Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0).

INTRODUCTION: Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial. METHODS AND ANALYSIS: A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become 'infant feeding helpers' in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences. TRIAL REGISTRATION NUMBER: ISRCTN17395671.

Views of female genital mutilation survivors, men and health-care professionals on timing of deinfibulation surgery and NHS service provision: qualitative FGM Sister Study.

Background: Female genital mutilation is an important UK health-care challenge. There are no health benefits of female genital mutilation, and it is associated with lifelong physical, psychological and sexual impacts. The annual cost to the NHS to care for survivors is £100M. Deinfibulation may improve the health and well-being of some women, but there is no consensus on the optimal timing of surgery for type 3 survivors. UK care provision is reportedly suboptimal. Objectives: We aimed to explore the views of survivors, men and health-care professionals on the timing of deinfibulation surgery and NHS service provision. Methods: This was a qualitative study informed by the Sound of Silence framework. This framework is useful for researching sensitive issues and the health-care needs of marginalised populations. A total of 101 interviews with 44 survivors, 13 men and 44 health-care professionals were conducted, supplemented by two workshops with affected communities (participants, n = 10) and one workshop with stakeholders (participants, n = 30). Data were analysed using a hybrid framework method. Results: There was no clear consensus between groups on the optimal timing of deinfibulation. However, within groups, survivors expressed a preference for deinfibulation pre pregnancy; health-care professionals preferred antenatal deinfibulation, with the caveat that it should be the survivor's choice. There was no consensus among men. There was agreement that deinfibulation should take place in a hospital setting and be undertaken by a suitable health-care professional. Decision-making around deinfibulation was complex. Deficiencies in professionals' awareness, knowledge and understanding resulted in impacts on the provision of appropriate care. Although there were examples of good practice and positive care interactions, in general, service provision was opaque and remains suboptimal, with deficiencies most notable in mental health. Deinfibulation reportedly helps to mitigate some of the impacts of female genital mutilation. Interactions between survivors and health-care professionals were disproportionately framed around the law. The way in which services are planned and provided often silences the perspectives and preferences of survivors and their families. Limitations: Only a minority of the interviews were conducted in a language other than English, and the recruitment of survivors was predominantly through maternity settings, which meant that some voices may not have been heard. The sample of men was relatively small, limiting interpretation. Conclusions: In general, service provision remains suboptimal and can silence the perspectives and preferences of survivors. Deinfibulation services need to be widely advertised and information should highlight that the procedure will be carried out in hospital by suitable health-care professionals and that a range of time points will be offered to facilitate choice. Future services should be developed with survivors to ensure that they are clinically and culturally appropriate. Guidelines should be updated to better reflect the needs of survivors and to ensure consistency in service provision. Future work: Research is needed to (1) map female genital mutilation service provision; (2) develop and test effective education to address deficits in awareness and knowledge for affected communities and health-care professionals; and (3) develop, monitor and evaluate clinically and culturally competent female genital mutilation services. Trial registration: Current Controlled Trials ISRCTN14710507. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme and will be published in full in Health Technology Assessment; Vol. 27, No. 3. See the NIHR Journals Library website for further project information.

Female genital mutilation (or cutting) involves changing or removing parts of a girl's or woman's genitalia when there is no medical reason to do so. Many women and girls who have been cut live in the UK, where female genital mutilation is illegal. Some girls and women who have been cut experience problems in getting pregnant and having their baby. There are four types of cutting. Type 3 involves cutting and sewing together the genitalia, leaving only a small hole. Women and girls with type 3 mutilation can have a small operation to open their vagina. We do not know when the best time is to have this operation. We would also like to know more about how NHS female genital mutilation services can best help women. To answer these questions, we talked to 141 people, who were women who have been cut, men and health-care professionals. They told us that there is no ideal time to have the operation. Women who have been cut would like the operation before they get pregnant, but health-care professionals would like women to have it during their pregnancy. Men were not sure when it should happen. They all agreed that the operation should take place in a hospital and be carried out by a skilled professional. The way that we support women and men could be better and we need to improve the help that is offered. Sometimes women and men did not know where to go for help or how to ask for help. Women, men and health-care professionals sometimes found it hard to talk about cutting. Some health professionals did not have the right skills to undertake the operation. They told us that they need more training and clearer guidance to ensure that women feel cared for and safe.

Relationship between primary school healthy eating and physical activity promoting environments and children's dietary intake, physical activity and weight status: a longitudinal study in the West Midlands, UK.

OBJECTIVE: We aimed to examine the association between food and physical activity environments in primary schools and child anthropometric, healthy eating and physical activity measures. DESIGN: Observational longitudinal study using data from a childhood obesity prevention trial. SETTING: State primary schools in the West Midlands region, UK. PARTICIPANTS: 1392 pupils who participated in the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) childhood obesity prevention trial (2011-2015). PRIMARY AND SECONDARY OUTCOME MEASURES: School environment (exposure) was categorised according to questionnaire responses indicating their support for healthy eating and/or physical activity. Child outcome measures, undertaken at three time points (ages 5-6, 7-8 and 8-9 years), included body mass index z-scores, dietary intake (using a 24-hour food ticklist) and physical activity (using an Actiheart monitor over 5 days). Associations between school food and physical activity environment categories and outcomes were explored through multilevel models. RESULTS: Data were available for 1304 children (94% of the study sample). At age 8-9 years, children in 10 schools with healthy eating and physical activity-supportive environments had a higher physical activity energy expenditure than those in 22 schools with less supportive healthy eating/physical activity environments (mean difference=5.3 kJ/kg body weight/24 hours; p=0.05). Children in schools with supportive physical activity environments (n=8) had a lower body mass index z-score than those in schools with less supportive healthy eating/physical activity environments (n=22; mean difference=-0.17, p=0.02). School food and physical activity promoting environments were not significantly associated with dietary outcomes. CONCLUSIONS: School environments that support healthy food and physical activity behaviours may positively influence physical activity and childhood obesity. TRIAL REGISTRATION NUMBER: ISRCTN97000586.

The ABA intervention for improving breastfeeding initiation and continuation: Feasibility study results.

The UK has low breastfeeding rates, with socioeconomic disparities. The Assets-based feeding help Before and After birth (ABA) intervention was designed to be inclusive and improve infant feeding behaviours. ABA is underpinned by the behaviour change wheel and offers an assets-based approach focusing on positive capabilities of individuals and communities, including use of a Genogram. This study aimed to investigate feasibility of intervention delivery within a randomised controlled trial (RCT). Nulliparous women ≥16 years, (n = 103) from two English sites were recruited and randomised to either intervention or usual care. The intervention - delivered through face-to-face, telephone and text message by trained Infant Feeding Helpers (IFHs) - ran from 30-weeks' gestation until 5-months postnatal. Outcomes included recruitment rates and follow-up at 3-days, 8-weeks and 6-months postnatal, with collection of future full trial outcomes via questionnaires. A mixed-methods process evaluation included qualitative interviews with 30 women, 13 IFHs and 17 maternity providers; IFH contact logs; and fidelity checking of antenatal contact recordings. This study successfully recruited women, including teenagers, from socioeconomically disadvantaged areas; postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3-days, 8-weeks and 6-months respectively. Breastfeeding at 8-weeks was obtained for 95.1% using routine data for non-responders. It was possible to recruit and train peer supporters to deliver the intervention with adequate fidelity. The ABA intervention was acceptable to women, IFHs and maternity services. There was minimal contamination and no evidence of intervention-related harm. In conclusion, the intervention is feasible to deliver within an RCT, and a definitive trial required.

The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6-7 years.

BACKGROUND: Systematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children. DESIGN: A cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible. SETTING: Primary schools, West Midlands, UK. PARTICIPANTS: Schools within a 35-mile radius of the study centre and all year 1 pupils (aged 5-6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses. INTERVENTIONS: The 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting 'Villa Vitality' (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities. MAIN OUTCOME MEASURES: The primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools. RESULTS: Two groups of schools were randomised: 27 in 2011 (n = 650 pupils) [group 1 (G1)] and another 27 in 2012 (n = 817 pupils) [group 2 (G2)]. Primary outcome data were available at first follow-up (n = 1249 pupils) and second follow-up (n = 1145 pupils) from 53 schools. The mean difference (MD) in BMI-z between the control and intervention arms was -0.075 [95% confidence interval (CI) -0.183 to 0.033] and -0.027 (95% CI -0.137 to 0.083) at 3 and 18 months post intervention, respectively. The main analyses showed no evidence of between-arm differences for any secondary outcomes. Third follow-up included data on 467 pupils from 27 G1 schools, and showed a statistically significant difference in BMI-z (MD -0.20, 95% CI -0.40 to -0.01). The mean cost of the intervention was £266.35 per consented child (£155.53 per child receiving the intervention). The incremental cost-effectiveness ratio associated with the base case was £46,083 per QALY (best case £26,804 per QALY), suggesting that the intervention was not cost-effective. LIMITATIONS: The presence of baseline primary outcome imbalance between the arms, and interschool variation in fidelity of intervention delivery. CONCLUSIONS: The primary analyses show no evidence of clinical effectiveness or cost-effectiveness of the WAVES study intervention. A post hoc analysis, driven by findings at third follow-up, suggests a possible intervention effect, which could have been attenuated by baseline imbalances. There was no evidence of an intervention effect on measures of diet or PA and no evidence of harm. FUTURE WORK: A realist evidence synthesis could provide insights into contextual factors and strategies for future interventions. School-based interventions need to be integrated within a wider societal framework and supported by upstream interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 8. See the NIHR Journals Library website for further project information.

Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA).

INTRODUCTION: Breast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman's feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care. METHODS AND ANALYSIS: A two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper-women interactions to assess intervention fidelity. ETHICS AND DISSEMINATION: Study results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol. TRIAL REGISTRATION NUMBER: ISRCTN14760978; Pre-results.

Process evaluation design in a cluster randomised controlled childhood obesity prevention trial: the WAVES study.

BACKGROUND: The implementation of a complex intervention is heavily influenced by individual context. Variation in implementation and tailoring of the intervention to the particular context will occur, even in a trial setting. It is recognised that in trials, evaluating the process of implementation of a complex intervention is important, yet process evaluation methods are rarely reported. The WAVES study is a cluster randomised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged 6-7 years, delivered by teachers in primary schools across the West Midlands, UK. The intervention promoted activities encouraging physical activity and healthy eating. This paper presents the methods used to assess implementation of the intervention. METHODS: Previous literature was used to identify the dimensions of intervention process and implementation to be assessed, including adherence, exposure, quality of delivery, participant responsiveness, context, and programme differentiation. RESULTS: Multiple methods and tools were developed to capture information on all these dimensions. These included observations, logbooks, qualitative evaluation, questionnaires and research team reflection. DISCUSSION: Data collection posed several challenges, predominantly when relying on teachers to complete paperwork, which they saw as burdensome on top of their teaching responsibilities. However, the use of multiple methods helped to ensure data on each dimension, where possible, was collected using more than one method. This also allowed for triangulation of the findings when several data sources on any one dimension were available. CONCLUSIONS: We have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster randomised controlled trial. These approaches can be transferred and adapted for use in other complex intervention trials. TRIAL REGISTRATION NUMBER: ISRCTN97000586.

Renal impairment and medication use among psychogeriatric inpatients.

OBJECTIVES: To determine the prevalence of renal impairment and the dosage appropriateness of several medications for which dosing guidelines in the advent of renal impairment are available. METHOD: The authors assessed the renal function and medication use of 37 psychogeriatric patients (mean age of 75 years) living in a psychiatric hospital. Renal function was determined by serum creatinine (SCr) levels and creatinine clearance (CCr) data using the Cockcroft and Gault equation. RESULTS: Thirteen of 37 patients (35%) were found to have renal impairment according to CCr data but only two patients (6%) were considered impaired according to SCr levels (k=0.19). Of 44 medications for which dosing guidelines were available, only two (5%) were prescribed inappropriately. CONCLUSION: These data suggest that CCr data should be used over SCr levels to determine renal impairment and to support the monitoring of psychogeriatric patients for declines in renal function and required medication adjustments.