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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Holly M Jones, MSc by Research
- 電話番号：+447808087967
- メール：hj409@exeter.ac.uk
研究連絡先のバックアップ
- 名前：Dr Pulsford
- メール：R.Pulsford@exeter.ac.uk
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in moderate-to-vigorous physical activity across pregnancy
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adjusted association between physical activity and glucose metrics during pregnancy
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Rob Andrews, PhD、University of Exeter
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 24-25-04
- 349691 (その他の識別子：IRAS)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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