Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001019190
Ethics application status
Approved
Date submitted
27/05/2019
Date registered
16/07/2019
Date last updated
27/04/2023
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
The face-to-face behavioural parenting and lifestyle (BPL) intervention will comprise of 6 x 90 min weekly group sessions (plus 2 x 45 min boosters at 3 months follow-up), incorporating the parenting and healthy lifestyle components trialled in our pilot. The 2 booster sessions will occur 3 months after completing the 6 intervention sessions.

The Booster sessions are a refresher of the Health Lifestyles modules (Booster Session 1) and the Parenting modules (Booster Session 2). The sessions will revise and solidify an understanding of all key messages and provide an opportunity for facilitated group discussions among participants. The sessions include a 20-minute presentation providing a summary of the key messages, along with a 25-minute Q&A to address some of the participants’ experiences and reflections in implementing the learnings.

Based on our pilot data, sessions will be delivered using audio-visual presentations, facilitator-led small group discussions, mini case studies and practical activities catering for parents’ range of literacy. These delivery modes emphasise that socially situated learning is key to effective delivery of health promotion messages. Groups of 6-8 parents/carers will participate in face-to-face sessions, 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, Hindi and Punjabi, 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 the weekly content:

Module 1: Building Healthy Habits - Building strong and healthy families, choosing water as a drink, getting active each day, switching off screens, getting enough sleep & healthy sleep habits.
Module 2: Healthy Eating Every Day - Understanding healthy eating, developing healthy eating habits, the importance of breakfast, healthy lunch & snack habits.
Module 3: Making Healthy Choices - Smart food swaps, healthier cooking methods, healthier choices away from home, understanding food labels, smart supermarket choices.
Module 4: Building Strong Families - Becoming a parent, the essential components of a strong family, understanding childhood development.
Module 5: Praise, Rewards, Rules & Consequences - Promoting positive behaviour, setting family rules, responding to children's behaviour, using consequences effectively.
Module 6: Improving Communication & Managing Emotions - Improving family communication, the importance of understanding emotions, helping children to deal with big emotions, reducing stress, sharing the load.

Booster A: Healthy Lifestyles
Booster B: Parenting

The BPL sessions will be facilitated by counsellors, psychologists or social workers for the parenting component and dietitians or nutritionists 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 General Parenting Questionnaire which measures general parenting behaviours/practices and constructs (sense of competence/efficacy). The Parenting Dimensions Inventory- Short version has been replaced by the General Parenting Questionnaire which measures general parenting behaviours/practices and constructs (sense of competence/efficacy).
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] 371478 0
Consumption of healthy foods will be measured by items from the Child Component NSW Population Health Survey 2007-2008, National Health Survey 2017-18 and Short survey instruments for children’s diet (the Sax Institute for the NSW Ministry of Health)
Timepoint [5] 371478 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [6] 372246 0
The Strengths and Difficulities Questionnaire will be used to measure socio-emotional problems
Timepoint [6] 372246 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [7] 372433 0
Parent's health knowledge will be measured using the Lifestyle & General Nutrition Knowledge Questionnaire
Timepoint [7] 372433 0
The outcome will be measured at baseline, end of trial and 12 months after the trial
Secondary outcome [8] 409292 0
Parent-reported participation in sports and other physical activity, measured using 1 item from the NSW Population Survey 2019.
Timepoint [8] 409292 0
The outcome will be measured at baseline, end of trial and 12 months after the intervention.
Secondary outcome [9] 409293 0
Child adherence to physical activity guidelines will be assessed using a composite measure of parent-reported accumulated moderate to vigorous physical activity (MVAP) of at least 60 minutes per day in 2 reference periods (past 7 days and a typical week).
Timepoint [9] 409293 0
The outcome will be measured at baseline, end of trial and 12 months after the intervention.
Secondary outcome [10] 409294 0
Leisure-time sedentary behaviours of children versus current guidelines for children will be assessed using parent-reported time spent in sedentary recreational screen time (i.e. television, seated electronic games and electronic device use other than for school work) in a typical week. It will be a composite measure using 1 item from the Sax Institute Short survey instruments for children's diet and physical activity, and 1 item from the Youth Risk Behaviour Surveillance System.
Timepoint [10] 409294 0
The outcome will be measured at baseline, end of trial and 12 months after the intervention.

Eligibility
Key inclusion criteria
1. Children aged between 5-11 years.
2. Families who live in the Greater Western Suburbs of Sydney.
3. Parents/carers who live in the same household as their child.
4. Are either Australian born or migrants (predominantly speaking Arabic, Hindi and Punjabi).
5. Live in socio-economically disadvantaged areas (< 1000 Index of socio-economic disadvantage).
6. 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
Sex
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. Contamination will be monitored through the contamination scale in our questionnaire and will be adjusted for during analysis. 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
Recruiting
Date of first participant enrolment
Anticipated
24/01/2022
Actual
23/02/2022
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
800
Accrual to date
65
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302724 0
Government body
Name [1] 302724 0
National Health and Medical Research Council
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 HREC
Ethics committee address [1] 303329 0
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93298 0
Prof Andre M.N. Renzaho
Address 93298 0
Translational Health Research Institute; School of Medicine
Western Sydney University
David Pilgrim Avenue, Campbelltown NSW 2560
Building 3; Office CA 3.1.17 Campbelltown Campus
Country 93298 0
Australia
Phone 93298 0
+61 2 4620 3506
Fax 93298 0
Email 93298 0
[email protected]
Contact person for public queries
Name 93299 0
Sanya Maniktala
Address 93299 0
Translational Health Research Institute; School of Medicine
Western Sydney University
David Pilgrim Avenue, Campbelltown NSW 2560
Building 3; Office CA 3.G.04 Campbelltown Campus
Country 93299 0
Australia
Phone 93299 0
+61 2 4620 3287
Fax 93299 0
Email 93299 0
[email protected]
Contact person for scientific queries
Name 93300 0
Andre Renzaho
Address 93300 0
Translational Health Research Institute; School of Medicine
Western Sydney University
David Pilgrim Avenue, Campbelltown NSW 2560
Building 3; Office CA 3.1.17 Campbelltown Campus
Country 93300 0
Australia
Phone 93300 0
+61 2 4620 3506
Fax 93300 0
Email 93300 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3112Study protocol    Peer-reviewed publications
3116Ethical approval    Ethical approval letter available on request by em... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInterventions for improving health literacy in migrants.2023https://dx.doi.org/10.1002/14651858.CD013303.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.