Pregnancy and weight monitoring : a feasibility study of weightcharts and midwife support

Funding Information The Burdett Trust for Nursing.Peer reviewedPublisher PD

Evaluating the long-term impact of the Fostering Changes training programme for foster carers in Wales, the Confidence in Care trial: study protocol for a randomized controlled trial

Background The Fostering Changes programme was developed by the Adoption and Fostering National Team at the Maudsley Hospital, South London, in conjunction with King’s College London. It is a 12-week group-based training programme for foster and kin carers, which aims to build positive relationships between carers and children, encourage positive child behaviour and set appropriate limits, through a practical skills-based approach. The programme also aims to improve foster carers’ understanding of the causes of children’s social and emotional difficulties and their confidence in applying this knowledge in various situations. Methods This is a pragmatic open-label individually randomised controlled trial, with embedded process evaluation. A total of 237 participants will be recruited from Welsh Local Authorities and Independent Fostering Providers; those allocated to the intervention group will be offered enrolment in the next Fostering Changes programme group at their site. Participants in the control group will be offered the Fostering Changes programme at the end of the follow-up period. Data will be collected at baseline, immediately following the 12 week Fostering Changes intervention, and 12 months from the start of the Fostering Changes programme. The primary outcome measure assesses the extent to which carers feel able to cope with and make positive changes to the lives of their foster children and is measured by the Carer Efficacy Questionnaire at 12 months. Discussion The trial will determine whether the Fostering Changes programme, in the long term, can deliver important, significant differences to the way foster carers build positive relationships with their foster children, encourage positive child behaviour and set appropriate limits, compared with usual care

A pragmatic randomised controlled trial of the fostering changes programme

Background Many looked after young people in Wales are cared for by foster or kinship carers, usually as a consequence of maltreatment or developmentally traumatising experiences within a family context. Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care. Objective To determine whether group-based training improves foster carer self-efficacy. Participants and setting Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks. Carers from households where one or more carer had previously attended the training were not eligible. Sixteen local authorities and three independent fostering providers in Wales took part. Methods The primary outcome measure was the Carer Efficacy Questionnaire assessed at 12 months. Secondary outcomes included the Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves. Results 312 consented foster carers were allocated to FC (n = 204) or usual care (n = 108) group. 65.3 % of FC group participants attended sufficient training sessions (8/12, including sessions three and four). There were no differences in carer-reported self-efficacy at 12 months (adjusted difference in means (95 % CI): -0.19 (-1.38 to 1.00)). Small differences in carer-reported child behaviour difficulties and carer coping strategies over time favoured the intervention but these effects diminished from three to 12 months. No other intervention effects were observed. Conclusions Although well-received by participants, training was associated with small and mostly short-term benefit for trial secondary outcomes. Previous articl

Qualitative process evaluation of the Fostering Changes program for foster carers as part of the Confidence in Care randomized controlled trial

Background Fostering Changes is an in-service training program for foster carers designed to enhance carer skills, coping strategies and carer-child relationships. The training program has been evaluated in a randomised controlled trial comparing Fostering Changes to usual care. Objective To conduct a qualitative process evaluation drawing on stakeholder perspectives to describe the logic model of Fostering Changes, identify potential mechanisms of impact of the program and enhance understanding of the trial results. Participants and setting Participants were stakeholders in the Fostering Changes program delivered in Wales, UK including foster carers invited to attend the program (18 attendees, eight non-attendees), two program developers, five trainers, 12 social workers who attended or recruited to the program. Methods Total population sampling with qualitative data collection methods. Qualitative data were subject to thematic analysis. Results A logic model summarising the program resources, activities and anticipated outcomes was generated. Implementation themes were quality of training, setting and group composition. Mechanisms of impact were identified with themes falling into two categories, group process and skills development. Potential barriers to effectiveness included a poor fit between the carer needs and the program in relation to levels of challenge being faced, age-appropriate content and responsiveness. Contextual factors were also relevant, including the existing relationship between foster carers and the agency and the perceived value of training

An app-, web- and social support-based weight loss intervention for adults with obesity: the HelpMeDoIt! feasibility RCT

Background: Finding solutions to rising levels of obesity continues to be a major public health focus. Social support has an important role in successful weight loss, and digital interventions can reach a large proportion of the population at low cost. Objective: To develop and assess the feasibility and acceptability of an application (app), web- and social support-based intervention in supporting adults with obesity to achieve weight loss goals. Design: Stage 1 – intervention development phase involved three focus groups (n = 10) with users, and think-aloud interviews and field testing with another group (n = 28). Stage 2 – the intervention and evaluation methods were explored in a feasibility randomised controlled trial with economic and process evaluation. Setting: Greater Glasgow and Clyde, UK. Participants: Adults with a body mass index of ≥ 30kg/m2 who owned a smartphone and were interested in losing weight were randomised 2 : 1 (intervention : control) and followed up at 12 months. Recruitment took place in April–October 2016. Interventions: The intervention group had access to HelpMeDoIt! for 12 months. This encouraged them to (1) set goals, (2) monitor progress and (3) harness social support by inviting ‘helpers’ from their existing social network. The control group received a healthy lifestyle leaflet. Main outcome measures: Data from stage 1 informed the intervention design. Key measures in stage 2 assessed the feasibility and acceptability of the intervention and trial methods against prespecified progression criteria. Three primary outcomes were explored: body mass index, diet and physical activity. Secondary outcomes included weight, waist and hip circumference, social support, self-efficacy, motivation, mental health, health-related quality of life, NHS resource use, participant-borne costs and intervention costs. Qualitative interviews with participants (n = 26) and helpers (n = 9) explored the feasibility and acceptability of the trial methods and intervention. Results: Stage 1 produced (1) a website that provided evidence-based information for lifestyle change and harnessing social support, and (2) an app that facilitated goal-setting, self-monitoring and supportive interaction between participants and their helper(s). Progression criteria were met, demonstrating that the intervention and trial methods were feasible and acceptable. A total of 109 participants (intervention, n = 73; control, n = 36) were recruited, with 84 participants (77%: intervention, 71%; control, 89%) followed up at 12 months. Data were successfully collected for most outcome measures (≥ 82% completion). Participants and helpers were generally positive, although helper engagement with the app was low. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it twice or more, 28 helpers enrolled via the app, and 19 (36%) participants interacted with their helper(s) via the app. Interview data indicated that HelpMeDoIt! prompted support from helpers that often occurred without the helpers using the app. Limitations: Early technical problems meant that some participants and helpers had difficulty accessing the app. Ethical constraints meant that we were unable to contact helpers directly for interview. Conclusions: The HelpMeDoIt! study demonstrated that a weight loss intervention delivered via an app and a website is feasible and acceptable. Progression criteria were met, supporting further evaluation of the intervention. Future work: To further explore (1) the motivation and engagement of helpers, (2) the programme theory and (3) the effectiveness and cost-effectiveness of the intervention. Trial registration: Current Controlled Trials ISRCTN85615983. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 3. See the NIHR Journals Library website for further project information

What are the challenges when recruiting to a trial in children’s social care? A qualitative evaluation of a trial of foster carer training

Background Randomised controlled trials (RCTs) are comparatively rare in UK social work, but can offer distinct advantages. Confidence in Care (CiC) is an RCT with embedded process evaluation evaluating Fostering Changes (FC), a 12-week training programme for foster and kinship carers to increase skills and coping strategies. In order to mitigate challenges in participant recruitment, an engagement strategy was designed to maximise this. Our aim is to explore experiences of key study stakeholders towards trial recruitment and identify broader messages about recruitment to social care trials. Methods Three focus groups were conducted, two with field-based recruiting staff (n = 7) and one with carers who attended the FC programme (n = 8). Five interviews were conducted with trainers who delivered FC, eight with foster carers who attended the programme, 18 with Foster Carers who elected not to take part in the programme, and 12 with social workers from participating trial sites. In addition, an away day for FC trainers was observed and discussions related to recruitment were noted. Transcribed audio-recorded data were inductively coded, double-coded by a second researcher, and thematically analysed. Results Six themes were identified. The first addressed pragmatic aspects of the intervention affecting recruitment (e.g. committing to a 12-week programme). A second focussed on accuracy of communication about the trial between provider agencies and carers. A third concerned the ability of recruiting staff to contact carers, a particular challenge in group-based recruitment. A fourth addressed trial methods and their communication (e.g. relationship between trial team and recruiting staff). A fifth explored lack of differentiation by carers between the roles of the various professionals (e.g. FC facilitators and provider agencies). The sixth addressed perceived differences between recruitment into social care and health studies. Conclusions Recruitment challenges in this social care setting were similar to those in healthcare. Some (e.g. gatekeeping by professional staff) may be rooted in randomisation anxiety, or unfamiliarity with research methods. Researchers more familiar with healthcare recruitment were however encouraged about the experience of working in this care setting. The original recruitment strategy and adaptations form the basis of further recommendations for research practice

The evaluation of the Scottish Borders/Food Train Eat Well Age Well implementation of the Patients Association Nutrition Checklist

Background: The Patients Association Nutrition Checklist (Checklist) is a simple tool that can be used to identify older adults who may be at risk of malnutrition at an early stage and provide simple advice and signpost to additional support. The Scottish Borders Council, in partnership with the Eat Well Age Well Charity, have been implementing the Checklist across health and social care organisations since Autumn 2021. Aims: To see if it was possible to use the Checklist in 12 organisations that work with older adults in the community, and to understand what the impact of the Checklist is for older adults and the staff who use it. Methods: Information regarding how the Checklist was used and the experiences of staff who work in the organisations was collected using online surveys. Organisation staff and the Checklist trainer (Eat Well Age Well) were interviewed about their experiences of using the Checklist. Key Findings: Use of the Checklist varied across organisations, data show it was completed with 461 older adults and that 7.4% were considered at risk of malnutrition. The Checklist: was easy to use; helped with difficult conversations and referrals to additional services (dietetics, GP); and was quick to deliver, costing £4.17-£6.83 per older adult. Things that made using the Checklist more difficult included: short appointment times; older adult capacity/communication issues; and staffing levels. As a result of using the Checklist, organisation staff developed improved skills and confidence spotting and managing malnutrition and health improvements were seen in older adults. Patient and Public Involvement (PPI): PPI representatives, using lived experience, contributed to the study design and interpretation/dissemination of results. Conclusions: Using the Checklist could help to increase awareness of malnutrition, improve conversations and prevent older adult ill-health. Recommendations for future use include embedding Checklist use at strategic level in organisations to support intended use of the Checklist

The READ-IT study protocol for a feasibility randomised controlled trial of using a support worker/family carer mediated online reading programme to teach early reading skills to adults with intellectual disabilities

Background: Many individuals with intellectual disability (ID) have not learnt basic reading skills by the time that they reach adulthood, potentially limiting their access to critical information. READ-IT is an online reading programme developed from the Headsprout® Early Reading (HER®) intervention and supplemented by support strategies tailored for adults with ID. HER® has been successfully used to teach adults with ID to read in a forensic setting by trained staff. The aim of this study is to assess the feasibility of delivering READ-IT to adults with ID by family carers/support workers and will assess whether it would be feasible to conduct a later definitive randomised controlled trial (RCT) of the effectiveness of the programme. The study will aim to contribute to the evidence base on improving outcomes for adults with ID and their caregivers. Methods: This study is a feasibility RCT, with embedded process evaluation. Forty-eight adults with ID will be recruited and allocated to intervention: control on a 1:1 basis. Intervention families will be offered the READ-IT programme immediately, continuing to receive usual practice and control participants will be offered the opportunity to receive READ-IT at the end of the trial follow-up period and will continue to receive usual practice. Data will be collected at baseline and 6 months post-randomisation. Discussion: The results of this study will inform a potential future definitive trial, to evaluate the effectiveness of READ-IT to improve reading skills. Such a trial would have significant scientific impact internationally in the intellectual disability field. Trial registration: ISRCTN1140909

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

Objective: To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods: Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions: Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results: Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions: There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464

The acceptability and feasibility of a planned pre-pregnancy weight loss intervention (the Plan-it Study): A Protocol Paper

Background: Women with obesity are at a greater risk of experiencing complications during the antenatal, intrapartum and postpartum periods. Despite many studies of weight management interventions in pregnancy, systematic reviews have demonstrated limited effectiveness, demonstrating a need to increase the focus on preconception health and build a greater awareness of the association between preconception health and maternal and child outcomes. Much of the research in pre-conception weight loss has been with very specific populations or has been small-scale. The aim of the Plan-it study is to establish if it is acceptable and feasible to conduct a study that asks women with overweight/ obesity (BMI of 25 or over) to delay removal of LARC to participate in a targeted pre-pregnancy weight loss intervention. Methods: The study will take a concurrent mixed methods approach incorporating use of routine NHS data and qualitative data collection and analysis across two work-packages: the first will establish the feasibility of defining and understanding the population through routine data and the second will provide an understanding of the feasibility and acceptability to stakeholders (LARC users and practitioners) of incorporating a pre-pregnancy weight loss intervention, in addition to identifying potentially suitable weight loss interventions and the theories underpinning them. The findings from the two work packages will contribute to a final report, which will delineate the key design elements of a future trial or identify the barriers that currently prevent such a trial taking place. Discussion: The preconception period provides an opportunity to intervene with a weight loss intervention in women with overweight/ obesity. The findings of this study will contribute to the evidence base for weight management in the preconception period and provides information, critical to consider, when developing a future intervention and associated feasibility tria