Clinical trial NCT04780867: Psychological and Lifestyle Factors on Health Outcomes
Official title: The Influence of Psychosocial and Lifestyle Factors on Immune Health and Injury Incidence During Phase One Training in UK Army Recruits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological
Stress
Immune Health
Vaccination
Respiratory Tract Infections
Injury
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: University of California, Los Angeles
name: Loughborough University
name: Ministry of Defence, United Kingdom
First posted: 2021-03-04
Enrollment: 1188
Sex: ALL
Minimum age (years): 16
Maximum age (years): 33
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

Men and women aged 16-33 years enrolled in phase one British Army training

Exclusion Criteria:

-

Primary outcomes:
measure: Antibody response to influenza vaccination - Aim 1
timeFrame: 1 month
measure: Physician diagnosed respiratory infection incidence - Aim 1
timeFrame: 6 months
measure: Physician diagnosed injury incidence - Aim 1
timeFrame: 6 months
measure: Antibody response to second hepatitis B vaccination - Aim 2
timeFrame: Routine group: 3 months; Delay group: 4 months
Secondary outcomes:
measure: Antibody response to influenza vaccination
timeFrame: 4 months
measure: Antibody response to first hepatitis B vaccination
timeFrame: Routine group: 1 months; Delay group: 2 months
measure: C-reactive protein
timeFrame: Baseline, 1-day post vaccination and 1 month
measure: Gene expression profiling
timeFrame: Baseline and 1 month
measure: Epstein Barr Virus serostatus/antibody titre
timeFrame: Baseline and 1 month
measure: Cytomegalovirus serostatus/antibody titre
timeFrame: Baseline and 1 month
measure: Torque Teno Virus plasma DNA
timeFrame: Baseline and 1 month
measure: Interleukin-6
timeFrame: Baseline and 1 month
measure: Hair cortisol
timeFrame: Baseline
Other outcomes:
Locations:
city: Catterick
country: United Kingdom
facility: Infantry Training Centre
state: North Yorkshire
Study officials:
affiliation: Liverpool John Moores University
name: Neil P Walsh, PHD
role: PRINCIPAL_INVESTIGATOR
References: