ORCID Profile
0000-0002-9164-8659
Current Organisation
University of Oxford
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Publisher: BMJ
Date: 02-2022
DOI: 10.1136/BMJOPEN-2021-051180
Abstract: New-onset hypertension affects approximately 10% of pregnancies and is associated with a significant increase in risk of cardiovascular disease in later life, with blood pressure measured 6 weeks postpartum predictive of blood pressure 5–10 years later. A pilot trial has demonstrated that improved blood pressure control, achevied via self-management during the puerperium, was associated with lower blood pressure 3-4 years postpartum. Physician Optimised Post-partum Hypertension Treatment (POP-HT) will formally evaluate whether improved blood pressure control in the puerperium results in lower blood pressure at 6 months post partum, and improvements in cardiovascular and cerebrovascular phenotypes. POP-HT is an open-label, parallel arm, randomised controlled trial involving 200 women aged 18 years or over, with a diagnosis of pre-ecl sia or gestational hypertension, and requiring antihypertensive medication at discharge. Women are recruited by open recruitment and direct invitation around time of delivery and randomised 1:1 to, either an intervention comprising physician-optimised self-management of postpartum blood pressure or, usual care. Women in the intervention group upload blood pressure readings to a ‘smartphone’ app that provides algorithm-driven in idualised medication-titration. Medication changes are approved by physicians, who review blood pressure readings remotely. Women in the control arm follow assessment and medication adjustment by their usual healthcare team. The primary outcome is 24-hour average ambulatory diastolic blood pressure at 6–9 months post partum. Secondary outcomes include: additional blood pressure parameters at baseline, week 1 and week 6 multimodal cardiovascular assessments (CMR and echocardiography) parameters derived from multiorgan MRI including brain and kidneys peripheral macrovascular and microvascular measures angiogenic profile measures taken from blood s les and levels of endothelial circulating and cellular biomarkers and objective physical activity monitoring and exercise assessment. An additional 20 women will be recruited after a normotensive pregnancy as a comparator group for endothelial cellular biomarkers. IRAS PROJECT ID 273353. This trial has received a favourable opinion from the London—Surrey Research Ethics Committee and HRA (REC Reference 19/LO/1901). The investigator will ensure that this trial is conducted in accordance with the principles of the Declaration of Helsinki and follow good clinical practice guidelines. The investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authors will acknowledge that the study was funded by the British Heart Foundation Clinical Research Training Fellowship (BHF Grant number FS/19/7/34148). Authorship will be determined in accordance with the ICMJE guidelines and other contributors will be acknowledged. NCT04273854 .
Publisher: BMJ
Date: 09-2022
DOI: 10.1136/BMJOPEN-2022-062525
Abstract: Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (GDM). Digital technologies can support PA at scale and remotely. The protocol describes a study designed to determine the feasibility and acceptability of a complex intervention known as +Stay Active. +Stay Active combines motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM. This is a non-randomised feasibility study using a mixed methods approach. Participants will be recruited from the GDM antenatal clinic at the Women Centre, John Radcliffe Hospital, Oxford. Following baseline assessments (visit 1) including self-reported and device determined PA assessment (wearing a wrist accelerometer), women will be invited to participate in an online motivational interview, then download and use the Stay-Active app (Android or iOS) (visit 2). Women will have access to Stay-Active until 36 weeks gestation, when engagement and PA levels will be reassessed (visit 3). The target s le size is 60 women. Primary outcomes are recruitment and retention rates, compliance and assessment of participant engagement and acceptability with the intervention. Secondary outcomes are assessment of blood glucose control, self-reported and device determined assessment of PA, usage and structured feedback of participant’s attitudes to +Stay Active, assessment of health costs and description of maternal and neonatal outcomes. This study will provide key insights into this complex intervention regarding engagement in smartphone technology and the wearing of accelerometers. These data will inform the development of a randomised controlled trial with refinements to intervention implementation. The study has received a favourable opinion from South Central—H shire B Research Ethics Committee REC reference: 20/SC/0342. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, conferences and seminar presentations. NCT11366562 .
Publisher: Springer Science and Business Media LLC
Date: 26-03-2022
DOI: 10.1186/S12884-022-04539-9
Abstract: Physical activity (PA) interventions are an important but underutilised component in the management of gestational diabetes mellitus (GDM). The challenge remains how to deliver cost effective PA interventions that have impact on in idual behaviour. Digital technologies can support and promote PA remotely at scale. We describe the development of a behaviourally informed smartphone application (Stay-Active) for women attending an NHS GDM clinic. Stay-Active will support an existing motivational interviewing intervention to increase and maintain PA in this population. The behaviour change wheel (BCW) eight step theoretical approach was used to design the application. It provided a systematic approach to understanding the target behaviour, identifying relevant intervention functions, and specifying intervention content. The target behaviour was to increase and maintain PA. To obtain a behavioural diagnosis, qualitative evidence was combined with focus groups on the barriers and facilitators to PA in women with GDM. The findings were mapped onto the Capability Opportunity Motivation-Behaviour (COM-B) model and Theoretical Domains Framework to identify what needs to change for the target behaviour and linked to appropriate intervention functions. Finally, behaviour changes techniques (BCT) and modes of delivery that are most likely to serve the intervention functions were selected. Current evidence, patient focus groups and input from key stakeholders informed Stay-Active’s development. We found that psychological capability, reflective and automatic motivation, social and physical opportunity needed to change to increase PA in women with GDM. The four key intervention functions identified were Enablement, Education, Persuasion and Training. Stay-Active incorporates these four intervention functions delivering ten BCTs including: goal setting, credible source, self-monitoring, action planning, prompts and cues. The final design of Stay-Active delivers these BCTs via an educational resource centre, with goal setting and action planning features, personalised performance feedback and in idualised promotional messages. The BCW has enabled the systematic and comprehensive development of Stay-Active to promote PA in women with GDM within an NHS Maternity service. The next phase is to conduct a trial to assess the feasibility and acceptability of a multi-component intervention that combines Stay-Active with PA Motivational Interviewing.
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Cristian Roman.