Gestational Diabetes Clinical Trial
— Post-GDM-DNAOfficial title:
Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia
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
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1c | Glycaemia | 12 weeks | |
Secondary | HbA1c | Glycaemia | 24 weeks | |
Secondary | Weight | kg | 12 weeks | |
Secondary | Weight | kg | 24 weeks | |
Secondary | Systolic and diastolic Blood pressure | mmHg | 12 weeks | |
Secondary | Systolic and Diastolic Blood pressure | mmHg | 24 weeks |
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