Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000017325
Ethics application status
Approved
Date submitted
10/01/2008
Date registered
14/01/2008
Date last updated
2/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing resilience and physical activity for heart health
Scientific title
Increasing psychosocial resilience and physical activity for heart health: a randomised trial of the READY (REsilience and Activity every DaY) program.
Universal Trial Number (UTN)
Trial acronym
READY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological well being, cardiovascular health 2700 0
Condition category
Condition code
Cardiovascular 2818 2818 0 0
Coronary heart disease
Mental Health 2820 2820 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an 11 x 2 hour session group program, with structured learning and practice activities. The program is based in cognitive behavioural theory, and strategies include psycho-education, stress management/inoculation, cognitive restructuring, goal setting, behaviour rehearsal, modeling, and self-monitoring. Home assignments will build on information presented in the sessions and include self-monitoring and skills practice. One 2 hour session will be on physical activity counselling
Intervention code [1] 2436 0
Behaviour
Intervention code [2] 2437 0
Lifestyle
Comparator / control treatment
The resilience training + physical activity counselling will be compared with resilience training without physical activity counselling
Control group
Active

Outcomes
Primary outcome [1] 3704 0
Psychosocial well being as measured by Ryff's Scales of Psychological Well-Being
Timepoint [1] 3704 0
measured at baseline, post-intervention (16 weeks), and follow-up (28 weeks)
Secondary outcome [1] 6248 0
Cardiovascular risk measured by waist circumference, resting blood pressure, cholesterol, blood glucose, and c reactive protein
Timepoint [1] 6248 0
measured at baseline, post-intervention (16 weeks), and follow-up (28 weeks)

Eligibility
Key inclusion criteria
1. Working in Education Queensland Townsville District
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Currently receiving psychiatric/psychological treatment (counseling or pharmacological) or have previously been diagnosed with a major psychiatric disorder (e.g. schizophrenia)
2. Currently have a medical condition which contraindicates physical activity participation as suggested by the 2005 Sports Medicine Australia screening guidelines (www.sma.org.au/pdfdocuments/new_pre_screening.pdf)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be volunteers recruited from staff from Education Queensland Townsville District, using information sessions and electronic communication. Individuals who are currently feeling distressed or depressed by work/family stress, life dissatisfaction or social isolation will be specifically invited to apply to participate. Respondents will be screened over the telephone by a research assistant (RA). The RA will provide eligible respondents with further details of the study, seek verbal consent, and schedule baseline assessment. Participants attending baseline assessment will be informed of the specific study requirements and asked to provide written consent before any data is collected. Participants completing baseline assessment will be randomly assigned to one of the three intervention conditions by the RA using a computer generated random number. Allocation is therefore concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
this is a cluster randomised trial, as participants are grouped by occupation and region.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 546 0
4810

Funding & Sponsors
Funding source category [1] 2961 0
Charities/Societies/Foundations
Name [1] 2961 0
Heart Foundation
Country [1] 2961 0
Australia
Primary sponsor type
University
Name
Dr Nicola Burton
Address
School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 2672 0
Individual
Name [1] 2672 0
Associate Professor Ken Pakenham
Address [1] 2672 0
Schoool of Psychology
University of Queensland
St Lucia QLD 4072
Country [1] 2672 0
Australia
Other collaborator category [1] 147 0
Individual
Name [1] 147 0
Associate Professor Ken Pakenham
Address [1] 147 0
School of Psychology
Uniersity of Queensland
St Lucia QLD 4072
Country [1] 147 0
Australia
Other collaborator category [2] 148 0
Individual
Name [2] 148 0
Professor Wendy Brown
Address [2] 148 0
School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country [2] 148 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4911 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 4911 0
University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 4911 0
Australia
Date submitted for ethics approval [1] 4911 0
Approval date [1] 4911 0
05/05/2007
Ethics approval number [1] 4911 0
2007000303

Summary
Brief summary
Depression and poor social support are significant risk factors for coronary heart disease (CHD), and acute life-event stressors can trigger coronary events. People experiencing such psychosocial difficulties are also more likely to be physically inactive, which is itself an independent risk factor for CHD. It is important therefore, to trial innovative heart health programs that promote both psychosocial functioning and physical activity. Resilience training programs offer a means by which to enhance resistance to stressors and improve psychosocial functioning, but do not directly address physical activity. In this study we propose to investigate (i) whether a resilience program designed for adults in the general population can improve psychosocial functioning and lower CHD risk indicators, and (ii) the added value of including a component to promote physical activity. If successful, the results from this trial will demonstrate an innovative means by which to prevent CHD in the general population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28287 0
Address 28287 0
Country 28287 0
Phone 28287 0
Fax 28287 0
Email 28287 0
Contact person for public queries
Name 11444 0
Nicola Burton
Address 11444 0
School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country 11444 0
Australia
Phone 11444 0
07 3365 6282
Fax 11444 0
07 3365 6877
Email 11444 0
[email protected]
Contact person for scientific queries
Name 2372 0
Nicola Burton
Address 2372 0
School of Human Movement Studies
University of Queensland
St Lucia QLD 4072
Country 2372 0
Australia
Phone 2372 0
07 3365 6282
Fax 2372 0
07 3365 6877
Email 2372 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.