Reduced-carbohydrate intervention to prevent gestational diabetes

• Research type

  Research Study

• Full title

  REduced-Carbohydrate intervention for managing Obesity and Reduction of gestational Diabetes (RECORD): A feasibility study

• IRAS ID

  279623

• Contact name

  Nerys Astbury

• Contact email

  nerys.astbury@phc.ox.ac.uk

• Sponsor organisation

  University of Oxford / Clinical Trials and Research Governance

• ISRCTN Number

  ISRCTN16235884

• Duration of Study in the UK

  1 years, 10 months, 31 days

• Research summary

  Research Summary:
  Gestational Diabetes (GDM) is a condition that develops during pregnancy, in which women’s blood glucose is high. GDM puts women and their babies at risk of medical problems in pregnancy and the long-term. Carrying or gaining too much weight whilst pregnant, increases the risk of developing GDM. GDM is diagnosed in the third trimester. By that time, many women have already gained too much weight and their babies have been exposed to high blood glucose levels. Effective ways to help limit weight gain and control blood glucose levels in women at risk of GDM, and that can be used early in pregnancy, are needed. \n\nWhat we eat affects our weight and blood glucose. Studies encouraging women to change their diet during pregnancy have helped to limit weight gain, but have been unable to prevent GDM. One way that might help to reduce weight gain and control blood glucose in pregnancy, is to follow a reduced-carbohydrate diet. Carbohydrates are the main source of energy, and eating carbohydrates leads to rise in blood glucose. Studies in non-pregnant people with diabetes, have shown that carbohydrate reduction leads to weight loss and lowers blood glucose in the short-term. Strict carbohydrate reduction may, however, not be appropriate in pregnancy. \n\nInstead, we developed a moderately reduced-carbohydrate dietary programme for women starting pregnancy with too much weight. We aim to test whether it is possible to deliver the programme alongside routine hospital appointments and how satisfied women are to follow it during the second and third trimester of pregnancy. We will monitor the impact of the programme on blood glucose and ketones, and explore its effect on weight gain and health outcomes throughout pregnancy. If successful, we will progress to a bigger study to investigate whether this diet can reduce the risk of developing GDM.\n

  Summary of Results:
  This was a trial testing the feasibility of a reduced-carbohydrate intervention in women with obesity during pregnancy, who were at risk of gestational diabetes. Recruitment and running of the trial was challenging during the COVID-19 pandemic. Women who chose to take part, found the intervention simple, practical, and overall acceptable, and retention and follow-up rates were good, suggesting the advice can be delivered by non-specialists, as well as that it is feasible to run the study processes alongside routine antenatal care. There were varying experiences in attempting to adhere to the diet, mainly pertaining to competing priorities, and the intervention did not lead to a meaningful reduction in carbohydrate intake. However, we observed promising potential effects of the intervention on secondary and exploratory outcomes, especially gestational weight gain and blood pressure. It is thus not justifiable to test the intervention in its current form in a larger trial, however, it may be worth refining this intervention and retesting it in a future feasibility trial.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  20/SC/0442

• Date of REC Opinion

  27 Jan 2021

• REC opinion

  Further Information Favourable Opinion