Physical Activity During Pregnancy in Women With Pre-existing Diabetes (PA-DIP)
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.
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Holly M Jones, MSc by Research
- Telefonní číslo: +447808087967
- E-mail: hj409@exeter.ac.uk
Studijní záloha kontaktů
- Jméno: Dr Pulsford
- E-mail: R.Pulsford@exeter.ac.uk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
This is an observational study, there is no intervention.
|
|
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.
|
This is an observational study, there is no intervention.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in moderate-to-vigorous physical activity across pregnancy
Časové okno: 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.
|
8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Adjusted association between physical activity and glucose metrics during pregnancy
Časové okno: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
|
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.
|
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
Časové okno: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
|
To examine the associations between physical activity (measured using the GENEActiv accelerometer) and dietary intake (as measured using Remote Food Photography Method)
|
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
Časové okno: 8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
|
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.
|
8 - 13 weeks gestation (Trimester 1), 18 - 22 weeks gestation (trimester 2), 26 - 31 weeks gestation (trimester 3)
|
|
Focus groups
Časové okno: Conducted once during pregnancy (between 8 and 31 weeks gestation)
|
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.
|
Conducted once during pregnancy (between 8 and 31 weeks gestation)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Rob Andrews, PhD, University of Exeter
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění endokrinního systému
- Metabolické choroby
- Autoimunitní onemocnění
- Onemocnění imunitního systému
- Poruchy metabolismu glukózy
- Chování
- Nutriční a metabolické nemoci
- Osobní spokojenost
- Diabetes mellitus, typ 2
- Diabetes Mellitus
- Diabetes mellitus, typ 1
- Psychická pohoda
- Motorická aktivita
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Cvičení
Další identifikační čísla studie
- 24-25-04
- 349691 (Jiný identifikátor: IRAS)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .