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 eval...

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Autores principales: 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, Karpe, Fredrik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7893661/
https://www.ncbi.nlm.nih.gov/pubmed/33597136
http://dx.doi.org/10.1136/bmjopen-2020-042069
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author 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
Karpe, Fredrik
author_facet 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
Karpe, Fredrik
author_sort Vasan, Senthil K
collection PubMed
description 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. ‘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. TRIAL REGISTRATION NUMBER: ISRCTN18467720.
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spelling pubmed-78936612021-03-03 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 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 Karpe, Fredrik BMJ Open Diabetes and Endocrinology 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. ‘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. TRIAL REGISTRATION NUMBER: ISRCTN18467720. BMJ Publishing Group 2021-02-17 /pmc/articles/PMC7893661/ /pubmed/33597136 http://dx.doi.org/10.1136/bmjopen-2020-042069 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Diabetes and Endocrinology
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
Karpe, Fredrik
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Diabetes and Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7893661/
https://www.ncbi.nlm.nih.gov/pubmed/33597136
http://dx.doi.org/10.1136/bmjopen-2020-042069
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