Gestational diabetes Pregnancy and Childbirth
Conditions
Interventions
75 pregnant individuals, at high risk of developing gestational diabetes will be recruited and randomised (25 in each arm) to receive one of three dietary interventions in the form of dietboxes conta
40% carbohydrate, 35% fat, 25% protein)
2. Active intervention 1: calorie restricted diet (1200 kCal
40% carbohydrate, 35% fat, 25% protein)
3. Active intervention 2: carbohydrate-restricted diet (2000 kCal
25% carbohydrate, 50% fat, 25% protein)
Randomisation will occur at the end of the baseline visit and will be stratified by BMI (<40 kg/m2
=40 kg/m2) and ethnicity (White ethnicity
Non-White ethnicity). The statistical software package Stata has been used to create four randomisation lists (excel spreadsheets), reflecting the stratification. This will be held by the study manage
Sponsors
University of Leicester
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant people aged =18 years 2. BMI >25 kg/m2 3. Confirmed pregnancy (=16 week’s gestation) 4. =1 risk factor for GDM (e.g., obesity, family history of diabetes, previous GDM, previous large baby weighing >4.5 kg, ethnicity at high risk of diabetes, or polycystic ovary syndrome) 5. Willing and able to consent to participate in the trial, with support from an interpreter if needed 6. Planned antenatal care at the same study centre, throughout their pregnancy (i.e. not planning to move away from the region before delivery)
Exclusion criteria
Exclusion criteria: 1. Women with evidence of multiple pregnancies 2. Termination planned 3. Pre-existing comorbidities such as renal failure, severe liver disease, cardiac failure, and psychiatric conditions requiring inpatient admission 4. Medications at the time of recruitment that may interfere with results (e.g., high-dose steroids, immunosuppressants). 5. Severe anaemia at the time of recruitment 6. Confirmed diagnosis of existing type 1 or type 2 diabetes mellitus 7. Haemoglobin A1c (HbA1c) at time of recruitment, indicative of GDM of >48 mmol/mol 8. Specialised dietary requirement (e.g., vegan or severe nut allergy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal fasting glycaemia measured by a fasting blood sample taken at the time of the 24 - 28 week oral glucose tolerance test (OGTT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maternal fasting glycaemia measured by a fasting blood sample taken at the time of the baseline (=16 weeks of pregnancy) oral glucose tolerance test (OGTT) 2. Maternal post-load glycaemia measured by a post-load blood sample at the time of the oral glucose tolerance test (OGTT) 3. Glycaemia TIR (%), TBR, average glucose, CV and SD from Continuous Glucose Monitor (CGM) Data and HbA1c blood sample at baseline (=16), 20, 24-28, 36 weeks of pregnancy (3 months postpartum HbA1c only) 4. Identification of insulin and indices of insulin resistance or secretion using blood sample collection taken 24-28 weeks of pregnancy when the participant has their routine OGTT (at fasting, 1-hour, and 2-hour post-load timepoints). 5. Identification of lipids using blood sample at baseline (=16), 24-28 (taken when the participants has their routine OGTT), and 36 weeks of pregnancy. 6. Maternal body composition changes measured using anthropometry and a 3D body scanning app at baseline (=16), 20, 24-28, 36 weeks of pregnancy and 3, 12, 24 months postnatally. (3D scanning App; baseline (=16), 24-28 and 36 weeks of pregnancy only). 7. Quantitation of liver and pancreatic fat in pregnancy using MRI at baseline (=16) and 24-28 weeks 8. Eating habits measured using the 24-hour recall questionnaire (Intake 24) at baseline (=16), 24-28 weeks and 36 weeks of pregnancy and 3, 12, 24 months postnatal. 9. Eating habits measured using the Three-Factor Eating Questionnaire (TFEQ) at baseline (=16) and 24-28 weeks of pregnancy and 3, 12, 24 months postnatal. 10. Dietary compliance using 3-day food diary and ordering information. Food diary to be completed at 20 weeks of pregnancy, food ordering to be documented weekly from the start of food intervention at baseline (=16) until completed at 24-28 weeks. 11. Quality of life measured using the EQ - 5D - 5L at baseline (=16), and 36 weeks of pregnancy plus 3, 12 and 24 months postnatally. 12. Physical activity using research-grade accelerometers | — |
Countries
England, United Kingdom
Contacts
Public ContactSylvia Brooks
Outcome results
None listed