DiabetesPA-DIPNCT07581106
Physical Activity During Pregnancy in Women With Pre-existing Diabetes
An observational study of Diabetes and Pregnancy, run by University of Exeter.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Physical Activity
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2026to 24 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants will be pregnant women with a diagnosis of T1D or T2D prior to conception.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dr Pulsford contact
About this study
Official title: Physical Activity During Pregnancy in Women With Pre-existing Diabetes, Support Needs, and Associations With Diabetes Management and Mental Health
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.
Read more
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.
Read the detailed description
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.
Dietary intake will be assessed using the Remote Food Photography Method (RFPM). Participants will submit photographs of meals and snacks via secure digital platforms. Images will be linked to study data using the assigned study identification number.
Continuous glucose monitoring (CGM) data corresponding to each monitoring period will be obtained from routine clinical data-sharing platforms used in standard care. De-identified glucose data will be securely transferred for analysis. Glucose metrics will be derived according to international consensus standards, including time in range, mean glucose, and glycaemic variability.
Diabetes-related emotional wellbeing will be assessed at each monitoring period using the 20-item Problem Areas in Diabetes (PAID) questionnaire administered electronically.
Qualitative Component
A purposive sub-sample of ~16 participants will be invited to participate in online focus groups. Discussions will explore experiences of physical activity during pregnancy, perceived barriers and facilitators, interactions between activity and diabetes self-management, and perceived support needs. Sessions will be audio-recorded, transcribed verbatim, anonymised, and analysed using reflexive thematic analysis.
Data Management and Quality Assurance
All participants will be assigned a unique study identification number. Identifiable information will be stored separately from research data. Data transfers between sites and the coordinating centre will use secure, approved electronic systems. Data will be stored on secure institutional servers with restricted access.
Accelerometer and CGM data will undergo predefined processing and validation procedures to ensure completeness and plausibility. Range and consistency checks will be applied to quantitative variables prior to analysis. Qualitative transcripts will be reviewed against audio recordings to ensure transcription accuracy.
Sample Size Considerations
The target sample size is 175 participants (75 with T1D and 100 with T2D). The study is powered to detect a clinically meaningful change in daily MVPA across pregnancy, accounting for repeated measures and potential clustering by site.
Statistical Analysis
Changes in MVPA across pregnancy will be analysed using multilevel linear modelling to account for repeated measures within participants and clustering by site. Pregnancy stage will be modelled both categorically (trimester) and continuously (gestational week). Associations between physical activity, glucose metrics, and emotional wellbeing will be examined using regression-based approaches adjusted for relevant covariates.
Missing quantitative data will be examined to determine patterns of missingness. Multilevel models inherently accommodate unbalanced repeated measures; additional sensitivity analyses will be conducted if appropriate. Qualitative data will be analysed using Braun and Clarke's reflexive thematic analysis to identify themes related to behavioural capability, opportunity, motivation, and contextual influences.
The study does not include an interventional component and involves no modification to usual clinical management.
- Being tested
- Physical Activity
- Keywords
- Physical Activity, Pre-existing diabetes, Type 1 Diabetes, Type 2 Diabetes, Pregnancy, Mental Health, Diabetes Distress
- Medical subject headings
- Diabetes Mellitus, Motor Activity, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
This is an observational study, there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical Activity | |
| 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. Receives: Other: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
Secondary outcomes (4)
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.
Measured: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
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)
Measured: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
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.
Measured: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
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.
Measured: Conducted once during pregnancy (between 8 and 31 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start11 May 2026 (estimated)
- Primary completion24 Jun 2027 (estimated)
- Study completion24 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Andrews, PhD, Study chair, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581106
- Sponsor's protocol ID
- 24-25-04
- Other IDs
- 349691
- Acronym
- PA-DIP
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity During Pregnancy in Women With Pre-existing Diabetes, Support Needs, and Associations With Diabetes Management and Mental Health
- ClinicalTrials.gov ID
- NCT07581106
- Acronym / sponsor ID
- PA-DIP / 24-25-04
- Keywords
- Physical Activity, Pre-existing diabetes, Type 1 Diabetes, Type 2 Diabetes, Pregnancy, Mental Health, Diabetes Distress
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 11 May 2026 (estimated)
- Primary completion
- 24 Jun 2027 (estimated)
- Study completion
- 24 Sep 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Dietary intake will be assessed using the Remote Food Photography Method (RFPM). Participants will submit photographs of meals and snacks via secure digital platforms. Images will be linked to study data using the assigned study identification number.
Continuous glucose monitoring (CGM) data corresponding to each monitoring period will be obtained from routine clinical data-sharing platforms used in standard care. De-identified glucose data will be securely transferred for analysis. Glucose metrics will be derived according to international consensus standards, including time in range, mean glucose, and glycaemic variability.
Diabetes-related emotional wellbeing will be assessed at each monitoring period using the 20-item Problem Areas in Diabetes (PAID) questionnaire administered electronically.
Qualitative Component
A purposive sub-sample of ~16 participants will be invited to participate in online focus groups. Discussions will explore experiences of physical activity during pregnancy, perceived barriers and facilitators, interactions between activity and diabetes self-management, and perceived support needs. Sessions will be audio-recorded, transcribed verbatim, anonymised, and analysed using reflexive thematic analysis.
Data Management and Quality Assurance
All participants will be assigned a unique study identification number. Identifiable information will be stored separately from research data. Data transfers between sites and the coordinating centre will use secure, approved electronic systems. Data will be stored on secure institutional servers with restricted access.
Accelerometer and CGM data will undergo predefined processing and validation procedures to ensure completeness and plausibility. Range and consistency checks will be applied to quantitative variables prior to analysis. Qualitative transcripts will be reviewed against audio recordings to ensure transcription accuracy.
Sample Size Considerations
The target sample size is 175 participants (75 with T1D and 100 with T2D). The study is powered to detect a clinically meaningful change in daily MVPA across pregnancy, accounting for repeated measures and potential clustering by site.
Statistical Analysis
Changes in MVPA across pregnancy will be analysed using multilevel linear modelling to account for repeated measures within participants and clustering by site. Pregnancy stage will be modelled both categorically (trimester) and continuously (gestational week). Associations between physical activity, glucose metrics, and emotional wellbeing will be examined using regression-based approaches adjusted for relevant covariates.
Missing quantitative data will be examined to determine patterns of missingness. Multilevel models inherently accommodate unbalanced repeated measures; additional sensitivity analyses will be conducted if appropriate. Qualitative data will be analysed using Braun and Clarke's reflexive thematic analysis to identify themes related to behavioural capability, opportunity, motivation, and contextual influences.
The study does not include an interventional component and involves no modification to usual clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with Type 1 Diabetes | – | Other: Physical Activity75 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. |
| Pregnant women with Type 2 Diabetes | – | Other: Physical Activity100 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be pregnant women with a diagnosis of T1D or T2D prior to conception.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityThis is an observational study, there is no intervention. | Other | Pregnant women with Type 1 Diabetes, Pregnant women with Type 2 Diabetes |
Primary outcome
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)
The primary outcome is the change in daily minutes of moderate-to-vigorous physical activity across pregnancy, measured using a wrist-worn GENEActiv accelerometer.
4 secondary outcomes
Adjusted association between physical activity and glucose metrics during pregnancy
Time frame: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
The associations between physical activity data with dietary intake
Time frame: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
The associations between physical activity and Problem Areas in Diabetes (PAID) responses
Time frame: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
Focus groups
Time frame: Conducted once during pregnancy (between 8 and 31 weeks gestation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Pulsford contact
Rob Andrews, PhD study chair
University of Exeter
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Pregnancy, run by University of Exeter.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly M Jones, MSc by Research (+447808087967, hj409@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.