GODDESS version 1
Research type
Research Study
Full title
The GestatiOnal Diabetes future DiabEteS prevention Study (GODDESS) - feasibility study
IRAS ID
177238
Contact name
Angus Forbes
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Women who develop a type of diabetes during pregnancy called gestational diabetes mellitus (GDM), are at higher risk of developing type 2 diabetes (T2DM) in the future compared to women without GDM. There are also at risk of further episodes of GDM in subsequent pregnancies. An estimated 1 in 20 pregnancies in the UK are affected by GDM, and the incidence is increasing. The children of mothers with diabetes in pregnancy are more likely to be obese or develop T2DM. T2DM is associated with long-term complications, but can be delayed or prevented in populations at high risk, through lifestyle interventions promoting healthy eating, physical activity or weight loss.
We have developed an intervention to help prevent T2DM through healthy eating, physical activity and weight loss in women with GDM, and want to undertake a feasibility study before we conduct a full scale trial of this intervention. We will recruit 60 women who have recently received a diagnosis of GDM. We will randomly assign 30 women to receive the intervention and 30 to receive usual care. Firstly we will examine the feasibility of conducting a trial through measuring the number of participants recruited and retained in the study. We will also assess acceptability of the trial and intervention from the participants' and healthcare professionals' perspectives. Secondly, we will measure a number of other factors in both groups for indications of preliminary efficacy of the intervention. These include weight loss, diet, physical activity, blood glucose, depression and diabetes risk perception. The results of this feasibility trial will be used to inform the full scale trial, where we will test the effectiveness of the intervention.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0794
Date of REC Opinion
25 Jun 2018
REC opinion
Further Information Favourable Opinion