Clinical trial NCT06389084: Parents Together: Supporting Parents to Promote Healthy Behaviours in Children
Official title: Parents Together: Supporting Parents to Promote Healthy Behaviours in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Eating Behaviours
Child Nutrition
Early Child Development
Parenting
Keywords: child eating behaviours
child nutrition
parenting
early child development
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child eating behaviours
timeFrame: 6 months post-randomization
Secondary outcomes:
measure: Dietary intake and food environment
timeFrame: 6 months post-randomization
measure: Nutritional risk
timeFrame: 6 months post-randomization
measure: Physical Activity, Sedentary Time, Sleep Duration
timeFrame: 6 months post-randomization
measure: Physical activity
timeFrame: 6 months post-randomization
measure: Social and emotional development
timeFrame: 6 months post-randomization
measure: Child development
timeFrame: 6 months post-randomization
measure: Family psychosocial health
timeFrame: 6 months post-randomization
measure: Parenting
timeFrame: 6 months post-randomization
measure: Parenting sense of competence
timeFrame: 6 months post-randomization
measure: sociodemographic, maternal and child characteristics
timeFrame: 6 months post-randomization
measure: zBMI
timeFrame: 6 months post-randomization
measure: Waist circumference
timeFrame: 6 months post-randomization
measure: Blood pressure
timeFrame: 6 months post-randomization
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michaels Hospital Pediatric Outpatient Clinic
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Catherine Birken, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: