Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001665224
Ethics application status
Approved
Date submitted
18/09/2018
Date registered
10/10/2018
Date last updated
4/07/2022
Date data sharing statement initially provided
2/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does omega-3 supplementation reduce aggressive behaviour in adult male prisoners?
Scientific title
Does Omega-3 Supplementation Attenuate Aggressive Behaviour in Adult Male Prisoners: A multi-centre randomised controlled trial of a Broadly Disseminable Strategy
Secondary ID [1] 296109 0
None
Universal Trial Number (UTN)
U1111-1220-6032
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Aggressive Behaviour 309688 0
Condition category
Condition code
Mental Health 308493 308493 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inmates will receive 5 capsules (omega-3 or placebo) on Mondays, Wednesdays and Fridays totalling 15 capsules per week. The active and placebo will be randomly assigned to Treatment A and Treatment B.
The algal DHA-O capsules are ~1 g with 509.2 mg/capsule DHA/EPA (i.e., DHA 324 mg/ capsule and EPA 185.3 mg/capsule), hence providing a daily dose of 1,091mg omega-3 (694mg DHA and 397mg EPA). The placebo capsules are a corn/soy oil blend which are identical in size and colour.
Duration of the intervention is 16 weeks.
Monitoring of adherence to the intervention will be by direct observation by the study personnel (the project officer) and for the active group, the change in the level of omega-3 levels in the blood will also be a measure of compliance
Intervention code [1] 312441 0
Treatment: Other
Comparator / control treatment
The placebo capsules are a corn/soy oil blend which are identical in size and colour to the active group.
Control group
Placebo

Outcomes
Primary outcome [1] 307468 0
Aggressive Behaviour as measured by the Inmate Behaviour Observation Scale (IBOS).
Timepoint [1] 307468 0
At baseline (prior to the commencement of intervention) and 16 weeks after the commencement of the intervention.
Primary outcome [2] 307469 0
Aggressive Behaviour as measured by the Aggression Questionnaire.
Timepoint [2] 307469 0
At baseline (prior to the commencement of intervention) and 16 weeks after the commencement of the intervention.
Secondary outcome [1] 351986 0
Attention Deficit Disorders Behaviour as measured by the Brown Attention Deficit Disorder Scales (BADDS) and the Conners Attention Deficit and Hyperactivity Disorder (ADHD) Scales
Timepoint [1] 351986 0
At baseline (prior to the commencement of intervention) and 16 weeks after the commencement of the intervention.
Secondary outcome [2] 351987 0
Depression and Anxiety as measured by the 21-item Depression, Anxiety and Stress Scale (DASS-21).
Timepoint [2] 351987 0
At baseline (prior to the commencement of intervention) and 16 weeks after the commencement of the intervention.
Secondary outcome [3] 351988 0
Impulsiveness as measured by the Barratt Impulsiveness Scale (BIS-Brief).
Timepoint [3] 351988 0
At baseline (prior to the commencement of intervention) and 16 weeks after the commencement of the intervention.
Secondary outcome [4] 351989 0
The composite measure of level of engagement in, and outcomes of, rehabilitation programs. as measured by the routinely collected data on program completion and concomitant attrition, as collected by the Managers of Offender Services and Programs within prisons.
Timepoint [4] 351989 0
At baseline (prior to the commencement of intervention) and 16 weeks after the commencement of the intervention.
Secondary outcome [5] 351990 0
Recidivism rates as assessed by data linkage to recidivism records held at the Head Offices from Corrective Services NSW Government and the Government of South Australia Department for Correctional Services.
Timepoint [5] 351990 0
at 2 years after their release date from the prison
Secondary outcome [6] 351991 0
Quality of Life will be measured using the validated SF-36 Quality of Life Questionnaire (adapted to suit inmates, which includes 3 questions on sleep).
Timepoint [6] 351991 0
At baseline (prior to the commencement of intervention) and 16 weeks after the commencement of the intervention.
Secondary outcome [7] 351992 0
Muscle Strength as assessed by hand grip strength using a dynamometer.
Timepoint [7] 351992 0
At baseline (prior to the commencement of intervention) and 16 weeks after the commencement of the intervention.

Eligibility
Key inclusion criteria
Inmate Behavioural Observation Scale (IBOS) of 1 or greater.
Blood omega-3 level of 6% or lower.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Inmate Behavioural Observation Scale (IBOS) of less than 1.
Inmates on any blood thinning medication.
Blood omega-3 level higher than 6%.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Participants will be block randomised USING PERMUTED BLOCKS (according to their IBOS, age and baseline omega-3 level) within each treatment centre to one of the 2 study arms. The randomisation will be performed by the research team's biostatistician using the RALLOC command in STATA V12 or higher (College Station TX).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total number of subjects to be enrolled in the trial is 600 from 6 centres with one or two cohorts per site as necessary. It is anticipated that 100 subjects will be recruited per site, however the larger sites may recruit more than 100 subjects and the smaller sites may recruit less than 100 subjects.
Our study is a randomised controlled trial powered to show a difference between treatment and placebo control of 25% in the proportion of participants experiencing a reduction in aggressive behaviour as measured by a change in the IBOS. Given the nature of prison populations, it is likely that there will be an effect of prison in the analysis and therefore a design effect accounting for the intra cluster correlation is incorporated in the sample size estimation with a conservatively estimated ICC of 0.03. Based on our pilot data we anticipate that attrition will likely be high (~40%) with the sample size for recruitment appropriately inflated to account for this. Overall, a total sample size of 600 (100 per prison) with 360 completing the study enables a difference of 25% to be detected with 80% power and an alpha level of 0.05.
In the simplest case this study is designed to determine the difference between groups as proportion of responders to the treatment allocation. This analysis will be performed using a Pearson's chi square analysis. In order to make full use of the data for the inmates who partially complete the study the IBOS scores will also be analysed using a form of generalised linear mixed model or generalised additive mixed models depending on the distribution of the IBOS scores. These models also allow for the correlated nature of repeated measures over time and the correlation between inmates from the same institution. Secondary measures will be analysed using linear mixed, or generalised linear mixed models again depending on the distributional form of the variable. These analyses will be conducted using STATA or R.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
COVID interrupted participant recruitment at all sites. And a mice plague interrupted recruitment at Wellington Correctional Centre.
Date of first participant enrolment
Anticipated
31/10/2018
Actual
16/04/2019
Date of last participant enrolment
Anticipated
24/12/2021
Actual
18/06/2021
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
600
Accrual to date
Final
314
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 24078 0
2541 - Nowra
Recruitment postcode(s) [2] 24081 0
2790 - Lithgow
Recruitment postcode(s) [3] 24082 0
2820 - Wellington
Recruitment postcode(s) [4] 24083 0
5085 - Northfield
Recruitment postcode(s) [5] 24084 0
5710 - Port Augusta
Recruitment postcode(s) [6] 28963 0
2325 - Cessnock

Funding & Sponsors
Funding source category [1] 300694 0
Government body
Name [1] 300694 0
National Health and Medical Research Council
Country [1] 300694 0
Australia
Funding source category [2] 300698 0
Commercial sector/Industry
Name [2] 300698 0
DSM Nutritional Products
Country [2] 300698 0
United States of America
Funding source category [3] 300699 0
Government body
Name [3] 300699 0
Corrective Services NSW
Country [3] 300699 0
Australia
Funding source category [4] 300700 0
Government body
Name [4] 300700 0
Department for Correctional Services SA
Country [4] 300700 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave
Wollongong
NSW 2522
Country
Australia
Secondary sponsor category [1] 300231 0
None
Name [1] 300231 0
Address [1] 300231 0
Country [1] 300231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301476 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 301476 0
Ethics committee country [1] 301476 0
Australia
Date submitted for ethics approval [1] 301476 0
04/04/2017
Approval date [1] 301476 0
26/06/2017
Ethics approval number [1] 301476 0
2017/163
Ethics committee name [2] 301479 0
Corrective Services NSW Ethics Committee
Ethics committee address [2] 301479 0
Ethics committee country [2] 301479 0
Australia
Date submitted for ethics approval [2] 301479 0
31/10/2017
Approval date [2] 301479 0
10/09/2018
Ethics approval number [2] 301479 0
D18.705098
Ethics committee name [3] 301480 0
NSW Justice Health & Forensic Mental Health Human Research Ethics Committee
Ethics committee address [3] 301480 0
Ethics committee country [3] 301480 0
Australia
Date submitted for ethics approval [3] 301480 0
25/05/2017
Approval date [3] 301480 0
Ethics approval number [3] 301480 0
G310-17
Ethics committee name [4] 301481 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [4] 301481 0
Ethics committee country [4] 301481 0
Australia
Date submitted for ethics approval [4] 301481 0
06/07/2017
Approval date [4] 301481 0
28/05/2018
Ethics approval number [4] 301481 0
1321/17
Ethics committee name [5] 301482 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (HREC)
Ethics committee address [5] 301482 0
Ethics committee country [5] 301482 0
Australia
Date submitted for ethics approval [5] 301482 0
31/08/2017
Approval date [5] 301482 0
04/12/2017
Ethics approval number [5] 301482 0
HREC/17/RAH/364 and CALHN Reference number: R20170901
Ethics committee name [6] 301483 0
Aboriginal Health Research Ethics Committee (AHREC)
Ethics committee address [6] 301483 0
Ethics committee country [6] 301483 0
Australia
Date submitted for ethics approval [6] 301483 0
13/06/2017
Approval date [6] 301483 0
Ethics approval number [6] 301483 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87146 0
Prof Barbara Meyer
Address 87146 0
School of Medicine
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Country 87146 0
Australia
Phone 87146 0
+61 (0)2 4221 3459
Fax 87146 0
Email 87146 0
[email protected]
Contact person for public queries
Name 87147 0
Barbara Meyer
Address 87147 0
School of Medicine
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Country 87147 0
Australia
Phone 87147 0
+61 (0)2 4221 3459
Fax 87147 0
Email 87147 0
[email protected]
Contact person for scientific queries
Name 87148 0
Barbara Meyer
Address 87148 0
School of Medicine
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Country 87148 0
Australia
Phone 87148 0
+61 (0)2 4221 3459
Fax 87148 0
Email 87148 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only.
When will data be available (start and end dates)?
Data will be available after all researchers involved in this trial have finished analysing and publishing the data. Immediately following the last publication from our research group. No end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal and case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Professor Barbara Meyer ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of omega-3 long chain polyunsaturated fatty acids on aggressive behaviour in adult male prisoners: a structured study protocol for a multi-centre, double-blind, randomised placebo-controlled trial and translation into policy and practice.2021https://dx.doi.org/10.1186/s13063-021-05252-2
N.B. These documents automatically identified may not have been verified by the study sponsor.