Pragmatic Lifestyle Pregnancy and Post Pregnancy Intervention for Overweight Women With Gestational Diabetes Mellitus: a Randomised Controlled Clinical Trial (PAIGE2)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
This study is designed to determine if a postnatal lifestyle intervention will lead to weight reduction over a 12 month period post-delivery in women who have been diagnosed with gestational diabetes mellitus and who have a BMI greater that 25 compared to women who receive routine care.
详细描述
Diabetes during pregnancy (Gestational Diabetes Mellitus (GDM) is defined as high blood sugars during pregnancy and it is becoming increasingly common which affects around 18% of pregnant women. GDM is usually diagnosed by an oral glucose tolerance test around 28 weeks gestation. Women with previous GDM have a 50% risk of developing it again in any future pregnancy, and are 7 times more likely to develop type 2 diabetes within the future compared to women without GDM.
There is evidence that lifestyle changes (diet and physical activity), can reduce the development of type 2 diabetes in people at high risk, such as women with previous GDM. The postnatal period (shortly after pregnancy) is an ideal time for women to make these changes to help prevent weight gain between pregnancies and generally reduce their risk of future type 2 diabetes. This study is designed to determine if a postnatal lifestyle intervention will lead to weight reduction over a 12 month period post-delivery.
Women who have been diagnosed with diabetes during pregnancy (GDM) and had a body mass index (BMI) >25 kg/m2 at the start of pregnancy, will be invited to take part in the study.
During their routine appointment at 32-36 weeks gestation women will be randomly allocated either to the intervention program or control group.
Women in the intervention group, will receive a 1-hour educational session during their routine diabetes antenatal clinic visit. In addition, they will be offered an activity tracker (following consent) to help monitor their daily step count and physical activity.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 years of age or older,
- •Women with a booking BMI ≥ 25 kg/m2 at <14 weeks gestation
- •GDM has been diagnosed in their current pregnancy.
- •Women will only continue to be included in the study if their fasting plasma glucose the morning after delivery indicates normality or impaired fasting plasma glucose outside of pregnancy (i.e.<7 mmol/l).
- •Women with a history of GDM directly preceding the current pregnancy, and who were given lifestyle advice and were performing self-monitoring of blood glucose from early pregnancy, will also be included if capillary glucose monitoring exceeds target values (fasting ≥ 5.3 mmol/l (95 mg/dl), 1h postprandial plasma glucose ≥ 7.8 mmol/l (140 mg/dl) thus negating the need for an OGTT.
排除标准
- •Pregnancy in which an anomaly has been detected on the 20-week fetal anomaly scan.
- •b.) History of diabetes outside of pregnancy or FPG ≥7 mmol/l the morning after delivery.
- •c.) History of heart, liver or chronic renal disease. d.) Medications that adversely affect glucose tolerance (e.g. steroids). e.) Inability to participate in moderate physical activity outside of pregnancy.
- •f.) Moderate/severe depressive illness or excess alcohol consumption. g.) Inability to understand adequately verbal explanations or written information in English, or special communication needs.
- •h.) Women who are planning another pregnancy within the next 12 months following delivery.
- •i.) Exclusion criteria for early post-partum glucose testing will include massive postpartum hemorrhage, steroid treatment prior to delivery or patient refusal.
- •If a woman requests an earlier discharge that does not allow time for the FPG test, she will be offered an appointment to return to the maternity unit within four weeks of birth for retesting.
结局指标
主要结局
Weight loss
时间窗: Change from baseline to 12 months postpartum
Weight loss
次要结局
- Waist circumference(Change from baseline to 12 months postpartum)
- Fasting glucose(Change from baseline to 12 months postpartum)
- Step counts (intervention group only)(Change from baseline to 12 months postpartum)
- Questionnaire data pertaining to physical activity, General Health and Well Being, Motivation to change and Risk Perception Survey for Developing Diabetes(Change from baseline to 12 months postpartum)