Protocol for a randomised trial evaluating a preconception-early childhood telephone-based intervention with tailored e-health resources for women and their partners to optimise growth and development among children in Canada: a Healthy Life Trajectory Initiative (HeLTI Canada)
Cindy‐Lee Dennis, Flavia Marini, Jennifer Abbass‐Dick, Stephanie A. Atkinson, Jon Barrett, Rhonda C. Bell, Anick Bérard, Howard Berger, Hilary K. Brown, Evelyn Constantin, Deborah Da Costa, Andrea Feller, Astrid Guttmann, Magdalena Janus, K.S. Joseph, Peter Jüni, Sarah Kimmins, Nicole Letourneau, Patricia Li, Stephen J. Lye, Jonathon L. Maguire, Stephen G. Matthews, David Millar, Dragana Misita, Kellie E. Murphy, Anne Monique Nuyt, Deborah L. O’Connor, Rulan S. Parekh, Andrew D. Paterson, Martine Puts, Joel G. Ray, Paul Roumeliotis, Stephen W. Scherer, Daniel Sellen, Sonia Semenic, Prakesh S. Shah, Graeme N. Smith, Robyn Stremler, Péter Szatmári, Deanna Telnner, Kevin E. Thorpe, Mark S. Tremblay, Simone N. Vigod, Mark Walker, Catherine S. Birken
Abstract
INTRODUCTION: The 'Developmental Origins of Health and Disease' hypothesis suggests that a healthy trajectory of growth and development in pregnancy and early childhood is necessary for optimal health, development and lifetime well-being. The purpose of this paper is to present the protocol for a randomised controlled trial evaluating a preconception-early childhood telephone-based intervention with tailored e-health resources for women and their partners to optimise growth and development among children in Canada: a Healthy Life Trajectory Initiative (HeLTI Canada). The primary objective of HeLTI Canada is to determine whether a 4-phase 'preconception to early childhood' lifecourse intervention can reduce the rate of child overweight and obesity. Secondary objectives include improved child: (1) growth trajectories; (2) cardiometabolic risk factors; (3) health behaviours, including nutrition, physical activity, sedentary behaviour and sleep; and (4) development and school readiness at age 5 years. METHOD AND ANALYSIS: A randomised controlled multicentre trial will be conducted in two of Canada's highly populous provinces-Alberta and Ontario-with 786 nulliparous (15%) and 4444 primiparous (85%) women, their partners and, when possible, the first 'sibling child.' The intervention is telephone-based collaborative care delivered by experienced public health nurses trained in healthy conversation skills that includes detailed risk assessments, individualised structured management plans, scheduled follow-up calls, and access to a web-based app with individualised, evidence-based resources. An 'index child' conceived after randomisation will be followed until age 5 years and assessed for the primary and secondary outcomes. Pregnancy, infancy (age 2 years) and parental outcomes across time will also be assessed. ETHICS AND DISSEMINATION: The study has received approval from Clinical Trials Ontario (CTO 1776). The findings will be published in peer-reviewed journals and disseminated to policymakers at local, national and international agencies. Findings will also be shared with study participants and their communities. TRIAL REGISTRATION NUMBER: ISRCTN13308752; Pre-results.