Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 4
- 主要终点
- To determine a clinically significant difference (absolute difference of ≥10%) in the proportion of participants who gain > 12kg throughout study period will be less in the intervention group compared to the the non-intervention group.
研究概览
简要总结
The purpose of this study is to investigate whether overweight but not obese pregnant African women having unlimited access to a health education-information technology (IT) based intervention package gain weight within the acceptable range of 8-12 kg during the pregnancy period.
Therefore, we hypothesize that unlimited access to health education via an IT-based intervention package has the potential to reduce the onset of obesity in African pregnant women.
To date (Aug 2015), 95% of patients have been recruited, 1320 potential subjects have been screened and 150 enrolled into the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •body-mass index (BMI) range of 25.1-29.9 kg/m2
- •Weeks of pregnancy: 16-20
- •singleton pregnancy
排除标准
- •Evidence of pre-existing cardiovascular disease or a metabolic disorder (i.e. gestational diabetes)
结局指标
主要结局
To determine a clinically significant difference (absolute difference of ≥10%) in the proportion of participants who gain > 12kg throughout study period will be less in the intervention group compared to the the non-intervention group.
时间窗: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
次要结局
- Change in plasma Vitamin C levels in both the mother and newborn(Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum; newborn: day of delivery, 6 weeks old, 12 weeks old)
- Change in blood pressure profiles(Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum; newborn: day of delivery, 6 weeks old, 12 weeks old)
- Improved resting heart rate(Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum; newborn: day of delivery, 6 weeks old, 12 weeks old)
- Clinically normal C-reactive protein levels (<1 mg/dL)(Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum; newborn: day of delivery, 6 weeks old, 12 weeks old)
- Improved awareness of food choices(Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, 6 weeks postpartum)
- Change in body composition (fat percentage, body water percentage, bone mass, muscle mass, bone density and visceral fat) of mother.(Mother: Baseline (12-16 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum)
- To determine what women actually know (and how much they understand) about the risk factors during their pregnancy.(Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum)
- Cost saving potential of intervention from a societal perspective.(September 2015)
- Apgar score >3(Newborn: Day of delivery)
研究者
Prof. Karen Sliwa
Professor
University of Cape Town