Psychological and Lifestyle Factors on Health Outcomes

Liverpool John Moores University

Status: Completed

Conditions: Immune Health; Vaccination; Psychological; Respiratory Tract Infections; Injury; Stress

Treatments: Behavioral: Delayed vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT04780867

1070/MODREC/20

Details and patient eligibility

About

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.

Enrollment: 1,188 patients

Sex: All

Ages: 16 to 33 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,188 participants in 2 patient groups

Routine vaccination (Control)

No Intervention group

Delay vaccination (Experimental)

Experimental group

Treatment:

Behavioral: Delayed vaccination