Well-Being, PsychologicalNCT06042452
Use of Personalized Recommendations, Through Genetic and Lifestyle Data, to Improve Healthcare Staff Wellbeing
A study testing Genetic in people with Well-Being, Psychological, run by FitnessGenes Ltd..
Trial summary
With the NHS under increasing pressure and strain, the health and wellbeing of staff is an important area to prioritize, to help reduce staff stress levels and increase retention of staff. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Genetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Mar 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health care staff within the NHS (including both clinical and administrative)
- Able to proficiently read English (reports are only produced in English)
Who cannot join
- Unable to proficiently read English
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploring the Utility and Effectiveness of Personalised Insights and Recommendations, Using Genetic and Lifestyle Data, to Improve Employee Health and Wellbeing
With the NHS under increasing pressure and strain, the health and wellbeing of staff is an important area to prioritize, to help reduce staff stress levels and increase retention of staff. This study will look to explore how efficacious personalised insights and recommendations are, based on genetic and lifestyle information, at improving the health and wellbeing of NHS employees. It will also explore how sustainable these recommendations are for long-term change. Recruitment of NHS staff as participants will take place across multiple NHS trusts including Bradford Teaching Hospital NHS Trust and Sandwell and West Birmingham NHS Trust.
Following consent to partake in the trial, participants will be asked to complete a pre-trial questionnaire which will explore health and wellbeing interests and motivations, perceptions of genetic testing, and a baseline measure of mental and physical wellbeing using a standardised and validated questionnaire (5-item World Health Organisation Well-being Index (WHO-5)). This, and all further questionnaires, will be completed online.
Read more
Participants will undertake a DNA test provided by FitnessGenes, free of charge. This test will require participants to provide a saliva sample via a spit test. This sample will then be analysed at an ISO-accredited laboratory and results provided back to the participant within 2-3 weeks. While awaiting the results, participants will have access to lifestyle traits calculated using questionnaire data collected when creating a FitnessGenes account.
Once their genetic data is added to a participant's FitnessGenes accounts, they will be asked to spend two weeks exploring this information. A questionnaire will then be completed to reassess participant's wellbeing measures and any changes in their perceptions of DNA testing. At this stage, some semi-structured interviews may be conducted, to those who consent to this, to gain further insight.
A 3-month follow up will be completed to assess whether the platform has had any long-lasting impacts on participants' health and wellbeing.
Read the detailed description
This will be a 6-week long study to explore the impact of FitnessGenes' platform, with a follow-up after 3 months. NHS staff from multiple NHS trusts will be recruited to partake in the study.
Following consent to partake in the trial, participants will be asked to complete a pre-trial questionnaire which will explore health and wellbeing interests and motivations, alongside taking a baseline measure of mental and physical wellbeing using the 5-item World Health Organization Well-being Index (WHO-5) which has been clinically validated. This, and all further questionnaires, will be completed online.
Participants will undertake a DNA test provided by FitnessGenes, free of charge. This test will require participants to provide a saliva sample via a spit test. This sample will then be analysed at an ISO-accredited laboratory and results provided back to the participant within 2-3 weeks. Test result data is stored in an encrypted format and saliva samples are anonymized using unique barcodes printed on the collection tubes, which do not contain any Personal Information. User identity data (email, name, address, contact info etc.) is kept in a separate database to user personal data (demographic, biometric, lifestyle, genetic etc.). This means all personal data is already kept in an anonymised form.
Once their genetic data is added to a participant's FitnessGenes account, they will be asked to spend a week exploring this upgraded information. A feedback questionnaire will be completed, 3 weeks after they have received their results, to assess participant's experiences of the platform and their results. At this stage, some semi-structured interviews may be conducted, to those who consent to this, to gain further insight.
A 3-month follow up, after the baseline measures were taken, will be completed to assess whether the platform has had any long-lasting impacts on participants' health and wellbeing. This follow up will be completed via a short online questionnaire.
The primary aim of the study is to assess changes in subjects' well-being, as evaluated by the 5-item World Health Organisation Well-being Index (WHO-5).
The investigators will adopt a repeated measures analysis, collecting raw WHO-5 scores from the same subjects at three discrete time points: baseline (i.e. before genetic analysis), 3 weeks after receiving genetic results and at 3 months after baseline. The investigators will also assess the internal consistency of the WHO-5 by performing a Cronbach's alpha test at the three time points.
To assess changes in well-being, raw WHO-5 scores (ranging from 0 to 25) will be multiplied by 4 and transformed into final scores of 0 - 100 for each subject. Descriptive statistics (mean and standard deviation) will be calculated for the 5 individual items of the WHO-5 and the final WHO-5 scores (0-100).
The main dependent variable to be evaluated will be the final WHO-5 Score (ranging from 0-100). The investigators will use repeated measures analysis to assess changes in mean final WHO-5 score across the three different time points.
Briefly, the investigators will assess the distributions of the WHO-5 scores and perform basic tests of normality (including Q-Q plot and performing a Shapiro-Wilkes test) and sphericity/equal variances (Mauchly's test). Depending on the distributions of this data, the investigators will select the appropriate statistical test to assess changes in mean final WHO-5 score.
Assuming normality and sphericity of data and no outliers, the investigators will perform a repeated measures (within-subjects) ANOVA to assess whether the mean final WHO-5 score is statistically significantly different across the three time points. Post-hoc tests will include paired T-tests to make pairwise comparisons in mean final WHO-5 score between the time points, with P-values adjusted using the Bonferroni multiple testing correction method. Depending on the demographic make-up of the subjects, the investigators may include other moderator variables (e.g. gender) to assess for interactions with time point.
If the assumptions behind these parametric tests are violated, a non-parametric alternative (e.g. Friedmans test) will be used to assess changes in mean WHO-5 score. All statistical analysis will be performed using R.
Repeated measures analysis will be used to evaluate the secondary outcomes related to user experience and perceptions of genetic testing.
- Conditions
- Well-Being, Psychological
- Being tested
- Genetic
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneticGenetic
A saliva sample test will be undertaken by all participants in order to analyze their DNA for personalizing their recommendations. The Global Screening Array (GSA) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Genetic | Experimental | Participants will have their DNA tested and this data alongside lifestyle data will personalize the information they receive Receives: Genetic: Genetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical and psychological well-being
5-Item World Health Organisation Well-being Index (WHO-5). This uses a Likert Scale from 0 ('At no time') to 5 ('All of the time').
A raw score of 0 (lowest well-being) to 25 (highest well-being) is possible on the WHO-5.
Measured: Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at a 3 month follow-up
Secondary outcomes (2)
Perceptions of DNA testing
A questionnaire using a scale from Strongly against to Strongly for.
Measured: Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at 3 month follow-up
How sustainable are the personalized recommendations
A questionnaire that will cover whether recommendations were followed (Yes/No), for how long (1-5 days, 1-2 weeks, 3-4 weeks, 1 month, > 2 months) and how easy participants found implementing the recommendations (scale from Very hard to very easy).
Measured: Measurements taken at 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startJan 2025 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FitnessGenes Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Grice, DPhil, Principal investigator, FitnessGenes Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042452
- Sponsor's protocol ID
- FG-NHS-Wellbeing
- Status last verified
- Feb 2024
- First submitted
- 7 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricciardi W, Boccia S. New challenges of public health: bringing the future of personalised healthcare into focus. Eur J Public Health. 2017 Oct 1;27(suppl_4):36-39. doi: 10.1093/eurpub/ckx164.
PubMed 29028243Sauerteig SO, Wijesuriya J, Tuck M, Barham-Brown H. Doctors' health and wellbeing: at the heart of the NHS's mission or still a secondary consideration? Int Rev Psychiatry. 2019 Nov-Dec;31(7-8):548-554. doi: 10.1080/09540261.2019.1586165. Epub 2019 May 14.
PubMed 31084440Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Ghasemi A, Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012 Spring;10(2):486-9. doi: 10.5812/ijem.3505. Epub 2012 Apr 20.
PubMed 23843808
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Utility and Effectiveness of Personalised Insights and Recommendations, Using Genetic and Lifestyle Data, to Improve Employee Health and Wellbeing
- ClinicalTrials.gov ID
- NCT06042452
- Acronym / sponsor ID
- FG-NHS-Wellbeing
- Conditions
- Well-Being, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- FitnessGenes Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Sep 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.
With the NHS under increasing pressure and strain, the health and wellbeing of staff is an important area to prioritize, to help reduce staff stress levels and increase retention of staff. This study will look to explore how efficacious personalised insights and recommendations are, based on genetic and lifestyle information, at improving the health and wellbeing of NHS employees. It will also explore how sustainable these recommendations are for long-term change. Recruitment of NHS staff as participants will take place across multiple NHS trusts including Bradford Teaching Hospital NHS Trust and Sandwell and West Birmingham NHS Trust.
Following consent to partake in the trial, participants will be asked to complete a pre-trial questionnaire which will explore health and wellbeing interests and motivations, perceptions of genetic testing, and a baseline measure of mental and physical wellbeing using a standardised and validated questionnaire (5-item World Health Organisation Well-being Index (WHO-5)). This, and all further questionnaires, will be completed online.
Participants will undertake a DNA test provided by FitnessGenes, free of charge. This test will require participants to provide a saliva sample via a spit test. This sample will then be analysed at an ISO-accredited laboratory and results provided back to the participant within 2-3 weeks. While awaiting the results, participants will have access to lifestyle traits calculated using questionnaire data collected when creating a FitnessGenes account.
Once their genetic data is added to a participant's FitnessGenes accounts, they will be asked to spend two weeks exploring this information. A questionnaire will then be completed to reassess participant's wellbeing measures and any changes in their perceptions of DNA testing. At this stage, some semi-structured interviews may be conducted, to those who consent to this, to gain further insight.
A 3-month follow up will be completed to assess whether the platform has had any long-lasting impacts on participants' health and wellbeing.
Detailed description
This will be a 6-week long study to explore the impact of FitnessGenes' platform, with a follow-up after 3 months. NHS staff from multiple NHS trusts will be recruited to partake in the study.
Following consent to partake in the trial, participants will be asked to complete a pre-trial questionnaire which will explore health and wellbeing interests and motivations, alongside taking a baseline measure of mental and physical wellbeing using the 5-item World Health Organization Well-being Index (WHO-5) which has been clinically validated. This, and all further questionnaires, will be completed online.
Participants will undertake a DNA test provided by FitnessGenes, free of charge. This test will require participants to provide a saliva sample via a spit test. This sample will then be analysed at an ISO-accredited laboratory and results provided back to the participant within 2-3 weeks. Test result data is stored in an encrypted format and saliva samples are anonymized using unique barcodes printed on the collection tubes, which do not contain any Personal Information. User identity data (email, name, address, contact info etc.) is kept in a separate database to user personal data (demographic, biometric, lifestyle, genetic etc.). This means all personal data is already kept in an anonymised form.
Once their genetic data is added to a participant's FitnessGenes account, they will be asked to spend a week exploring this upgraded information. A feedback questionnaire will be completed, 3 weeks after they have received their results, to assess participant's experiences of the platform and their results. At this stage, some semi-structured interviews may be conducted, to those who consent to this, to gain further insight.
A 3-month follow up, after the baseline measures were taken, will be completed to assess whether the platform has had any long-lasting impacts on participants' health and wellbeing. This follow up will be completed via a short online questionnaire.
The primary aim of the study is to assess changes in subjects' well-being, as evaluated by the 5-item World Health Organisation Well-being Index (WHO-5).
The investigators will adopt a repeated measures analysis, collecting raw WHO-5 scores from the same subjects at three discrete time points: baseline (i.e. before genetic analysis), 3 weeks after receiving genetic results and at 3 months after baseline. The investigators will also assess the internal consistency of the WHO-5 by performing a Cronbach's alpha test at the three time points.
To assess changes in well-being, raw WHO-5 scores (ranging from 0 to 25) will be multiplied by 4 and transformed into final scores of 0 - 100 for each subject. Descriptive statistics (mean and standard deviation) will be calculated for the 5 individual items of the WHO-5 and the final WHO-5 scores (0-100).
The main dependent variable to be evaluated will be the final WHO-5 Score (ranging from 0-100). The investigators will use repeated measures analysis to assess changes in mean final WHO-5 score across the three different time points.
Briefly, the investigators will assess the distributions of the WHO-5 scores and perform basic tests of normality (including Q-Q plot and performing a Shapiro-Wilkes test) and sphericity/equal variances (Mauchly's test). Depending on the distributions of this data, the investigators will select the appropriate statistical test to assess changes in mean final WHO-5 score.
Assuming normality and sphericity of data and no outliers, the investigators will perform a repeated measures (within-subjects) ANOVA to assess whether the mean final WHO-5 score is statistically significantly different across the three time points. Post-hoc tests will include paired T-tests to make pairwise comparisons in mean final WHO-5 score between the time points, with P-values adjusted using the Bonferroni multiple testing correction method. Depending on the demographic make-up of the subjects, the investigators may include other moderator variables (e.g. gender) to assess for interactions with time point.
If the assumptions behind these parametric tests are violated, a non-parametric alternative (e.g. Friedmans test) will be used to assess changes in mean WHO-5 score. All statistical analysis will be performed using R.
Repeated measures analysis will be used to evaluate the secondary outcomes related to user experience and perceptions of genetic testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genetic | Experimental | Genetic: GeneticParticipants will have their DNA tested and this data alongside lifestyle data will personalize the information they receive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Health care staff within the NHS (including both clinical and administrative)
- Able to proficiently read English (reports are only produced in English)
Key exclusion criteria (1 listed)
- Unable to proficiently read English
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 |
|---|---|---|
| GeneticA saliva sample test will be undertaken by all participants in order to analyze their DNA for personalizing their recommendations. The Global Screening Array (GSA) will be used. | Genetic | Genetic |
Primary outcome
Change in physical and psychological well-being
Time frame: Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at a 3 month follow-up
5-Item World Health Organisation Well-being Index (WHO-5). This uses a Likert Scale from 0 ('At no time') to 5 ('All of the time'). A raw score of 0 (lowest well-being) to 25 (highest well-being) is possible on the WHO-5.
2 secondary outcomes
Perceptions of DNA testing
Time frame: Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at 3 month follow-up
How sustainable are the personalized recommendations
Time frame: Measurements taken at 3 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 29028243Ricciardi W, Boccia S. New challenges of public health: bringing the future of personalised healthcare into focus. Eur J Public Health. 2017 Oct 1;27(suppl_4):36-39. doi: 10.1093/eurpub/ckx164.
- Background: PubMed 31084440Sauerteig SO, Wijesuriya J, Tuck M, Barham-Brown H. Doctors' health and wellbeing: at the heart of the NHS's mission or still a secondary consideration? Int Rev Psychiatry. 2019 Nov-Dec;31(7-8):548-554. doi: 10.1080/09540261.2019.1586165. Epub 2019 May 14.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 23843808Ghasemi A, Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012 Spring;10(2):486-9. doi: 10.5812/ijem.3505. Epub 2012 Apr 20.
- Advancing personalized care being a key focus in the NHS Long Term PlanLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Well-Being, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
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.
Stuart Grice, DPhil principal investigator
FitnessGenes Ltd.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic in people with Well-Being, Psychological, run by FitnessGenes Ltd..
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 2 inclusion and 1 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Geraldine M Campbell, MSc (01869255770, geraldine.campbell@fitnessgenes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical and psychological well-being (time frame: Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at a 3 month follow-up). 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 NCT06042452, which also lists 4 linked publications.
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 28 Feb 2024.