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Erratum published on 17 June 2020, see Nutrients 2020, 12(6), 1793.
Article

Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial

1
Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK
2
Cambridge Universities NHS Foundation Trust, Cambridge CB2 0QQ, UK
3
Norwich Medical School, University of East Anglia, Norwich NR4 7UQ, UK
4
NIHR Cambridge Biomedical Research Centre—Diet, Anthropometry and Physical Activity Group, MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge CB2 0QQ, UK
5
Institute of Cellular Medicine, University of Newcastle, Cambridge NE4 5PL, UK
*
Author to whom correspondence should be addressed.
Nutrients 2020, 12(4), 1165; https://doi.org/10.3390/nu12041165
Received: 31 March 2020 / Revised: 11 April 2020 / Accepted: 16 April 2020 / Published: 22 April 2020
Gestational diabetes mellitus (GDM) annually affects 35,000 pregnancies in the United Kingdom, causing suboptimal health outcomes to the mother and child. Obesity and excessive gestational weight gain are risk factors for GDM. The Institute of Medicine recommends weight targets for women that are overweight and obese, however, there are no clear guidelines for women with GDM. Observational data suggest that modest weight loss (0.6–2 kg) after 28 weeks may reduce risk of caesarean section, large-for-gestational-age (LGA), and maternal postnatal glycaemia. This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes). A total of 500 women with GDM (National Institute of Health and Care Excellence (NICE) 2015 criteria) and body mass index (BMI) ≥25 kg/m2 will be randomised to receive a standard (2000 kcal/day) or reduced energy (1200 kcal/day) diet box containing all meals and snacks from 28 weeks to delivery. Women and caregivers will be blinded to the allocations. Food diaries, continuous glucose monitoring, and anthropometry will measure dietary compliance, glucose levels, and weight changes. Women will receive standard antenatal GDM management (insulin/metformin) according to NICE guidelines. The secondary endpoints include caesarean section rates, LGA, and maternal postnatal glucose concentrations. View Full-Text
Keywords: gestational diabetes; pregnancy; study protocol; randomised controlled trial; large-for-gestational age; diet; dietary intervention; maternal or gestational weight gain; continuous glucose monitoring (CGM); neonatal outcomes; neonatal hypoglycaemia; neonatal growth; maternal obesity gestational diabetes; pregnancy; study protocol; randomised controlled trial; large-for-gestational age; diet; dietary intervention; maternal or gestational weight gain; continuous glucose monitoring (CGM); neonatal outcomes; neonatal hypoglycaemia; neonatal growth; maternal obesity
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MDPI and ACS Style

Kusinski, L.C.; Murphy, H.R.; De Lucia Rolfe, E.; Rennie, K.L.; Oude Griep, L.M.; Hughes, D.; Taylor, R.; Meek, C.L. Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial. Nutrients 2020, 12, 1165. https://doi.org/10.3390/nu12041165

AMA Style

Kusinski LC, Murphy HR, De Lucia Rolfe E, Rennie KL, Oude Griep LM, Hughes D, Taylor R, Meek CL. Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial. Nutrients. 2020; 12(4):1165. https://doi.org/10.3390/nu12041165

Chicago/Turabian Style

Kusinski, Laura C., Helen R. Murphy, Emanuella De Lucia Rolfe, Kirsten L. Rennie, Linda M. Oude Griep, Deborah Hughes, Roy Taylor, and Claire L. Meek. 2020. "Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial" Nutrients 12, no. 4: 1165. https://doi.org/10.3390/nu12041165

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