About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Eligible participants will be pregnant women with a diagnosis of T1D or T2D prior to conception.
Trial design
Cohort
Prospective
Treatments tested in this trial
Physical Activity
Other interventionThis is an observational study, there is no intervention.
Treatment groups
Trial outcomes
Primary outcomes
Change in moderate-to-vigorous physical activity across pregnancy
The primary outcome is the change in daily minutes of moderate-to-vigorous physical activity across pregnancy, measured using a wrist-worn GENEActiv accelerometer.
Secondary outcomes
Adjusted association between physical activity and glucose metrics during pregnancy
This outcome estimates the adjusted association between physical activity and glucose metrics during pregnancy using multivariable linear regression models. Physical activity will be measured as daily minutes of moderate-to-vigorous physical activity derived from GENEActiv accelerometers and exercise diaries. Glucose metrics will be derived from continuous glucose monitoring data and will include time in range (%), mean glucose (mmol/L), and glycaemic variability.
The associations between physical activity data with dietary intake
To examine the associations between physical activity (measured using the GENEActiv accelerometer) and dietary intake (as measured using Remote Food Photography Method)
The associations between physical activity and Problem Areas in Diabetes (PAID) responses
To examine the associations between physical activity and diabetes related distress (measured by the problem areas in diabetes 20-item questionnaire). Each item is scored from 0 - 4 then the scores for each item are summed, and multiplied by 1.25 to generate a total score out of 100. Scores of over 40 indicate severe diabetes distress.
Focus groups
Conduct focus groups with pregnant women with pre-existing diabetes to explore the barriers and facilitators to participating in physical activity, and support needed to encourage physical activity.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: