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).

Affiliation

Dennis CL(1)(2), Marini F(2), Dick JA(3), Atkinson S(4), Barrett J(5)(6), Bell R(7), Berard A(8)(9), Berger H(2)(5), Brown HK(10)(11), Constantin E(12)(13), Da Costa D(13)(14), Feller A(15), Guttmann A(16)(17), Janus M(18), Joseph KS(19), Jüni P(2)(20), Kimmins S(21), Letourneau N(22), Li P(12), Lye S(23), Maguire JL(2)(24), Matthews SG(23)(25), Millar D(26), Misita D(7), Murphy K(5)(27), Nuyt AM(9)(12), O'Connor DL(17)(28), Parekh RS(17)(24), Paterson A(11)(17), Puts M(29), Ray J(2)(11)(16), Roumeliotis P(30), Scherer S(17)(31), Sellen D(11)(28), Semenic S(13)(32), Shah PS(24)(27), Smith GN(33), Stremler R(29)(17), Szatmari P(17)(34)(35), Telnner D(36), Thorpe K(11), Tremblay MS(37)(38), Vigod S(16)(35)(39), Walker M(40)(41), Birken C(17)(24).
Author information:
(1)Lawrence S. Bloomburg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada [Email]
(2)St Michael's Hospital, Toronto, Ontario, Canada.
(3)Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, Ontario, Canada.
(4)Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
(5)Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario, Canada.
(6)Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
(7)Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada.
(8)Faculty of Pharmacy, University of Montreal, Montreal, Québec, Canada.
(9)Saint Justine Hospital, Montreal, Québec, Canada.
(10)Department of Health & Society
(Scarborough Campus), University of Toronto, Toronto, Ontario, Canada.
(11)Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
(12)Department of Pediatrics, McGill University, Montreal, Québec, Canada.
(13)McGill University Health Centre, Montreal, Ontario, Canada.
(14)School of Physical and Occupational Therapy, McGill University, Montreal, Québec, Canada.
(15)Niagara Region Public Health, Thorold, Ontario, Canada.
(16)Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
(17)The Hospital for Sick Children, Toronto, Ontario, Canada.
(18)Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada.
(19)Department of Obstetrics and Gynecology, University of British Columbia, Vancouver, British Columbia, Canada.
(20)Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
(21)Department of Animal Science, McGill University, Montreal, Québec, Canada.
(22)Faculty of Nursing, University of Calgary, Calgary, Alberta, Canada.
(23)Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada.
(24)Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
(25)Department of Physiology, University of Toronto, Toronto, Ontario, Canada.
(26)Monarch Maternal and Newborn Health Centre, Ottawa, Ontario, Canada.
(27)Mount Sinai Hospital, Toronto, Ontario, Canada.
(28)Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.
(29)Lawrence S. Bloomburg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.
(30)Eastern Ontario Health Unit, Cornwall, Ontario, Canada.
(31)Department of Molecular Genetics, University of Toronto, Toronto, Ontario, Canada.
(32)Ingram School of Nursing, McGill University, Montreal, Québec, Canada.
(33)Department of Obstetrics and Gynecology, Queen's University, Kingston, Ontario, Canada.
(34)Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
(35)Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
(36)Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.
(37)Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
(38)Department of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.
(39)Women's College Hospital, Toronto, Ontario, Canada.
(40)Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, Ontario, Canada.
(41)The Ottawa Hospital, Ottawa, Ontario, Canada.

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.