Preventing and Addressing At-obesity-Risk Early Years INtervention with Home Visits in Toronto (PARENT): a Pragmatic RCT
- Conditions
- Child Obesity
- Interventions
- Behavioral: Parenting education program
- Registration Number
- NCT03219697
- Lead Sponsor
- The Hospital for Sick Children
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Parenting education program Parenting education program 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.
- Primary Outcome Measures
Name Time Method zBMI at 6 months and 12 months post-randomization Measure the difference in age and sex-standardized BMI z-score (zBMI)
- Secondary Outcome Measures
Name Time Method Mental health at 6 months and 12 months post-randomization Assess mental health by Strengths and Difficulties Questionnaire
sociodemographic, maternal and child characteristics at 6 months and 12 months post-randomization 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).
Physical Activity At 12 months post-randomization Direct measures of physical activity using accelerometry
Parenting at 6 months and 12 months post-randomization Parenting (using the Parenting Scale)
blood pressure 6 and 12 months post-randomization measurement of diastolic and systolic blood pressure in children 3 years of age and older
Feasibility of intervention at 12 months post randomization 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).Physical Activity, Sedentary Time, Sleep Duration at 6 months and 12 months post-randomization Parent reported measures of physical activity, sedentary time, and sleep duration (based on the Canadian Community Health Survey),
Psychosocial Health at 6 months and 12 months post-randomization family psychosocial health (using the Parental Stress Index)
Eating behaviour and dietary intake at 6 months and 12 months post-randomization Assess eating behaviour and dietary intake using the Nutrition Screening Tool for Every Preschooler (NutriSTEP)
ZBMI at 6 months and 12 months post-randomization Measure the difference in age and sex-standardized BMI z-score (zBMI)
Maternal Mental Health at 6 months and 12 months post-randomization maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire)
Waist circumference 6 and 12 months post randomization measured waist circumference using a tape measure
laboratory measures of cardiometabolic risk At 12 months post-randomization laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status
Cost effectiveness analysis at 12 months post-randomization to determine the incremental costs of the intervention
Trial Locations
- Locations (2)
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada