Reduced-carbohydrate intervention to prevent gestational diabetes

Not Applicable

Completed

• Conditions: Gestational diabetes; Pregnancy and Childbirth; Diabetes mellitus arising in pregnancy

• Registration Number: ISRCTN16235884
• Lead Sponsor: niversity of Oxford

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36581990/ (added 29/12/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38229418/ (added 22/01/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study Completion: 2022-12-31
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

Current inclusion criteria as of 12/10/2021:
1. Pregnant women at <20 weeks’ gestation
2. 18 years of age and above
3. BMI =30 kg/m² at baseline assessment
4. Planned antenatal care at the study setting until delivery
5. Women who are able to provide written informed consent

Previous inclusion criteria:
1. Pregnant women at <15 weeks’ gestation
2. 18 years of age and above
3. BMI =30 kg/m² at baseline assessment
4. Planned antenatal care at the study setting until delivery
5. Women who are able to provide written informed consent

Exclusion Criteria

1. Severe congenital anomaly (confirmed by ultrasound)
2. Planned termination of pregnancy
3. Pre-pregnancy diagnosis of diabetes (type 1 or type 2), renal disease, severe liver disease, organ transplant, cardiac failure (Grade II New York Heart Association, and more severe), severe neurological disorder (including epilepsy), severe psychiatric disease requiring in-patient admission
4. A fasting plasma glucose level of 5.6 mmol/l or above or a 2-hour plasma glucose level of 7.8 mmol/l or above, at the baseline OGTT
5. Taking metformin, as it affects glycaemia
6. History or suspicion of, eating disorder
7. Hyperemesis gravidarum
8. Women unable to understand spoken and written English
9. Previous bariatric surgery
10. Women participating in other intervention research studies that may affect their weight, health behaviours or blood glucose control
11. Any other significant disease or disorder which, in the opinion of the Chief Investigator or clinical co-investigators, may either put the participants at risk because of participation in the trial, or may influence the result of the study, or the participant’s ability to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility progression criteria:<br>1. Adoption of the intervention: mean reduction in total carbohydrate intake per day in the intervention group, assessed by dietary composition analysis at the baseline visit (<20 weeks’ gestation) and at the follow-up visit (24-28 weeks’ gestation)<br>2. Retention rate: proportion of participants from whom OGTT data is available at the follow-up visit, documented during the follow-up visit at 24-28 weeks’ gestation<br><br>Updated 31/05/2022: the baseline visit was changed from <15 weeks’ gestation” to <20 weeks’ gestation”.