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Guelph Family Health Study: Full Study (GFHS)

2018年9月18日 更新者：Jess Haines、University of Guelph
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.

研究概览

地位

未知

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (预期的)

900

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Ontario
      • Guelph、Ontario、加拿大、N1G 2W1
        • 招聘中
        • Univeristy of Guelph
        • 接触：
        • 接触：
        • 首席研究员：
          • Jess Haines, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年 及以上 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • plan to move away within the next year
  • have children with severe health conditions (e.g., cerebral palsy) that prevent participation in study activities.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control
Families randomized to control will receive monthly emails containing publicly available handouts on general child health.
行为的：Control
monthly emails with general health information
实验性的：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.
行为的：Intervention - 4 Home Visits
4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Child - change in BMI
大体时间：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).
Baseline, 6 Months and 18 Months

次要结果测量

结果测量
措施说明
大体时间
Child - change in waist circumference
大体时间：Baseline, 6 Months, 18 Months
Trained staff will measure waist circumference at the top of the iliac crest to the nearest 0.1cm, using the NIH protocol.
Baseline, 6 Months, 18 Months
Child - change in % body fat
大体时间：Baseline, 6 Months, 18 Months
Trained staff will use bioelectrical impedance analysis to assess child body composition and use the equation by Kusher to determine % body fat.
Baseline, 6 Months, 18 Months
Child - change in sleep duration
大体时间：Baseline, 6 Months, 18 Months
Sleep duration will be assessed using the wActiSleep+ Activity Monitor (ActiGraph). Activity monitors will be worn on the child's non-dominant wrist for 7 consecutive days. Sleep measures will be determined using the validated Sadeh algorithm.
Baseline, 6 Months, 18 Months
Child - change physical activity
大体时间：Baseline, 6 Months, 18 Months
Physical activity will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for physical activity for preschool children will be used to determine physical activity.
Baseline, 6 Months, 18 Months
Child - change in sedentary behaviour
大体时间：Baseline, 6 Months, 18 Months
Sedentary behaviour will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for sedentary behaviour for preschool children will be used to assess sedentary behaviour.
Baseline, 6 Months, 18 Months
Child - change in dietary behaviour (sugar sweetened beverages, fruit and vegetable intake, etc).
大体时间：Baseline, 6 Months, 18 Months
To assess children's dietary intake, parents will be asked record all food and beverages that their child consumes over a 3-days period (2 weekdays and 1 weekend day). Data will be analyzed for energy and nutrient intake via ESHA nutrient analysis software.
Baseline, 6 Months, 18 Months
Adult and child - change in family meals
大体时间：Baseline, 6 Months, 18 Months
Parents will report frequency of family meals using an item from The Home Environment Inventory.
Baseline, 6 Months, 18 Months
Adult - change in BMI
大体时间：Baseline, 6 Months, 18 Months
Trained staff will use standard practices to measure adult height to the nearest 0.1 cm with a stadiometer and adult 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).
Baseline, 6 Months, 18 Months
Adult - change in waist circumference
大体时间：Baseline, 6 Months, 18 Months
Trained staff will measure waist circumference at the top of the iliac crest to the nearest 0.1cm, using the NIH protocol.
Baseline, 6 Months, 18 Months
Adult - change in % body fat
大体时间：Baseline, 6 Months, 18 Months
Trained staff will measure parental body composition using air displacement plethysmography, i.e., BODPOD™.
Baseline, 6 Months, 18 Months
Adult - change in sleep duration
大体时间：Baseline, 6 Months, 18 Months
Sleep duration will be assessed using the wActiSleep+ Activity Monitor (ActiGraph). Activity monitors will be worn on the participants non-dominant wrist for 7 consecutive days. Sleep measures will be determined using the a validated Sadeh algorithm.
Baseline, 6 Months, 18 Months
Adult - change in physical activity
大体时间：Baseline, 6 Months, 18 Months
Physical activity will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the participant's hip for 7 consecutive days. Validated cut-off values for physical activity will be used to determine physical activity.
Baseline, 6 Months, 18 Months
Adult - change in sedentary behaviour
大体时间：Baseline, 6 Months, 18 Months
Sedentary behaviour will be assessed using the wActiSleep+ Activity Monitor (Actigraph). Activity monitors will be worn on the child's hip for 7 consecutive days. Validated cut-off values for sedentary behaviour will be used to assess sedentary behaviour.
Baseline, 6 Months, 18 Months
Adult - change in dietary behaviour
大体时间：Baseline, 6 Months, 18 Months
To assess parent's dietary intake, parents will complete one 24-hour recall using the Automated Self-Administered 24-hour-Canada (ASA24®) dietary recall system, a web-based tool that collects and codes 24-hour recalls using the Canadian Nutrient File.
Baseline, 6 Months, 18 Months
Adult - motivation for lifestyle change
大体时间：Baseline, 6 Months, 18 Months
Treatment Self-Regulation Questionnaire will be used to assess family level of autonomous motivation.
Baseline, 6 Months, 18 Months
Social determinants of obesity
大体时间：Baseline, 6 Months, 18 Months
The investigators will assess parental education, marital status, annual household income, parental work patterns, food security, parent perception of neighbourhood safety, and access to grocery stores and indoor and outdoor spaces to be physically active.
Baseline, 6 Months, 18 Months
Cost-effectiveness of Intervention
大体时间：Baseline, 6 Months, 18 Months
The cost effectiveness of the study intervention will be assessed from a societal perspective. The direct costs associated with the intervention will be assessed, as well as health services use and indirect patient costs for both intervention and control groups. Direct costs of the intervention will be estimated from process data collected during the intervention. Through surveys at post-intervention, data will also be collected on costs to families for participating in the intervention, including time spent on home visits and other time costs associated with implementing the intervention recommendations. Health services use will be collected from parents and from linkage with administrative datasets (Ontario Health Insurance Plan). Parents will also be asked to report indirect patient costs, including number of missed school/work days.
Baseline, 6 Months, 18 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Guelph

调查人员

  • 首席研究员：Jess Haines, PhD、Unviersity of Guelph
  • 研究主任：David Ma, PhD、University of Guelph

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年6月1日

初级完成 (预期的)

2020年6月1日

研究完成 (预期的)

2020年9月1日

研究注册日期

首次提交

2016年10月13日

首先提交符合 QC 标准的

2016年10月17日

首次发布 (估计)

2016年10月20日

研究记录更新

最后更新发布 (实际的)

2018年9月20日

上次提交的符合 QC 标准的更新

2018年9月18日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 14AP009

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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