In endorsing the International Governance Framework in November 2020, the HeLTI Council recognized that HeLTI research teams should benefit from the efforts invested in the implementation of the trials, but also promote and maximize the use of data by the global research community to generate evidence that can be used to affect policy. To optimize the potential of collaborative research between studies, the teams made substantial human and financial investments to harmonize virtually all aspects of the initiative including study design; case report form (CRF) generation; standardized biobanking operating and monitoring procedures; standardized training and quality control procedures for key elements of the study interventions; and harmonization of key outcome measures, including anthropometric measures and indicators of early child development. Internationally accepted data and biobanking standards and norms were adopted for the collection, processing, handling and storage of data and biological specimens. Currently, and with the support of Maelstrom Research, teams have fully harmonized the collection and management of more than 1,900 core data variables and biospecimens from preconception through to early childhood (5 years). Common database structures using REDCap facilitate cross-country data analyses. Meta-data are published on: The Maelstrom Research website.
The trial interventions were also collaboratively designed to address common and harmonized domains across the four countries and intervention phases. In all sites, the integrated intervention package promotes behaviour change to optimize maternal preconception body weight, improve diet and physical activity during preconception and pregnancy, health during pregnancy, reduce perinatal depression, increase exclusive breastfeeding, and improve parental nurturing care. The design of the intervention is however adapted to the specific context and needs of each country, including the public health platforms that are nationally available for delivering the interventions (e.g. health system versus community based). Consortium-wide intervention fidelity protocols and retention strategies are being implemented.
The four HeLTI trials have similar overarching objectives: assess the effects of cumulative impact health promotion interventions on childhood growth and development, with childhood obesity/body composition at 5 years of age being the key outcomes. We have worked hard to harmonize exposures and outcomes across studies, paving the way for harmonized analyses. Data will become available sequentially as follow-up for each phase is completed. The analysis of trial specific intermediate outcomes will be conducted sequentially as follow-up concludes for each phase, followed by harmonized analyses. A key goal will be to determine if, across settings, the study interventions shift sentinel health related behaviours indicators (diet, physical activity, mental health status) toward healthier maternal and infant profiles. This section will outline the challenges and strategies for the analysis plan with the goal of minimizing bias, promoting interdisciplinary collaboration, and optimizing the impact of the study finding on health policy.
Presentation: SOP Harmonization