Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

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.

Original publication

DOI

10.1136/bmjopen-2020-046311

Type

Journal article

Journal

BMJ Open

Publication Date

10/02/2021

Volume

11

Keywords

clinical trials, community child health, preventive medicine, public health, quality in health care, social medicine, Alberta, Child, Child, Preschool, Female, Growth and Development, Health Resources, Humans, Multicenter Studies as Topic, Ontario, Pregnancy, Randomized Controlled Trials as Topic, Telephone