Introduction: The Healthy Life Trajectories Initiative (HeLTI) is a collaboration between Canada, China, India, South Africa and WHO to develop international randomized controlled trials that will implement and test context-specific community-based approaches to prevent overweight and obesity in children – an escalating problem globally – and to improve health of women across preconception, pregnancy and first five years of their child’s life. To facilitate data sharing and co-analysis across the four low, middle and high incomes countries, one of the objectives of HeLTI is to prospectively harmonize the information that will be collected.
Methods: Prior to the recruitment of participants, lists of core variables to be collected across countries for mothers, fathers, and children are generated through monthly consensus workshops. Once the list of core variables is defined, questionnaires allowing collection of the variables are created and, when possible, standard questionnaires or devices are adopted. The harmonization process is guided by the approach developed by Maelstrom Research and have been supported by over 20 data managers and content experts from all collaborating countries.
Results: Core variables will be defined for ten time points (one preconception, two during pregnancy, one at delivery and six from birth to 5 years old). Currently, the work is completed for the first six time points. The exposures and outcomes of interest selected span 17 domains of information (e.g., socio-demographic characteristics, diseases, physical measures) for a total of 1,046 variables. Most variables created relate to the lifestyle and behaviours (n=426) and psychological measures and assessment (n=149) domains.
Conclusion: Prospectively harmonizing clinical trials with different ethnic and cultural specificities is challenging, but feasible. This collaborative approach will enable comparative analysis of interventions, and assessment of the impact of different biological mechanisms and biological-environmental interactions. Such information should facilitate global policy development to benefit maternal and child health.
Stephanie Atkinson– Professor, McMaster University
Catherine Birken– Professor, University of Toronto
Cindy-Lee Dennis– Women’s Health Research Chair, Li Ka Shing Knowledge Institute, St. Michael's Hospital; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto
William Fraser– Professor, Université de Sherbrooke
Isabel Fortier– Associate professor, Research Institute of the McGill University Health Centre