| dc.description.abstract | Aim and objectives The aim of this thesis is to investigate methods to prevent the progression to type 2 diabetes in the immediate postnatal period, in women diagnosed with gestational diabetes mellitus (GDM). The objectives of this thesis are to explore the views of pregnant women diagnosed with gestational diabetes and healthcare professionals, with regards to the use of an app in the postnatal period which will provide information about diet for type 2 diabetes prevention. The development of a protocol for a single-arm feasibility study on a Mediterranean-style diet for the prevention of type 2 diabetes in the postnatal period. To pilot the trial design and study processes and assess the feasibility of a large-scale trial on the effectiveness of a Mediterranean-style diet in postnatal period for type 2 diabetes prevention. To examine the acceptability of a Mediterranean-style diet for type 2 diabetes prevention in women taking part in a feasibility study and explore the opinions of women and healthcare professionals on trial processes. To develop a protocol for a pilot trial on metformin for the prevention of type 2 diabetes in the postnatal period. Pilot the trial design and study processes and assess the feasibility of a large-scale trial on the effectiveness of metformin in postnatal period for type 2 diabetes prevention. Methods The methods employed in this thesis include a cross-sectional survey, a single arm mixed method feasibility study with qualitative evaluation (which included the use of an app) and a mixed method randomised controlled double blind feasibility study with the use of metformin or placebo. Results Survey The survey demonstrated that app usage is part of everyday life, with 84% (85/101) of pregnant GDM women and 82% (71/87) of healthcare professionals using apps daily. All pregnant women who participated in this survey had a device by which they could access apps (100%, 101/101) and 95% (179/188) of the participants had a smartphone. The participants agreed that an app which provides dietary information in the postnatal period for diabetes prevention would be welcomed by postnatal women with GDM history. Single arm feasibility study on a Mediterranean-style diet for the prevention of T2D in the postnatal period (MERIT) A total of 69% (83/121) of eligible multi-ethnic women agreed to participate and 67% (56/83) of those initially recruited commenced the intervention. The last visit (12 months postnatally) was completed by 73.2% (41/56) of participants. A higher number of participants completed visit 2 (which is at 6 months postnatally) 80.4% (45/56), but this visit was completed remotely due to COVID-19 pandemic lockdown restrictions, whereas visit 3 was completed face-to-face. Participants had high engagement with the coach, both face-to-face and via phone-calls or text messages. Adherence based on the ESTEEM diet questionnaire was high at the end of the study. There was a trend of reduction of total dysglycaemia, and the participants weight was also reduced by 1.3kg, from visit 1 (6 to 13 weeks) to visit 3 (12 months postnatally). Clinical effectiveness discussion is exploratory due to the small sample size. The intervention and trial processes were acceptable to women and healthcare professionals, adherence was high when women had a supportive environment, provided by their family and the health coach. The group chat function was not successful in this study. Randomised double-blind placebo-controlled pilot trial on metformin for the prevention of T2D in the postnatal period (OMAhA) A total of 57.9% (175/302) of eligible multi-ethnic women agreed to take part in the study, out of those 82.3% (144/175) were randomised to receive metformin or placebo. The attendance rates for visits 2 (6 months) and 3 (12 months) were similar, with 54.6% (71/130) and 55.7 (64/115) attending each visit respectively. Due to the COVID-19 pandemic visit 3 was completed over the phone for 21.7% (39/115) of the participants which led to limited blood samples collection. Total dysglycaemia reduction was evident in the metformin group (18.3%) compared to the placebo group (24.7%) but this discussion is exploratory, and the study is not powered to measure effectiveness. The metformin group maintained their weight throughout the study, whereas the placebo group gained 400g. Adherence was 54.1% (participants who took at least 75% of the recommended dosage). The study was acceptable to both women and healthcare professionals, but the element of peer-support should be included in future studies. Conclusion It is feasible and acceptable to recruit women in the postnatal period in studies that are focused on diabetes prevention and introduce dietary or pharmacological interventions. The MERIT protocol will have to be revised to address how follow-up rates can be improved. The OMAhA protocol will also be revised to target improvement in adherence and follow-up rates. The COVID-19 pandemic lockdown restrictions and staffing issues have impacted data collection of both studies. More research is needed in this population with larger sample sizes to be able to prove efficacy. The strongest motivator that affects adherence and retention is the woman’s perception of her own risk of developing diabetes. Future studies should include the element of peer support and an education session about the risk of Type 2 Diabetes in postnatal period. | en_US |
