TY - JOUR
T1 - Pregnancy-related interventions in mothers at risk for gestational diabetes in Asian India and low and middle-income countries (PRIMORDIAL study)
T2 - Protocol for a randomised controlled trial
AU - Vasan, Senthil K.
AU - Jobe, Modou
AU - Mathews, Jiji
AU - Cole, Fatoumata
AU - Rathore, Swathi
AU - Jarjou, Ousman
AU - Thompson, Dylan
AU - Jarde, Alexander
AU - Bittaye, Mustapha
AU - Ulijaszek, Stanley
AU - Fall, Caroline
AU - Osmond, Clive
AU - Prentice, Andrew
AU - Karpe, Fredrik
N1 - 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.
PY - 2021/2/17
Y1 - 2021/2/17
N2 - 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.
AB - 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.
KW - diabetes in pregnancy
KW - maternal medicine
KW - obstetrics
KW - preventive medicine
KW - public health
UR - http://www.scopus.com/inward/record.url?scp=85100946350&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-042069
DO - 10.1136/bmjopen-2020-042069
M3 - Article
AN - SCOPUS:85100946350
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e042069
ER -
