Physical Activity During Pregnancy in Women With Pre-existing Diabetes

Sponsor
University of Exeter
Study ID
NCT07581106
Status
Not Yet Recruiting

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Conditions

  • Diabetes
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Physical Activity — OTHER
    This is an observational study, there is no intervention.

Study Details

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.

Key Dates

First listed
May 12, 2026
Start date
May 11, 2026
Status verified
Jan 2026
Primary completion
Jun 24, 2027
Completion
Sep 24, 2027

Study Design

Enrollment
175 participants (estimated)

Arms

  • Arm: Pregnant women with Type 1 Diabetes
    75 women with Type 1 Diabetes will be recruited to take part in the study. A subset of \~8 of these women will be invited to take part in a focus group.
  • Arm: Pregnant women with Type 2 Diabetes
    100 women with Type 2 Diabetes will be recruited to take part in this study. A subset of \~8 of these women will be invited to take part in a focus group.

Primary Outcome Measure

Change in moderate-to-vigorous physical activity across pregnancy [ Time Frame: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3) ]

Central Contacts

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