scholarly journals Improving pregnancy outcome in obese women: the UK Pregnancies Better Eating and Activity randomised controlled Trial

2017 ◽  
Vol 5 (10) ◽  
pp. 1-414 ◽  
Author(s):  
Lucilla Poston ◽  
Ruth Bell ◽  
Annette L Briley ◽  
Keith M Godfrey ◽  
Scott M Nelson ◽  
...  
Keyword(s):  
Pilot Study ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Cost Utility ◽  
Research Centre ◽  
Behavioural Intervention ◽  
Development Phase ◽  
Effective Interventions ◽  
Randomised Controlled ◽  
The Uk

BackgroundObesity in pregnancy is associated with insulin resistance, which underpins many common complications including gestational diabetes mellitus (GDM) and fetal macrosomia.ObjectivesTo assess the effect of a complex behavioural intervention based on diet and physical activity (PA) on the risk of GDM and delivery of a large-for-gestational age (LGA) infant.DesignThree phases: (1) the development phase, (2) the pilot study and (3) a multicentre randomised controlled trial (RCT) comparing a behavioural intervention to improve glycaemic control with standard antenatal care in obese pregnant women. A cost–utility analysis was undertaken to estimate the cost-effectiveness of the health training (intervention) over and above standard care (control).SettingPilot study: antenatal clinics in four inner-city UK hospitals. RCT: eight antenatal clinics in eight UK inner-city hospitals.ParticipantsWomen were eligible for inclusion if they had a body mass index of ≥ 30 kg/m2, were pregnant with a single fetus and at 15+0to 18+6weeks’ gestation, were able to give written informed consent and were without predefined disorders.InterventionThe intervention comprised an initial session with a health trainer, followed by eight weekly sessions. Dietary advice recommended foods with a low dietary glycaemic index, avoidance of sugar-sweetened beverages and reduced saturated fats. Women were encouraged to increase daily PA.Main outcome measuresDevelopment phase: intervention development, acceptability and optimal approach for delivery. Pilot study: change in dietary and PA behaviours at 28 weeks’ gestation. RCT: the primary outcome of the RCT was, for the mother, GDM [as measured by the International Association of the Diabetes and Pregnancy Study Groups (IADPSG)’s diagnostic criteria] and, for the infant, LGA delivery (i.e. customised birthweight ≥ 90th centile for gestational age).ResultsDevelopment phase: following a literature meta-analysis, a study of dietary intention questionnaires and semistructured interviews, an intervention based on behavioural science was developed that incorporated optimal and acceptable methods for delivery. Pilot study: the pilot study demonstrated improvement in dietary behaviours in the intervention compared with the standard care arm but no increase in objectively measured PA. Process evaluation demonstrated feasibility and general acceptability. RCT: the RCT showed no effect of the intervention on GDM in obese pregnant women or the number of deliveries of LGA infants. There was a reduction in dietary glycaemic load (GL) and reduced saturated fat intake, an increase in PA and a modest reduction in gestational weight gain, all secondary outcomes. Lower than expected was the number of LGA infant deliveries in all women, which suggested that universal screening for GDM with IADPSG’s diagnostic criteria, and subsequent treatment, may reduce the number of deliveries of LGA infants. According to the cost–utility analysis, the estimated probability that the UK Pregnancies Better Eating and Activity Trial (UPBEAT) behavioural intervention is cost-effective at the £30,000/quality-adjusted life-year willingness-to-pay threshold was 1%.LimitationsIncluded the high refusal rate for participation and self-reported assessment of diet and PA.ConclusionsThe UPBEAT intervention, an intense theoretically based intervention in obese pregnant women, did not reduce the risk of GDM in women or the number of LGA infant deliveries, despite successfully reducing the dietary GL. Based on total cost to the NHS provider and health gains, the UPBEAT intervention provided no supporting evidence to suggest that the intervention represents value for money based on the National Institute for Health and Care Excellence benchmarks for cost-effectiveness.Future workAlternative strategies for reducing the risk of GDM in obese pregnant women and the number of LGA infant deliveries should be considered, including development of clinically effective interventions to prevent obesity in women of reproductive age, of clinically effective interventions to reduce weight retention following pregnancy and of risk stratification tools in early pregnancy.Trial registrationCurrent Controlled Trials ISRCTN89971375 and UK Clinical Research Network Portfolio 5035.FundingThis project was funded by the NIHR Programme Grant for Applied Research programme and will be published in full inProgramme Grants for Applied Research, Vol. 5, No. 10. See the NIHR journals library website for further project information. Contributions to funding were also provided by the Chief Scientist Office CZB/4/680, Scottish Government Health Directorates, Edinburgh; Guys and St Thomas’ Charity, Tommy’s Charity (Lucilla Poston, Annette L Briley, Paul T Seed) and the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, UK and the Academy of Finland, Finland. Keith M Godfrey was supported by the National Institute for Health Research through the NIHR Southampton Biomedical Research Centre. Lucilla Poston and Keith M Godfrey were supported by the European Union’s Seventh Framework Programme (FP7/2007-2013), project EarlyNutrition under grant agreement number 289346.

scholarly journals Randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain (TOPIC): a pilot study to assess feasibility of a large multicentre trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e023679
Author(s):  
Joyce Yeung ◽  
Lee Middleton ◽  
Kostas Tryposkiadis ◽  
Amy Kerr ◽  
Jane Daniels ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Local Anaesthetics ◽  
Chest Wall Resection ◽  
Thoracic Epidural ◽  
American Society ◽  
Randomised Controlled ◽  
The Uk

ObjectivesThoracotomy is considered one of the most painful surgical procedures. The incidence of chronic post-thoracotomy pain (CPTP) is up to 50%. Paravertebral blockade (PVB) may be superior to thoracic epidural blockade (TEB) in preventing CPTP. The specific objective of this pilot study was to assess the feasibility of conducting a larger trial to determine whether PVB at thoracotomy is more effective in reducing CPTP compared with TEB.DesignA randomised, parallel, external pilot study was conducted to assess whether a large randomised trial of TEB and PVB with CPTP as the primary outcome is feasible.SettingTwo adult thoracic centres in the UK.ParticipantsAll adult patients admitted for elective open thoracotomy. Participants were excluded if they were American Society of Anesthesiologists physical status IV or V; or if there is contraindication to local anaesthetics; infection near the proposed puncture site; coagulation/thoracic spine disorders; required chest wall resection or emergency thoracic surgery or had a previous thoracotomy.ResultsAll patients presenting for thoracotomy were screened over a 12-month period with 194 found to be eligible. Of these, 69 (36%) were randomised (95% CI 29% to 42%). Discounting five participants who died, 54 of 64 participants (84%) returned questionnaire booklets at 6 months. The number of participants indicating at least a moderate level of chest pain at 6 months was lower with PVB but with high levels of uncertainty (RR: 0.7; 95% CI 0.3 to 1.7 for worst pain; RR: 0.3; 95% CI 0.0 to 2.8 for average pain). There were no safety concerns.ConclusionsA large, multicentre randomised controlled trial of PVB versus TEB is feasible as it is possible to randomise and follow up participants with high fidelity. Pain scores were lower on average with PVB compared with TEB but a much larger trial is required to confirm this reliably.Trial registration numberISRCTN45041624

scholarly journals Educational films for improving screening and self-management of gestational diabetes in India and Uganda (GUIDES): study protocol for a cluster-randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Laura L. Oakley ◽  
Deepa R ◽  
Arthur Namara ◽  
Biswamitra Sahu ◽  
Iliatha Papachristou Nadal ◽  
...  
Keyword(s):  
Gestational Diabetes ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Self Report ◽  
Self Management ◽  
Secondary Outcome ◽  
Behavioural Intervention ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings. Methods Two independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome. Discussion Screening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings. Trial registration ClinicalTrials.gov NCT03937050, registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605, registered on 26 February 2020.

scholarly journals Stress and Psychopathology Reduction in Pregnant Women through Online Cognitive Behavioural Therapy during COVID-19: A Feasibility Study

2021 ◽  
Vol 11 (7) ◽  
pp. 100
Author(s):  
Jose A. Puertas-Gonzalez ◽  
Carolina Mariño-Narvaez ◽  
Borja Romero-Gonzalez ◽  
Maria Isabel Peralta-Ramirez
Keyword(s):  
Pregnant Women ◽  
Cognitive Behavioural Therapy ◽  
Psychological Health ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Behavioural Intervention ◽  
Stress Vulnerability ◽  
Cognitive Behavioural ◽  
Cognitive Behavioural Intervention ◽  
Randomised Controlled

Background: The global pandemic has affected the psychological health of the population, including pregnant women. Due to the difficulty of offering conventional therapies to reduce stress in this population, studies are needed to show the effect of online therapies. Therefore, the objective was to test the effect of online cognitive behavioural therapy in pregnant women during the pandemic on the main variables of stress and psychopathology. Methods: The sample consisted of 16 pregnant women who participated in a weekly cognitive behavioural intervention for 8 weeks. Prenatal concerns, general stress, stress vulnerability, resilience and psychopathology were assessed. Results: The results show a reduction in prenatal concerns, perceived stress, stress vulnerability and psychopathology, as well as an increase in resilience. Conclusions: Online cognitive behavioural intervention may be effective in pregnant women, so it is important to conduct a randomised controlled trial to certify these findings.

scholarly journals SMARThealth Pregnancy: Feasibility and Acceptability of a Complex Intervention for High-Risk Pregnant Women in Rural India: Protocol for a Pilot Cluster Randomised Controlled Trial

2021 ◽  
Vol 2 ◽  
Author(s):  
Shobhana Nagraj ◽  
Stephen H. Kennedy ◽  
Vivekananda Jha ◽  
Robyn Norton ◽  
Lisa Hinton ◽  
...  
Keyword(s):  
Decision Support ◽  
Pilot Study ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Rural India ◽  
Cluster Randomised ◽  
Randomised Controlled

Introduction: India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy.Methods/Design: A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods.Discussion: It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03968952.

scholarly journals Effect of a behavioural intervention in obese pregnant women (the UPBEAT study): a multicentre, randomised controlled trial

2015 ◽  
Vol 3 (10) ◽  
pp. 767-777 ◽  
Author(s):  
Lucilla Poston ◽  
Ruth Bell ◽  
Helen Croker ◽  
Angela C Flynn ◽  
Keith M Godfrey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Behavioural Intervention ◽  
Randomised Controlled
Sign in / Sign up

Export Citation Format

Share Document