Clinical trial NCT05943366: Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults
Official title: Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults: a Mixed-methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Healthy Aging
Dehydration
Keywords: feasibility
malnutrition
dehydration
digital health
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prior to completing baseline measures, participants will be randomised in a 1:1 ratio to receive the intervention (KOKU-Nut) or to the control group and receive usual care. Randomisation will be undertaken by a separate member of the research team using the Sealed Envelope randomisation service.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Unable to communicate in English
* Have a known cognitive impairment

Primary outcomes:
measure: Self-reported use of KOKU
timeFrame: 12 weeks
measure: Recruitment rates
timeFrame: 6 months
measure: Retention rates
timeFrame: 12 weeks
measure: Acceptability of the intervention and study design
timeFrame: 12-16 weeks
measure: Acceptability of the intervention
timeFrame: 12 weeks
measure: Usability of the intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in dietary intake
timeFrame: Baseline, 12 weeks
measure: Risk of malnutrition
timeFrame: Baseline, 12 weeks
measure: Risk of malnutrition
timeFrame: Baseline, 12 weeks
measure: Change in physical function
timeFrame: Baseline, 12 weeks
measure: Change in physical function
timeFrame: Baseline, 12 weeks
measure: Change in health related quality of life
timeFrame: Baseline, 12 weeks
measure: Change in health related quality of life
timeFrame: Baseline, 12 weeks
measure: Change in BMI
timeFrame: Baseline, 12 weeks
measure: Participants socio-demographic characteristics
timeFrame: Baseline
measure: Change in mood
timeFrame: Baseline, 12 weeks
measure: Change in frailty status
timeFrame: Baseline, 12 weeks
measure: Adverse events
timeFrame: From recruitment until study end (approximately 14 weeks)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester
Study officials:
affiliation: University of Manchester
name: Emma Stanmore
role: PRINCIPAL_INVESTIGATOR
References: