Stress Clinical Trial
Official title:
The Influence of Psychosocial and Lifestyle Factors on Immune Health and Injury Incidence During Phase One Training in UK Army Recruits
Verified date | April 2023 |
Source | Liverpool John Moores University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1188 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 33 Years |
Eligibility | Inclusion Criteria: Men and women aged 16-33 years enrolled in phase one British Army training Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Infantry Training Centre | Catterick | North Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Liverpool John Moores University | Loughborough University, Ministry of Defence, United Kingdom, University of California, Los Angeles, University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibody response to influenza vaccination - Aim 1 | 1 month | ||
Primary | Physician diagnosed respiratory infection incidence - Aim 1 | 6 months | ||
Primary | Physician diagnosed injury incidence - Aim 1 | 6 months | ||
Primary | Antibody response to second hepatitis B vaccination - Aim 2 | Routine group: 3 months; Delay group: 4 months | ||
Secondary | Antibody response to influenza vaccination | 4 months | ||
Secondary | Antibody response to first hepatitis B vaccination | Routine group: 1 months; Delay group: 2 months | ||
Secondary | C-reactive protein | Baseline, 1-day post vaccination and 1 month | ||
Secondary | Gene expression profiling | Baseline and 1 month | ||
Secondary | Epstein Barr Virus serostatus/antibody titre | Baseline and 1 month | ||
Secondary | Cytomegalovirus serostatus/antibody titre | Baseline and 1 month | ||
Secondary | Torque Teno Virus plasma DNA | Baseline and 1 month | ||
Secondary | Interleukin-6 | Baseline and 1 month | ||
Secondary | Hair cortisol | Baseline |
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