Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial
Abstract Background Obesity in pregnancy increases the risk of gestational diabetes mellitus (GDM) and associated adverse outcomes. Despite metabolic differences, all pregnant women with obesity are considered to have the same risk of developing GDM. Improved risk stratification is required to enabl...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-03-01
|
| Series: | Pilot and Feasibility Studies |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40814-022-01021-3 |
| _version_ | 1818356829216833536 |
|---|---|
| author | Ola F. Quotah Glen Nishku Jessamine Hunt Paul T. Seed Carolyn Gill Anna Brockbank Omoyele Fafowora Ilektra Vasiloudi Opeoluwa Olusoga Ellie Cheek Jannelle Phillips Katarzyna G. Nowak Lucilla Poston Sara L. White Angela C. Flynn |
| author_facet | Ola F. Quotah Glen Nishku Jessamine Hunt Paul T. Seed Carolyn Gill Anna Brockbank Omoyele Fafowora Ilektra Vasiloudi Opeoluwa Olusoga Ellie Cheek Jannelle Phillips Katarzyna G. Nowak Lucilla Poston Sara L. White Angela C. Flynn |
| author_sort | Ola F. Quotah |
| collection | DOAJ |
| description | Abstract Background Obesity in pregnancy increases the risk of gestational diabetes mellitus (GDM) and associated adverse outcomes. Despite metabolic differences, all pregnant women with obesity are considered to have the same risk of developing GDM. Improved risk stratification is required to enable targeted intervention in women with obesity who would benefit the most. The aim of this study is to identify pregnant women with obesity at higher risk of developing GDM and, in a pilot randomised controlled trial (RCT), test feasibility and assess the efficacy of a lifestyle intervention and/or metformin to improve glycaemic control. Methods Women aged 18 years or older with a singleton pregnancy and body mass index (BMI) ≥ 30kg/m2 will be recruited from one maternity unit in London, UK. The risk of GDM will be assessed using a multivariable GDM prediction model combining maternal age, mid-arm circumference, systolic blood pressure, glucose, triglycerides and HbA1c. Women identified at a higher risk of developing GDM will be randomly allocated to one of two intervention groups (lifestyle advice with or without metformin) or standard antenatal care. The primary feasibility outcomes are study recruitment, retention rate and intervention adherence and to collect information needed for the sample size calculation for the definitive trial. A process evaluation will assess the acceptability of study processes and procedures to women. Secondary patient-centred outcomes include a reduction in mean glucose/24h of 0.5mmol/l as assessed by continuous glucose monitoring and changes in a targeted maternal metabolome, dietary intake and physical activity. A sample of 60 high-risk women is required. Discussion Early risk stratification of GDM in pregnant women with obesity and targeted intervention using lifestyle advice with or without metformin could improve glucose tolerance compared to standard antenatal care. The results from this feasibility study will inform a larger adequately powered RCT should the intervention show trends for potential effectiveness. Trial registration This study has been approved by the NHS Research Ethics Committee (UK IRAS integrated research application system; reference 18/LO/1500). EudraCT number 2018-000003-16 . |
| first_indexed | 2024-12-13T20:03:26Z |
| format | Article |
| id | doaj.art-c362be02ef464f5db712bde18427723b |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-12-13T20:03:26Z |
| publishDate | 2022-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-c362be02ef464f5db712bde18427723b2022-12-21T23:33:06ZengBMCPilot and Feasibility Studies2055-57842022-03-01811910.1186/s40814-022-01021-3Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trialOla F. Quotah0Glen Nishku1Jessamine Hunt2Paul T. Seed3Carolyn Gill4Anna Brockbank5Omoyele Fafowora6Ilektra Vasiloudi7Opeoluwa Olusoga8Ellie Cheek9Jannelle Phillips10Katarzyna G. Nowak11Lucilla Poston12Sara L. White13Angela C. Flynn14Department of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonDepartment of Women and Children’s Health, School of Life Course Sciences, King’s College LondonAbstract Background Obesity in pregnancy increases the risk of gestational diabetes mellitus (GDM) and associated adverse outcomes. Despite metabolic differences, all pregnant women with obesity are considered to have the same risk of developing GDM. Improved risk stratification is required to enable targeted intervention in women with obesity who would benefit the most. The aim of this study is to identify pregnant women with obesity at higher risk of developing GDM and, in a pilot randomised controlled trial (RCT), test feasibility and assess the efficacy of a lifestyle intervention and/or metformin to improve glycaemic control. Methods Women aged 18 years or older with a singleton pregnancy and body mass index (BMI) ≥ 30kg/m2 will be recruited from one maternity unit in London, UK. The risk of GDM will be assessed using a multivariable GDM prediction model combining maternal age, mid-arm circumference, systolic blood pressure, glucose, triglycerides and HbA1c. Women identified at a higher risk of developing GDM will be randomly allocated to one of two intervention groups (lifestyle advice with or without metformin) or standard antenatal care. The primary feasibility outcomes are study recruitment, retention rate and intervention adherence and to collect information needed for the sample size calculation for the definitive trial. A process evaluation will assess the acceptability of study processes and procedures to women. Secondary patient-centred outcomes include a reduction in mean glucose/24h of 0.5mmol/l as assessed by continuous glucose monitoring and changes in a targeted maternal metabolome, dietary intake and physical activity. A sample of 60 high-risk women is required. Discussion Early risk stratification of GDM in pregnant women with obesity and targeted intervention using lifestyle advice with or without metformin could improve glucose tolerance compared to standard antenatal care. The results from this feasibility study will inform a larger adequately powered RCT should the intervention show trends for potential effectiveness. Trial registration This study has been approved by the NHS Research Ethics Committee (UK IRAS integrated research application system; reference 18/LO/1500). EudraCT number 2018-000003-16 .https://doi.org/10.1186/s40814-022-01021-3Gestational diabetesMaternal obesityLifestyle interventionMetformin |
| spellingShingle | Ola F. Quotah Glen Nishku Jessamine Hunt Paul T. Seed Carolyn Gill Anna Brockbank Omoyele Fafowora Ilektra Vasiloudi Opeoluwa Olusoga Ellie Cheek Jannelle Phillips Katarzyna G. Nowak Lucilla Poston Sara L. White Angela C. Flynn Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial Pilot and Feasibility Studies Gestational diabetes Maternal obesity Lifestyle intervention Metformin |
| title | Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial |
| title_full | Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial |
| title_fullStr | Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial |
| title_full_unstemmed | Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial |
| title_short | Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial |
| title_sort | prevention of gestational diabetes in pregnant women with obesity protocol for a pilot randomised controlled trial |
| topic | Gestational diabetes Maternal obesity Lifestyle intervention Metformin |
| url | https://doi.org/10.1186/s40814-022-01021-3 |
| work_keys_str_mv | AT olafquotah preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT glennishku preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT jessaminehunt preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT paultseed preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT carolyngill preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT annabrockbank preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT omoyelefafowora preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT ilektravasiloudi preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT opeoluwaolusoga preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT elliecheek preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT jannellephillips preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT katarzynagnowak preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT lucillaposton preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT saralwhite preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial AT angelacflynn preventionofgestationaldiabetesinpregnantwomenwithobesityprotocolforapilotrandomisedcontrolledtrial |