Clinical Trials Directory

Trials / Completed

CompletedNCT04780867

Psychological and Lifestyle Factors on Health Outcomes

The Influence of Psychosocial and Lifestyle Factors on Immune Health and Injury Incidence During Phase One Training in UK Army Recruits

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,188 (actual)
Sponsor
Liverpool John Moores University · Academic / Other
Sex
All
Age
16 Years – 33 Years
Healthy volunteers
Accepted

Summary

Psychosocial and lifestyle factors in Army recruits likely contribute to increased susceptibility to infection and injury during basic Army training. The primary aim of this study is to assess the influence of psychosocial and lifestyle factors at the start of basic Army training on immune health (e.g. respiratory infection and antibody response to influenza vaccination) and injury during training, in an observational design. A secondary aim is to establish whether changes in psychosocial and lifestyle factors during training impact immune health (e.g. response to hepatitis B vaccination). Using an interventional design, participants will be randomly allocated into two experimental groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDelayed vaccinationFirst and second hepatitis B vaccinations will be delayed by 1 month in the interventional group to establish whether changes in psychosocial and lifestyle factors during training impact immune health.

Timeline

Start date
2020-10-19
Primary completion
2023-01-31
Completion
2023-01-31
First posted
2021-03-04
Last updated
2023-10-05

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04780867. Inclusion in this directory is not an endorsement.