Preventing and Addressing At-obesity-Risk Early Years iNtervention With Home Visits in Toronto (PARENT): A Pragmatic RCT

Study Overview
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Brief Summary
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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
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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

Official Title
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Preventing and Addressing At-obesity-Risk Early Years iNtervention With Home Visits in Toronto (PARENT): A Pragmatic RCT

Conditions
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Child Obesity

Intervention / Treatment
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* Behavioral: Parenting education program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenting education program<br>8 weeks of group parenting education sessions followed by two optional booster sessions. 2 public health nurse home/virtual visits and 4 coaching calls over a period of 6 months. | Behavioral: Parenting education program<br>* 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.<br>|
| No Intervention: Control<br>Receive regular health care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| zBMI | Measure the difference in age and sex-standardized BMI z-score (zBMI) | at 6 months and 12 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental health | Assess mental health by Strengths and Difficulties Questionnaire | 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) | at 6 months and 12 months post-randomization | 
| ZBMI | Measure the difference in age and sex-standardized BMI z-score (zBMI) | 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), | at 6 months and 12 months post-randomization | 
| Physical Activity | Direct measures of physical activity using accelerometry | At 12 months post-randomization | 
| Psychosocial Health | family psychosocial health (using the Parental Stress Index) | at 6 months and 12 months post-randomization | 
| Maternal Mental Health | maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire) | at 6 months and 12 months post-randomization | 
| Parenting | Parenting (using the Parenting Scale) | 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). | at 6 months and 12 months post-randomization | 
| Waist circumference | measured waist circumference using a tape measure | 6 and 12 months post randomization | 
| blood pressure | measurement of diastolic and systolic blood pressure in children 3 years of age and older | 6 and 12 months post-randomization | 
| laboratory measures of cardiometabolic risk | laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status | At 12 months post-randomization | 
| Feasibility of intervention | feasibility of study design (i.e., recruitment, outcome assessment) feasibility of intervention (i.e., intervention fidelity) acceptability of study design (i.e., randomization), acceptability of intervention (i.e., attendance, parent satisfaction). | at 12 months post randomization | 
| Cost effectiveness analysis | to determine the incremental costs of the intervention | at 12 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood obesity prevention;