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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Stress; Immune Health; Psychological; Vaccination; Injury
• Intervention / Treatment: Behavioral: Delayed vaccination

• Study Type: Interventional
• Enrollment (Actual): 1188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason P Edwards, PHD; Phone Number: 07517424345; Email: j.p.edwards@ljmu.ac.uk

Study Locations

• United Kingdom
  • North Yorkshire
    • Catterick, North Yorkshire, United Kingdom, DL9 3PS
      • Infantry Training Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine vaccination (Control)
Experimental: Delay vaccination (Experimental)	Behavioral: Delayed vaccination; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Collaborators: University of California, Los Angeles; University of Nottingham; Loughborough University; Ministry of Defence, United Kingdom
• Investigators: Principal Investigator: Neil P Walsh, PHD, Liverpool John Moores University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 1070/MODREC/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No