Guelph Family Health Study: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- change in adiposity
研究概览
简要总结
The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile.
To achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk.
We hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve:
- a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period.
- higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes)
- lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period.
We further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.
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 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •families who have a child aged 18 months through 5 years
- •live the Guelph area
- •have a parent who can respond to questionnaires in English
排除标准
- •families who plan to move during the study period
- •children with severe health conditions (such as severe cerebral palsy) that would prohibit them from participating in study activities
结局指标
主要结局
change in adiposity
时间窗: baseline, 6 month follow-up
次要结局
- change in child's fruit and vegetable intake(baseline, 6-month follow-up)
- change in child's biomarkers of diabetes and cardiovascular disease risk(baseline, 6-month follow-up)
- change in child's sleep duration(baseline, 6-months)
- change in sedentary behaviour(baseline, 6-month follow-up)
- change in waist circumference(baseline, 6-month follow-up)
- change in child's diastolic blood pressure(baseline, 6-month follow-up)
- change in body mass index(baseline, 6-month follow-up)
- change in frequency of family meals(baseline, 6-month follow-up)
- change in child's physical activity(baseline, 6-months)
- change in child's sugar-sweetened beverage intake(baseline, 6-month follow-up)
研究者
Jess Haines
Associate Professor
University of Guelph
