Health Improvement After Pregnancy (HIP) Program Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Metabolic Syndrome Z Score
研究概览
简要总结
Recent Canadian studies, public opinion polls and the Canadian Heart Health Strategy and Action Plan state that women's heart health is a key national priority; it should be addressed through improving heart health awareness and prevention, and reducing care inequities for women in general and younger women in particular. The investigators have developed an innovative and interactive mobile website based postpartum lifestyle modification program (regular physical activity and nutritional guidance), based on established national guidelines, to improve heart disease risk factors in women. The investigators will conduct a trial to determine if the mobile website based lifestyle modification program can be maintained and reduces a collection of risk factors, which occurring together, greatly increases the risk of developing heart disease. The investigators hypothesize that the interactive mobile website directing regular physical activity and personalized nutritional guidance, compared to standard postpartum care, will be motivational and result in a reduced modified metabolic syndrome z score at 8 months postpartum among the intervention group.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •must own or have daily access to one or more of the following; smart phone, tablet or laptop computer
排除标准
- •Living greater than 100km from Kingston General Hospital
- •Having an existing and long term contraindication to exercise at the time of recruitment
研究组 & 干预措施
Standard of Care
Participants in this arm will receive care as per the usual standards from Kingston General Hospital and their primary care provider.
HIP Program
Participants in this arm will follow the HIP Program in addition to their usual care from Kingston General Hospital and their primary care provider.
干预措施: HIP Program (Behavioral)
结局指标
主要结局
Metabolic Syndrome Z Score
时间窗: 32 weeks postpartum
The primary outcome measure is the metabolic syndrome (MetS) z score, a continuous score of the five metabolic syndrome variables that make up the Adult Treatment Panel (ATP) III diagnostic criteria (waist circumference, blood pressure, high density lipoprotein, triglycerides and glucose). Differences between study arms will be compared.
次要结局
- Adherence to the HIP Program; Percent of Workouts Completed(32 weeks postpartum)
- Differences in Biochemical Cardiovascular Risk Markers(32 weeks postpartum)
- Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Midpoint(20 weeks postpartum)
- Change in Anthropomorphic Measurements and Blood Pressure from Baseline at Study Completion(32 weeks postpartum)
- Change in Anthropomorphic Measurements and Blood Pressure from Midpoint to Study Completion(32 weeks postpartum)
- Adherence to the HIP Program; Percent of Step Counting Completed(32 weeks postpartum)
- Adherence to the HIP Program; Percent of Dietary Logs Completed(32 weeks postpartum)
研究者
Dr. Graeme Smith
Professor and Head of Obstetrics and Gynecology
Queen's University