A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,032
- 试验地点
- 16
- 主要终点
- Amount of calcium supplement ingested
研究概览
简要总结
The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.
详细描述
This study is a non-inferiority trial that compares the effect of a dosing strategy involving lower overall dose and fewer administrations per day to the current WHO recommendation. The comparator arm, Regimen B, prescribes 3 doses per day (consistent with current WHO standard) and was found to be burdensome in qualitative studies. The experimental arm, Regimen A, prescribes 2 doses per day and has been associated with greater satisfaction. On face value Regimen A should result in 33% less amount of supplement ingested than Regimen B. However, we hypothesize that the difference in amount ingested, when rolled out in routine practice will be MUCH LESS than that BECAUSE THE LOWER DOSE REGIMEN RESULTS IN HIGHER LEVELS OF ADHERENCE. We hypothesize that THE DIFFERENCE IN AMOUNT CONSUMED WILL BE NEGLIGIBLE OR will not exceed 15%. Hence, we hypothesize that Regimen A is not inferior to Regimen B in terms of total amount of supplement ingested (within a 15% margin of inferiority).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Attendance at ANC clinic in a primary care facility in Kakamega north
排除标准
- •Gestational age < 16 weeks,
- •Gestational age > 30 weeks,
- •Dietary or medicinal consumption of adequate calcium (according to the screening survey),
- •Intention to leave study community before 8weeks from date of interview
结局指标
主要结局
Amount of calcium supplement ingested
时间窗: 8 weeks after ANC consultation, during which recruitment into the study occurred
This is the actual number of supplements ingested expressed as a percentage of the number of supplements expected to be ingested since the ANC consultation if 100% adherent to the current WHO recommendation. \[Total number of calcium supplements consumed/(Number of days since last ANC consultation X 3)\] X 100
次要结局
- Motivation(8 weeks after ANC consultation, during which recruitment into the study occurred)
- Adherence to related recommendations(8 weeks after ANC consultation, during which recruitment into the study occurred)
- Satisfaction(8 weeks after ANC consultation, during which recruitment into the study occurred)
- Self-efficacy(8 weeks after ANC consultation, during which recruitment into the study occurred)