A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With Gestational Diabetes Mellitus - RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Oral glucose tolerance test (OGTT), fasting and 2 hours blood glucose level after intake up til 75gr glucose (1.75gr/kg body weight)
研究概览
简要总结
In this study, the investigators will test a new way to communicate advice on diet and lifestyle to women with gestational diabetes mellitus by app downloaded on women's smartphone. The app wishes to motivate women to have a healthy diet, and be physically active. It allows automatic transfer of blood glucose measures from the glucose meter to the smartphone. The women will answer questionnaires during pregnancy and be followed up three months postpartum.
详细描述
Gestational diabetes mellitus (GDM), diabetes occuring for the first time during pregnancy, is an increasing problem worldwide. It may affect both the woman's and their offspring's health. Women with GDM have an increased risk of developing type 2 diabetes later in life. Pregnancy, offers a window of opportunity to instigate lasting changes beneficial for them and their families. Considering new technology available and used by women generally, new methods to communicate lifestyle and dietary advice are required.
The present study, a multi-center, randomised controlled trial includes five outpatients clinics in the greater Oslo Region and will include 230 pregnant women with gestational diabets mellitus. Data will be collected by three questionnaires during the study period, one at entry, before 33+0 weeks of gestation, one at 36 weeks and the last questionnaire at around three months postpartum. During pregnancy, the questionniares will be answered using an iPad while the last questionnaire will be on a website or through an interview.
Additional information will be collected from the women's medical record.
The intervention in this study is an app, called the Pregnant+ app (Gravid+) for smartphone. The app aims to reach women who are fluent in either Norwegian, Urdu or Somali. It has been translated from Norwegian and culturally adapted to women speaking Urdu or Somali. Women participating in the study can choose between different food cultures and they can set their personal lifestyle goals. Information about gestational diabetes, psysical activity, diet and food recipes are provided in the app. Half of the women in this study, will be given the app, downloaded on their smartphone.The opportunity to automatically transfer bloodglucose measures to the smartphone, presented in either a list or a graph, gives women an overview and therefore easier controll over their glucose levels.
The intervention will take place in the ordinary consultation at the outpatient clinics and no extra consultation are needed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First visit with gestational diabetes in this pregnancy
- •Has her own smartphone
- •Pregnancy up to 32 weeks and 6 days of gestation
- •Fluent in Norwegian, Urdu or Somali
- •Aged 18 years old and older
排除标准
- •Pregnant with more than one fetus
- •Lactose or gluten intolerance
- •Known type 1 diabetes (insulin dependent)
- •Known type 2 diabetes
结局指标
主要结局
Oral glucose tolerance test (OGTT), fasting and 2 hours blood glucose level after intake up til 75gr glucose (1.75gr/kg body weight)
时间窗: Approximately three months after delivery.
Part of routine care for women who had GDM, is an OGTT about three months postpartum, taken at their laboratory and reported to the investigators.Number of participants with level below 7.5 mmol
次要结局
- complications of pregnancy(Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum)
- Depression(Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum)
- Knowledge of gestational diabetes(Data will be collected prior to 33 weeks gestation, and at 36 weeks gestation)
- Physical activity(Data wil be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum)
- Motivation for physical activity(Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum)
- Dietary intake measured by "Fit for fødsel Food questionnaire"(Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum)
- Complications for the newborn(at birth)
- Starting medication for controlling blood glucose levels for the pregnant woman(during pregnancy)
- Motivation for eating healthy(Data will be collected prior to 33 weeks gestation, at 36 weeks, up to 4 months postpartum)
- Mode of delivery and complications at birth for the mother(at birth)
- Condition of the newborn(at birth and approx three months postpartum)
- Blood glucose control during pregnancy(during pregnancy)
- HbA1c(Approx three months postpartum)
研究者
Mirjam Lukasse
Associate professor
Oslo Metropolitan University