Child Obesity
Conditions
Keywords
Childhood obesity 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
Interventions
BEHAVIORALParenting education program
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.
Sponsors
Heart and Stroke Foundation of Ontario
The Physicians' Services Incorporated Foundation
Ontario Child Health Support Unit
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
18 Months to 48 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| zBMI | at 6 months and 12 months post-randomization | Measure the difference in age and sex-standardized BMI z-score (zBMI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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), |
| Physical Activity | At 12 months post-randomization | Direct measures of physical activity using accelerometry |
| Psychosocial Health | at 6 months and 12 months post-randomization | family psychosocial health (using the Parental Stress Index) |
| Maternal Mental Health | at 6 months and 12 months post-randomization | maternal mental health (Depression Anxiety Stress Scale and Patient Health Questionnaire) |
| 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). |
| Waist circumference | 6 and 12 months post randomization | measured waist circumference using a tape measure |
| blood pressure | 6 and 12 months post-randomization | measurement of diastolic and systolic blood pressure in children 3 years of age and older |
| laboratory measures of cardiometabolic risk | At 12 months post-randomization | laboratory measures of cardiometabolic risk (cholesterol, insulin, glucose), iron and vitamin D status |
| 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). |
| Cost effectiveness analysis | at 12 months post-randomization | to determine the incremental costs of the intervention |
| Parenting | at 6 months and 12 months post-randomization | Parenting (using the Parenting Scale) |
Countries
Canada
Outcome results
None listed