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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Ontario | OTHER |
| The Physicians' Services Incorporated Foundation | OTHER |
| Ontario Child Health Support Unit | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenting education program | Experimental | 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. |
|
| Control | No Intervention | Receive regular health care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenting education program | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine S Birken, MD, MSc | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada | ||
| The Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36600302 | Derived | Rae S, Maguire J, Aglipay M, Barwick M, Danavan K, Haines J, Jenkins J, Klaassen M, Moretti ME, Ong F, Persaud N, Porepa M, Straus S, Tavares E, Willan A, Birken C. Randomized controlled trial evaluating a virtual parenting intervention for young children at risk of obesity: study protocol for Parenting Addressing Early Years Intervention with Coaching Visits in Toronto (PARENT) trial. Trials. 2023 Jan 4;24(1):8. doi: 10.1186/s13063-022-06947-w. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Randomized Control Trial
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|
| 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 |
| at 12 months post randomization |
| Cost effectiveness analysis | to determine the incremental costs of the intervention | at 12 months post-randomization |
| Toronto |
| Ontario |
| M5G 0A4 |
| Canada |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |