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临床试验/NCT07581106
NCT07581106尚未招募不适用

Physical Activity During Pregnancy in Women With Pre-existing Diabetes, Support Needs, and Associations With Diabetes Management and Mental Health

University of Exeter0 个研究点目标入组 175 人开始时间: 2026年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
175

研究概览

简要总结

Pregnancy can be more challenging for women with pre-existing (Type 1 or Type 2 diabetes) because it increases the risk of complications such as early births or babies being born larger than usual. Keeping blood sugar levels under control is very important to reduce these risks but the hormonal changes that happen during pregnancy make this harder to manage and can cause added stress for expectant mothers. There have been improvements in technology to monitor and manage blood sugar levels, however, there have not been many improvements in pregnancy outcomes in this population Physical activity and exercise during pregnancy have many benefits such as cardiovascular health and lower chance of pregnancy complications. For individuals with diabetes, physical activity can also help manage blood sugar levels and reduce insulin requirements. However, there is limited research on physical activity in women with pre-existing diabetes.

This study aims to find out how physical activity levels change throughout pregnancy, and how physical activity may be linked to blood sugar levels and diabetes related mental health. To determine what needs to be improved regarding physical activity during pregnancy in diabetes, it is crucial to first understand what activity patterns women engage in throughout pregnancy. In addition, what support is needed and when, will be explored Pregnant women (aged 18years or older) with a diagnosis of type 1 or type 2 diabetes before becoming pregnant will be invited to take part. Participants will be recruited during routine clinic visits.

Physical activity during pregnancy in women with pre-existing diabetes will be explored using both measurable activity data and patient experiences of being physically activity during pregnancy. Pregnant women with pre-existing diabetes will be invited to take part from early in their pregnancy. Participants will wear a wrist-based activity monitor for seven days in each trimester, complete an exercise diary and record meals through remote food photography during this time. At the end of each monitoring period, they will complete a questionnaire on diabetes-related emotional distress. Participants will share their continuous glucose monitor and insulin pump data (if applicable), with permission, through the online platforms they normally use to share data with their healthcare team.

Participants will have the option to join a focus group which will be held online via a video conferencing service (e.g.Zoom). This will involve group discussions will be audio recorded, and cover topics including experiences and feelings about physical activity, and what support regarding physical activity would they find useful.

There are no direct health benefits for participants, but the study may help improve future guidance and support for women with diabetes during pregnancy.

This study involves minimal risks. It requires no change in usual treatment or care, no additional clinical visits over and above those routinely scheduled, and no changes in usual behaviour. Within the observational study, there is a small risk of discomfort from wearing the activity monitor for seven days, if this becomes severe irritation, the participant will be informed they can remove the monitor and contact the research team. When conducting the focus groups there is a risk that some topics may bring out discussions which are sensitive, and the potential for participants being upset by something another participant may have said. If participants feel upset by participation in the focus group, they will be made aware they can leave at any time, and participants will directed to further support if required.

详细描述

This is a multi-centre, mixed-methods observational study designed to examine physical activity patterns across pregnancy in women with pre-existing Type 1 diabetes (T1D) or Type 2 diabetes (T2D), and to investigate associations with glucose control and diabetes-related emotional wellbeing. The study integrates longitudinal quantitative assessments with qualitative insights into participant experiences.

The study will be conducted across NHS sites in the South West of England. Following informed consent, participants will be assigned a unique study identification number. The study is observational and does not involve any intervention or alteration to routine clinical care.

Quantitative Data Collection

Physical activity will be assessed using objective and self-reported measures. Device-measured physical activity will be collected using a GENEActiv wrist-worn accelerometer worn continuously for 7 days during each trimester (8-13, 18-22, and 26-31 weeks' gestation). Accelerometer data will be processed using validated analytical software to derive summary metrics including daily minutes of moderate-to-vigorous physical activity (MVPA), total activity, sedentary time, and sleep.

Structured exercise will be recorded using a study diary completed during each monitoring period. The diary captures activity type, timing, and perceived intensity, and includes prospective and retrospective components to characterise habitual behaviour.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 8 - 20 weeks pregnant (this will allow completion of at least two measures during pregnancy)
  • Singleton pregnancy
  • Confirmed diagnosis of T1D or T2D
  • Over 18 years old
  • Willing and able to provide informed consent
  • Receiving care at one of the participating NHS sites

排除标准

  • Multiple pregnancy
  • Absolute contra-indication to PA according to 2019 Canadian Guidelines for physical activity during pregnancy , examples include ruptured membranes, preeclampsia and intrauterine growth restriction, full list available here37
  • No diagnoses of T1D or T2D prior to pregnancy
  • Gestational Diabetes

研究者

申办方类型
Other
责任方
Sponsor

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