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Psychological and Lifestyle Factors on Health Outcomes

Primary Purpose

Psychological, Stress, Immune Health

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Delayed vaccination

About this trial

This is an interventional basic science trial for Psychological

Eligibility Criteria

16 Years - 33 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

Infantry Training Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine vaccination (Control)

Delay vaccination (Experimental)

Arm Description

Outcomes

Primary Outcome Measures

Antibody response to influenza vaccination - Aim 1

Physician diagnosed respiratory infection incidence - Aim 1

Physician diagnosed injury incidence - Aim 1

Antibody response to second hepatitis B vaccination - Aim 2

Secondary Outcome Measures

Antibody response to influenza vaccination

Antibody response to first hepatitis B vaccination

C-reactive protein

Gene expression profiling

Epstein Barr Virus serostatus/antibody titre

Cytomegalovirus serostatus/antibody titre

Torque Teno Virus plasma DNA

Interleukin-6

Hair cortisol

Full Information

NCT ID

NCT04780867

First Posted

February 15, 2021

Last Updated

October 4, 2023

Sponsor

Liverpool John Moores University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04780867

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

October 19, 2020 (Actual)

Primary Completion Date

January 31, 2023 (Actual)

Study Completion Date

January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Liverpool John Moores University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Routine vaccination (Control)

Arm Type

No Intervention

Arm Title

Delay vaccination (Experimental)

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Delayed vaccination

Intervention Description

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.

Primary Outcome Measure Information:

Title

Antibody response to influenza vaccination - Aim 1

Time Frame

1 month

Title

Physician diagnosed respiratory infection incidence - Aim 1

Time Frame

6 months

Title

Physician diagnosed injury incidence - Aim 1

Time Frame

6 months

Title

Antibody response to second hepatitis B vaccination - Aim 2

Time Frame

Routine group: 3 months; Delay group: 4 months

Secondary Outcome Measure Information:

Title

Antibody response to influenza vaccination

Time Frame

4 months

Title

Antibody response to first hepatitis B vaccination

Time Frame

Routine group: 1 months; Delay group: 2 months

Title

C-reactive protein

Time Frame

Baseline, 1-day post vaccination and 1 month

Title

Gene expression profiling

Time Frame

Baseline and 1 month

Title

Epstein Barr Virus serostatus/antibody titre

Time Frame

Baseline and 1 month

Title

Cytomegalovirus serostatus/antibody titre

Time Frame

Baseline and 1 month

Title

Torque Teno Virus plasma DNA

Time Frame

Baseline and 1 month

Title

Interleukin-6

Time Frame

Baseline and 1 month

Title

Hair cortisol

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

33 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged 16-33 years enrolled in phase one British Army training Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil P Walsh, PHD

Organizational Affiliation

Liverpool John Moores University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Infantry Training Centre

City

Catterick

State/Province

North Yorkshire

ZIP/Postal Code

DL9 3PS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

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Psychological and Lifestyle Factors on Health Outcomes

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