Development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trial
<p><strong>Introduction:</strong> Previous trials of dietary interventions to prevent gestational diabetes mellitus (GDM) have yielded only limited success. Low-carbohydrate diets have shown promise for the treatment of type 2 diabetes, but there is no evidence to support...
| Main Authors: | , , , , , , |
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| Format: | Journal article |
| Language: | English |
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BMJ Publishing Group
2022
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| _version_ | 1797109144480645120 |
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| author | Michalopoulou, M Hirst, JE Jebb, SA MacKillop, LH Dyson, P Wire, A Astbury, NM |
| author_facet | Michalopoulou, M Hirst, JE Jebb, SA MacKillop, LH Dyson, P Wire, A Astbury, NM |
| author_sort | Michalopoulou, M |
| collection | OXFORD |
| description | <p><strong>Introduction:</strong> Previous trials of dietary interventions to prevent gestational diabetes mellitus (GDM) have yielded only limited success. Low-carbohydrate diets have shown promise for the treatment of type 2 diabetes, but there is no evidence to support their use in pregnancy. The aim of this study is to explore the feasibility of a moderately reduced-carbohydrate dietary intervention delivered from mid-pregnancy alongside routine antenatal care.</p>
<p><strong>Methods and analysis:</strong> This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Sixty women who are pregnant <20 weeks’ gestation, with body mass index ≥30 kg/m<sup>2</sup> at their antenatal booking appointment, will be randomised 2:1 intervention or control (usual care) and followed up until delivery. The intervention is a moderately reduced-carbohydrate diet (~130–150 g total carbohydrate/day), designed to be delivered alongside routine antenatal appointments. Primary outcomes are measures of adoption of the diet and retention of participants. Secondary outcomes include incidence of GDM, change in markers of glycaemic control, gestational weight gain, total carbohydrate and energy intake. Process outcomes will examine resources and management issues. Exploratory outcomes include further dietary changes, quality of life, maternal and neonatal outcomes, and qualitative measures.</p>
<p><strong>Ethics and dissemination:</strong> This trial was reviewed and approved by the South-Central Oxford B Research Ethics Committee NHS National Research Ethics Committee and the Health Research Authority (Reference: 20/SC/0442). The study results will inform whether to progress to a full-scale RCT to test the clinical effectiveness of the RECORD programme to prevent GDM in women at high risk. The findings will be published in peer-reviewed journals and presented at conferences.</p>
<p><strong>Trial registration number:</strong> ISRCTN16235884.</p> |
| first_indexed | 2024-03-07T07:37:50Z |
| format | Journal article |
| id | oxford-uuid:588b13bb-a1b3-49dc-bca6-0bc0b1dfb3f9 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:37:50Z |
| publishDate | 2022 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oxford-uuid:588b13bb-a1b3-49dc-bca6-0bc0b1dfb3f92023-03-22T06:45:30ZDevelopment and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:588b13bb-a1b3-49dc-bca6-0bc0b1dfb3f9EnglishSymplectic ElementsBMJ Publishing Group2022Michalopoulou, MHirst, JEJebb, SAMacKillop, LHDyson, PWire, AAstbury, NM<p><strong>Introduction:</strong> Previous trials of dietary interventions to prevent gestational diabetes mellitus (GDM) have yielded only limited success. Low-carbohydrate diets have shown promise for the treatment of type 2 diabetes, but there is no evidence to support their use in pregnancy. The aim of this study is to explore the feasibility of a moderately reduced-carbohydrate dietary intervention delivered from mid-pregnancy alongside routine antenatal care.</p> <p><strong>Methods and analysis:</strong> This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Sixty women who are pregnant <20 weeks’ gestation, with body mass index ≥30 kg/m<sup>2</sup> at their antenatal booking appointment, will be randomised 2:1 intervention or control (usual care) and followed up until delivery. The intervention is a moderately reduced-carbohydrate diet (~130–150 g total carbohydrate/day), designed to be delivered alongside routine antenatal appointments. Primary outcomes are measures of adoption of the diet and retention of participants. Secondary outcomes include incidence of GDM, change in markers of glycaemic control, gestational weight gain, total carbohydrate and energy intake. Process outcomes will examine resources and management issues. Exploratory outcomes include further dietary changes, quality of life, maternal and neonatal outcomes, and qualitative measures.</p> <p><strong>Ethics and dissemination:</strong> This trial was reviewed and approved by the South-Central Oxford B Research Ethics Committee NHS National Research Ethics Committee and the Health Research Authority (Reference: 20/SC/0442). The study results will inform whether to progress to a full-scale RCT to test the clinical effectiveness of the RECORD programme to prevent GDM in women at high risk. The findings will be published in peer-reviewed journals and presented at conferences.</p> <p><strong>Trial registration number:</strong> ISRCTN16235884.</p> |
| spellingShingle | Michalopoulou, M Hirst, JE Jebb, SA MacKillop, LH Dyson, P Wire, A Astbury, NM Development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trial |
| title | Development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trial |
| title_full | Development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trial |
| title_fullStr | Development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trial |
| title_full_unstemmed | Development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trial |
| title_short | Development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes (RECORD): protocol for a feasibility randomised controlled trial |
| title_sort | development and testing of a reduced carbohydrate intervention for the management of obesity and reduction of gestational diabetes record protocol for a feasibility randomised controlled trial |
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