Viewing Study NCT05943366


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Study NCT ID: NCT05943366
Status: RECRUITING
Last Update Posted: 2024-05-09
First Post: 2023-05-31
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults
Sponsor: Chloe French
Organization:

Study Overview

Official Title: Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults: a Mixed-methods Study
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: