REduced-Carbohydrate intervention for managing Obesity and Reduction of gestational Diabetes (RECORD): a randomized controlled feasibility trial
Author(s)
Type
Journal Article
Abstract
AIM: To test the feasibility and acceptability of a reduced-carbohydrate dietary program, intended to reduce the risk of gestational diabetes. MATERIALS AND METHODS: Fifty-one pregnant women at <20 weeks' gestation, with body mass index ≥30 kg/m2 , and a normal baseline oral glucose tolerance test (OGTT), were randomized 2:1 to an intervention or control group and followed-up until delivery. The dietary intervention aimed at providing 130-150 g carbohydrate/day. Feasibility outcomes assessed at 24-28 weeks' gestation, included adoption of the reduced-carbohydrate diet by the intervention group, and retention of all participants, assessed by completion of a second OGTT. Changes in glycemia, weight gain and dietary intake, and the maternal and neonatal outcomes were also assessed. Participants were interviewed about their experience of the intervention and the study. RESULTS: Forty-nine of 51 participants attended the follow-up OGTT, a retention rate of 96% (95% confidence interval [CI] 86.8%-98.9%). In the intervention group, carbohydrate intake at follow-up was 190.4 (95% CI 162.5-215.6) g/day, a reduction of -24.6 (95% CI -51.5-2.4) g/day from baseline. Potentially favourable effects of the intervention on glucose control, weight gain and blood pressure were observed, but the study was not powered to detect significant differences in these. Participants found the intervention acceptable, and were content with the study processes, but some reported barriers to sustained adherence, mainly pertaining to competing priorities. CONCLUSIONS: Retention was high, suggesting the study processes are feasible, but the carbohydrate reduction in the intervention group was small, and did not meet progression criteria, limiting the likelihood of achieving the desired goal to prevent gestational diabetes. TRIAL REGISTRATION NUMBER: ISRCTN16235884.
Date Issued
2024-04
Date Acceptance
2023-12-19
Citation
Diabetes, Obesity and Metabolism: a journal of pharmacology and therapeutics, 2024, 26 (4), pp.1407-1420
ISSN
1462-8902
Publisher
Wiley
Start Page
1407
End Page
1420
Journal / Book Title
Diabetes, Obesity and Metabolism: a journal of pharmacology and therapeutics
Volume
26
Issue
4
Copyright Statement
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any
medium, provided the original work is properly cited and is not used for commercial purposes.
© 2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
medium, provided the original work is properly cited and is not used for commercial purposes.
© 2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/38229418
Subjects
clinical trial
dietary intervention
obesity therapy
primary care
real-world evidence
weight control
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2024-01-16