Psychological and Lifestyle Factors on Health Outcomes

Not Applicable

Completed

• Conditions: Psychological; Respiratory Tract Infections; Stress; Immune Health; Vaccination; Injury
• Interventions: Behavioral: Delayed vaccination

• Registration Number: NCT04780867
• Lead Sponsor: Liverpool John Moores University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-19
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1188

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delay vaccination (Experimental)	Delayed vaccination	-

Primary Outcome Measures

Name	Time	Method
Antibody response to second hepatitis B vaccination - Aim 2	Routine group: 3 months; Delay group: 4 months
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Infantry Training Centre; 🇬🇧 Catterick, North Yorkshire, United Kingdom