Developing a lifestyle intervention for women with GDM
Research type
Research Study
Full title
Developing a lifestyle intervention for women with Gestational Diabetes Mellitus (GDM). V1
IRAS ID
234484
Contact name
Marlene Sinclair
Contact email
Sponsor organisation
Ulster University
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
The overall aim of the study is to investigate whether increasing physical activity, reducing sedentary behavior and providing social support can improve maternal and fetal outcomes for women diagnosed with gestational diabetes mellitus (GDM).
GDM is glucose intolerance, which begins or is first diagnosed during pregnancy (Metzger and Coustan 1998). The number of women being diagnosed with GDM during pregnancy has increased in recent years. The increase in cases of GDM is due in part to a change in diagnostic criteria due to studies such as that by the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) Study Cooperative Research Group (2008) which identified maternal and fetal risks associated with diabetes at lower glucose levels than that of diabetes diagnosis and
the 2015 NICE guidelines (NICE 2015). The rate of GDM is also increasing due to growing rates of overweight and obesity (World Health Organisation (WHO) 2015) and higher maternal age at delivery (Lin et al. 2016).Women diagnosed with GDM are six times more likely to go on to be diagnosed with type 2 diabetes in the future (Bellamy et al. 2009). In addition, babies born to mothers with GDM are more likely to go on to be obese adults due to intrauterine programming (RCOG) 2011).
The study has 4 phases; this ethics application applies only to phase 3. Phase 1 is a systematic literature review. Phase 2 is data analysis of linked databases, through the Honest Broker service (Full ethical approval obtained REF:15/NW/0763). Phase 3 is focus groups/interviews with women who have previously had GDM and had attended the Ulster Hospital. The focus groups will inform the design of the intervention in phase 4. Phase 4 is a lifestyle intervention (RCT) taking place at the Ulster Hospital with women diagnosed with GDM.
REC name
HSC REC B
REC reference
17/NI/0194
Date of REC Opinion
19 Oct 2017
REC opinion
Favourable Opinion