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)
K S Joseph,
Peter Jüni,
Cindy-Lee Dennis,
Nicole Letourneau,
David Millar,
Astrid Guttmann,
Rhonda Bell,
Kellie Murphy,
Jon Barrett,
Anick Bérard,
Jonathon L Maguire,
Magdalena Janus,
Evelyn Constantin,
Patricia Li,
Howard Berger,
Anne Monique Nuyt,
Deborah Da Costa,
Flavia Marini,
Jennifer Abbass Dick,
Stephanie Atkinson,
Hillary K Brown,
Andrea Feller,
Sarah Kimmins,
Stephen Lye,
Stephen G Matthews,
Dragana Misita
Affiliations
K S Joseph
BC Children`s Hospital Research Institute, Vancouver, British Columbia, Canada
Peter Jüni
professor
Cindy-Lee Dennis
3 Lawrence S. Bloomburg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada
Nicole Letourneau
8 Faculty of Nursing, University of Calgary, Calgary, Alberta, Canada
David Millar
Cancer Center, Massachusetts General Hospital, Boston, Massachusetts, USA
Astrid Guttmann
Division of Paediatric Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada
Rhonda Bell
Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada
Kellie Murphy
2 Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada
Jon Barrett
Department of Obstetrics and Gynecology, McMaster University, Hamilton, ON, Canada
Anick Bérard
1 Research Center, CHU Sainte-Justine, Montreal, Quebec, Canada
Jonathon L Maguire
Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
Magdalena Janus
Offord Centre for Child Studies, Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada
Evelyn Constantin
Department of Pediatrics, McGill University, Montreal, Québec, Canada
Department of Health & Society (Scarborough Campus), University of Toronto, Toronto, Ontario, Canada
Andrea Feller
Niagara Region Public Health, Thorold, Ontario, Canada
Sarah Kimmins
Department of Animal Science, McGill University, Montreal, Québec, Canada
Stephen Lye
SAMRC Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg-Braamfontein, South Africa
Stephen G Matthews
Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada
Dragana Misita
Department of Agricultural, Food and Nutritional Sciences, University of Alberta, Edmonton, Alberta, Canada
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.
