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)
Authors: Dennis Cindy-Lee , Marini Flavia , Dick Jennifer Abbass , Atkinson Stephanie , Barrett Jon , Bell Rhonda , Berard Anick , Berger Howard , Brown Hillary K , Constantin Evelyn , Da Costa Deborah , Feller Andrea , Guttmann Astrid , Janus Magdalena , Joseph K S , Jüni Peter , Kimmins Sarah , Letourneau Nicole , Li Patricia , Lye Stephen , Maguire Jonathon L , Matthews Stephen G , Millar David , Misita Dragana , Murphy Kellie , Nuyt Anne Monique , O"Connor Deborah L , Parekh Rulan Savita , Paterson Andrew , Puts Martine , Ray Joel , Roumeliotis Paul , Scherer Stephen , Sellen Daniel , Semenic Sonia , Shah Prakesh S , Smith Graeme N , Stremler Robyn , Szatmari Peter , Telnner Deanna , Thorpe Kevin , Tremblay Mark S , Vigod Simone , Walker Mark , Birken Catherine 
Published: February 2021

IntroductionThe ‘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 analysisA 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 disseminationThe 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 numberISRCTN13308752; Pre-results.