Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
STUDY SUMMARY
TITLE Post-delivery intervention in women with previous gestational diabetes mellitus for weight loss, glycaemia and cardiovascular health DESIGN Feasibility study Allocation: RCT AIMS To determine the feasibility of a post-delivery intervention to improve glycemia and cardiovascular function and promote weight loss in women who have had gestational diabetes.
OUTCOME MEASURES Primary outcome; Effect of intervention on HbA1c: difference in HbA1c between intervention arm and control arm measured at 12 weeks.
Secondary Outcomes;
-
Adherence to intervention;
-
Willingness to be randomised to post-delivery intervention;
-
Process measures to evaluate patient experience of study and intervention;
-
Participants' preferred time to commence the study, within the start date allowance of 6 weeks - 6 month post-delivery.
-
Between-arm differences and within-arm differences to evaluate:
-
Effect of intervention on HbA1c at 12 and 24 weeks
-
Effect of intervention on weight and BMI at 12 and 24 weeks
-
Effect of intervention on systolic and diastolic blood pressure at 12 and 24 weeks
-
Effect of intervention on lipid profile (total cholesterol, HDL, LDL) at 12 and 24 weeks
-
Effect of intervention on physical activity at 12 and 24 weeks POPULATION We will recruit 50 women aged 18-45 with previous gestational diabetes and randomise them to 1 of 2 arms to commence study at 6 weeks - 6 months post-delivery. Women starting the study at 13 weeks post-delivery will have their routine post-delivery HbA1c act as baseline HBA1c.
ELIGIBILITY Pregnant women with gestational diabetes (women will be given the option to start the study between 6 weeks and 6 months post-delivery) or women who have given birth in the last 12 months and had gestational diabetes during that pregnancy; aged 18-45; and access to a smartphone with an operating system of iOS 9.0 or above, or Android 5.0 or above.
DURATION Study duration: 1/4/21-1/9/22. Participant duration: 24 weeks
详细描述
STUDY OBJECTIVES Objectives
To assess:
-
Effect of intervention on HbA1c at 12 and 24 weeks
-
Adherence to intervention
-
Participants' preferred time to commence the study, within the start date allowance of 6 weeks - 6 month post-delivery.
-
Qualitative data on how participants found post-delivery intervention
-
Effect of intervention on weight at 12 and 24 weeks
-
Effect of intervention on systolic and diastolic blood pressure at 12 and 24 weeks
-
Effect of intervention on lipid profile (total cholesterol, HDL, LDL) at 12 and 24 weeks
-
Effect of intervention on physical activity at 12 and 24 weeks
-
STUDY DESIGN We will conduct a feasibility study for an open-label, randomised, controlled trial of a personalised post-delivery intervention (DNA Nudge) to improve weight, glycaemia and cardiovascular function in women with previous GDM.
The study is designed to be remote, to enable the study to begin and continue in the pandemic and minimise barriers to recruitment. Study participants will be provided with equipment and instructions to collect samples and measurements at home. Contact with the research team will be over telephone or Microsoft Teams video call.
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
- 是
入选标准
- •Pregnant women with gestational diabetes (women will be given the option to start the study between 6 weeks and 6 months post-delivery) or
- •women who have given birth in the last 12 months and had gestational diabetes during that pregnancy
- •aged 18-45,
- •access to a smartphone with an operating system of iOS 9.0 or above, or Android 5.0 or above
排除标准
- •Diabetes outside of pregnancy (diagnosis of type 1 or 2 diabetes; or HbA1c 48 mmol/mol or above).
- •Health contra-indications to moderate-vigorous exercise.
- •Planning pregnancy during the study period or become pregnant during the study period. -Cancer
- •kidney disease
- •liver disease
- •pancreatitis.
- •gastric bypass surgery or similar weight loss surgery
结局指标
主要结局
HbA1c
时间窗: 12 weeks
Glycaemia
次要结局
- Systolic and diastolic Blood pressure(12 weeks)
- Systolic and Diastolic Blood pressure(24 weeks)
- HbA1c(24 weeks)
- Weight(24 weeks)