Postnatal lifestyle intervention in women with previous GDM-2
Research type
Research Study
Full title
Pragmatic Pregnancy and Post Pregnancy Lifestyle Intervention for Overweight Women with Gestational Diabetes Mellitus: a randomised controlled clinical trial (PAIGE2)
IRAS ID
250005
Contact name
David R McCance
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Gestational Diabetes Mellitus (GDM), defined as high blood sugar levels during pregnancy, is an increasing health problem worldwide. Increased maternal weight is a major risk factor for GDM. Women with GDM are 7 times more likely to develop future type 2 diabetes compared to women without GDM. There is good evidence outside of pregnancy that lifestyle change (diet and physical activity) can reduce the development of type 2 diabetes in people at risk. A recent review of postnatal lifestyle intervention trials concluded that no single intervention was superior and that further research was urgently needed in this area.
We have recently completed a pilot program for overweight women with previous GDM (PAIGE). Women randomised to PAIGE attended a one-hour group education session during their check-up visit; received 3 months free Slimming World membership and maintained regular contact with study staff. The results showed a significant 3.9 kgs weight reduction at 6 months among 31 women in PAIGE vs 29 women who received usual care, supporting its clinical usefulness.
PAIGE2 aims to recruit larger numbers of subjects, across 6 maternity hospitals and over a longer period. Women will be recruited to the intervention or control (usual care) groups shortly after the diagnosis of GDM at 28 weeks gestation. Women randomised to the intervention group (PAIGE2) will attend a one-hour education program during a routine pregnancy attendance (32-36 weeks gestation). Women in the intervention arm will be contacted 6-8 weeks post-delivery to provide further information and a free referral to Slimming World. Contact will be maintained via phone calls and text messages in the intervention group and both arms will attend follow-ups at 6 and 12 months postnatally. The primary outcome is weight reduction at 12 months.
REC name
HSC REC A
REC reference
18/NI/0228
Date of REC Opinion
21 Dec 2018
REC opinion
Favourable Opinion