Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults
- Conditions
- Healthy AgingMalnutritionDehydration
- Interventions
- Device: Keep-on-Keep-Up Nutrition (KOKU-Nut)
- Registration Number
- NCT05943366
- Lead Sponsor
- Chloe French
- Brief Summary
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:
1. Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial.
2. Adherence to the intervention, motivations, barriers and facilitators of engaging with KOKU-Nut
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Aged 65 years or older
- Living independently in the community
- Have access to the internet (to complete online dietary assessment)
- Willing to use an iPad or tablet (their own or one provided) for the duration of the study
- Unable to communicate in English
- Have a known cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KOKU-Nut Keep-on-Keep-Up Nutrition (KOKU-Nut) 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.
- Primary Outcome Measures
Name Time Method Acceptability of the intervention 12 weeks 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
Retention rates 12 weeks Calculated as the number of participants who completed the study divided by the number of participants randomised
Usability of the intervention 12 weeks 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.
Recruitment rates 6 months Cumulative recruitment against target rate each month
Self-reported use of KOKU 12 weeks 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
Acceptability of the intervention and study design 12-16 weeks This will be assessed qualitatively through semi-structured one-to-one interviews with a subset of participants
- Secondary Outcome Measures
Name Time Method Change in physical function Baseline, 12 weeks Grip strength (kg) will be assessed on a Jamar hydraulic dynamometer three times on each hand with the best score used for analysis
Change in dietary intake Baseline, 12 weeks Intake of food groups will be generated from a 3-day food diary inputted onto Intake24 software to identify adherence to the Eatwell guide.
Change in frailty status Baseline, 12 weeks 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.
Adverse events From recruitment until study end (approximately 14 weeks) Number of adverse events that occurred as a result of participation in the study
Risk of malnutrition Baseline, 12 weeks 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.
Participants socio-demographic characteristics Baseline Age, gender, marital status, occupation, education, income, ethnicity, smoking status, use of digital technology, shopping and cooking habits.
Change in health related quality of life Baseline, 12 weeks 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
Change in BMI Baseline, 12 weeks Body weight \[kg\] and height \[m\] to calculate body mass index (BMI)
Change in mood Baseline, 12 weeks 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.
Trial Locations
- Locations (1)
Manchester
🇬🇧Manchester, United Kingdom