Pregnancy-related interventions in mothers at risk for gestational diabetes in Asian India and low and middle-income countries (PRIMORDIAL study): protocol for a randomised controlled trial
Pregnancy-related interventions in mothers at risk for gestational diabetes in Asian India and low and middle-income countries (PRIMORDIAL study): protocol for a randomised controlled trial
Introduction Lifestyle modification is the mainstay of gestational diabetes mellitus (GDM) prevention. However, clinical trials evaluating the safety and efficacy of diet or physical activity (PA) in low-income and middle-income settings such as Africa and India are lacking. This trial aims to evaluate the efficacy of yoghurt consumption and increased PA (daily walking) in reducing GDM incidence in high-risk pregnant women. Methods and analysis The study is a 2×2 factorial, open-labelled, multicentre randomised controlled trial to be conducted in Vellore, South India and The Gambia, West Africa. â € High-risk' pregnant women (n=1856) aged ≥18 years and ≤16 weeks of gestational age, with at least one risk factor for developing GDM, will be randomised to either (1) yoghurt (2) PA (3) yoghurt +PA or (4) standard antenatal care. Participants will be followed until 32 weeks of gestation with total active intervention lasting for a minimum of 16 weeks. The primary endpoint is GDM incidence at 26-28 weeks diagnosed using International Association of the Diabetes and Pregnancy Study Groups criteria or elevated fasting glucose (≥5.1 mmol/L) at 32 weeks. Secondary endpoints include absolute values of fasting plasma glucose concentration at 32 weeks gestation, maternal blood pressure, gestational weight gain, intrapartum and neonatal outcomes. Analysis will be both by intention to treat and per-protocol. Continuous outcome measurements will be analysed using multiple linear regression and binary variables by logistic regression. Ethics and dissemination The study is approved by Oxford Tropical Research Ethics Committee (44-18), ethics committees of the Christian Medical College, Vellore (IRB 11367) and MRCG Scientific Coordinating Committee (SCC 1645) and The Gambia Government/MRCG joint ethics committee (L2020.E15). Findings of the study will be published in peer-reviewed scientific journals and presented in conferences.
diabetes in pregnancy, maternal medicine, obstetrics, preventive medicine, public health
Vasan, Senthil K.
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Jobe, Modou
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Mathews, Jiji
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Cole, Fatoumata
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Rathore, Swathi
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Jarjou, Ousman
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Thompson, Dylan
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Jarde, Alexander
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Bittaye, Mustapha
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Ulijaszek, Stanley
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Fall, Caroline
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Osmond, Clive
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Prentice, Andrew M.
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Karpe, Fredrik
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17 February 2021
Vasan, Senthil K.
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Jobe, Modou
dc51c8fe-552a-423e-b9c1-32ca720383dc
Mathews, Jiji
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Cole, Fatoumata
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Rathore, Swathi
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Jarjou, Ousman
da4e4392-1d2b-43f9-9444-fbe280e8e3d2
Thompson, Dylan
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Jarde, Alexander
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Bittaye, Mustapha
268c25e5-0d40-4687-bdb9-394bacdbb1ce
Ulijaszek, Stanley
713e983e-90aa-4994-9dfa-58ae75917162
Fall, Caroline
7171a105-34f5-4131-89d7-1aa639893b18
Osmond, Clive
2677bf85-494f-4a78-adf8-580e1b8acb81
Prentice, Andrew M.
6b851f61-f989-48f6-8109-9a7408254728
Karpe, Fredrik
05abcb32-83b7-44eb-ab12-7c360f4f9c12
Vasan, Senthil K., Jobe, Modou, Mathews, Jiji, Cole, Fatoumata, Rathore, Swathi, Jarjou, Ousman, Thompson, Dylan, Jarde, Alexander, Bittaye, Mustapha, Ulijaszek, Stanley, Fall, Caroline, Osmond, Clive, Prentice, Andrew M. and Karpe, Fredrik
(2021)
Pregnancy-related interventions in mothers at risk for gestational diabetes in Asian India and low and middle-income countries (PRIMORDIAL study): protocol for a randomised controlled trial.
BMJ Open, 11 (2), [e042069].
(doi:10.1136/bmjopen-2020-042069).
Abstract
Introduction Lifestyle modification is the mainstay of gestational diabetes mellitus (GDM) prevention. However, clinical trials evaluating the safety and efficacy of diet or physical activity (PA) in low-income and middle-income settings such as Africa and India are lacking. This trial aims to evaluate the efficacy of yoghurt consumption and increased PA (daily walking) in reducing GDM incidence in high-risk pregnant women. Methods and analysis The study is a 2×2 factorial, open-labelled, multicentre randomised controlled trial to be conducted in Vellore, South India and The Gambia, West Africa. â € High-risk' pregnant women (n=1856) aged ≥18 years and ≤16 weeks of gestational age, with at least one risk factor for developing GDM, will be randomised to either (1) yoghurt (2) PA (3) yoghurt +PA or (4) standard antenatal care. Participants will be followed until 32 weeks of gestation with total active intervention lasting for a minimum of 16 weeks. The primary endpoint is GDM incidence at 26-28 weeks diagnosed using International Association of the Diabetes and Pregnancy Study Groups criteria or elevated fasting glucose (≥5.1 mmol/L) at 32 weeks. Secondary endpoints include absolute values of fasting plasma glucose concentration at 32 weeks gestation, maternal blood pressure, gestational weight gain, intrapartum and neonatal outcomes. Analysis will be both by intention to treat and per-protocol. Continuous outcome measurements will be analysed using multiple linear regression and binary variables by logistic regression. Ethics and dissemination The study is approved by Oxford Tropical Research Ethics Committee (44-18), ethics committees of the Christian Medical College, Vellore (IRB 11367) and MRCG Scientific Coordinating Committee (SCC 1645) and The Gambia Government/MRCG joint ethics committee (L2020.E15). Findings of the study will be published in peer-reviewed scientific journals and presented in conferences.
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Main document_clean_20012021
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Pregnancy- related interventions
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Accepted/In Press date: 27 January 2021
e-pub ahead of print date: February 2021
Published date: 17 February 2021
Additional Information:
Funding Information:
Funding This study is supported by grants jointly from Medical Research Council, UK (MR/R020345/1) and Newton Fund-Director of Biotechnology, India (BT/IN/DBT-MRC/DIFD/JM/12/2018–19) The study is partly supported by the Global Challenges Research fund, University of Oxford, UK (0006138) Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, UK, GCRF, UK, DBT, India, healthcare systems or competent authorities.
Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.
Keywords:
diabetes in pregnancy, maternal medicine, obstetrics, preventive medicine, public health
Identifiers
Local EPrints ID: 447672
URI: http://eprints.soton.ac.uk/id/eprint/447672
ISSN: 2044-6055
PURE UUID: 452758be-3681-40fe-99ad-0403c134ddd0
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Date deposited: 18 Mar 2021 17:34
Last modified: 06 Jun 2024 01:35
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Contributors
Author:
Senthil K. Vasan
Author:
Modou Jobe
Author:
Jiji Mathews
Author:
Fatoumata Cole
Author:
Swathi Rathore
Author:
Ousman Jarjou
Author:
Dylan Thompson
Author:
Alexander Jarde
Author:
Mustapha Bittaye
Author:
Stanley Ulijaszek
Author:
Andrew M. Prentice
Author:
Fredrik Karpe
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