A Dietitian-led Cluster Randomised Controlled Trial on the Effectiveness of mHealth Education on Health Outcomes Among Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 4
- 主要终点
- Changes in Gestational Weight Gain
研究概览
简要总结
Gestational weight gain (GWG), weight gain of a mother during pregnancy, is an important determinant that influence the health outcomes of mothers and fetus. There is an increasing trend of pregnant women using mobile health (mHealth) to assess for pregnancy-related health information. While evidence on the effectiveness of mHealth education on improving pregnancy outcomes among pregnant women is growing, the findings had been inconclusive with scarcity of such data in Malaysia. The objective of the study is to determine the effectiveness of a 9-month mHealth intervention on GWG and other outcomes (prenatal knowledge, physical activity, psychosocial well-being, nutritional status, quality of life and sleep quality) among pregnant women.
详细描述
This study will evaluate the usability, feasibility and practicality of a previously developed smartphone application with complete alpha and beta testing on pregnancy outcomes in a cluster randomised control trial (RCT).
The study will be completed by involving the nutrition intervention using either mHealth interventions or conventional methods that will be carried out among pregnancy women.
Subjects will be allocated into groups according to respective health clinics, namely, two interventions group which are:
Group 1: mHealth intervention group
Group 2: mHealth intervention group + dietitian consultation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Malaysian women
- •18 - 40 years old
- •Single pregnancy
- •At first trimester or second trimester
- •All ethnicities
- •Meet or did not meet with dietitian before
- •With or without diseases (diabetes mellitus with/ without low dose insulin, hypertension, hyperlipidaemia, overweight/ obese)
- •Own smart phone with internet access
- •All BMI categories
排除标准
- •Diagnosed by medical doctor with major psychiatric problems (bipolar depression, schizophrenia, suicidal risk)
- •Multiple pregnancies
- •On other intervention program
- •Grand multipara
- •Severe comorbidities (cardiac diseases, severe anaemia)
- •Type 1 diabetes mellitus or Type 2 diabetes mellitus with high dose insulin
结局指标
主要结局
Changes in Gestational Weight Gain
时间窗: 3 points time (Baseline, 6th month, 9th month/ delivery)
Weight gain (kg)
次要结局
- Prenatal knowledge(1 point1 time (Baseline))
- Physical activity(2 points time (Baseline, 6th month))
- Pregnancy outcome (Infant complications)(1 point time (9th month/ delivery))
- Nutritional status(3 points time (Baseline, 6th month, 9th month/ delivery))
- Sleep quality(3 points time (Baseline, 6th month, 9th month/ delivery))
- Quality of life (well being)(3 points time (Baseline, 6th month, 9th month/ delivery))
- Pregnancy outcome (Type of delivery)(1 point time (9th month/ delivery))
- Pregnancy outcome (Born term)(1 point time (9th month/ delivery))
- Pregnancy outcome (Infant weight)(1 point time (9th month/ delivery))
- Pregnancy outcome (Infant length)(1 point time (9th month/ delivery))
- Pregnancy outcome (Apgar Score)(1 point time (9th month/ delivery))
- Psychosocial well-being(3 points time (Baseline, 6th month, 9th month/ delivery))
- Pregnancy outcome (Infant head circumference)(1 point time (9th month/ delivery))
- Pregnancy outcome ( Infant breast circumference)(1 point time (9th month/ delivery))
- Pregnancy outcome (Infant gender)(1 point time (9th month/ delivery))
- Pregnancy outcome (Maternal complications)(1 point time (9th month/ delivery))
研究者
Chan Yoke Mun
Professor
Universiti Putra Malaysia