Post-delivery intervention for women with previous gestational diabetes to improve health
Post Delivery Intervention in Women With Previous Gestational Diabetes Mellitus to Improve Glycaemia
This study is testing a personalized program for women who had gestational diabetes after giving birth to see if it can help them improve their blood sugar, lose weight, and boost their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Imperial College Healthcare NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06022601 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the effectiveness of a personalized post-delivery intervention designed to improve glycemia, promote weight loss, and enhance cardiovascular health in women who have experienced gestational diabetes. Participants will be randomly assigned to either the intervention group or a control group, with outcomes measured at 12 and 24 weeks. The study will utilize remote methods for data collection and participant engagement, minimizing barriers to participation. Key outcomes include changes in HbA1c levels, weight, blood pressure, and lipid profiles.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 who have had gestational diabetes and are within 6 weeks to 6 months post-delivery.
Not a fit: Patients with pre-existing diabetes, significant health contraindications, or those planning to become pregnant during the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes for women with a history of gestational diabetes, reducing their risk of developing type 2 diabetes and cardiovascular diseases.
How similar studies have performed: Other studies have shown promise in similar interventions for managing gestational diabetes, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Edward Mullins
- Email: edward.mullins@imperial.ac.uk
- Phone: 07881029947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.