An interventional study of Keep-on-Keep-Up Nutrition (KOKU-Nut) in Malnutrition, Healthy Aging and Dehydration, sponsored by Chloe French. Recruiting at 1 site in United Kingdom. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Chloe French · Not applicable, Interventional, and Supportive care
Trial Design: This is a feasibility randomised controlled trial.
Aim: The study aims to assess the feasibility of conducting a randomised controlled trial using a digital health tool (Keep-On-Keep-Up Nutrition, KOKU-Nut) to improve dietary intake in community-dwelling older adults.
Objectives:
Study population:
Community-dwelling adults aged 65 and older
Intervention:
Participants in the intervention group will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period. A crib sheet and contact details for the research team will be available if participants require additional support to help with technical issues.
Control:
Participants will continue with usual care and receive a leaflet developed by Age UK about the importance of a healthy lifestyle.
Timing and duration 3 month intervention with interviews carried out approximately one week after the intervention period
Background:
Dietary patterns can play an important role in health in older age. Apps that encourage dietary change are available and commonly used in younger populations, however; few are designed for the nutritional and technical requirements of older adults. Keep-On-Keep-Up Nutrition (KOKU-Nut) is the latest development of the digital tool and includes nutritional games based on the Eatwell guide to nudge older adults to improve their diet with a specific focus on protein, fibre and fluid. The innovation process has brought together researchers, clinicians, software designers and older users to co-develop the digital tool.
In this study, researchers will test the practicality of KOKU-Nut as an intervention before further larger studies are conducted to assess it's effectiveness.
The aim of this study is to assess the feasibility of conducting a randomised controlled trial using this digital health tool (KOKU-Nut) to improve dietary intake in community-dwelling older adults. Participants will be randomised to receive usual care and an information booklet about living a healthy lifestyle or to the intervention group and asked to engage with KOKU-Nut 3 times a week for 12 weeks.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 30 is below the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →This is the only study on the registry with Chloe French as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will be helped to download KOKU-Nut onto their ipad or tablet during the baseline visit and will receive training. In cases where participants do not have the necessary devices or data to join the intervention, a tablet with KOKU-Nut installed will be provided for the duration of the intervention. Participants will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period.
Device: Keep-on-Keep-Up Nutrition (KOKU-Nut)
Participants will continue with usual care and will receive a leaflet developed by Age UK about the importance of a healthy lifestyle including information on the importance of staying active and nutrition.
Keep-on-Keep-Up (KOKU) is a free, tablet-based strength and balance exercise application that was soft launched in 2020 (https://kokuhealth.com/). KOKU is approved by the National Health Service (NHS) and Organisation for the Review of Care and Health Apps (ORCHA) as a lifestyle app and has been viewed positively by older adults after 6 weeks of independent use. KOKU-Nut is the latest development of this interactive platform and includes nutritional games based on the UK dietary guidelines to nudge older adults to improve their diet with a specific focus on protein, fibre and fluid.
Self-reported use of KOKU
Participants asked about their engagement with KOKU as part of the follow up case report. Participants respond with the option that suits their use best from the following options: every day; 3-4 times a week; 1-2 times a week; once or twice a month
Time frame: 12 weeks
Recruitment rates
Cumulative recruitment against target rate each month
Time frame: 6 months
Retention rates
Calculated as the number of participants who completed the study divided by the number of participants randomised
Time frame: 12 weeks
Acceptability of the intervention and study design
This will be assessed qualitatively through semi-structured one-to-one interviews with a subset of participants
Time frame: 12-16 weeks
Acceptability of the intervention
A questionnaire developed by the research team along with the 11-item, 7-point modified treatment evaluation inventory. Higher scores indicate higher acceptability, with a score of 44 indicating moderate acceptability
Time frame: 12 weeks
Usability of the intervention
Participants in intervention group will complete the 10-item system usability scale (SUS) to assess perceived usability of the intervention. Responses are measured on a 5-point Likert scale ranging from one (strongly disagree) to five (strongly agree). A score \>68 is considered above average usability and \>80 is considered high usability.
Time frame: 12 weeks
Change in dietary intake
Intake of food groups will be generated from a 3-day food diary inputted onto Intake24 software to identify adherence to the Eatwell guide.
Time frame: Baseline, 12 weeks
Risk of malnutrition
The malnutrition universal screening tool (MUST) will also be used to assess risk of malnutrition based on BMI, unplanned weight loss and acute disease effect. For each component participants receive a score between 0-2 and cumulative scores are calculated (which can range from 0-6) such that 0 indicates low risk, 1 indicates medium risk and a score of 2 or more indicates a high risk of malnutrition.
Time frame: Baseline, 12 weeks
Risk of malnutrition
The Global Leadership Initiative on Malnutrition (GLIM) diagnostic criteria will also be used to assess risk of malnutrition. Participants are assessed on 3 phenotypic criteria (non-volitional weight loss, low body mass index, and reduced muscle mass) and 2 etiologic criteria (reduced food intake or assimilation, and inflammation of disease burden). To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present.
Time frame: Baseline, 12 weeks
Change in physical function
Participants will be instructed to rise from a chair 5 times as quickly as possible with arms folded across their chest and the researcher will record the time taken to complete the task. The researcher will then calculate lower limb muscle power using a validated equation.
Time frame: Baseline, 12 weeks
Change in physical function
Grip strength (kg) will be assessed on a Jamar hydraulic dynamometer three times on each hand with the best score used for analysis
Time frame: Baseline, 12 weeks
Change in health related quality of life
The EuroQol visual analogue scale (EQ-VAS) will be used for participants to describe their perceived state of health. The score can range from 0 (lowest level of health) to 100 (best health imaginable) where participants indicate how they perceive their current health status both on a number line and numerically.
Time frame: Baseline, 12 weeks
Change in health related quality of life
The participants perceived state of health and quality of life will be assessed using the validated EuroQol- 5 Dimension (EQ-5D-5L). The EQ-5D-5Lcomprises five questions assessing mobility, self-care, usual activities, pain or discomfort and anxiety or depression to produce an overall score representing the participant's health profile. The score ranges from one (full health) to zero (state of health equitable to death) with the option to have negative values that indicates a state of health considered to be worse than death
Time frame: Baseline, 12 weeks
Change in BMI
Body weight \[kg\] and height \[m\] to calculate body mass index (BMI)
Time frame: Baseline, 12 weeks
Participants socio-demographic characteristics
Age, gender, marital status, occupation, education, income, ethnicity, smoking status, use of digital technology, shopping and cooking habits.
Time frame: Baseline
Change in mood
Participants will complete the 4-item Geriatric depression scale as part of the baseline and follow-up questionnaire. A cumulative scores of 0 indicates participant is not depressed, a score of 1 shows uncertainty and a score between 2 and 4 (inclusive) indicates the participant is depressed.
Time frame: Baseline, 12 weeks
Change in frailty status
Researcher will assess frailty of participants based on descriptions and images included in the clinical frailty scale. Scores range from 1 (very fit) to 9 (terminally ill) and a score 5 or more indicates frailty.
Time frame: Baseline, 12 weeks
Adverse events
Number of adverse events that occurred as a result of participation in the study
Time frame: From recruitment until study end (approximately 14 weeks)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Oct 2024, 6 months after the start.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 6 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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