Psychological and Lifestyle Factors on Health Outcomes

Study Overview
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Brief Summary
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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.

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

Conditions
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Psychological, Stress, Immune Health, Vaccination, Respiratory Tract Infections, Injury

Intervention / Treatment
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* Behavioral: Delayed vaccination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 16-33 years enrolled in phase one British Army training Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For aim 1, an observational design will be used to examine 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. For aim 2, the recruited cohort will be divided into two 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine vaccination (Control)<br> | |
| Experimental: Delay vaccination (Experimental)<br> | Behavioral: Delayed vaccination<br>* First 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to influenza vaccination - Aim 1 |  | 1 month | 
| Physician diagnosed respiratory infection incidence - Aim 1 |  | 6 months | 
| Physician diagnosed injury incidence - Aim 1 |  | 6 months | 
| Antibody response to second hepatitis B vaccination - Aim 2 |  | Routine group: 3 months; Delay group: 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to influenza vaccination |  | 4 months | 
| Antibody response to first hepatitis B vaccination |  | Routine group: 1 months; Delay group: 2 months | 
| C-reactive protein |  | Baseline, 1-day post vaccination and 1 month | 
| Gene expression profiling |  | Baseline and 1 month | 
| Epstein Barr Virus serostatus/antibody titre |  | Baseline and 1 month | 
| Cytomegalovirus serostatus/antibody titre |  | Baseline and 1 month | 
| Torque Teno Virus plasma DNA |  | Baseline and 1 month | 
| Interleukin-6 |  | Baseline and 1 month | 
| Hair cortisol |  | Baseline |