Psychological and Lifestyle Factors on Health Outcomes

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780867
• Other study ID #: 1070/MODREC/20
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2023
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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: -

Related Conditions & MeSH terms

• Immune Health
• Injury
• Psychological
• Respiratory Tract Infections
• Stress
• Vaccination

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Infantry Training Centre	Catterick	North Yorkshire

Sponsors (5)

Lead Sponsor	Collaborator
Liverpool John Moores University	Loughborough University, Ministry of Defence, United Kingdom, University of California, Los Angeles, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

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