Gestational diabetes Pregnancy and Childbirth
Conditions
Interventions
Participants will be asked to give consent to join the study during pregnancy, shortly before they are due to give birth. They will begin the diet intervention at 6-13 weeks after childbirth, and cont
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women diagnosed with gestational diabetes as per the National Institute for Health and Care Excellence (NICE) criteria at time of consent and who are treated with metformin and/or insulin in pregnancy. 2. Aged 16 years or over at the time of consent. 3. Able and willing to follow a Mediterranean diet until 1 year after childbirth. 4. Smartphone user
Exclusion criteria
Exclusion criteria: 1. Unable to provide written informed consent in English 2. Diagnosed with pre-existing type 1 or type 2 diabetes 3. Body Mass Index of = 50 kg/m2 4. Allergic to nuts 5. Concomitant participation in: -another dietary interventional study during pregnancy; -another interventional study in the postnatal period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of screened women who are eligible for participation 2. Proportion of eligible women who consent to participate in the study, and who commence the intervention at 6-13 weeks. 3. Rates of follow-up at 6 months and 1 year after delivery. 4. Proportion of recruited women who adhere to the intervention of a Mediterranean based diet. Adherence will be measured as: 4.1 Proportion of women who engage with the coach (in an intervention session, and/or through interaction with the App) – measured continuously from 6-13 weeks postnatally to 12 months postnatally 4.2 Proportion of women who consume nuts and olive oil as self-reported (daily through the App) 4.3 Mediterranean diet adherence as self-reported through the ESTEEM diet questionnaire at 6 months and 12 months postnatally | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of women who engage with the lifestyle App, and frequency of engagement (on the App, engagement is defined as interaction e.g. logging a goal or sending a message), assessed continuously from 6-13 weeks postnatally to 12 months postnatally. 2. Women’s views relating to factors influencing their initial participation, the acceptability and adherence to the intervention, and the interaction with the App, through interviews 2-3 months and 5-8 months after the start of the intervention. 3. Robustness of the trial processes (measured as frequency of protocol deviations, data queries, issues with nuts and oil supplies, and major monitoring findings), assessed continuously throughout the trial. 4. Healthcare professionals’ views of the acceptability of delivering the intervention and adhering with the study protocol, through interviews during the intervention phase of the trial. 5. Proportion of women with normoglycaemia, and dysglycaemia (impaired glucose tolerance, pre-diabetes, T2D) through blood tests at 6 months and 12 months after delivery. 6. Weight change at 6 months and 1 year after delivery. 7. Preliminary relevant cost data to inform future economic evaluation, through clinical data collection at 6 months and 12 months postnatally. | — |
Countries
England, United Kingdom
Outcome results
None listed