Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults

NCT05943366 | Recruiting

• 1 other identifier: 17372
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial.
2. 2.Adherence to the intervention, motivations, barriers and facilitators of engaging with KOKU-Nut

Conditions

Malnutrition; Healthy Aging; Dehydration

Keywords

feasibility; malnutrition; dehydration; digital health

Outcome Measures

Primary Outcomes (6)

• 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

  12 weeks

• Recruitment rates

  Cumulative recruitment against target rate each month

  6 months

• Retention rates

  Calculated as the number of participants who completed the study divided by the number of participants randomised

  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

  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

  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.

  12 weeks

Secondary Outcomes (12)

• Change in dietary intake

  Baseline, 12 weeks

• Risk of malnutrition

  Baseline, 12 weeks

• Risk of malnutrition

  Baseline, 12 weeks

• Change in physical function

  Baseline, 12 weeks

• Change in physical function

  Baseline, 12 weeks

Study Arms (2)

KOKU-Nut

EXPERIMENTAL

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)

Usual care

NO INTERVENTION

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.

Interventions

Keep-on-Keep-Up Nutrition (KOKU-Nut) DEVICE

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.

KOKU-Nut

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chloe French: lead

Study Sites (1)

Manchester

Manchester, United Kingdom

RECRUITING

Related Publications (1)

• French C, Burden S, Stanmore E. Digital Intervention (Keep-On-Keep-Up Nutrition) to Improve Nutrition in Older Adults: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 30;13:e50922. doi: 10.2196/50922.

  PMID: 38687981 DERIVED

MeSH Terms

Conditions

Malnutrition; Dehydration

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma Stanmore

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe French

CONTACT

07581770599; chloe.french@manchester.ac.uk

Sorrel Burden

CONTACT

3067856; sorrel.burden@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the intervention, participants and researchers will be unblinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 13, 2023
• Study Start: March 25, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)