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Pregnancy is a teachable moment for behaviour change. Multiple guidelines target pregnant women for behavioural intervention. This systematic review of systematic reviews reports the effectiveness of interventions delivered during pregnancy on changing women's behaviour across multiple behavioural domains. Fourteen databases were searched for systematic reviews published from 2008, reporting interventions delivered during pregnancy targeting smoking, alcohol, diet or physical activity as outcomes. Data on behaviour change related to these behaviours are reported here. Quality was assessed using the JBI critical appraisal tool for umbrella reviews. Consistency in intervention effectiveness and gaps in the evidence-base are described. Searches identified 24,388 results; 109 were systematic reviews of behaviour change interventions delivered in pregnancy, and 36 reported behavioural outcomes. All smoking and alcohol reviews identified reported maternal behaviours as outcomes (n = 16 and 4 respectively), whereas only 16 out of 89 diet and/or physical activity reviews reported these behaviours. Most reviews were high quality (67%) and interventions were predominantly set in high-income countries. Overall, there was consistent evidence for improving healthy diet behaviours related to increasing fruit and vegetable consumption and decreasing carbohydrate intake, and fairly consistent evidence for increase in some measures of physical activity (METs and VO2 max) and for reductions in fat intake and smoking during pregnancy. There was a lack of consistent evidence across reviews reporting energy, protein, fibre, or micronutrient intakes; smoking cessation, abstinence or relapse; any alcohol behaviours. The most consistent review evidence is for interventions improving dietary behaviours during pregnancy compared with other behaviours, although the majority of diet reviews prioritised reporting health-related outcomes over behavioural outcomes. Heterogeneity between reported behaviour outcomes limits ability to pool data in meta-analysis and more consistent reporting is needed. Limited data are available for alcohol interventions in pregnancy or interventions in low- or middle-income-countries, which are priority areas for future research.

Maternal weight management is a priority due to pregnancy risks for women and babies. Interventions significantly improve maternal diet, physical activity, weight, and pregnancy outcomes. There are complex barriers to midwives' implementation of guidelines; low self-efficacy is a core implementation barrier. The GLOWING intervention uses social cognitive theory (SCT) to address evidence-based barriers to practice. The intervention aimed to support midwives' implementation of guidelines. An external rehearsal pilot cluster randomised controlled trial in four NHS Trusts (clusters) in England, UK. Clusters were randomised to intervention (where all eligible midwives received the intervention) or control (no intervention delivered) arms. A random sample of 100 midwives were invited to complete questionnaires pre- and post-intervention. UK guideline recommendations relating to midwives' practice were categorised into: 1) communication-related behaviours (including weight- and risk-communication), and 2) support/intervention-related behaviours (including diet/nutrition, physical activity, weight management, referrals/signposting). Questionnaires were developed using SCT constructs (self-efficacy, outcome expectancies, intentions, behaviours) and 7-point Likert scale, converted to a 0-100 scale. Higher scores were more positive. Descriptive statistics compared intervention and control arms, pre- and post-intervention. Seventy-four midwives consented and 68 returned questionnaires. Pre-intervention, self-efficacy for support/intervention-related behaviours scored lowest. In controls, there was limited difference between the pre- and post-intervention scores. Post-intervention, mean (SD) scores were consistently higher among intervention midwives than controls, particularly for support/intervention self-efficacy (71.4 (17.1) vs. 58.4 (20.1)). Mean (SD) self-efficacy was higher post-intervention than pre-intervention for all outcomes among intervention midwives, and consistently higher than controls. Mean differences pre- and post-intervention were greatest for support/intervention self-efficacy (17.92, 95% CI 7.78-28.07) and intentions (12.68, 95% CI 2.76-22.59). Self-efficacy was particularly increased for diet/nutrition and physical activity (MD 24.77, 95% CI 14.09-35.44) and weight management (18.88, 95% CI 7.88-29.88) behaviours, which showed the largest increase in scores. This study supports the theoretical models used to develop GLOWING, where low self-efficacy was a core implementation barrier. Results suggest that GLOWING successfully targets self-efficacy, potentially with a positive impact on guideline implementation. A definitive trial is required to determine effectiveness. ISRCTN46869894, retrospectively registered 25/05/2016, http://isrctn.com/ISRCTN46869894.

Background Whilst there has been increasing research interest in interventions which promote physical activity during pregnancy few studies have yielded detailed insights into the views and experiences of overweight and obese pregnant women themselves. The qualitative study described in this paper aimed to: (i) explore the views and experiences of overweight and obese pregnant women; and (ii) inform interventions which could promote the adoption of physical activity during pregnancy. Methods The study was framed by a combined Subtle Realism and Theory of Planned Behaviour (TPB) approach. This enabled us to examine the hypothetical pathway between beliefs and physical activity intentions within the context of day to day life. The study sample for the qualitative study was chosen by stratified, purposive sampling from a previous study of physical activity measurements in pregnancy. Research participants for the current study were recruited on the basis of Body Mass Index (BMI) at booking and parity. Semi-structured, in-depth interviews were conducted with 14 overweight and obese pregnant women. Data analysis was undertaken using a Framework Approach and was informed by TPB. Results Healthy eating was often viewed as being of greater importance for the health of mother and baby than participation in physical activity. A commonly cited motivator for maintaining physical activity during pregnancy is an aid to reducing pregnancy-related weight gain. However, participants often described how they would wait until the postnatal period to try and lose weight. A wide range of barriers to physical activity during pregnancy were highlighted including both internal (physical and psychological) and external (work, family, time and environmental). The study participants also lacked access to consistent information, advice and support on the benefits of physical activity during pregnancy. Conclusions Interventions to encourage recommended levels of physical activity in pregnancy should be accompanied by accessible and consistent information about the positive effects for mother and baby. More research is required to examine how to overcome barriers to physical activity and to understand which interventions could be most effective for overweight/obese pregnant women. Midwives should be encouraged to do more to promote activity in pregnancy.

Background Pregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives’ implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures. Methods GLOWING was a multi-centre parallel-group pilot cluster RCT comparing the delivery of a behaviour change intervention for midwives (delivered as training workshops) with usual practice. The clusters were four NHS Trusts in Northeast England, randomised to intervention or control arms. Blinding of allocation was not possible due to the nature of the intervention. We aimed to deliver the intervention to all eligible midwives in the intervention arm, in groups of 6 midwives per workshop, and to pilot questionnaire data collection for a future definitive trial. Intervention arm midwives’ acceptability of GLOWING content and delivery was assessed using a mixed methods questionnaire, and pregnant women’s acceptability of trial procedures by interviews. Quantitative data were analysed descriptively and qualitative data thematically. Results In intervention arm Trusts, 100% of eligible midwives ( n  = 67) were recruited to, and received, the intervention; however, not all workshops had the planned number of attendees (range 3–8). The consent rate amongst midwives randomised ( n  = 100) to complete questionnaires was 74% ( n  = 74) (95% CI 65%, 83%), and overall completion rate 89% ( n  = 66) (95% CI 82%, 96%). Follow-up response rate was 66% ( n  = 49) (95% CI 55%, 77%), with a marked difference between intervention (39%, n  = 15) and control (94%, n  = 34) groups potentially due to the volume of research activities. Overall, 64% ( n  = 47) (95% CI 53%, 75%) completed both baseline and follow-up questionnaires. Midwives viewed the intervention as acceptable and directly relevant to routine practice. The least popular components related to scripted role-plays. Pregnant women viewed the recruitment and trial processes to be acceptable. Conclusions This rigorously conducted pilot study demonstrated feasibility intervention delivery and a high level of acceptability amongst participants. It has provided information required to refine the intervention and trial protocol, enhancing confidence that a definitive trial could be carried out. Trial registration ISRCTN46869894; retrospectively registered 25th May 2016, www.isrctn.com/ISRCTN46869894 .

Background As part of the internal pilot of the EMPOWER trial investigating the second-line antiemetic therapies in severe emesis in pregnancy ( https://www.isrctn.com/ISRCTN16924692 ), a qualitative study of women’s views was carried out, to improve our understanding of why women did, or did not, consent to participation in the trial. Interviews were also conducted with site research staff, to broaden our analysis and explore other factors affecting recruitment. Methods The sample comprised women who accepted or declined trial participation ( n =21) and site research staff ( n =22). A structured topic guide was used, in four email interviews and 17 telephone interviews with women, and semi-structured telephone interviews were carried out with staff. Of the women interviewed, seven had declined trial participation, and of the staff interviewed, 16 were research midwives/research nurses and six were principal investigators. All transcripts were checked for accuracy, anonymised and entered into NVIVO12 for indexing and retrieval. Data was analysed using a reflexive thematic analytic approach. In total, 72 codes were generated from the thematic analysis, and 36 from each sample group. Results Three key themes based on all the interviews were (a) the diversity of recruitment pathways and boundaries of care, (b) the impact of trial complexity on recruitment and staff morale and (c) the ethics of caring for a patient with emesis. Ethical issues discussed included the use of double dummy and time to treat, particularly those suffering severely from the effects of nausea and vomiting. To illustrate these themes, staff perspectives are given more prominence. Conclusions The main reason the trial was stopped related to the high proportion of women ineligible for recruitment due to prior treatment with study drug(s) because of unanticipated changes in clinical practice. The qualitative results also demonstrate the impact of the trial on women and staff and highlight how the diversity of referral pathways, boundaries of care and the complexity of the trial and protocol resulted in additional barriers to successful trial recruitment. Qualitative work in pilot and feasibility studies of a clinical trial is recommended, to evaluate whether recruitment strategies remain viable in unanticipated contexts. Trial registration Trial registration number ISRCTN16924692 . Date: 08/01/2018

Background Inexpensive, reliable objective methods are needed to measure physical activity (PA) in large scale trials. This study compared the number of pedometer step counts with accelerometer data in pregnant women in free-living conditions to assess agreement between these measures. Methods Pregnant women (n = 58) with body mass index ≥25 kg/m 2 at median 13 weeks' gestation wore a GT1M Actigraph accelerometer and a Yamax Digi-Walker CW-701 pedometer for four consecutive days. The Spearman rank correlation coefficients were determined between pedometer step counts and various accelerometer measures of PA. Total agreement between accelerometer and pedometer step counts was evaluated by determining the 95% limits of agreement estimated using a regression-based method. Agreement between the monitors in categorising participants as active or inactive was assessed by determining Kappa. Results Pedometer step counts correlated moderately (r = 0.36 to 0.54) with most accelerometer measures of PA. Overall step counts recorded by the pedometer and the accelerometer were not significantly different (medians 5961 vs. 5687 steps/day, p = 0.37). However, the 95% limits of agreement ranged from -2690 to 2656 steps/day for the mean step count value (6026 steps/day) and changed substantially over the range of values. Agreement between the monitors in categorising participants to active and inactive varied from moderate to good depending on the criteria adopted. Conclusions Despite statistically significant correlations and similar median step counts, the overall agreement between pedometer and accelerometer step counts was poor and varied with activity level. Pedometer and accelerometer steps cannot be used interchangeably in overweight and obese pregnant women.

Background Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives’ guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives’ implementation of weight management guidelines. Methods GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial. Discussion This pilot study has been developed to support community midwives’ implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness. Trial registration ISRCTN46869894 ; retrospectively registered 25th May 2016.

Background Obese and overweight women may benefit from increased physical activity (PA) during pregnancy. There is limited published data describing objectively measured PA in such women. Methods A longitudinal observational study of PA intensity, type and duration using objective and subjective measurement methods. Fifty five pregnant women with booking body mass index (BMI) ≥ 25 kg/m 2 were recruited from a hospital ultrasound clinic in North East England. 26 (47%) were nulliparous and 22 (40%) were obese (BMI ≥ 30 kg/m 2 ). PA was measured by accelerometry and self report questionnaire at 13 weeks, 26 weeks and/or 36 weeks gestation. Outcome measures were daily duration of light, moderate or vigorous activity assessed by accelerometry; calculated overall PA energy expenditure, (PAEE), and PAEE within four domains of activity based on self report. Results At median 13 weeks gestation, women recorded a median 125 mins/day light activity and 35 mins/day moderate or vigorous activity (MVPA). 65% achieved the minimum recommended 30 mins/day MVPA. This proportion was maintained at 26 weeks (62%) and 36 weeks (71%). Women achieving more than 30 mins/day MVPA in the first trimester showed a significant reduction in duration of MVPA by the third trimester (11 mins/day, p = 0.003). Walking, swimming and floor exercises were the most commonly reported recreational activities but their contribution to estimated energy expenditure was small. Conclusion Overweight and obese pregnant women can achieve and maintain recommended levels of PA throughout pregnancy. Interventions to promote PA should target changes in habitual activities at work and at home, and in particular walking.

Diet, physical activity, smoking and alcohol behaviour-change interventions delivered in pregnancy aim to prevent adverse pregnancy outcomes. This review reports a synthesis of evidence from meta-analyses on the effectiveness of interventions at reducing risk of adverse health outcomes. Sixty-five systematic reviews (63 diet and physical activity; 2 smoking) reporting 602 meta-analyses, published since 2011, were identified; no data were identified for alcohol interventions. A wide range of outcomes were reported, including gestational weight gain, hypertensive disorders, gestational diabetes (GDM) and fetal growth. There was consistent evidence from diet and physical activity interventions for a significantly reduced mean gestational weight gain (ranging from −0.21 kg (95% confidence interval −0.34, −0.08) to −5.77 kg (95% CI −9.34, −2.21). There was evidence from larger diet and physical activity meta-analyses for a significant reduction in postnatal weight retention, caesarean delivery, preeclampsia, hypertension, GDM and preterm delivery, and for smoking interventions to significantly increase birth weight. There was no statistically significant evidence of interventions having an effect on low or high birthweight, neonatal intensive care unit admission, Apgar score or mortality outcomes. Priority areas for future research to capitalise on pregnancy as an opportunity to improve the lifelong wellbeing of women and their children are highlighted.

Maternal weight management increases risks for women and babies and is a public health priority. Interventions can substantially improve maternal diet and physical activity behaviours and pregnancy outcomes. Low self-efficacy is a core barrier to midwives' implementation of guidelines. GLOWING used social cognitive theory to address evidence-based barriers to practice, aiming to support midwives' guidelines implementation. This study was a pilot cluster randomised controlled trial in four UK National Health Service Trusts (clusters) in England. Clusters were randomised to intervention (midwives received intervention) or control (no intervention). Guideline recommendations for midwives' practice were: first, communication-related behaviours (weight-communication and risk-communication); and second, support and intervention-related behaviours (diet and nutrition, physical activity, weight management, and referrals and signposting). Questionnaires were designed using social cognitive theory constructs (eg, self-efficacy, outcome expectancies, intentions, behaviours), higher scores being more positive. Following Consolidated Standards of Reporting Trials guidelines for pilot trials, descriptive statistics were used to compare arms, before and after the intervention. 100 midwives were randomised to complete questionnaires before and after the intervention. 74% consented, and 68% returned questionnaires. Pre-intervention, self-efficacy for support, and intervention-related behaviours scored lowest. In controls, the difference between pre-intervention and post-intervention scores were negligible. Post-intervention scores were consistently higher in midwives in the intervention group than the control group, particularly for support and intervention self-efficacy (mean 71·4 [SD 17·1] vs 58·4 [20·1]). Self-efficacy was higher after the intervention than before the intervention for all outcomes among intervention midwives: weight-communication (mean 76·3 [SD 16·7] vs 67·2 [21·1]), risk-communication (79·4 [16·4] vs 68·6 [14·9]), diet, nutrition, and physical activity (76·4 [16·0] vs 49·3 [16·5]), weight management (72·1 [18·3] vs 48·3 [19·8]), referrals and signposting (63·3 [26·0] vs 47·9 [17·3]), and consistently higher than controls. Results support the theoretical models used to develop GLOWING: low self-efficacy is a core implementation barrier. Results suggest GLOWING successfully targets self-efficacy, potentially with positive implications for guideline implementation. A strength of this work is the rigorous evidence-based theoretical approach to intervention development, largely absent in maternity-based research. A limitation is that this is a pilot trial. A definitive trial is required to determine effectiveness. National Institute for Health Research Postdoctoral Fellowship (reference PDF-2011-04-034).