NCT06389084

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

April 24, 2024

Last Update Submit

December 13, 2024

Conditions

Keywords

child eating behaviourschild nutritionparentingearly child development

Outcome Measures

Primary Outcomes (1)

  • Child eating behaviours

    Child Eating Behaviour Questionnaire (CEBQ)

    6 months post-randomization

Secondary Outcomes (13)

  • Dietary intake and food environment

    6 months post-randomization

  • Nutritional risk

    6 months post-randomization

  • Physical Activity, Sedentary Time, Sleep Duration

    6 months post-randomization

  • Physical activity

    6 months post-randomization

  • Social and emotional development

    6 months post-randomization

  • +8 more secondary outcomes

Study Arms (2)

Intervention/treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants randomized to the control group receive regular health care.

Interventions

parenting course and coaching calls

Intervention/treatment

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Michaels Hospital Pediatric Outpatient Clinic

Toronto, Ontario, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Study Officials

  • Catherine Birken, MD, MSc

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Birken, MD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist, Staff Pediatrician

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 29, 2024

Study Start

June 1, 2024

Primary Completion

March 31, 2025

Study Completion

December 31, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations