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临床试验/ISRCTN11366562
ISRCTN11366562进行中(未招募)未知

A feasibility study to evaluate the use of a smartphone application to support delivery of a physical activity complex intervention ‘Stay Active’ in women with gestational diabetes mellitus

Oxford University Hospitals NHS Trust0 个研究点目标入组 67 人开始时间: 2021年2月11日最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
67

研究概览

简要总结

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36171028/ (added 29/09/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38745288/ (added 20/05/2024)

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • Current inclusion criteria as of 15/08/2022:
  • 1. Women who are more than 20 completed weeks pregnant and less than 33 completed weeks pregnant with a singleton pregnancy
  • 2. Abnormal Oral Glucose Tolerance Test (OGTT) as defined by IADPSG, HbA1C, fasting plasma glucose or random blood glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic.
  • 3. Using GDm-Health to monitor their blood glucose
  • 4. Aged between 18 and 45 years
  • 5. Willing and able to provide informed consent for participation in the study
  • 6. Have, and use, a smartphone
  • Previous inclusion criteria:
  • 1. Women who are more than 24 completed weeks pregnant and less than 33 completed weeks pregnant with a singleton pregnancy
  • 2. Abnormal Oral Glucose Tolerance Test (OGTT) as defined by IADPSG, HbA1C, fasting plasma glucose or random blood glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic.
  • 3. Using GDm-Health to monitor their blood glucose
  • 4. Aged between 18 and 45 years
  • 5. Willing and able to provide informed consent for participation in the study
  • 6. Have, and use, a smartphone

排除标准

  • 1. Multiple pregnancy
  • 2. GDM not diagnosed by OGTT, HbA1C or fasting plasma glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID 19) pandemic
  • 3. An absolute contra-indication to physical activity as per 2019 Canadian guidelines (Mottola M et al, 2018) e.g. preterm rupture of membranes, limited mobility, haemodynamically significant heart disease, restrictive lung disease
  • 4 Unable to understand written or spoken English language

研究者

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