Guelph Family Health Study: Full Study
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Child - change in BMI
研究概览
简要总结
The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The investigators primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study will also assess the cost-effectiveness of the intervention from a societal perspective.
详细描述
The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study also assess the cost-effectiveness of the intervention from a societal perspective.
The investigators will randomly allocate 356 socio-economically diverse Ontario families to receive either: 1) 4 motivational coaching home visits, bi-weekly emails, and mailed behaviour supports (intervention group), or 2) Monthly emails with general health information (control group). Primary and secondary outcomes will be assessed at baseline, post-intervention (6-months), and 18-month follow-up, and data will be analyzed by intention to treat.
This study tests a novel and promising approach to obesity prevention - an approach that engages families at home, where they eat, play, and sleep. The interdisciplinary investigator team has partnered with parents and key knowledge users in public health and primary care to develop this intervention. As a result, this research could provide a sustainable model for early life obesity prevention, leading to long-term improvements in health and reduction in costs to the health system and society as a whole.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •families who have at least 1 child age 18 months - 5 years
- •families who live in the Guelph area
- •families who can respond to English surveys
排除标准
- •plan to move away within the next year
- •have children with severe health conditions (e.g., cerebral palsy) that prevent participation in study activities.
研究组 & 干预措施
Control
Families randomized to control will receive monthly emails containing publicly available handouts on general child health.
干预措施: Control (Behavioral)
Intervention - 4 Home Visits
Families randomized to the intervention will receive: a) 4 home visits from a health educator, b) weekly e-mails, and c) monthly mailed behavioural supports.
干预措施: Intervention - 4 Home Visits (Behavioral)
结局指标
主要结局
Child - change in BMI
时间窗: Baseline, 6 Months and 18 Months
Trained staff will use standard practices to measure child height to the nearest 0.1 cm with a Shorrboard stadiometer and child weight to the nearest 0.1 kg using a Seca scale. BMI will be the ratio of weight (kg) to the square of standing height (m).
次要结局
- Child - change in waist circumference(Baseline, 6 Months, 18 Months)
- Child - change in % body fat(Baseline, 6 Months, 18 Months)
- Child - change in sleep duration(Baseline, 6 Months, 18 Months)
- Child - change physical activity(Baseline, 6 Months, 18 Months)
- Child - change in sedentary behaviour(Baseline, 6 Months, 18 Months)
- Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc).(Baseline, 6 Months, 18 Months)
- Adult and child - change in family meals(Baseline, 6 Months, 18 Months)
- Adult - motivation for lifestyle change(Baseline, 6 Months, 18 Months)
- Social determinants of obesity(Baseline, 6 Months, 18 Months)
- Cost-effectiveness of Intervention(Baseline, 6 Months, 18 Months)
- Adult - change in BMI(Baseline, 6 Months, 18 Months)
- Adult - change in waist circumference(Baseline, 6 Months, 18 Months)
- Adult - change in % body fat(Baseline, 6 Months, 18 Months)
- Adult - change in sleep duration(Baseline, 6 Months, 18 Months)
- Adult - change in physical activity(Baseline, 6 Months, 18 Months)
- Adult - change in sedentary behaviour(Baseline, 6 Months, 18 Months)
- Adult - change in dietary behaviour(Baseline, 6 Months, 18 Months)
研究者
Jess Haines
Associate Professor/GFHS Associate Director
University of Guelph