Effect of Intensive Nutrition Training, Education, and Support Versus Standard Care in Reducing the Need for Insulin Therapy in Gestational Diabetes (INTENSE-GDM): A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Percentage of insulin-treated
研究概览
简要总结
The treatment of gestational diabetes (GDM) primarily revolves around consuming an optimal diet that does not cause blood glucose levels to become excessively high and provides an adequate supply of micro- and macronutrients without resulting in excessive weight gain during pregnancy. In some cases, it may become necessary to supplement with insulin during pregnancy. However, insulin treatment is associated with personal, health-related, and healthcare cost-related implications. The rationale for this study is the lack of knowledge regarding whether the extent of support and guidance from a dietitian during pregnancy has an impact on the treatment outcomes for both the mother and the child in cases of GDM. The overall objective is to investigate differences in clinical, cost-related, and patient-reported outcomes between women with GDM randomised to either intensive dietary therapy or standard dietary care (control). The primary endpoint is the effect of intensive dietary therapy on the likelihood of remaining treated with diet only vs. needing insulin therapy. The study design is a randomised controlled parallel group open-label effectiveness trial including 214 women with GDM.
详细描述
Gestational diabetes (GDM) is defined as glucose intolerance with onset or first recognition during pregnancy. The disease is characterized by hyperglycaemia and a marked insulin resistance secondary to placental hormonal release. Risk factors for developing GDM in pregnancy include obesity, excessive gestational weight gain, previous GDM, glucosuria, family history of diabetes, ethnicity, and hypertension. Hyperglycaemia is associated with serious short- and long-term complications for mother and child including delivering large-for-gestational-age (LGA) babies, macrosomia, preterm birth, caesarean section, preeclampsia, birth injury, respiratory distress syndrome, neonatal hypoglycaemia, jaundice, and increased admission to neonatal intensive care unit (NICU). First-line treatment in GDM after diagnosis is dietary therapy including a systematic and detailed dietary assessment to identify relevant areas for adjusting the diet and overall lifestyle. The overall goals with dietary therapy are 1) To provide adequate calories and micro- and macronutrients to meet the needs of pregnancy consistent with maintaining normoglycaemia, 1) To improve glycaemic control; and 3) To secure appropriate gestational weight gain and avoid excessive weekly gestational weight gain. Currently, no evidence exists for specific recommendations concerning the optimal frequency, intensity, or duration of visits with a dietitian for improving maternal, foetal, or neonatal outcomes. National clinical guidelines for treatment of GDM recommends up to three visits with a dietitian depending on the time of diagnosis. However, in the latest national clinical guidelines under review this has been changed to only one visit.
In most cases dietary improvements are sufficient to achieve glycaemic goals but around one third of all women with GDM will need insulin therapy at some point during pregnancy. Decision about additional insulin therapy is based on a combination of ultrasound findings and dietary glycemic control as indicated by the blood glucose protocol as assessed by an obstetrician. Insulin therapy can improve glycaemic control and has been shown to be effective in reducing the rate of macrosomia in GDM. But use of insulin during pregnancy is also associated with several clinical implications, increased hospital and medical costs as well as higher costs in relation to delivery, and neonatal care, and personal burden affecting women with GDM.
In summary, the most optimal way to deliver dietary therapy to women with GDM is not known. The possibility that intensive dietary therapy may reduce the need for initiating insulin treatment without increasing hospital service costs for these women in comparison with women receiving standard dietary care needs to be explored.
The overall objective is to investigate the effectiveness and hospital service costs of implementing an intervention with intensive dietary counselling and support during pregnancy in women with GDM.
The INTENSE-GDM trial is a randomised controlled parallel group open-label effectiveness trial including 214 women with GDM. Participants will attend one consultation with a dietitian in the standard care group and up to 5 consultations (including 2 mandatory follow-up visits and 2 optional follow-up visits) with a dietitian in the intensive dietary counselling group. Both groups will receive one end-of-intervention telephone call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The randomisation list will be made by a researcher/statistician not involved in the trial, who will be the only person to access the randomisation list during the trial.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed women with GDM referred to Department of Obstetrics Herlev Hospital
- •Women diagnosed with GDM based on 2-hour OGTT plasma glucose value ≥ 9.0 mmol/l
- •Women diagnosed with GDM based on at least 2 plasma glucose measurements above targets (either pre-prandial ≥6.0 mmol/l, or 2-hours postprandial ≥8.0 mmol/l)
- •GA at GDM diagnosis ≤ 34
- •Women with an estimated probability of ≥20% for initiating insulin treatment during pregnancy. The estimated probability is based on a logistic regression model developed at SDCC and includes the following variables: prepregnancy BMI, GA at GDM diagnosis, and HbA1c at GDM diagnosis. In cases where HbA1c has not been measured during the initial visit with the dietitian (screening visit), prepregnancy BMI, GA at the time of diagnosis and 2H OGTT will be used to estimate the probability of initiating insulin therapy.
- •Provided voluntary written informed parental consent in Danish or English or after translation by an interpreter for non-Danish and non-English speaking parents
排除标准
- •Bariatric surgery
- •Other intercurrent illness (e.g., cancer, ulcerative colitis) as judged by medical experts
- •Uncontrolled medical issues, as judged by medical experts
- •Concomitant participation in other clinical trials that could interfere with the INTENSE- GDM Trial as evaluated by the principle investigator
- •Unable to understand the informed consent/procedures regardless of spoked language
研究组 & 干预措施
Intensive dietary care group
Women randomised to the intensive dietary intervention group will receive one initial dietary counselling consultation (60 min), and two mandatory follow-up consultations (2 x 30 min) with a dietitian. In addition, participants in this group will be offered 1-2 follow-up consultations (1-2 x 15-30 min) if needed.
干预措施: Dietary treatment (Behavioral)
Standard dietary care group
Women randomised to the standard dietary care group will receive one dietary counselling consultation (60 min) according to the initial dietary counselling described without any follow-up consultations with a dietitian. Participants are encouraged to follow their dietary plan until delivery.
干预措施: Dietary treatment (Behavioral)
结局指标
主要结局
Percentage of insulin-treated
时间窗: From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks
Percentage of women with GDM treated with insulin therapy in the two study groups
次要结局
- Large for gestational age (LGA)(At delivery, assessed from study completion up to 24 weeks)
- Neonatal hypoglycaemia(From date of randomisation until data of discharge after child delivery, assessed from study completion up to 24 weeks)
- Admission to neonatal intensive care unit (NICU)(From date of randomisation until data of discharge after child delivery, assessed from study completion up to 24 weeks)
- Maternal body weight(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
- Prescribed insulin(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
- Small for gestational age (SGA)(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
- Maternal glycaemic control(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
- Onset of insulin treatment(From date of randomisation until date of first insulin prescription, assessed from study completion up to 24 weeks)
- Macrosomia (birth weight >4,500 g)(From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks)
研究者
Bettina Ewers
Head of Nutrition
Steno Diabetes Center Copenhagen