Lifestyle interventions among pregnant women living with pre-existing conditions

Background: Little is known about the best way to support pregnant women with pre-existing conditions, such as chronic hypertension, to adopt evidence-based healthy behaviours that are proven to reduce blood pressure. Through quantitative and qualitative methods, this thesis aimed to contribute new evidence and understanding about how to optimise lifestyle support for pregnant women with chronic hypertension. Methods: The thesis is comprised of three core work packages: 1. A systematic review collated evidence on the effect of lifestyle interventions on weight and blood pressure outcomes for those with existing conditions. 2. A qualitative evidence synthesis of local clinical guidelines was conducted to explore current practice recommendations for weight management during pregnancy. 3. A mixed methods intervention development study using the Person-Based Approach was undertaken involving an online survey, focus groups and early feasibility testing with healthcare professionals and women. Results: A clear lack of interventional trials to support pregnant women with chronic hypertension was evident; exposing a key evidence gap subsequently addressed in this thesis. Interrogation of 28 diverse clinical practice guidelines revealed inconsistencies across local recommendations with limited practical information for clinicians to share with women about weight management strategies during pregnancy. A risk narrative prevailed which sat in opposition to maternity policy rhetoric that promotes partnership working with women. An online survey of pregnant, or recently pregnant, women (n=85) provided a first step in understanding lifestyle behaviours in the context of pregnancy and chronic hypertension, that has not been undertaken before. Respondents were motivated and confident to engage in healthy behaviours despite less than half recalling being provided with lifestyle support at hypertension diagnosis or during pregnancy. Actual behaviours of participants did not meet recommendations for some women indicating scope for improving the support women receive to optimise this area of their health. A theoretically underpinned, evidence-based lifestyle App, named DAPHNY, was iteratively developed with women (n=21) and healthcare professionals (n=23). The DAPHNY App was viewed positively by participants as a beneficial, novel tool. Logic models demonstrated how key intervention features could lead to meaningful access and engagement and subsequent behaviour change. For example, goal setting, monitoring progress and a reward/ recognition system were implemented; increasing motivation for ongoing App use. Participants who tested the App at home mostly accessed pages to record blood pressure and step count but less accessed informational pages. Thematic analysis exposed the complexity of the health lifestyle discourse within current maternity care pathways for women with hypertension, where lifestyle support is not embedded within routine antenatal conversations. The technical focus of appointments, underlying assumptions and biases, personal barriers and conflicting priorities were reasoned as significant challenges in the implementation of enduring and meaningful lifestyle support for women to better control their blood pressure. Embedding lifestyle information alongside existing self-monitoring Apps and within care pathways with ongoing, reciprocal conversations with a healthcare professional, were suggested strategies to increase engagement and support successful implementation. Conclusion: This thesis exposes, and subsequently addresses, the lack of evidence to optimise lifestyle behaviours in a pregnant population living with chronic hypertension. The dominant risk narrative of clinical guidelines and antenatal appointments meant little space was given to lifestyle support as an adjunct to regular monitoring and medication administration; the current status quo for blood pressure management. Development of the DAPHNY App, underpinned by a distinguished behavioural framework for developing digital interventions and sociological theory, provides new and important data to support women with chronic hypertension and healthcare professionals with this currently overlooked aspect of blood pressure management. Future research priorities include utilising mixed-methods to further modify, test and evaluate the implementation of a lifestyle component within a self-monitoring blood pressure App and explore the incorporation of this within antenatal consultations; continued work with stakeholders to understand and breakdown barriers and challenges to implementation; and exploration of alternative methods of antenatal care delivery that support professionals in their health promotion role that better meet the needs of women with chronic hypertension. Striving for a holistic and partnership approach that includes lifestyle support to manage blood pressure should be a priority to enhance women’s overall experience of pregnancy alongside improved long-term cardiovascular health

Placental Localization and Perinatal Outcome

This retrospective case-control study was designed to investigate the relationship between placental localization and intrauterine growth restriction (IUGR). Pregnant women with an anatomic survey from January 1, 2000, to December 31, 2005, and delivery of the pregnancy at Yale-New Haven Hospital (YNHH) were identified using clinical and billing records. Multiple gestation, fetal anomaly, and incomplete medical information were reasons for exclusion. Cases (N=69) were consecutive pregnancies with evidence of IUGR (estimated fetal weight \u3c10th percentile for gestational\u3eage) at last follow-up ultrasound. Randomly selected controls (N=258) from the same time period had no evidence of IUGR. Maternal, ultrasound, delivery, and perinatal data were collected by retrospective medical record review, and IUGR cases and non-IUGR controls were compared using the Students t-test, Wilcoxon test, Chi-square analysis, Fishers exact test, and ANOVA. Placental location was determined from the anatomic survey record (obtained at 18.4 ± 1.2 weeks gestation in the IUGR group and 18.2 ± 1.0 weeks gestation in the control group; P=0.18). Multivariate logistic regression with adjustment for confounders was used to investigate the association between IUGR and placental localization. Consistent with known predictors of IUGR, the IUGR group had a higher proportion of black women (36.4% vs. 19.8%, P=0.03), chronic hypertension (26.0% vs. 3.5%, P\u3c0.001), and hypertensive disorders of pregnancy (36.2% vs. 5.0%, P\u3c0.001). Mean birth weights of IUGR and non-IUGR pregnancies differed by 2 kilograms (3244 ± 625 grams vs. 1277 ± 637 grams, P\u3c0.001). IUGR infants were more likely to receive antenatal steroids, deliver preterm, deliver by cesarean section, and be admitted to neonatal intensive care. In both IUGR and non-IUGR pregnancies, the placenta was most commonly anterior or posterior. Unilateral placentas were three times more common in the IUGR group than in the non-IUGR group (17.4% vs. 5.0%, P=0.01). IUGR pregnancies were over four times as likely as control subjects to have unilaterally-located placentas compared to anterior placentas (OR 4.8, 95% confidence interval, 1.9-11.7). Adjusting for ethnicity, chronic hypertension, and hypertensive disorders of pregnancy did not affect this finding (OR 4.6, 95% confidence interval 1.6-13.5). In conclusion, we compared a group of 69 IUGR pregnancies to 258 non-IUGR controls and found intrauterine growth restriction to be associated with unilateral placentation

Inclusion of under-served groups in trials: an audit at a UK primary care clinical trials unit

Background: Clinical trials need to include patients who are representative of the population who may receive the tested interventions in the future. The importance of inclusivity is recognised by ethical and funding bodies and has public support. Appropriate inclusion is required to provide equitable evidence-based healthcare and to comply with ethical principles for research. However, there is little information about the inclusivity of most under-served groups in UK clinical trials. Methods: This audit assesses the inclusion of under-served groups in trials run by the Oxford Primary Care Clinical Trials Unit (PC-CTU). We included trials with ethical approval between 2017 and 2023. We checked protocols, patient-facing information and selected data collection tools for information on the under-served groups in the INCLUDE guidance and protected characteristics in the UK Equality Act 2010, to identify explicit exclusions and data collection. Results: We included 19 trials. They were in a variety of clinical conditions, testing different types of interventions, both Clinical Trial of an Investigational Medicinal Product (CTIMP) and non-CTIMP. Most were non-commercially funded. We reviewed 21 protocols, 29 Patient Information Sheets/Leaflets and 40 data collection tools. Common exclusions were based on age (19), sex or gender (11), language (8), capacity to consent (14), pregnancy (11), multiple health conditions (10) and severity of illness (17). Trials most often collected data on age (19), sex or gender (15), ethnicity (16), education (11), address (13), mental health conditions (6), who gave consent (19), addiction (6), multiple health conditions (10), severity of illness (17), smoking status (12) and obesity (13). Conclusions: Often, exclusions were due to the focusing of the trial for a specific group, such as older people, women, or people being treated for a specific severity of condition. However, many explicit exclusions may not have been essential, may have reduced the inclusivity of the trials and might limit the applicability of the trial’s findings to people to whom the tested interventions might be relevant. These include the exclusion of people aged under 18, people without English language fluency and people without capacity to consent. All trials could have collected more informative data on under-served group status

Clinical guidelines for the management of weight during pregnancy: a qualitative evidence synthesis of practice recommendations across NHS Trusts in England

Background Women who enter pregnancy with a Body Mass Index above 30 kg/m2 face an increased risk of complications during pregnancy and birth. National and local practice recommendations in the UK exist to guide healthcare professionals in supporting women to manage their weight. Despite this, women report inconsistent and confusing advice and healthcare professionals report a lack of confidence and skill in providing evidence-based guidance. A qualitative evidence synthesis was conducted to examine how local clinical guidelines interpret national recommendations to deliver weight management care to people who are pregnant or in the postnatal period. Methods A qualitative evidence synthesis of local NHS clinical practice guidelines in England was conducted. National Institute for Health and Care Excellence and Royal College of Obstetricians and Gynaecologists guidelines for weight management during pregnancy constructed the framework used for thematic synthesis. Data was interpreted within the embedded discourse of risk and the synthesis was informed by the Birth Territory Theory of Fahy and Parrat. Results A representative sample of twenty-eight NHS Trusts provided guidelines that included weight management care recommendations. Local recommendations were largely reflective of national guidance. Consistent recommendations included obtaining a weight at booking and informing women of the risks associated with being obese during pregnancy. There was variation in the adoption of routine weighing practices and referral pathways were ambiguous. Three interpretive themes were constructed, exposing a disconnect between the risk dominated discourse evident in the local guidelines and the individualised, partnership approach emphasised in national level maternity policy. Conclusions Local NHS weight management guidelines are rooted in a medical model rather than the model advocated in national maternity policy that promotes a partnership approach to care. This synthesis exposes the challenges faced by healthcare professionals and the experiences of pregnant women who are in receipt of weight management care. Future research should target the tools utilised by maternity care providers to achieve weight management care that harnesses a partnership approach empowering pregnant and postnatal people in their journey through motherhood

Gluten-free diet intervention reduces thiamine intake in two weeks, increases glycaemic response and decreases body weight in four weeks, with no long term nutritional deficiencies

This research investigated the effects of gluten free diet (GFD) on nutritional intake, glycaemic and insulin response. In a cross-sectional study, participants who consumed gluten-containing diet (GCD; n = 11) and GFD (n = 11) completed a food diary, blood glucose and insulin measurements. In a pre-post intervention study (n = 11), glycaemic and insulin responses were tested before and after four weeks of a GFD. Food intake was recorded before and after two weeks. No significant differences in nutrient intake, glycaemic or insulin responses were found in the cross-sectional study. In the intervention study, there was a significant reduction in body weight (p = .007) and body mass index (BMI) (p = .004) after four weeks and lower thiamine intake (p = .021) after two weeks of GFD. Glycaemic response was significantly higher (p

Culture-independent detection of nontuberculous mycobacteria in clinical respiratory samples

Culture-based detection of nontuberculous Mycobacteria (NTM) in respiratory samples is time consuming and can be subject to overgrowth by nonmycobacterial bacteria. We describe a single-reaction TaqMan quantitative PCR assay for the direct detection of NTM species in clinical samples that is specific, sensitive, and robust

Intervention development and optimisation of a multi-component digital intervention for the monitoring and management of hypertensive pregnancy: the My Pregnancy Care Intervention

Background: Hypertensive disorders of pregnancy affect around 10% of pregnancies and remain a major cause of maternal and foetal morbidity and mortality. Trials have shown that self-monitoring blood pressure during pregnancy is safe, but self-monitoring alone does not improve blood pressure control or pregnancy outcomes. This study aimed to develop and optimise a multicomponent intervention to support blood pressure monitoring, hypertension management and urine testing within current care pathways. Methods: Relevant literature, input from patient and public contributors (PPI) and stakeholder groups, and the researcher’s previous experience were used to develop an initial intervention. Think-aloud interviews and focus groups with women from diverse backgrounds with lived experience of hypertension in pregnancy and healthcare professionals provided feedback on the intervention prototype (n = 29). The MRC Framework for Developing Complex Interventions guided the processes to optimise the intervention’s acceptability and maximise engagement. A detailed tabulation of participants’ views and logic models was produced using the COM-B model of Behaviour Change. Results: The prototype intervention was acceptable and viable to both pregnant women with experience of hypertensive pregnancy and healthcare professionals. Emerging themes centred on how the intervention could be optimised within current National Health Service care pathways and the lives of pregnant women to support behaviour change. Key target behaviours to support the intervention included increasing understanding of blood pressure management, engagement with the intervention, monitoring blood pressure and urine and taking appropriate actions based on those readings. This informed the development of recommendations involving clear action timelines for women and evidence-based guidance to support decision-making by healthcare professionals. The findings were used to produce the multi-component My Pregnancy Care intervention, consisting of a smartphone application and an information leaflet to support blood pressure self-monitoring and proteinuria self-testing, self-management of antihypertensive medication and smartphone application use. Conclusions: This research provided comprehensive insight into the needs of pregnant women with hypertension and their healthcare teams regarding self-monitoring and management of blood pressure. This supported the development of a tailored multi-component digital intervention that addresses barriers to blood pressure self-management by being user-friendly, persuasive and acceptable. It is hoped that the intervention will support the monitoring and management process, collaboration between healthcare professionals and women, clinical action and improved clinical outcomes

Social rearing environment influences dog behavioral development

Early life experiences are known to influence behavior later in life. In dogs, environmental influences of early home rearing could be exploited to improve the chances of developing adult behavior most suited to the adult environment. For working dog organizations, such as Guide Dogs, suitable adult behavior is important to ensure that dogs can fulfill their role as guides for people with visual impairment. Here, we test the hypothesis that dogs' home rearing environment will influence behavioral development. To investigate this hypothesis, carers of potential guide dogs (puppy walkers) completed a questionnaire, termed the Puppy Walker Questionnaire (PWQ), about the dog's behavior at 5, 8, and 12 months of age. An additional 11 questions were answered about the home environment at the last assessment. Because no questionnaire existed which measured behavior most relevant to Guide Dogs, questions from an existing questionnaire (Canine Behaviour and Research Questionnaire) were combined with additional questions. Thus, a subsidiary aim of the study was to test the reliability of the PWQ for measuring behavioral development of potential guide dogs. The PWQ, scored on a 100-mm visual analogue scale, grouped into 5 new scales: trainability, distractibility, general anxiety, body sensitivity, and stair anxiety, with 4 Canine Behaviour and Research Questionnaire scales: excitability, separation-related behavior, attachment and attention seeking, and energy level. For each reliable scale, multivariate linear regression identified significant predictors from the home environmental questions. The results suggest that home rearing environment is indeed important for behavioral development: 9 of 11 environmental variables were significant predictors of behavioral scores. Those environmental variables that appeared most important were social in nature. Dogs were scored as higher in energy level, excitability, and distractibility if they had been raised in a home with children, lower on energy level and distractibility the more experience of puppy walking their carer had, and lower on separation-related behavior the more they had been able to play with other dogs. These findings have implications for matching between dogs' early and later home environments. Follow-up of dogs in this study could help to elucidate effects on guiding suitability and matching between dog and guide dog owner

Gluten-free diet intervention reduces thiamine intake in two weeks, increases glycaemic response and body weight in four weeks, with no long term nutritional deficiencies

This research investigated the effects of gluten free diet (GFD) on nutritional intake, glycaemic and insulin response. In a cross-sectional study, participants who consumed gluten-containing diet (GCD; n=11) and GFD (n=11) completed a food diary, blood glucose and insulin measurements. In a pre-post intervention study (n= 11), glycaemic and insulin responses were tested before and after four weeks of a GFD. Food intake was recorded before and after two weeks. No significant differences in nutrient intake, glycaemic or insulin responses were found in the cross-sectional study. In the intervention study, there was a significant reduction in body weight (p=0.007) and body mass index (BMI) (p=0.004) after four weeks and lower thiamine intake (p=0.021) after two weeks of GFD. Glycaemic response was significantly higher (p<0.05) following GFD with no differences in insulin response. These differences were not evident if GFD was followed for a longer period, possibly due to improved food choices