Effects of a Web/Smartphone-based Lifestyle Coaching Program on Gestational Weight Gain in Pregnant Women With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Percentage of patients who have excessive gestational weight gain (EGWG)
研究概览
简要总结
Gestational diabetes mellitus (GDM) affects one fifth of Singaporean pregnancies and can result in short and long term complications for mother and child. Mobile applications are effective in improving diabetes care and weight related behaviors through improved self-management. A multidisciplinary healthcare team from National University Hospital, Singapore has worked with Jana Care to develop the Habits-GDM smartphone app, a lifestyle coaching program specific for gestational diabetes. It consists of interactive lessons to provide patient education, diet, activity and weight tracking tools, messaging platform for coaching and motivating patients towards healthy behavior beneficial for gestational diabetes. It interfaces with the Aina device, a novel hardware sensor that plugs into any smartphone and can be used for glucose monitoring. This study aims to test the effectiveness of this app in preventing excessive weight gain in pregnancy among patients with gestational diabetes.
详细描述
Gestational diabetes mellitus (GDM) is defined as glucose intolerance of any degree with onset or first recognition during pregnancy. In Singapore, 20-30% of pregnant women are affected by GDM. If poorly controlled, GDM is associated with various maternal and perinatal morbidities such as increased cesarean deliveries, preeclampsia, preterm labour, macrosomia, neonatal hypoglycemia etc. It is well recognized now that GDM is also associated with long-term metabolic complications in mothers and offspring. Women with a history of GDM have increased risk of GDM in subsequent pregnancies, and at high risk of developing Type 2 diabetes after pregnancy. Infants born to mothers with GDM are also at increased risk of developing obesity and diabetes in later life. An increasing number of studies, including studies in Singapore, suggest that screening and management of GDM can be cost-effective, although these results are highly dependent on intervention efficacy.
In Singapore, individuals with GDM are first advised to adopt diet modification, and if glycemic control is not on target despite diet control, insulin therapy is the next line of treatment. In all cases, patients need to perform self-monitoring of blood glucose (SMBG) to guide treatment decisions. These strategies aim to reduce the risks maternal and perinatal complications. In addition to that, preventing excessive gestational weight gain (GWG) is another important goal in women with GDM. This is because excessive GWG is not only associated with higher risks of delivering a large for gestational age infant, but is also the strongest risk factor for postpartum weight retention, and an important predictor for future development of Type 2 diabetes. Lifestyle intervention programs have been shown to be effective in reducing GWG in pregnant women.
One thing in common among diet modification, SMBG and achieving optimum GWG is that they involve self-management, and hence require a certain degree of self-efficacy in women with GDM. To achieve this in the National University Hospital (NUH), patients are referred to a gestational diabetes clinic for education. At this time, if the patient's plasma glucose at 0 minute and/or 120 minutes of a 75g oral glucose tolerance test (OGTT) is <7.0 mmol/L and <11.1 mmol/L respectively, this is conducted in a group teaching session lasting 1 - 1.5 hours, with 4 - 6 patients per group, led by a diabetes nurse educator and a dietitian. If the patient's plasma glucose at 0 minutes and/or 120 minutes of a 75g OGTT is ≥7.0 and ≥11.1 mmol/L respectively, this is conducted in an individual session lasting 1 hour with a diabetes nurse educator and a dietitian. Patients are initiated on capillary glucose monitoring, typically 7 times a day, 2-3 days in a week. Subsequently, their care is provided by their obstetrician until such time as the obstetrician feels that insulin is required, in which case they are often referred back to the endocrinology service for the initiation and management of insulin therapy. Capillary glucose monitoring is carried out using a glucometer that is purchased by the patient, and the patient duly records blood glucose on a paper record which will be shown to her obstetrician at the clinic appointments every 2 - 4 weeks. In addition, weight is generally monitored at the clinic visit. Advice on diet and lifestyle modification is provided by the obstetrician based on the results of capillary glucose monitoring at the clinic visit. In between appointments, there is limited interaction between healthcare providers unless the patient identifies a problem and contacts the provider.
This arrangement has some limitations. Firstly, it has been demonstrated that spacing learning activities over a period of time improves encoding and long term retention of information. As such, the current method of providing all the education that a patient needs in a single session is less likely to be optimal for retention of information. Secondly, the collection of information (through capillary glucose monitoring) is often separated from any feedback from health care providers by days or weeks. In general, the lifestyle activities (whether diet or physical activities) which generate any abnormal blood glucose results occur in close proximity to the glucose readings (often hours before rather than weeks). By the time feedback is received, the patient often does not recall the events that generated the abnormal readings. More importantly, it does not provide any meaningful feedback to the patient that allows modification of the risk of an episode of hyperglycemia. In fact, this generates a significant amount of distress for the patient. It has been shown that the distress perceived in response to a stressor is much greater when the person experiencing the stressor does not have a way to control the occurrence of the stressor. In this context, the lack of timely feedback that is actionable related to blood glucose or weight, results in significant distress on the part of patients and results in a failure to adhere to efforts to monitor or control blood glucose. In a recent mixed-methods feasibility study to assess acceptability of mobile-application based support tool for women with GDM in NUH, most reported significant stress from the burden of management and desire for supporting tools that would aid control of blood glucose as an adjunct to self-monitoring.
It is the investigators' hypothesis that by providing education that is spaced out over 1-2 weeks and providing feedback that is timely and actionable to the patient, it will improve adherence to lifestyle modification, reduce patient distress and improve clinical outcomes for women with GDM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent.
- •Women aged 21 years and older.
- •Singleton pregnancy.
- •GDM diagnosed between 12 to 30 weeks of gestation, based on the 2013 World Health Organization (WHO) criteria, i.e. either of the following: fasting plasma glucose ≥5.1 mmol/L, 60-minute plasma glucose ≥10.0 mmol/L, 120-minute plasma glucose ≥8.5 mmol/L, during a 75g oral glucose tolerance test (OGTT).
- •Possesses a smartphone and ability to navigate a smartphone app.
- •Proficient in English language.
- •Plan to deliver the baby in National University Hospital.
排除标准
- •Multiple pregnancy.
- •Pre-existing diabetes (type 1 diabetes, type 2 diabetes, or other specific types of diabetes) diagnosed prior to current pregnancy.
- •GDM diagnosed before 12 weeks of gestation.
- •No weight available in first trimester (at or before 12 weeks gestation) of the pregnancy.
- •Need for insulin therapy from the start of diagnosis of GDM, as determined by the primary clinician.
- •Heart failure.
- •Chronic kidney disease
- •Feeding and eating disorders.
- •History of bariatric surgery.
- •Long-term systemic corticosteroids use.
- •Impaired mobility.
- •Concomitant participation in another clinical study (i.e. Phase I-III clinical studies) with investigational medicinal product(s).
结局指标
主要结局
Percentage of patients who have excessive gestational weight gain (EGWG)
时间窗: during the pregnancy until delivery
Percentage of patients who have EGWG is the proportion of subjects whose gestational weight gain (GWG) exceed the upper range of recommended weight gain for corresponding pre-pregnancy BMI (in this study, this is calculated using the first recorded weight and height in pregnancy at or before 12 weeks gestation) according to the 2009 IOM guidelines. * GWG is calculated by subtracting the first recorded weight (in kilograms) in pregnancy at or before 12 weeks gestation from the most recent weight measurement taken in the hospital (either in the clinic or in the ward) prior to delivery. * Pre-pregnancy BMI is calculated using the first recorded weight (in kilograms) and height (in meters) in pregnancy at or before 12 weeks gestation.
次要结局
- Absolute gestational weight gain(during the pregnancy until delivery)
- Proportion of glucose readings above glycemic targets(From recruitment until delivery)
- Percentage of patients who have EGWG according to the 2009 US IOM guidelines stratified by whether or not the subject has EGWG for the gestational weeks at recruitment(during the pregnancy until delivery)
- Absolute GWG stratified by whether or not the subject has EGWG for the gestational weeks at recruitment(during the pregnancy until delivery)
- Depression score(Between 35-37 weeks of gestation)
- Premature delivery(At delivery)
- Neonatal intensive care unit admission(First 24 hours from birth)
- Adherence to SMBG(From recruitment until delivery)
- Birth weight(At birth)
- Average readings of self-monitored blood glucose(From recruitment until delivery)
- Proportion of subjects who progress to needing metformin and/or insulin therapy(From recruitment until delivery)
- Mode of delivery(At delivery)
- Hypertensive disorders in pregnancy(During the pregnancy until delivery)
- Anxiety score(Between 35-37 weeks of gestation)
- Apgar score(At birth)
- Birth trauma(At birth)
- Respiratory distress needing intubation(At birth)
- Shoulder dystocia(At birth)
- Neonatal hypoglycemia(First 24 hours from birth)
