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.
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DOI：
10.1136/bmjopen-2020-042069
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发表时间：
2021-02-17
期刊：
影响因子：
2.9
通讯作者：
Karpe F
中科院分区：
文献类型：
--
作者：
Vasan SK;Jobe M;Mathews J;Cole F;Rathore S;Jarjou O;Thompson D;Jarde A;Bittaye M;Ulijaszek S;Fall C;Osmond C;Prentice A;Karpe F
改变生活方式是预防妊娠期糖尿病的主要措施。然而，在非洲和印度等低收入和中等收入地区，缺乏评估饮食或体力活动（PA）安全性和有效性的临床试验。本试验旨在评估酸奶消费和增加PA（每日步行）在降低高危孕妇GDM发病率方面的功效。本研究是一项2×2析因、开放标签、多中心随机对照试验，将在印度南部的韦洛雷和西非的冈比亚进行。年龄≥18岁且胎龄≤16周的“高风险”孕妇（n=1856），至少有一个发生GDM的风险因素，将被随机分配接受（1）酸奶（2）PA（3）酸奶+PA或（4）标准产前护理。参与者将被随访至妊娠32周，总的积极干预持续至少16周。主要终点是使用国际糖尿病和妊娠研究组协会标准诊断的26-28周GDM发生率或32周空腹血糖升高（≥5.1 mmol/L）。次要终点包括妊娠32周时空腹血糖浓度的绝对值、母体血压、妊娠期体重增加、产时和新生儿结局。将通过意向治疗和符合方案进行分析。将使用多元线性回归和二元变量logistic回归分析连续结局测量值。本研究获得牛津热带研究伦理委员会（44-18）、基督教医学院伦理委员会、韦洛雷（IRB 11367）和MRCG科学协调委员会（SCC 1645）以及冈比亚政府/MRCG联合伦理委员会（L2020.E15）的批准。研究结果将发表在同行评审的科学期刊上，并在会议上发表。ISRCTN 18467720。
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. 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. 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. ISRCTN18467720.
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影响因子：
5.1
作者：
Cho, N. H.;Shaw, J. E.;Malanda, B.
通讯作者：
Malanda, B.
DOI：
10.1530/rep-10-0088
发表时间：
2010-09
期刊：
Reproduction (Cambridge, England)
影响因子：
--
作者：
Catalano PM
通讯作者：
Catalano PM
DOI：
10.3109/14767058.2011.587921
发表时间：
2012-06-01
影响因子：
1.8
作者：
Jiwani, Aliya;Marseille, Elliot;Kahn, James G.
通讯作者：
Kahn, James G.
影响因子：
4.8
作者：
Ebrahimi, Farnaz Sahhaf;Rad, Aziz Homayouni;Khalili, Leila
通讯作者：
Khalili, Leila
影响因子：
5
作者：
Asgharian, Hanieh;Homayouni-Rad, Aziz;Mohammad-Alizadeh-Charandabi, Sakineh
通讯作者：
Mohammad-Alizadeh-Charandabi, Sakineh