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NCT Number: NCT06389084

Parents Together: Supporting Parents to Promote Healthy Behaviours in Children

The Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle behaviours, help build strong family relationships, and promote child development and mental health.

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Key information

Conditions

Child Eating Behaviours Child Nutrition Early Child Development Parenting

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michaels Hospital Pediatric Outpatient Clinic, Toronto, Ontario, Canada

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About this study

This study will determine whether an intervention combining group-based parenting skills training and public health nurse coaching calls with a focus on healthy eating behaviours and nutrition, activity and sleep, compared to regular health care will lead to improved eating behaviours, movement behaviours, health and mental health in children aged 2-5 years and their caregivers.

Healthy children will be identified through primary care practices participating in The Applied Reearch Group for Kids (TARGet Kids!). Families who participate in this study will be randomly assigned to one of the two study groups that will run for 6-months:

Group A: Receive 8 weeks of group parenting education sessions and up to 4 public health nurse coaching calls. Group B: Receive regular health care.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Child enrolled in the The Applied Reearch Group for Kids (TARGet Kids!) cohort study Family is able to participate in English

Exclusion criteria

Children with a sibling already enrolled in the study Children with severe developmental delay or disability

Treatment and study plan

Parents Together parenting course

Behavioral

parenting course and coaching calls

Primary outcomes

  1. Child eating behaviours

    Time frame: 6 months post-randomization

    Child Eating Behaviour Questionnaire (CEBQ)

Secondary outcomes

  1. Dietary intake and food environment

    Time frame: 6 months post-randomization

    Parent reported measures of dietary intake, and food environment (based on the Canadian Community Health Survey)

  2. Nutritional risk

    Time frame: 6 months post-randomization

    Nutrition Screeening Tool for Every Preschooler (NutriSTEP)

  3. Physical Activity, Sedentary Time, Sleep Duration

    Time frame: 6 months post-randomization

    Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey)

  4. Physical activity

    Time frame: 6 months post-randomization

    Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey)

  5. Social and emotional development

    Time frame: 6 months post-randomization

    Strengths and Difficulty Questionnaire (SDQ)

  6. Child development

    Time frame: 6 months post-randomization

    Ages and Stages Questionnaire-3 (ASQ-3)

  7. Family psychosocial health

    Time frame: 6 months post-randomization

    Parenting Stress Index (PSI) and Patient Health Questionnaire (PHQ-9)

  8. Parenting

    Time frame: 6 months post-randomization

    Parenting Scale

  9. Parenting sense of competence

    Time frame: 6 months post-randomization

    Parenting Sense of Competency Scale-Revised (PSOC-R

  10. sociodemographic, maternal and child characteristics

    Time frame: 6 months post-randomization

    parent self-reported income, maternal education, ethnicity, immigration status, and marital status, questions about parents health, exposures during pregnancy, family medical history (based on the Canadian Community Health Survey)

  11. zBMI

    Time frame: 6 months post-randomization

    Measure the difference in age and sex-standardized BMI z-score (zBMI) using child height and weight

  12. Waist circumference

    Time frame: 6 months post-randomization

    Measure waist circumference using a tape measure

  13. Blood pressure

    Time frame: 6 months post-randomization

    Measurement of diastolic and systolic blood pressure in children

    Measurement of diastolic and systolic blood pressure in children

    Measurement of diastolic and systolic blood pressure in children

    Measurement of diastolic and systolic blood pressure in children

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Birken, MD, MSc

CONTACT

[email protected]

416-813-7654 ext. 301544

Michelle Mitchell

CONTACT

[email protected]

416-525-5417

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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