Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001019190
Ethics application status
Approved
Date submitted
27/05/2019
Date registered
16/07/2019
Date last updated
16/07/2019
Date data sharing statement initially provided
16/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Strong Families Trial: Randomised controlled trial of a family strengthening program to prevent unhealthy weight gain among 5- to 11-year old children from at risk families.
Scientific title
The Strong Families Trial: Randomised controlled trial of a family strengthening program to prevent unhealthy weight gain among 5- to 11-year old children from at risk families.
Secondary ID [1] 298184 0
APP1138403
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unhealthy weight gain 312767 0
childhood obesity 312982 0
Condition category
Condition code
Public Health 311263 311263 0 0
Health promotion/education
Diet and Nutrition 311488 311488 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Behavioural parenting and lifestyle (BPL) intervention comprising of an 8 x 2 hour weekly group sessions (plus 2 boosters at 3 months follow-up).

This is consistent with the NSW Go4Fun® program, participants in the behavioural parenting and lifestyle (BPL) arm will receive 8 x 2 hour weekly group sessions (plus 2 boosters at 3 months), incorporating the parenting and healthy lifestyle components trialled in our pilot. There will be 2 booster sessions which will occur between the end of the trial and follow-up measurements. Based on our pilot data, sessions will be delivered using audio-visual presentations, facilitator-led small group discussions, mini case studies, practical and hands on activities, and supermarket tours catering for parents’ range of literacies. These delivery modes emphasise that socially situated learning is key to effective delivery of health promotion messages. Groups of 10–12 parents/carers will participate in sessions in community settings, with experienced bilingual group facilitators. Participants will receive take-home materials for secondary carers. Given that 37–56% of the population in our target areas are migrants speaking mainly Arabic, Vietnamese, Chinese and Hindi/Punjab, the BPL modules will be delivered in each of these languages in addition to English, thus addressing language barriers, cultural dimensions and beliefs related to obesity and its risk factors. Homogeneity is neither possible nor desirable; external validity is more important.

Below is an outline of weekly content;

Developing child confidence & social skills: Positive attention/praise, rewarding positive behaviours, setting clear communication strategies, giving clear directions, peer relations and friendship; and displaying empathy
Improving family relationships and communication: Parent-child relationship, communicating feelings, family rules/limit setting, effective discipline, positive family time and family meetings; and improving children’s communication through role modelling e.g. listening, negotiation, and decision making.
Managing family stress for a healthy family: How to reduce parenting stress through balancing work and family and priority setting, family mediation and problem solving, family rituals and chores; anger management; and managing pocket money.
Legal issues: Understanding government policies such as corporal punishment, child abuse and domestic violence, and drugs and alcohol; child’s health, safety, and wellbeing; and parents’ rights, duties, and responsibilities.
Healthy food habits: Ultimate Guide to Healthy Eating: understanding healthy eating; food groups, eating out vs. home cooking, portion sizes, healthy breakfasts, lunches and snacks; positive meal times; eating meals together as a family; and making healthy choices at home and away from home.
Making healthy meals: Healthy lunchboxes, recipe formulation, and cooking methods.
Smart Shopping: Food labels & marketing, smart choices, supervised supermarket tours.
Physical activity: Increasing incidental activity, integrating physical activity in family routine, parents as a role mode.

The BPL sessions will be faciliatated by counsellors for the parenting component, dieticians for the lifestyle component.
Intervention code [1] 314415 0
Lifestyle
Intervention code [2] 314575 0
Behaviour
Comparator / control treatment
Participants in the control arm will receive the usual care (self-directed access to and utilisation of parenting and child health services).
Control group
Active

Outcomes
Primary outcome [1] 320010 0
Primary outcome for this trial is BMI-z. BMI is a composite measure computed using child weight and height, and the z score values for BMI-for-age will be calculated using the WHO 2007 reference. Child's height and weight will be taken by the study staff using seca height measuring portable stadiometer and seca weight measuring scale respectively.
Timepoint [1] 320010 0
Anthropometric measurements will be taken at baseline, at the end of the trial and 12 months post trial.
Primary outcome [2] 320399 0
Cost per BMIz saved and incremental cost per quality-adjusted life-year gained.
The incremental cost per unit of clinically meaningful change in BMIz at 12 month's post intervention. The costs of resources used to implement the intervention will include training, staff and travel costs; family or household costs (resources related to food shopping and activities); and health care resources. These resources will be captured in three parts: 1) a questionnaire will be developed to capture the costs associated with the intervention; 2) a parent self-reported questionnaire will be administered to estimate and compare differences in family and household costs i.e. cost offsets (savings incurred as a result of the intervention from reductions in negative health outcomes) and costs consequent upon changes in behaviour of the child or parent (additional cost of parent making healthier meals or of buying new sports shoes so child can take up a sport); and 3) health care utilisation will be captured by obtaining individual level linked Medicare data. The study specific self-report questionnaire will be designed to collect cost data.
Timepoint [2] 320399 0
Incremental cost per quality-adjusted life-year gained at baseline, end of trial and 12 months after the trial.
Secondary outcome [1] 370207 0
The Secondary outcomes to be measured is Family Functioning using the Mc Masters Family Assessment Device
Timepoint [1] 370207 0
Secondary outcomes will be measured at baseline, end of trial and 12 months post trial.
Secondary outcome [2] 371471 0
General parenting is measured using the Parenting Dimensions Inventory- Short Version
Timepoint [2] 371471 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [3] 371473 0
Feeding related parenting will be measured using the Child Feeding Questionnaire
Timepoint [3] 371473 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [4] 371475 0
Child's Health quality of life (Qol) will be measured by the Child Health Utility 9D
Timepoint [4] 371475 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [5] 371477 0
Physical activity will be measured by the Short survey instruments for children’s physical activity (the Sax Institute for the NSW Ministry of Health)
Timepoint [5] 371477 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [6] 371478 0
Consumption of healthy foods will be measured by the Short survey instruments for children’s diet (the Sax Institute for the NSW Ministry of Health)
Timepoint [6] 371478 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [7] 372246 0
The Strengths and Difficulities Questionnaire will be used to measure socio-emotional problems
Timepoint [7] 372246 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [8] 372433 0
Parent's health knowledge will be measured using the Lifestyle & General Nutrition Knowledge Questionnaire
Timepoint [8] 372433 0
The outcome will be measured at baseline, end of trial and 12 months after the trial

Eligibility
Key inclusion criteria
1. Children aged between 5-11 years
2. Families who live in the Greater Western Suburbs of Sydney or Western or Northern suburbs of Melbourne Parents who live in the same household as their child
3. Are either Australian born or migrants (predominantly speaking Arabic, Vietnamese, Chinese and Hindi/Punjab)
4. Live in socio-economically disadvantaged areas (< 1000 Index of socio-economic disadvantage)
5. For households with two or more eligible children, we will include the child who had the most recent birthday.
Minimum age
5 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Self-reported mental or major physical illness or intellectual disability among parents/carers and/or their eligible offspring which would hamper effective participation and/or lead to inability to commit to the group process

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)
The intervention will be allocated at the postcode level i.e. we will randomise by postcode (as a cluster) where all eligible families within the postcode will be invited to participate and eligible family in control postcode continue as usual. This way we will work with our GIS expert to create buffer zones between postcodes. Postcodes with an Index of Relative Socio-economic Disadvantage <1000 will be selected on the basis of convenience. Postcodes (clusters) will be randomised to the trial intervention or control group using a minimisation approach to maximise the balance across baseline variables namely the estimated % of migrant populations and estimated prevalence of childhood obesity (Extracted from the Australian Bureau of Statistics). Cluster randomisation is required because the prevalence of poor family functioning is more likely to be clustered by geographic location and randomising a group of families in the same geographic postcode will allow the intervention to be delivered to families within the same social networks.

Allocation concealment: sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated using a computer software (i.e., Stata® software), to be done by a Statistician based at Monash University.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Intervention effects will be estimated based on the intention-to-treat principle with participants and postcodes analysed according to the trial arm they were randomised to. This approach captures the profile of the intervention group compared to the control group at individual and postcode level. It is particularly well suited to this type of evaluation, as it accounts for potential unobserved differences between the intervention and control groups that (if not accounted for) could bias results. The intervention effect will be estimated either using random/mixed effects linear regression models fitted by maximum likelihood estimation to allow for clustering variation (for continuous outcomes) or marginal logistic regression models with information sandwich (“robust”) estimates of standard error (for dichotomous outcomes). The models will evaluate the impact of the interventions over time by testing for an interaction between time and intervention group, adjusting for baseline characteristics and other variables (standard demographic variables such as age, sex, income, education, and SEIFA). Furthermore, mean and standard deviation or median and percentiles will be reported as summary statistics for numerical variables and percentage will be reported for categorical variables. Model assumptions will be checked and appropriate adjustments to the analysis made where necessary. All tests will be two- sided, and p-value <0.05 will be considered statistically significant”.
For the economic evaluation, cost-effectiveness will be estimated by comparing the direct costs and outcomes of BPL over usual care from a societal perspective at 12 months’ pots-trial. The within-trial analysis will adopt a micro-costing approach to calculate the costs of resources used to implement the intervention, including training, staff and travel costs; family or household costs (resources related to food shopping and activities); and health care resources.
These resources will be captured in three parts:
1) a questionnaire will be developed to capture the costs associated with the intervention;
2) a parent self-reported questionnaire will be administered to estimate and compare differences in family and household costs i.e. cost offsets (savings incurred as a result of the intervention from reductions in negative health outcomes) and costs consequent upon changes in behaviour of the child or parent (additional cost of parent making healthier meals or of buying new sports shoes so child can take up a sport);
3) health care utilisation will be captured by obtaining individual level linked Medicare data. This will include the government rebate expenditure and the out-of-pocket costs incurred by the family.
An incremental cost-effectiveness ratio (ICER) will be determined as the incremental cost per unit of clinically meaningful change in BMI (0.15BMIz) at 12 months’ post intervention, based on the primary outcome. Additional cost-effectiveness analyses will be conducted to determine incremental cost per quality adjusted life year (QALY) gained. Confidence intervals for the cost-effectiveness ratio and other one-way and two-way sensitivity analyses will be undertaken by varying significant parameters. The resource impact of the intervention on the household will be separately analysed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 302724 0
Government body
Name [1] 302724 0
National Health and Medical Research Council
Address [1] 302724 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 302724 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
65 Second Ave Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 303192 0
None
Name [1] 303192 0
Address [1] 303192 0
Country [1] 303192 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303329 0
Western Sydney University HERC
Ethics committee address [1] 303329 0
Werrington South Campus, Great Western Hwy, Werrington NSW 2747
Ethics committee country [1] 303329 0
Australia
Date submitted for ethics approval [1] 303329 0
Approval date [1] 303329 0
04/02/2019
Ethics approval number [1] 303329 0
H13033

Summary
Brief summary
Childhood obesity is a serious public health problem which tracks into adulthood. While some community-based prevention efforts have been shown to be successful, this is not the case for disadvantaged culturally diverse populations. Family dysfunction contributes to unhealthy eating and physical activity (PA) patterns among children and is common in disadvantaged populations. Family-focused programs that include positive support are effective in improving family dynamics and may be important in preventing childhood obesity in these populations. We will test whether a 8-week behavioural parenting and lifestyle (BPL) intervention (+2 boosters) for parents and carers of 5-11 year-old children is effective, sustainable and cost-effective in improving children’s anthropometric outcomes and family functioning. Measurements at baseline, end of intervention and 6 months post-intervention will assess changes in children’s weight, PA, and eating behaviours, as well as in family functioning and parent knowledge and behaviour. This family-centred intervention has the potential to reduce obesity through improved family functioning in relation to eating and physical activity patterns in children in disadvantaged and multi-ethnic populations. Cost-effective programs are urgently needed to reduce childhood obesity and its inequalities among ‘at-risk’ populations
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93298 0
Prof Andre M.N. Renzaho
Address 93298 0
Western Sydney University, Second Ave Kingswood, NSW 2747
Country 93298 0
Australia
Phone 93298 0
+61 2 47360107
Fax 93298 0
Email 93298 0
andre.renzaho@westernsydney.edu.au
Contact person for public queries
Name 93299 0
Mrs Jacqui Lentini
Address 93299 0
Western Sydney University, Second Ave Kingswood, NSW 2747
Country 93299 0
New Zealand
Phone 93299 0
+61 2 9852 5342
Fax 93299 0
Email 93299 0
j.lentini@westernsydney.edu.au
Contact person for scientific queries
Name 93300 0
Prof Andre Renzaho
Address 93300 0
Western Sydney University, Second Ave Kingswood, NSW 2747
Country 93300 0
Australia
Phone 93300 0
+61 2 47360107
Fax 93300 0
Email 93300 0
andre.renzaho@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3112 0
Study protocol
Citation [1] 3112 0
Link [1] 3112 0
Email [1] 3112 0
Other [1] 3112 0
Peer-reviewed publications
Attachment [1] 3112 0
Type [2] 3116 0
Ethical approval
Citation [2] 3116 0
Link [2] 3116 0
Email [2] 3116 0
Other [2] 3116 0
Ethical approval letter available on request by email to CI or contacting WSU ethics committee
Attachment [2] 3116 0
Summary results
No Results