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

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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13308752
Enrollment
5230
Registered
2019-02-27
Start date
2021-01-14
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity among children Nutritional, Metabolic, Endocrine

Interventions

Current interventions, as of 17/06/2024: The intervention will be provided in 4 phases: (1) preconception, (2) pregnancy, (3) infancy [0-2 years], and (4) early childhood [3-5 years]. Each phase has
70%) will be followed until age 5 years and assessed for the primary and secondary outcomes. Pregnancy, infancy (age 2 years), and parental outcomes will also be assessed. In addition, among the 4444

Sponsors

Canadian Institutes of Health Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 17/06/2024: 1. Non-pregnant female 2. No child OR a child between 3-12 months postpartum 3. Planning a pregnancy in the next 3 years 4. Understands written English, 5. Resides in Canada ______ Previous inclusion criteria: 1. Non-pregnant female 2. No child OR one child between 3-12 months postpartum 3. Planning a pregnancy in the next 3 years 4. Understands written English, 5. Resides in Ontario or Alberta

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 17/06/2024: 1. Type 1 diabetes _____ Previous exclusion criteria: 1. Type 1 diabetes 2. Two or more children

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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 sche

Countries

Canada

Contacts

Public ContactAlvaro Ferreira
FerreiraAlv@smh.ca+1 416 864 6060 ext. 77057

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026