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OpenTrials
Completed

NCT Number: NCT04780867

Psychological and Lifestyle Factors on Health Outcomes

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.

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Key information

Age range

16 year–33 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Infantry Training Centre

Catterick, North Yorkshire, DL9 3PS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Delayed vaccination

Behavioral

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 outcomes

  1. Antibody response to influenza vaccination - Aim 1

    Time frame: 1 month

  2. Physician diagnosed respiratory infection incidence - Aim 1

    Time frame: 6 months

  3. Physician diagnosed injury incidence - Aim 1

    Time frame: 6 months

  4. Antibody response to second hepatitis B vaccination - Aim 2

    Time frame: Routine group: 3 months; Delay group: 4 months

Secondary outcomes

  1. Antibody response to influenza vaccination

    Time frame: 4 months

  2. Antibody response to first hepatitis B vaccination

    Time frame: Routine group: 1 months; Delay group: 2 months

  3. C-reactive protein

    Time frame: Baseline, 1-day post vaccination and 1 month

  4. Gene expression profiling

    Time frame: Baseline and 1 month

  5. Epstein Barr Virus serostatus/antibody titre

    Time frame: Baseline and 1 month

  6. Cytomegalovirus serostatus/antibody titre

    Time frame: Baseline and 1 month

  7. Torque Teno Virus plasma DNA

    Time frame: Baseline and 1 month

  8. Interleukin-6

    Time frame: Baseline and 1 month

  9. Hair cortisol

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2021
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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