Prospective harmonisation of four international randomised controlled trials in Canada, China, India and South Africa: the Healthy Life Trajectories Initiative.

ABSTRACT:

Objectives

The Healthy Life Trajectories Initiative (HeLTI) is an international multistudy consortium that supports the development and integration of four randomised controlled trials (RCTs) conducted in South Africa, India, China and Canada. HeLTI aims to evaluate interventions to improve the health and well-being of mothers and children, starting from preconception through pregnancy and early childhood until age 5 years. This paper describes the process by which we prospectively harmonised the participating studies and provides a descriptive analysis of the study-specific harmonisation potential.

Design

Prospective harmonisation of four international RCTs.

Methods

A list of core variables to be collected across ten waves of data collection was defined. Taking this

SUBMITTER: Bergeron J 

PROVIDER: S-EPMC11877250 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature