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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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
Intervention code [2] 287954 0
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

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.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Families not meeting the inclusion criteria (stated above)

Study design
Purpose of the study
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 287953 0
Government body
Name [1] 287953 0
Australian Research Council
Address [1] 287953 0
Australian Research Council
GPO Box 2702
Canberra ACT 2601
Country [1] 287953 0
Funding source category [2] 287955 0
Name [2] 287955 0
Cancer Council of South Australia
Address [2] 287955 0
202 Greenhill Road
Eastwood SA 5063
Country [2] 287955 0
Primary sponsor type
Flinders University of South Australia
GPO Box 2100
Adelaide SA 5001
Secondary sponsor category [1] 286676 0
Name [1] 286676 0
Address [1] 286676 0
Country [1] 286676 0

Ethics approval
Ethics application status
Ethics committee name [1] 289879 0
Social and Behavioural Research Ethics Committee
Ethics committee address [1] 289879 0
Flinders University of South Australia
GPO Box 2100
Adelaide SA 5001
Ethics committee country [1] 289879 0
Date submitted for ethics approval [1] 289879 0
Approval date [1] 289879 0
Ethics approval number [1] 289879 0

Brief summary
Adopting a healthy diet is an effective way to reduce overweight and obesity and associated diseases, including some cancers. Dietary habits are primarily established and maintained in family environments, with influence potentially disseminating across generations and across diverse types of family relationships, although these processes may differ between ethnic groups. Additionally, genetic and environmental risk factors for overweight and disease cluster in families, making them an important target for dietary-focused disease prevention. The study will test the effectiveness of provision of family health history infromation as a motivator for diet and lifestyle improvement. This study will also assess how influence processes within family networks can best be harnessed to promote healthy dietary behaviour, across some of Australia’s largest ethnic groups.
Trial website
Trial related presentations / publications
Rhodes, K., Chan, F., Prichard, I., Coveney, J., Ward, P. & Wilson, C. (2016). Intergenerational transmission of dietary behaviours: A qualitative study of Anglo-Australian, Chinese-Australian and Italian-Australian three generation families. Appetite, 103, 309-317. http://dx.doi.org/10.1016/j.appet.2016.04.036, (IF= 2.691) Q1

Hughes, D., Hutchinson, A., Prichard, I., Chapman, J., & Wilson, C. (2015). Challenges associated with recruiting multigenerational, multicultural families into a randomised controlled trial: Balancing feasibility with validity. Contemporary Clinical Trials, 43, 185-193 DOI:10.1016/j.cct.2015.06.004 (IF = 1.935) Q1

Sharp, G., Hutchinson, A.D., Prichard, I., & Wilson, C. (2013). Validity and reliability of the Food-Life Questionnaire. Short Form. Appetite, 70, 112-118. http://dx.doi.org/10.1016/j.appet.2013.07.001 (IF= 2.691) Q1

Wilson, C.J., de la Haye, K., Coveney, J., Hughes, D., Hutchinson, A., Miller, C., Prichard, I., Ward, P., and Koehly, L.M. (2016). Protocol for a randomized controlled trial testing the impact of feedback on familial risk of chronic diseases on family-level intentions to participate in preventive lifestyle behaviors.
BMC Public Health, 16, 965, Published 13th September 2016, doi: 10.1186/s12889-016-3623-7 (IF = 2.26) Q1
Public notes

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

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary