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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06389084
Other study ID # 179939
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source The Hospital for Sick Children
Contact Catherine Birken, MD, MSc
Phone 416-813-7654
Email catherine.birken@sickkids.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 128
Est. completion date December 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 5 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Parents Together parenting course
parenting course and coaching calls

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child eating behaviours Child Eating Behaviour Questionnaire (CEBQ) 6 months post-randomization
Secondary Dietary intake and food environment Parent reported measures of dietary intake, and food environment (based on the Canadian Community Health Survey) 6 months post-randomization
Secondary Nutritional risk Nutrition Screeening Tool for Every Preschooler (NutriSTEP) 6 months post-randomization
Secondary Physical Activity, Sedentary Time, Sleep Duration Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey) 6 months post-randomization
Secondary Physical activity Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey) 6 months post-randomization
Secondary Social and emotional development Strengths and Difficulty Questionnaire (SDQ) 6 months post-randomization
Secondary Child development Ages and Stages Questionnaire-3 (ASQ-3) 6 months post-randomization
Secondary Family psychosocial health Parenting Stress Index (PSI) and Patient Health Questionnaire (PHQ-9) 6 months post-randomization
Secondary Parenting Parenting Scale 6 months post-randomization
Secondary Parenting sense of competence Parenting Sense of Competency Scale-Revised (PSOC-R 6 months post-randomization
Secondary sociodemographic, maternal and child characteristics 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) 6 months post-randomization
Secondary zBMI Measure the difference in age and sex-standardized BMI z-score (zBMI) using child height and weight 6 months post-randomization
Secondary Waist circumference Measure waist circumference using a tape measure 6 months post-randomization
Secondary Blood pressure 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
6 months post-randomization
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