MalnutritionNCT05943366
Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults
A study testing Keep-on-Keep-Up Nutrition (KOKU-Nut) in people with Malnutrition and Healthy Aging, run by Chloe French at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Healthy Aging, Dehydration
- What is being tested?
- Keep-on-Keep-Up Nutrition (KOKU-Nut)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Unable to communicate in English
- Have a known cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults: a Mixed-methods Study
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.
Read more
Objectives:
- Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial.
- 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
Read the 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.
- Conditions
- Malnutrition, Healthy Aging, Dehydration
- Being tested
- Keep-on-Keep-Up Nutrition (KOKU-Nut)
- Keywords
- feasibility, malnutrition, dehydration, digital health
- Medical subject headings
- Malnutrition, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Recruitment rates
Cumulative recruitment against target rate each month
Measured: 6 months
Retention rates
Calculated as the number of participants who completed the study divided by the number of participants randomised
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, 12 weeks
Change in BMI
Body weight [kg] and height [m] to calculate body mass index (BMI)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks
Adverse events
Number of adverse events that occurred as a result of participation in the study
Measured: From recruitment until study end (approximately 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start25 Mar 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chloe French
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chloe French, University of Manchester
- Investigators
- Emma Stanmore, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943366
- Sponsor's protocol ID
- 17372
- Status last verified
- May 2024
- First submitted
- 31 May 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38687981
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults: a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT05943366
- Acronym / sponsor ID
- 17372
- Conditions
- Malnutrition, Healthy Aging, Dehydration
- Keywords
- feasibility, malnutrition, dehydration, digital health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chloe FrenchUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| KOKU-Nut | Experimental | Device: 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to communicate in English
- Have a known cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keep-on-Keep-Up Nutrition (KOKU-Nut)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. | Device | KOKU-Nut |
Primary outcome
Self-reported use of KOKU
Time frame: 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
Recruitment rates
Time frame: 6 months
Cumulative recruitment against target rate each month
Retention rates
Time frame: 12 weeks
Calculated as the number of participants who completed the study divided by the number of participants randomised
Acceptability of the intervention and study design
Time frame: 12-16 weeks
This will be assessed qualitatively through semi-structured one-to-one interviews with a subset of participants
Acceptability of the intervention
Time frame: 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
Usability of the intervention
Time frame: 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.
12 secondary outcomes
Change in dietary intake
Time frame: Baseline, 12 weeks
Risk of malnutrition
Time frame: Baseline, 12 weeks
Risk of malnutrition
Time frame: Baseline, 12 weeks
Change in physical function
Time frame: Baseline, 12 weeks
Change in physical function
Time frame: Baseline, 12 weeks
Change in health related quality of life
Time frame: Baseline, 12 weeks
Change in health related quality of life
Time frame: Baseline, 12 weeks
Change in BMI
Time frame: Baseline, 12 weeks
Participants socio-demographic characteristics
Time frame: Baseline
Change in mood
Time frame: Baseline, 12 weeks
Change in frailty status
Time frame: Baseline, 12 weeks
Adverse events
Time frame: From recruitment until study end (approximately 14 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 38687981French 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.
- Individual participant dataSharing planned: No
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Stanmore principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keep-on-Keep-Up Nutrition (KOKU-Nut) in people with Malnutrition and Healthy Aging, run by Chloe French at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloe French (07581770599, chloe.french@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported use of KOKU (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.