Physical Activity During Pregnancy in Women With Pre-existing Diabetes

NCT07581106 | Not Yet Recruiting

• 2 other identifiers: 24-25-04349691
• Study Type: observational
• Target: 175
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Diabetes; Pregnancy

Keywords

Physical Activity; Pre-existing diabetes; Type 1 Diabetes; Type 2 Diabetes; Pregnancy; Mental Health; Diabetes Distress

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)

• Focus groups

  Conducted once during pregnancy (between 8 and 31 weeks gestation)

Study Arms (2)

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.

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.

Other: Physical Activity

Interventions

Physical Activity OTHER

This is an observational study, there is no intervention.

Pregnant women with Type 1 Diabetes; Pregnant women with Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be pregnant women with a diagnosis of T1D or T2D prior to conception.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Psychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Autoimmune Diseases; Immune System Diseases; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rob Andrews, PhD

  University of Exeter

  STUDY CHAIR

Central Study Contacts

Holly M Jones, MSc by Research

CONTACT

+447808087967; hj409@exeter.ac.uk

Dr Pulsford

CONTACT

R.Pulsford@exeter.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: May 12, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): June 24, 2027
• Study Completion (Estimated): September 24, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-01