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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parenting; Early Child Development; Child Nutrition; Child Eating Behaviours
• Intervention / Treatment: Behavioral: Parents Together parenting course

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Birken, MD, MSc; Phone Number: 301544 416-813-7654; Email: catherine.birken@sickkids.ca
• Study Contact Backup: Name: Michelle Mitchell; Phone Number: 416-525-5417; Email: michelle.mitchell@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/treatment; One or two caregivers of each enrolled child will attend an 8-week virtual parent/caregiver education program delivered by a Public Health Nurse. Additionally, the Public Health Nurse will deliver up to 4 individual coaching calls designed to address participant-identified goals related to the group content. The coaching calls will focus on helping to apply the messages and skills from the group sessions and making community connections.	Behavioral: Parents Together parenting course; parenting course and coaching calls
No Intervention: Control; Participants randomized to the control group receive regular health care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child eating behaviours	Child Eating Behaviour Questionnaire (CEBQ)	6 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Nutritional risk	Nutrition Screeening Tool for Every Preschooler (NutriSTEP)	6 months post-randomization
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
Physical activity	Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey)	6 months post-randomization
Social and emotional development	Strengths and Difficulty Questionnaire (SDQ)	6 months post-randomization
Child development	Ages and Stages Questionnaire-3 (ASQ-3)	6 months post-randomization
Family psychosocial health	Parenting Stress Index (PSI) and Patient Health Questionnaire (PHQ-9)	6 months post-randomization
Parenting	Parenting Scale	6 months post-randomization
Parenting sense of competence	Parenting Sense of Competency Scale-Revised (PSOC-R	6 months post-randomization
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
zBMI	Measure the difference in age and sex-standardized BMI z-score (zBMI) using child height and weight	6 months post-randomization
Waist circumference	Measure waist circumference using a tape measure	6 months post-randomization
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Catherine Birken, MD, MSc, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: parenting; child nutrition; early child development; child eating behaviours
• Other Study ID Numbers: 179939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No