Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04780867
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological and Lifestyle Factors on Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nFor 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody response to influenza vaccination - Aim 1', 'timeFrame': '1 month'}, {'measure': 'Physician diagnosed respiratory infection incidence - Aim 1', 'timeFrame': '6 months'}, {'measure': 'Physician diagnosed injury incidence - Aim 1', 'timeFrame': '6 months'}, {'measure': 'Antibody response to second hepatitis B vaccination - Aim 2', 'timeFrame': 'Routine group: 3 months; Delay group: 4 months'}], 'secondaryOutcomes': [{'measure': 'Antibody response to influenza vaccination', 'timeFrame': '4 months'}, {'measure': 'Antibody response to first hepatitis B vaccination', 'timeFrame': 'Routine group: 1 months; Delay group: 2 months'}, {'measure': 'C-reactive protein', 'timeFrame': 'Baseline, 1-day post vaccination and 1 month'}, {'measure': 'Gene expression profiling', 'timeFrame': 'Baseline and 1 month'}, {'measure': 'Epstein Barr Virus serostatus/antibody titre', 'timeFrame': 'Baseline and 1 month'}, {'measure': 'Cytomegalovirus serostatus/antibody titre', 'timeFrame': 'Baseline and 1 month'}, {'measure': 'Torque Teno Virus plasma DNA', 'timeFrame': 'Baseline and 1 month'}, {'measure': 'Interleukin-6', 'timeFrame': 'Baseline and 1 month'}, {'measure': 'Hair cortisol', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological', 'Stress', 'Immune Health', 'Vaccination', 'Respiratory Tract Infections', 'Injury']}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '33 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen and women aged 16-33 years enrolled in phase one British Army training\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04780867', 'briefTitle': 'Psychological and Lifestyle Factors on Health Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Liverpool John Moores University'}, 'officialTitle': 'The Influence of Psychosocial and Lifestyle Factors on Immune Health and Injury Incidence During Phase One Training in UK Army Recruits', 'orgStudyIdInfo': {'id': '1070/MODREC/20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine vaccination (Control)'}, {'type': 'EXPERIMENTAL', 'label': 'Delay vaccination (Experimental)', 'interventionNames': ['Behavioral: Delayed vaccination']}], 'interventions': [{'name': 'Delayed vaccination', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Delay vaccination (Experimental)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DL9 3PS', 'city': 'Catterick', 'state': 'North Yorkshire', 'country': 'United Kingdom', 'facility': 'Infantry Training Centre', 'geoPoint': {'lat': 54.37542, 'lon': -1.63328}}], 'overallOfficials': [{'name': 'Neil P Walsh, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liverpool John Moores University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool John Moores University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nottingham', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, {'name': 'Loughborough University', 'class': 'OTHER'}, {'name': 'Ministry of Defence, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}