Status:
UNKNOWN
Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia
Lead Sponsor:
Imperial College Healthcare NHS Trust
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
STUDY OBJECTIVES Objectives To assess: 1. Effect of intervention on HbA1c at 12 and 24 weeks 2. Adherence to intervention 3. Participants' preferred time to commence the study, within the start date...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06022601
Start Date
March 1 2023
End Date
September 30 2024
Last Update
September 5 2023
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS