Protocol for a randomised controlled trial of a family strengthening program to prevent unhealthy weight gain among 5 to 11-year-old children from at-risk families : the Strong Families Trial

Background: Obesity is an increasing health concern in Australia among adult and child populations alike and is often associated with other serious comorbidities. While the rise in the prevalence of childhood obesity has plateaued in high-income countries, it continues to increase among children from disadvantaged and culturally diverse backgrounds. The family environment of disadvantaged populations may increase the risk of childhood obesity through unhealthy eating and lifestyle practices. The Strong Families Trial aims to assess the effectiveness of a mixed behavioural and lifestyle intervention for parents and carers of at-risk populations, i.e. families from culturally diverse and disadvantaged backgrounds, in preventing unhealthy weight gain among children aged 5 to 11 years. Methods: Eight hundred families from low socio-economic areas in Greater Western Sydney, NSW, and Melbourne, VIC, will be recruited and randomised into a lifestyle intervention or control group. The intervention comprises 90-minute weekly sessions for 6 weeks (plus two-booster sessions) of an integrated, evidence-based, parenting and lifestyle program that accounts for the influences of family functioning. Primary (anthropometric data) and secondary (family functioning, feeding related parenting, physical activity, consumption of healthy foods, health literacy, family and household costs) outcome measures will be assessed at baseline, immediately following the intervention, and 12 months post-intervention. Discussion: This study will elucidate methods for engaging socially disadvantaged and culturally diverse groups in parenting programs concerned with child weight status. Trial Registration: This study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619001019190). Registered 16 July 2019

A collaborative network trial to evaluate the effectiveness of implementation strategies to maximize adoption of a school-based healthy lunchbox program: a study protocol

IntroductionAn important impediment to the large-scale adoption of evidence-based school nutrition interventions is the lack of evidence on effective strategies to implement them. This paper describes the protocol for a “Collaborative Network Trial” to support the simultaneous testing of different strategies undertaken by New South Wales Local Health Districts to facilitate the adoption of an effective school-based healthy lunchbox program (‘SWAP IT’). The primary objective of this study is to assess the effectiveness of different implementation strategies to increase school adoption of the SWAP across New South Wales Local Health Districts.MethodsWithin a Master Protocol framework, a collaborative network trial will be undertaken. Independent randomized controlled trials to test implementation strategies to increase school adoption of SWAP IT within primary schools in 10 different New South Wales Local Health Districts will occur. Schools will be randomly allocated to either the intervention or control condition. Schools allocated to the intervention group will receive a combination of implementation strategies. Across the 10 participating Local Health Districts, six broad strategies were developed and combinations of these strategies will be executed over a 6 month period. In six districts an active comparison group (containing one or more implementation strategies) was selected. The primary outcome of the trial will be adoption of SWAP IT, assessed via electronic registration records captured automatically following online school registration to the program. The primary outcome will be assessed using logistic regression analyses for each trial. Individual participant data component network meta-analysis, under a Bayesian framework, will be used to explore strategy-covariate interactions; to model additive main effects (separate effects for each component of an implementation strategy); two way interactions (synergistic/antagonistic effects of components), and full interactions.DiscussionThe study will provide rigorous evidence of the effects of a variety of implementation strategies, employed in different contexts, on the adoption of a school-based healthy lunchbox program at scale. Importantly, it will also provide evidence as to whether health service-centered, collaborative research models can rapidly generate new knowledge and yield health service improvements.Clinical trial registrationThis trial is registered prospectively with the Australian New Zealand Clinical Trials Registry (ACTRN12623000558628)

A collaborative network trial to evaluate the effectiveness of implementation strategies to maximize adoption of a school-based healthy lunchbox program: a study protocol

Introduction: An important impediment to the large-scale adoption of evidence-based school nutrition interventions is the lack of evidence on effective strategies to implement them. This paper describes the protocol for a “Collaborative Network Trial” to support the simultaneous testing of different strategies undertaken by New South Wales Local Health Districts to facilitate the adoption of an effective school-based healthy lunchbox program (‘SWAP IT’). The primary objective of this study is to assess the effectiveness of different implementation strategies to increase school adoption of the SWAP across New South Wales Local Health Districts. Methods: Within a Master Protocol framework, a collaborative network trial will be undertaken. Independent randomized controlled trials to test implementation strategies to increase school adoption of SWAP IT within primary schools in 10 different New South Wales Local Health Districts will occur. Schools will be randomly allocated to either the intervention or control condition. Schools allocated to the intervention group will receive a combination of implementation strategies. Across the 10 participating Local Health Districts, six broad strategies were developed and combinations of these strategies will be executed over a 6 month period. In six districts an active comparison group (containing one or more implementation strategies) was selected. The primary outcome of the trial will be adoption of SWAP IT, assessed via electronic registration records captured automatically following online school registration to the program. The primary outcome will be assessed using logistic regression analyses for each trial. Individual participant data component network meta-analysis, under a Bayesian framework, will be used to explore strategy-covariate interactions; to model additive main effects (separate effects for each component of an implementation strategy); two way interactions (synergistic/antagonistic effects of components), and full interactions. Discussion: The study will provide rigorous evidence of the effects of a variety of implementation strategies, employed in different contexts, on the adoption of a school-based healthy lunchbox program at scale. Importantly, it will also provide evidence as to whether health service-centered, collaborative research models can rapidly generate new knowledge and yield health service improvements. Clinical trial registration: This trial is registered prospectively with the Australian New Zealand Clinical Trials Registry (ACTRN12623000558628)