Preconception-early childhood telephone-based intervention to optimize growth and development among children in Canada: A Healthy Life Trajectory Initiative (HeLTI-Canada)

Child overweight and obesity rate (at age 5 years) measured as the proportion of children with BMI >85 percentile using the WHO growth reference ranges, by sex, at age 5 years. Height/length and weight will be measured using standardized instruments and procedures.

Child outcomes (all at age 5 years):
1.1 The reduction of the mean age and sex-adjusted BMI z-scores at age 5 as well as growth trajectories, as measured by BMI z scores from birth to age 5. BMI-z scores will be defined using the WHO growth standards, and reference ranges, as appropriate by age. Head circumference will be measured as part of the growth trajectory.
1.2 Cardiometabolic risk (CMR) will be measured as the sum of z-scores from waist circumference, systolic blood pressure, glucose, triglycerides, and (inverse) high-density lipoprotein (HDL). Individual measures will also be examined as continuous variables. Other measures including diastolic blood pressure, blood measures (total cholesterol, LDL, non-HDL, HbA1c, CRP, and insulin) will be collected.
1.3 Health Behaviours:
1.3.1 Dietary intake will be measured using the parent-reported Canadian adaptation of the automated self-administered 24-hour dietary assessment tool (ASA24-Canada).
1.3.2 Physical activity, screen time, and sleep will be measured using questions adapted from the Canadian Health Measures Survey and the 24-hour movement guidelines for children and youth.
1.4 Development and mental health: Cognitive development will be measured using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) and executive function using the Neuro-PSYchological Assessment NEPSY-II administered by psychometrists.
1.5 Behavioural development will be measured using the Strengths and Difficulties Questionnaire and the Child Behavioural Questionnaire (CBQ).
1.6 Emotional development will be measured using the parent-reported, Age-specific Ages and Stages Questionnaire Socio-emotional Scale (ASQ-SE).
1.7 School readiness will be measured using the Early Development Instrument (EDI).
1.8 Health care utilization will be collected using provincial administrative data (e.g. ICES in Ontario). This will include measurement of routine child outpatient health visits, including adherence to vaccination schedules as per provincial standards; and non-routine outpatient health visits, emergency department visits and unplanned hospital admissions (rate/year, specific diagnoses, and procedures).

Parental Outcomes.
2.1 Weight: Assessed by self-report for women and their partners during the preconception period (12 months and 36 months post-randomization), pregnancy (28 weeks gestation), and postpartum at 24, 36, 48 and 60 months. Overweight and obesity will be calculated using BMI >25 and >30 kg/m2 respectfully as cutoffs.
2.2 Waist circumferences will be assessed for women and their partners during the preconception period (12 months and 36 months post-randomization), pregnancy (28 weeks gestation), and postpartum at 24, 36, 48 and 60 months.
2.3 Mid-upper arm circumference will be assessed for mothers and their partners postpartum at 24, 36, 48 and 60 months.
2.4 Blood pressure and blood measures (e.g., total cholesterol, HDL, TRG, LDL, insulin, glucose, HbA1c, CBC, ferritin and folate) will be collected from mothers postpartum at 24, 36, 48 and 60 months.
2.5 Dietary intake will be measured using the Canadian Diet History Questionnaire II and assessed for women and their partners during the preconception period (12 months and 36 months), from mothers during pregnancy by 28 weeks gestation, and postpartum from mothers at 24 and 60 months and from mothers’ partners at 60 months.
2.6 Physical activity will be assessed by questions adapted from the Canadian Community Health Survey, Canadian Health Measures Survey from women and their partners during the preconception period at 12, 24 and 36 months post-randomization, from mothers and their partners during pregnancy by 28 weeks gestation, and from mothers and their partners postpartum at 12, 24 and 60 months.
2.7 Screen time will be assessed for women and their partners during the preconception period (12, 24 and 36 months post-randomization), during pregnancy (by 28 weeks gestation), and postpartum at 12, 24 and 60 months.
2.8 Parent sleep will be assessed by the Pittsburgh Sleep Quality Index (PSQI) during the preconception period (12, 24 and 36 months post-randomization), during pregnancy (by 28 weeks gestation), and postpartum at 2, 6, 12, 24, 36, 48 and 60 months.
2.9 Mental Health:
2.9.1 Depression symptoms will be measured by the:
2.9.1.1 Patient Health Questionnaire – 9 (PHQ-9) -- From women and their partners during the preconception period (12, 24 and 36 months post-randomization), during pregnancy (by 28 weeks gestation), and postpartum at 24, 36, and 60 months.
2.9.2.2 Edinburgh Postnatal Depression Scale (EPDS) from primiparous women and their partners during pregnancy (by 28 weeks gestation) and postpartum at 2, 6, and 12 months.
2.9.3 Anxiety will be measured by the GAD-7 and life stress by the Life Stressor Checklist-Revised (LSC-R) from women and their partners during the preconception period (12, 24 and 36 months post-randomization), pregnancy (by 28 weeks gestation), and postpartum (24 and 60 months).
2.9.4 Perceived stress will be measured using the Perceived Stress (PSS) questionnaire from women and their partners during pregnancy (by 28 weeks gestation).
2.9.5 Self-Efficacy will be measured using the GSE questionnaire from women and their partners during pregnancy (by 28 weeks gestation).
Relationship satisfaction with partner will be assessed by the Dyadic Adjustment Scale (DAS) from women and their partners during the preconception period (12, 24 and 36 months post-randomization), pregnancy (by 28 weeks gestation), and postpartum (6, 12, 24, 36, 48 and 60 months).
2.9.6 Social support will be measured from women and their partners during the preconception period (12 and 36 months post-randomization), pregnancy (by 28 weeks gestation), and postpartum (24 and 60 months).
2.9.7 Co-parenting will be determined by the Coparenting Relationship Scale, parenting style, including authoritarian and permissive parenting, by the Parenting Scale, parenting self-efficacy by the Parenting Sense of Competence Scale (PSOC) parenting stress by the Parenting Stress Index Short-Form (PSI-SF) from women and their partners during the preconception period (12 months post-randomization) and postpartum (6, 24, 36 and 60 months).


Infant/early child outcomes:
3.1 Height/length and weight from birth to age 5 years
3.2 Weight gain velocity in the first year
3.3 Percentage of children who cross their growth centile curve at age 0-4 years
3.4 Health Behaviours at age 0-4 years:
3.4.1 Breastfeeding will be assessed using WHO definitions
3.4.2 Nutritional risk by the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
3.4.3 Physical activity, screen time, and sleep by questions adapted from the Canadian Health Measures Survey and the 24-hour Movement Guidelines for Early Years (0-4)
3.5 Development and mental health at age 0-4 years:
3.5.1 Language development determined by the Infant Toddler Checklist (ITC)
3.5.2 Temperament by the Infant Behaviour Questionnaire(IBQ) for children ages 6-15 months, the Early Childhood Behavior Questionnaire (ECBQ) for children ages 18-36 months
3.5.3 Emotional development by the age-specific Ages and Stages Questionnaire Social Emotional scale (ASQ-SE), developmental delay by the Ages and Stages Questionnaire (ASQ-3)