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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
99
8-week parent/caregiver education program, followed by two booster sessions. You and/or your partner will attend weekly parenting sessions which will take place either at the office of your child's primary care provider or virtually. Our Toronto Public Health Nurse, will arrange 2 home visits/virtual visits with you and your family along with 4 coaching calls during the 6 months. This first home visit will include learning more about your routines at home, and what is available in your neighbourhood. The home visits will focus on helping to apply the messages and skills from the group sessions for your family, and making connections in your community that you find helpful such as recreational or nutrition programs or other supports for your family.
St Michael's Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
zBMI
Measure the difference in age and sex-standardized BMI z-score (zBMI)
Time frame: at 6 months and 12 months post-randomization
Mental health
Assess mental health by Strengths and Difficulties Questionnaire
Time frame: at 6 months and 12 months post-randomization
Eating behaviour and dietary intake
Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
Time frame: at 6 months and 12 months post-randomization
ZBMI
Measure the difference in age and sex-standardized BMI z-score (zBMI)
Time frame: at 6 months and 12 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),
Time frame: at 6 months and 12 months post-randomization
Physical Activity
Direct measures of physical activity using accelerometry
Time frame: At 12 months post-randomization
Psychosocial Health
family psychosocial health (using the Parental Stress Index)
Time frame: at 6 months and 12 months post-randomization
Maternal Mental Health
maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire)
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Time frame: at 6 months and 12 months post-randomization
Parenting
Parenting (using the Parenting Scale)
Time frame: at 6 months and 12 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 - captured by the Nutrition and Health Questionnaire (NHQ).
Time frame: at 6 months and 12 months post-randomization
Waist circumference
measured waist circumference using a tape measure
Time frame: 6 and 12 months post randomization
blood pressure
measurement of diastolic and systolic blood pressure in children 3 years of age and older
Time frame: 6 and 12 months post-randomization
laboratory measures of cardiometabolic risk
laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status
Time frame: At 12 months post-randomization
Feasibility of intervention
1. feasibility of study design (i.e., recruitment, outcome assessment) 2. feasibility of intervention (i.e., intervention fidelity) 3. acceptability of study design (i.e., randomization), 4. acceptability of intervention (i.e., attendance, parent satisfaction).
Time frame: at 12 months post randomization
Cost effectiveness analysis
to determine the incremental costs of the intervention
Time frame: at 12 months post-randomization