ISRCTN70595832已完成未知
DALI: Vitamin D And Lifestyle Intervention for gestational diabetes mellitus (GDM) prevention: a randomised controlled trial
VU University Medical Center (Netherlands)0 个研究点目标入组 880 人开始时间: 2011年12月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 880
研究概览
简要总结
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23829946 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26112044 2017 process evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/28882133 2018 cost-effectiveness results in: https://www.ncbi.nlm.nih.gov/pubmed/29540227 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31182492 (added 15/04/2020) 2019 review in https://pubmed.ncbi.nlm.nih.gov/31845115/ (added 28/05/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Pre-pregnancy body mass index (BMI) (self-reported weight, measured height) is >= 29 kg/m2)
- •2. Aged 18 years or more
- •3. Gestational age at recruitment < 12 weeks
- •4. Sufficiently fluent in major language of the country of recruitment
- •5. Being able to be moderately physically active
- •6. Giving written informed consent
- •7. Agree to give birth in one of the participating hospitals
排除标准
- •1. Pre-existing diabetes
- •2. Diagnosed with (gestational) diabetes mellitus before randomisation, defined as fasting glucose = 5.1 mmol/l and/or 1 hour glucose = 10 mmol/l and/or 2 hour glucose = 8.5 mmol/l at baseline
- •3. Not able to walk at least 100 meters safely
- •4. Requirement for complex diets
- •5. Advanced chronic conditions (eg valvular heart disease)
- •6. Sgnificant psychiatric disease
- •7. Unable to speak major language of the country of recruitment fluently
- •8. Known abnormal calcium metabolism (hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria) or hypercalciuria detected at screening (0.6 mmol/mmol creatinine in spot morning urine)
- •9. Twin pregnancy
研究者
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撤回
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