Preventing and Addressing At-obesity-Risk Early Years INtervention with Home Visits in Toronto (PARENT): a Pragmatic RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- zBMI
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
zBMI
时间窗: at 6 months and 12 months post-randomization
Measure the difference in age and sex-standardized BMI z-score (zBMI)
次要结局
- Mental health(at 6 months and 12 months post-randomization)
- sociodemographic, maternal and child characteristics(at 6 months and 12 months post-randomization)
- Physical Activity(At 12 months post-randomization)
- Parenting(at 6 months and 12 months post-randomization)
- blood pressure(6 and 12 months post-randomization)
- Feasibility of intervention(at 12 months post randomization)
- Physical Activity, Sedentary Time, Sleep Duration(at 6 months and 12 months post-randomization)
- Psychosocial Health(at 6 months and 12 months post-randomization)
- Eating behaviour and dietary intake(at 6 months and 12 months post-randomization)
- ZBMI(at 6 months and 12 months post-randomization)
- Maternal Mental Health(at 6 months and 12 months post-randomization)
- Waist circumference(6 and 12 months post randomization)
- laboratory measures of cardiometabolic risk(At 12 months post-randomization)
- Cost effectiveness analysis(at 12 months post-randomization)
研究者
Catherine Birken
Principal Investigator
The Hospital for Sick Children