Open Access Study protocol

Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial

Catherine B Lombard1*, Cheryce L Harrison1, Samantha L Kozica1, Sophia Zoungas1, Catherine Keating3 and Helena J Teede12

Author Affiliations

1 Monash Centre for Health Research and Implementation (MCHRI), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

2 Diabetes and Vascular Medicine Unit, Monash Health, Melbourne, Australia

3 Deakin Health Economics, Deakin University, Melbourne, Australia

For all author emails, please log on.

BMC Public Health 2014, 14:608  doi:10.1186/1471-2458-14-608

Published: 16 June 2014



To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities.


Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and nā€‰=ā€‰21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program.


Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally.

Trial registration

ANZ clinical trial registry ACTRN12612000115831. Date of registration 24/01/2012

Obesity; Prevention; Lifestyle; Women; Rural; Implementation; Translation; Population; RE-AIM