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
- 2
- 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)
研究组 & 干预措施
.HEDUAfrica IT package+ std care info
The HEDUAfrica IT package website aims to target disadvantaged gravid women representing the core aspect of the intervention. The website is available on a touch screen panel at the two intervention clinics, (Cape Town and Soweto, SA). A healthcare worker will assist women with the touchscreen tablet at the follow up sessions. The website content includes a number of short videos and health messages related to a pregnancy-specific-disease outcomes. Patients participating in the IT package also receive std car info
Participants are also asked to complete 2 questionnaires (24 hour dietary recall assessment and short messaging service technology driven) in conjunction to engaging with the HEDUAfrica website. The intervention is standardized across all participants in the intervention group.
干预措施: HEDUAfrica IT package+ standard care (Behavioral)
Health awareness brochure + std care
Participants in the non-intervention group at another clinic in Soweto, will receive an enhanced form of standard care. This will include, in conjunction with the normal form of care at each clinic,a health awareness brochure that will focus specifically on health information relating to obesity, diabetes, diet, exercise and breastfeeding at each follow-up sessions. These participants will also be asked to fill out the 24 hour dietary recall assessment and short messaging service technology questionnaire (exactly the same as the intervention group) with help from a healthcare worker.
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