipate that these results will inform the development of a future powered randomized controlled design trial to test the true effectiveness of KOKU-Nut.

Trial Registration
ClinicalTrials.gov NCT05943366; https://classic.clinicaltrials.gov/ct2/show/NCT05943366

International Registered Report Identifier (IRRID)
PRR1-10.2196/50922