Clinical trial NCT03219697: Preventing and Addressing At-obesity-Risk Early Years INtervention with Home Visits in Toronto (PARENT): a Pragmatic RCT
Official title: Preventing and Addressing At-obesity-Risk Early Years INtervention with Home Visits in Toronto (PARENT): a Pragmatic RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Keywords: Childhood obesity prevention;
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
name: The Physicians' Services Incorporated Foundation
name: Ontario Child Health Support Unit
First posted: 2017-07-17
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: PREVENTION

Brief summary: The PARENT Trial aims to determine if the Parents Together program consisting of parent workshops, home visits 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, help build strong family relationships, and promote child mental health.

Detailed description: This study will determine whether a primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, compared to regular health care will lead to improved weight status in 18 months- 4 year old children.

Healthy children at risk for obesity will be identified through primary care practices participating in TARGet Kids!. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6-months:

Group A: Receive 8 weeks of group parenting education sessions, 2 additional group sessions, with 2-4 public health nurse home/virtual visits Group B: Receive regular health care

Eligibility criteria: Inclusion Criteria:

* Children at risk for childhood obesity (meeting any of the risk factors below):
* birth weight greater than 3500g
* weight gain in first year of life (crossing of at least 1 percentile line of weight for age or weight for length percentile)
* maternal or paternal obesity,
* gestational smoking at birth
* low median household self-reported income
* availability of at least one caregiver to participate in trial

Exclusion Criteria:

* Young children with Prader-Willi syndrome or severe developmental delays
* obesity or severe obesity (defined as zBMI \>2 for all ages)
* families not fluent in English
* children with a sibling already enrolled in the study
* families who reside beyond the Toronto Public Health catchment areas

Primary outcomes:
measure: zBMI
timeFrame: at 6 months and 12 months post-randomization
Secondary outcomes:
measure: Mental health
timeFrame: at 6 months and 12 months post-randomization
measure: Eating behaviour and dietary intake
timeFrame: at 6 months and 12 months post-randomization
measure: ZBMI
timeFrame: at 6 months and 12 months post-randomization
measure: Physical Activity, Sedentary Time, Sleep Duration
timeFrame: at 6 months and 12 months post-randomization
measure: Physical Activity
timeFrame: At 12 months post-randomization
measure: Psychosocial Health
timeFrame: at 6 months and 12 months post-randomization
measure: Maternal Mental Health
timeFrame: at 6 months and 12 months post-randomization
measure: Parenting
timeFrame: at 6 months and 12 months post-randomization
measure: sociodemographic, maternal and child characteristics
timeFrame: at 6 months and 12 months post-randomization
measure: Waist circumference
timeFrame: 6 and 12 months post randomization
measure: blood pressure
timeFrame: 6 and 12 months post-randomization
measure: laboratory measures of cardiometabolic risk
timeFrame: At 12 months post-randomization
measure: Feasibility of intervention
timeFrame: at 12 months post randomization
measure: Cost effectiveness analysis
timeFrame: at 12 months post-randomization
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Catherine S Birken, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: