NCT06042452

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

September 7, 2023

Last Update Submit

February 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at a 3 month follow-up

Secondary Outcomes (2)

  • Perceptions of DNA testing

    Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at 3 month follow-up

  • How sustainable are the personalized recommendations

    Measurements taken at 3 month follow-up

Study Arms (1)

Genetic

EXPERIMENTAL

Participants will have their DNA tested and this data alongside lifestyle data will personalize the information they receive

Genetic: Genetic

Interventions

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.

Genetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health care staff within the NHS (including both clinical and administrative)
  • Able to proficiently read English (reports are only produced in English)

You may not qualify if:

  • Unable to proficiently read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 29028243BACKGROUND
  • Sauerteig 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.

    PMID: 31084440BACKGROUND
  • Topp 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.

    PMID: 25831962BACKGROUND
  • Ghasemi 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.

    PMID: 23843808BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Stuart Grice, DPhil

    FitnessGenes Ltd.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geraldine M Campbell, MSc

CONTACT

Samantha Decombel, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 18, 2023

Study Start

January 1, 2025

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share