Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001033730
Ethics application status
Approved
Date submitted
12/09/2013
Date registered
17/09/2013
Date last updated
2/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A cross-cultural comparison of the impact of family health information on health behaviour.
Scientific title
A randomised controlled trial investigating the impact of provision of a family health history on participation in health promoting behaviours among three generation families with Anglo, Italian and Vietnamese cultural backgrounds.
Secondary ID [1] 283209 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Participation in health promoting behaviours 290071 0
Condition category
Condition code
Public Health 290452 290452 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating families will be randomly allocated to the intervention or control condition. Halfway through the trial, the Intervention group will receive an education booklet containing their own family health history pedigree with health history of breast cancer, colorectal cancer, heart disease and diabetes highlighted. Information for the family health history pedigree is provided by the parent generation in each family – at baseline, each enrolled parent is encouraged to talk with family members and then complete a questionnaire to identify their first and second degree relatives, their age (if living) and to indicate if each of these family members has ever received a diagnosis for heart disease, diabetes, breast cancer or colorectal cancer (and if so, the age at diagnosis). This information is entered into Progeny software program, which produces a pedigree diagram of listed family members, with any disease status highlighted. Intervention families receive this information three months after baseline, control families receive the information after they have completed the study.

The family is sent the booklet in the post and participants identify themselves as being at either average or above average risk for a chronic disease. They are followed up a few days' later by phone call to discuss the information sent. The booklet also contains information about familial and environmental risk factors, and screening and prevention strategies.

The time between baseline and follow-up is six months. Therefore, for intervention families, the time between baseline and intervention is three months, and the time between intervention and follow-up is three months.

At follow-up, intervention families are asked, via questionnaire, if they could determine their disease risk using the booklet and pedigree sent to them. They are also asked if they shared this information with any other family members, and if so, with whom they shared the information. In addition, following the trial, a subsample of 18 intervention families will be interviewed to determine efficacy of the health information booklet and pedigree to encourage change to more healthful behaviours.
Intervention code [1] 287935 0
Behaviour
Intervention code [2] 287954 0
Lifestyle
Comparator / control treatment
Families in the Control group do not receive the family health education package during the trial. They will receive the education booklet containing their own family health history pedigree upon completion of the trial.
Control group
Active

Outcomes
Primary outcome [1] 290479 0
Dietary choice
Timepoint [1] 290479 0
At baseline and again at follow-up (six months after baseline), all participants are asked to report (via questionnaire) frequency of fruit, vegetable, fast food and snack intake over the past 7 days.
Primary outcome [2] 290499 0
Physical activity
Timepoint [2] 290499 0
At baseline and again at follow-up (six months after baseline), all participants are asked to report (via questionnaire) the time they spent doing vigorous and moderate exercise, time spent walking and time spent sitting over the past 7 days.
Primary outcome [3] 290500 0
Intentions to engage in healthy lifestyle and eating behaviours
Timepoint [3] 290500 0
At baseline and again at follow-up (six months after baseline), all participants are invited to complete (via questionnaire) questions indicating their satisfaction of their own level of fruit & veg, and fibre consumption, physical activity level alcohol consumption and smoking, as well as their intention to increase fruit & veg, and fibre consumption, physical activity, and to decrease alcohol consumption nand smoking behaviour. For those behaviours that they intend to change, paticipants are also asked to indicate via likert scale, how confident they feel in achieving these intentions. In addition, at follow up, participants are asked if they have made any changes to these behaviours over the past 6 months.
Secondary outcome [1] 304594 0
Sharing of health-related information within the family
Timepoint [1] 304594 0
At follow-up (six months post baseline), all adult participants in the intervention group are asked to indicate with whom in their family and social network they shared the intervention materials.

Eligibility
Key inclusion criteria
1. Families with Anglo-Australian, Italian-Australian, or Vietnamese-Australian cultural identity.
2. At least five members of the family are required to participate, spanning 3 generations and including at least one parent and one child aged 10-18.
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families not meeting the inclusion criteria (stated above)

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created in Microsoft Excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
17/05/2012
Date of last participant enrolment
Anticipated
Actual
20/05/2013
Date of last data collection
Anticipated
Actual
23/01/2014
Sample size
Target
750
Accrual to date
Final
379
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287953 0
Government body
Name [1] 287953 0
Australian Research Council
Country [1] 287953 0
Australia
Funding source category [2] 287955 0
Charities/Societies/Foundations
Name [2] 287955 0
Cancer Council of South Australia
Country [2] 287955 0
Australia
Primary sponsor type
University
Name
Flinders University of South Australia
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 286676 0
None
Name [1] 286676 0
Address [1] 286676 0
Country [1] 286676 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289879 0
Social and Behavioural Research Ethics Committee
Ethics committee address [1] 289879 0
Ethics committee country [1] 289879 0
Australia
Date submitted for ethics approval [1] 289879 0
Approval date [1] 289879 0
26/02/2012
Ethics approval number [1] 289879 0
5514

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

Contacts
Principal investigator
Name 42918 0
Prof Carlene Wilson
Address 42918 0
Olivia Newton John Cancer Wellness Research Centre
Austin Health,
Studley Rd., HEIDELBERG
Victoria 3084
Country 42918 0
Australia
Phone 42918 0
+61 3 9496 9967
Fax 42918 0
Email 42918 0
[email protected]
Contact person for public queries
Name 42919 0
Carlene Wilson
Address 42919 0
Discipline of Public Health
Flinders University of South Australia
GPO Box 2100
Adelaide SA 5001
Country 42919 0
Australia
Phone 42919 0
+61 0439 442857
Fax 42919 0
Email 42919 0
[email protected]
Contact person for scientific queries
Name 42920 0
Carlene Wilson
Address 42920 0
Discipline of Public Health
Flinders University of South Australia
GPO Box 2100
Adelaide SA 5001
Country 42920 0
Australia
Phone 42920 0
+61 0439 442857
Fax 42920 0
Email 42920 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.