Psychological and Lifestyle Factors on Health Outcomes

Sponsor

Liverpool John Moores University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04780867

Collaborator

University of Nottingham (Other), University of California, Los Angeles (Other), Loughborough University (Other), Ministry of Defence, United Kingdom (Other)

786

Enrollment

Location

Arms

22.4

Anticipated Duration (Months)

35.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Stress Immune Health Vaccination Respiratory Tract Infections Injury	Behavioral: Delayed vaccination	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

786 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 19, 2020

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 33 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Infantry Training Centre	Catterick	North Yorkshire	United Kingdom	DL9 3PS

Sponsors and Collaborators

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

Investigators

Principal Investigator: Neil P Walsh, PHD, Liverpool John Moores University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liverpool John Moores University

ClinicalTrials.gov Identifier:

NCT04780867

Other Study ID Numbers:

1070/MODREC/20

First Posted:

Mar 4, 2021

Last Update Posted:

Apr 21, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Tract Infections

Study Results

No Results Posted as of Apr 21, 2021