Text Messages With Financial Incentives for Men With Obesity: A Randomized Clinical Trial.

Importance: Effective weight loss interventions are needed for men with obesity. Objective: To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group. Design, Setting, and Participants: An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023. Interventions: Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline. Main Outcomes and Measures: The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison. Results: Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, -3.2%; 97.5% CI, -4.6% to -1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, -1.4%; 97.5% CI, -2.9% to 0.0, P = .05). The mean (SD) weight changes were -5.7 (7.4) kg for the text messaging with financial incentives group, -3.0 (7.5) kg for the text messaging alone group, and -1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were -4.8% (6.1%) for the text messaging with financial incentives group, -2.7% (6.3%) for text messaging alone group, and -1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group. Conclusion and Relevance: Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesity. Trial Registration: isrctn.org Identifier: ISRCTN91974895.

Recruiting men from across the socioeconomic spectrum via GP registers and community outreach to a weight management feasibility randomised controlled trial.

BACKGROUND: Men, particularly those living in disadvantaged areas, are less likely to participate in weight management programmes than women despite similar levels of excess weight. Little is known about how best to recruit men to weight management interventions. This paper describes patient and public involvement in pre-trial decisions relevant to recruitment and aims to report on recruitment to the subsequent men-only weight management feasibility trial, including the: i) acceptability and feasibility of recruitment; and ii) baseline sample characteristics by recruitment strategy. METHODS: Men with BMI ≥30 kg/m2 and/or waist circumference ≥ 40 in. were recruited to the feasibility trial via two strategies; community outreach (venue information stands and word of mouth) and GP letters, targeting disadvantaged areas. Recruitment activities (e.g. letters sent, researcher venue hours) were recorded systematically, and baseline characteristics questionnaire data collated. Qualitative interviews (n = 50) were conducted three months post-recruitment. Analyses and reporting followed a complementary mixed methods approach. RESULTS: 105 men were recruited within four months (community n = 60, GP letter n = 45). Community outreach took 2.3 recruiter hours per participant and GP letters had an opt-in rate of 10.2% (n = 90/879). More men were interested than could be accommodated. Most participants (60%) lived in more disadvantaged areas. Compared to community outreach, men recruited via GP letters were older (mean = 57 vs 48 years); more likely to report an obesity-related co-morbidity (87% vs 44%); and less educated (no formal qualifications, 32% vs 10%, degree educated 11% vs 41%). Recruitment strategies were acceptable, a sensitive approach and trusting relationships with recruiters valued, and the 'catchy' study name drew attention. CONCLUSIONS: Targeted community outreach and GP letters were acceptable strategies that successfully recruited participants to a men-only weight management feasibility trial. Both strategies engaged men from disadvantaged areas, a typically underserved population. Using two recruitment strategies produced samples with different health risk profiles, which could add value to research where either primary or secondary prevention is of interest. Further work is required to examine how these strategies could be implemented and sustained in practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03040518 , 2nd February 2017.

Exploring the use and experience of an infant feeding genogram to facilitate an assets-based approach to support infant feeding.

BACKGROUND: A lack of perceived social support influences women's infant feeding behaviours. The Infant Feeding Genogram is a visual co-constructed diagram which details people/services that can provide support to women and can facilitate a connection between mothers and their existing assets landscape. The aim of this study is to explore women's and infant feeding helpers' experiences and use of an infant feeding genogram delivered to the intervention group of the "Assets-based infant feeding help Before and After birth (ABA)" randomised feasibility trial. METHODS: 103 primiparous mothers aged 16+ years were recruited to the trial (trial registration number) in two sites (Site A and Site B) with low breastfeeding prevalence in the UK. Infant feeding helpers (IFHs) co-constructed a genogram at the first antenatal meeting for the intervention group (n = 50), and then provided proactive, woman-centered support from ~ 32 weeks gestation to up to 5 months postnatal. Infant feeding helpers' and women's experiences of the infant feeding genogram were collected via interviews or focus groups. Completed genograms were shared with researchers. Content analysis of the genograms and qualitative data from the interviews and focus groups were analysed thematically. RESULTS: Data comprised 32 completed genograms, and qualitative insights from all 13 infant feeding helpers (two focus groups; 4 interviews) and interviews with a purposive sample of 21 of 50 intervention group women between 4 and 21 weeks after birth. Content analysis of the genograms highlighted variations, with more personal, individualised genograms completed at Site B compared to Site A. The perceived impact of the genogram was related to the IFHs' application of the tool. The genogram was either used as intended to raise women's awareness of available assets and motivate help-seeking behaviour, or as a data collection tool with limited perceived utility. Negative and positive unintended consequences of genogram use were highlighted. CONCLUSIONS: The genogram has the potential to offer a woman, family and community-centred approach that focusses on building assets for infant feeding. However, variations in genogram application indicate that revised training is required to clarify the purpose and ensure it is used as intended. TRIAL REGISTRATION: ISRCTN ISRCTN14760978 ; Registered 30 January 2017.

Women's and peer supporters' experiences of an assets-based peer support intervention for increasing breastfeeding initiation and continuation: A qualitative study.

BACKGROUND AND CONTEXT: Breastfeeding peer support is valued by women, but UK trials have not demonstrated efficacy. The ABA feasibility trial offered proactive peer support underpinned by behaviour change theory and an assets-based approach to women having their first baby, regardless of feeding intention. This paper explores women's and infant feeding helpers' (IFHs) views of the different components of the ABA intervention. SETTING AND PARTICIPANTS: Trained IFHs offered 50 women an antenatal meeting to discuss infant feeding and identify community assets in two English sites-one with a paid peer support service and the other volunteer-led. Postnatally, daily contact was offered for the first 2 weeks, followed by less frequent contact until 5 months. METHODS: Interviews with 21 women and focus groups/interviews with 13 IFHs were analysed using thematic and framework methods. RESULTS: Five themes are reported highlighting that women talked positively about the antenatal meeting, mapping their network of support, receiving proactive contact from their IFH, keeping in touch using text messaging and access to local groups. The face-to-face antenatal visit facilitated regular text-based communication both in pregnancy and in the early weeks after birth. Volunteer IFHs were supportive of and enthusiastic about the intervention, whereas some of the paid IFHs disliked some intervention components and struggled with the distances to travel to participants. CONCLUSIONS: This proactive community assets-based approach with a woman-centred focus was acceptable to women and IFHs and is a promising intervention warranting further research as to its effect on infant feeding outcomes.

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.

Women's views about a free breast pump service: Online survey informing intervention development.

Improving breastfeeding outcomes is a global priority; however, in the United Kingdom, continuation of breastfeeding remains low. Growing empirical evidence suggests a free breast pump service might be an acceptable and feasible incentive intervention to improve breastfeeding outcomes and reduce heath inequalities. To inform intervention development, we conducted an online survey with women recruited via social media using snowball sampling. Data were analysed descriptively (closed questions) with qualitative thematic analysis (free text). The survey was completed by 666 women, most of whom had recently breastfed and used a breast pump. Participants agreed that free pump hire (rental/loan; 567 women; 85.1%) or a free pump to keep (408; 61.3%) should be provided. Free text comments provided by 408 women (free pump) and 309 women (free hire) highlighted potential benefits: helping women to continue breastfeeding; express milk; overcome difficulties; and pump choice. Concerns are possible effect on breast milk supply, reduced breastfeeding, pumps replacing good support for breastfeeding, and pump hire hygiene. Personal and societal costs are important issues. Some suggested a pump service should be for low-income mothers, those with feeding difficulties or sick/preterm infants. A one-size service would not suit all and vouchers were proposed. Some suggested fees and deposits to prevent waste. To our knowledge, this is the first study reporting views about the acceptability of providing a free breast pump hire service. Mothers support and wish to have a say in breast pump service development. Future evaluations should address impact on feeding outcomes, professional support, hygiene for hired pumps, and costs.

Proactive telephone support provided to breastfeeding mothers of preterm infants after discharge: a randomised controlled trial.

AIM: The aim was to evaluate the effectiveness of proactive telephone support provided to breastfeeding mothers of preterm infants after discharge from neonatal intensive care units (NICU). METHODS: Between March 2013 and December 2015, a randomised controlled trial was conducted at six NICUs across Sweden. At each NICU, a breastfeeding support team recruited, randomised and delivered the support to participating mothers. The intervention group received a daily proactive telephone call up to 14 days after discharge from the support team. The control group could initiate telephone contact themselves. Primary outcome was exclusive breastfeeding eight weeks after discharge. Secondary outcomes were maternal satisfaction with breastfeeding, attachment, quality of life and parental stress. RESULTS: In total, 493 mothers were randomised, 231 to intervention group and 262 to control group. There were no differences between the groups for exclusive breastfeeding, odds ratio 0.96, 95% CI 0.66-1.38, nor for maternal satisfaction with breastfeeding, attachment or quality of life. The intervention group reported significantly less parental stress than the controls, t = 2.44, 95% CI 0.03-0.23, effect size d = 0.26. CONCLUSION: In this trial, proactive telephone support was not associated with increased exclusive breastfeeding prevalence eight weeks following discharge. However, intervention group mothers showed significantly lower parental stress.

Breastfeeding and risk for ceasing in mothers of preterm infants-Long-term follow-up.

Breastfeeding is challenging for mothers of preterm infants. The aim of this paper is to describe risk factors for ceasing breastfeeding and methods of feeding until 12 months postnatal age in mothers who breastfed their preterm infants at discharge from neonatal intensive care units (NICUs). The data come from a randomised controlled trial, which evaluated the effectiveness on exclusive breastfeeding at 8 weeks of proactive telephone support compared with reactive support offered to mothers of preterm infants following discharge from NICU. Six NICUs across Sweden randomised a total of 493 mothers. We used regression and survival analyses to assess the risk factors for ceasing breastfeeding and the long-term outcomes of the intervention. The results showed that 305 (64%) of the infants were breastfed at 6 months and 49 (21%) at 12 months. Partial breastfeeding at discharge, low maternal educational level, and longer length of stay in the NICU increased the risk for ceasing breastfeeding during the first 12 months. Furthermore, the Kaplan-Meier analysis showed that the proportion of mothers who ceased breastfeeding did not differ between the intervention (n = 231) and controls (n = 262) during the first 12 months (log-rank test p = .68). No difference was found between groups on method of feeding. More than 85% of the infants were fed directly at the breast. These findings provide important insights for health professionals who are supporting mothers of preterm infants to breastfeed long term. Registered in www.clinicaltrials.gov (NCT01806480).

Routinely collected infant feeding data: Time for global action.

The importance of breastfeeding is clear. However, global action to support breastfeeding is hindered by the lack of reliable standard data, which continues to impede progress. Routinely collected data can monitor the effectiveness of health policy, evaluate interventions, and enhance international research collaboration and comparisons. Use of routine data to support effective public health initiatives such as smoking cessation has been demonstrated. However, the data collected about infant feeding practices worldwide is inconsistent in timing, methods, definitions, detail, storage, and consistency. Improvements to the reach and quality of routinely collected data about infant feeding are needed to strengthen the global evidence and policy base. An international collaborative effort is called for to progress this.

Breastfeeding booklet and proactive phone calls for increasing exclusive breastfeeding rates: RCT protocol.

Breastfeeding is associated with infant and maternal health benefits and considerable potential savings to health services. Despite this, only 37% of infants globally are exclusively breastfed for 6 months. Interventions are needed to improve breastfeeding rates. The aim of this study is to determine whether written breastfeeding information in pregnancy and proactive breastfeeding-focused support phone calls, provided by a health professional educated in breastfeeding management, increase exclusive breastfeeding rates at 3 months compared with general birth-related information with proactive support calls or standard care. This is a single-centre, randomised, controlled, three-arm, superiority study with blind outcome assessment. Eligible participants will include primigravidae with singleton pregnancies who speak Croatian, attending six primary care obstetric practices. We estimate a total sample size of 459, with computer generated stratified randomisation of 153 women per arm. Participants in the intervention and active control groups will receive booklets in pregnancy, phone calls 2 weeks later, and 2, 6 and 10 weeks after birth. The primary outcome will be the proportion of women exclusively breastfeeding at 3 months. Secondary outcomes will compare: infant feeding practices and attitudes, social support, breastfeeding difficulties, breastfeeding self efficacy and utilisation of breastfeeding support services. Follow-up at 6 months will compare exclusive and any breastfeeding and utilised support services. Analysis will be by intention to treat. This trial will contribute to future evidence syntheses identifying the most effective forms of breastfeeding support.

Breast pumps as an incentive for breastfeeding: a mixed methods study of acceptability.

Increasing breastfeeding rates would improve maternal and child health, but multiple barriers to breastfeeding persist. Breast pump provision has been used as an incentive for breastfeeding, although effectiveness is unclear. Women's use of breast pumps is increasing and a high proportion of mothers express breastmilk. No research has yet reported women's and health professionals' perspectives on breast pumps as an incentive for breastfeeding. In the Benefits of Incentives for Breastfeeding and Smoking cessation in pregnancy (BIBS) study, mixed methods research explored women's and professionals' views of breast pumps as an incentive for breastfeeding. A survey of health professionals across Scotland and North West England measured agreement with 'a breast pump costing around £40 provided for free on the NHS' as an incentive strategy. Qualitative interviews and focus groups were conducted in two UK regions with a total of 68 participants (pregnant women, new mothers, and their significant others and health professionals) and thematic analysis undertaken. The survey of 497 health professionals found net agreement of 67.8% (337/497) with the breast pump incentive strategy, with no predictors of agreement shown by a multiple ordered logistic regression model. Qualitative research found interrelated themes of the 'appeal and value of breast pumps', 'sharing the load', 'perceived benefits', 'perceived risks' and issues related to 'timing'. Qualitative participants expressed mixed views on the acceptability of breast pumps as an incentive for breastfeeding. Understanding the mechanisms of action for pump type, timing and additional support required for effectiveness is required to underpin trials of breast pump provision as an incentive for improving breastfeeding outcomes. © 2016 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.

How UK internet websites portray breast milk expression and breast pumps: a qualitative study of content.

BACKGROUND: Exclusive breastfeeding for six months is recommended but few parents achieve this; particularly younger and less well-educated mothers. Many parents introduce infant formula milk to manage feeding but describe a desire to express breastmilk alongside a lack of support or information. The Internet is highlighted as a key resource. This study aimed to examine UK websites on expressing breastmilk to identify key messages and how information is provided. METHODS: We used search terms in Google to identify websites with information rich content on expressing breastmilk and breast pumps. Ten sites were purposively selected at two time points in 2013 and 2014 to represent 3 categories: commercial, NHS or 3(rd) sector (voluntary or not for profit). Each site was reviewed by two researchers, data and reflective analytical notes were uploaded into NVivo and thematic data analysis undertaken. RESULTS: Sites varied considerably in their design, use of images, videos, audio files, product placement and marketing opportunities. Three key themes emerged: depiction of expressing; reasons to express; and recommendations about expressing. Inconsistent and conflicting information was common within and between sites. Expressing was portrayed as similar to, but easier than, breastfeeding although at the same time difficult and requiring to be learned. Expressed breastmilk is promoted by mainly commercial sites as immediately available, although pumps were also presented as needing to be concealed, not heard or seen. Health benefits were the overarching reason for expressing. Although predicated on separation from the baby, commercial sites identified this as a positive choice while other sites focused on separation due to circumstance. Commercial sites emphasised restrictions related to breastfeeding, lack of sleep and bonding with the father and wider family. Non-commercial sites emphasised hand expression, with some not mentioning breast pumps. Practical information about starting expressing in relation to infant age or duration of breastfeeding was conflicting. CONCLUSIONS: Internet information about expressing breastmilk is inconsistent, incomplete and not evidence informed. The lack of research evidence on the relationship between expressing and feeding outcomes has provided opportunities for commercial companies, which have the potential to further exacerbate observed health inequalities. Access to good quality information based on robust evidence is urgently required.

Short-stay urgent hospital admissions of children with convulsions: A mixed methods exploratory study to inform out of hospital care pathways.

OBJECTIVE: To inform interventions focused on safely reducing urgent paediatric short stay admissions (SSAs) for convulsions. METHODS: Routinely acquired administrative data from hospital admissions in Scotland between 2015-2017 investigated characteristics of unscheduled SSAs (an urgent admission where admission and discharge occur on the same day) for a diagnosis of febrile and/or afebrile convulsions. Semi-structured interviews to explore perspectives of health professionals (n = 19) making referral or admission decisions about convulsions were undertaken. Interpretation of mixed methods findings was complemented by interviews with four parents with experience of unscheduled SSAs of children with convulsion. RESULTS: Most SSAs for convulsions present initially at hospital emergency departments (ED). In a subset of 10,588 (11%) of all cause SSAs with linked general practice data available, 72 (37%) children with a convulsion contacted both the GP and ED pre-admission. Within 30 days of discharge, 10% (n = 141) of children admitted with afebrile convulsions had been readmitted to hospital with a further convulsion. Interview data suggest that panic and anxiety, through fear that the situation is life threatening, was a primary factor driving hospital attendance and admission. Lengthy waits to speak to appropriate professionals exacerbate parental anxiety and can trigger direct attendance at ED, whereas some children with complex needs had direct access to convulsion professionals. CONCLUSIONS: SSAs for convulsions are different to SSAs for other conditions and our findings could inform new efficient convulsion-specific pre and post hospital pathways designed to improve family experiences and reduce admissions and readmissions.

Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial.

INTRODUCTION: The reproductive years can increase women's weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development. METHODS AND ANALYSIS: Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost-utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants' experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences. TRIAL REGISTRATION NUMBER: ISRCTN16299220.

Significant others, situations and infant feeding behaviour change processes: a serial qualitative interview study.

BACKGROUND: Exclusive breastfeeding until six months followed by the introduction of solids and continued breastfeeding is recommended by the World Health Organisation. The dominant approach to achieving this has been to educate and support women to start and continue breastfeeding rather than understanding behaviour change processes from a broader perspective. METHOD: Serial qualitative interviews examined the influences of significant others on women's feeding behaviour. Thirty-six women and 37 nominated significant others participated in 220 interviews, conducted approximately four weekly from late pregnancy to six months after birth. Responses to summative structured questions at the end of each interview asking about significant influences on feeding decisions were compared and contrasted with formative semi-structured data within and between cases. Analysis focused on pivotal points where behaviour changed from exclusive breastfeeding to introducing formula, stopping breastfeeding or introducing solids. This enabled us to identify processes that decelerate or accelerate behaviour change and understand resolution processes afterwards. RESULTS: The dominant goal motivating behaviour change was family wellbeing, rather than exclusive breastfeeding. Rather than one type of significant other emerging as the key influence, there was a complex interplay between the self-baby dyad, significant others, situations and personal or vicarious feeding history. Following behaviour change women turned to those most likely to confirm or resolve their decisions and maintain their confidence as mothers. CONCLUSIONS: Applying ecological models of behaviour would enable health service organisation, practice, policy and research to focus on enhancing family efficacy and wellbeing, improving family-centred communication and increasing opportunities for health professionals to be a constructive influence around pivotal points when feeding behaviour changes. A paradigm shift is recommended away from the dominant approach of support and education of individual women towards a more holistic, family-centred narrative approach, whilst acknowledging that breastfeeding is a practical skill that women and babies have to learn.

The effectiveness of proactive telephone support provided to breastfeeding mothers of preterm infants: study protocol for a randomized controlled trial.

BACKGROUND: Although breast milk has numerous benefits for infants' development, with greater effects in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter breastfeeding duration than mothers of term infants. One of the explanations proposed is the difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home environment. A person-centred proactive telephone support intervention after discharge from NICU is expected to promote mothers' sense of trust in their own capacity and thereby facilitate breastfeeding. METHODS/DESIGN: A multicentre randomized controlled trial has been designed to evaluate the effectiveness and cost-effectiveness of person-centred proactive telephone support on breastfeeding outcomes for mothers of preterm infants. Participating mothers will be randomized to either an intervention group or control group. In the intervention group person-centred proactive telephone support will be provided, in which the support team phones the mother daily for up to 14 days after hospital discharge. In the control group, mothers are offered a person-centred reactive support where mothers can phone the breastfeeding support team up to day 14 after hospital discharge. The intervention group will also be offered the same reactive telephone support as the control group. A stratified block randomization will be used; group allocation will be by high or low socioeconomic status and by NICU. Recruitment will be performed continuously until 1116 mothers (I: 558 C: 558) have been included. PRIMARY OUTCOME: proportion of mothers exclusively breastfeeding at eight weeks after discharge. SECONDARY OUTCOMES: proportion of breastfeeding (exclusive, partial, none and method of feeding), mothers satisfaction with breastfeeding, attachment, stress and quality of life in mothers/partners at eight weeks after hospital discharge and at six months postnatal age. Data will be collected by researchers blind to group allocation for the primary outcome. A qualitative evaluation of experiences of receiving/providing the intervention will also be undertaken with mothers and staff. DISCUSSION: This paper presents the rationale, study design and protocol for a RCT providing person-centred proactive telephone support to mothers of preterm infants. Furthermore, with a health economic evaluation, the cost-effectiveness of the intervention will be assessed.

Insights from and limitations of data linkage studies: analysis of short-stay urgent admission referral source from routinely collected Scottish data.

INTRODUCTION: This study identified the referral source for urgent short-stay admissions (SSAs) and compared characteristics of children with SSA stratified by different referral sources. METHODS: Routinely acquired data from urgent admissions to Scottish hospitals during 2015-2017 were linked to data held by the three referral sources: emergency department (ED), out-of-hours (OOH) service and general practice (GP). RESULTS: There were 171 039 admissions including 92 229 (54%) SSAs. Only 171 (19%) of all of Scotland's GP practices contributed data. Among the subgroup of 10 588 SSAs where GP data were available (11% all SSA), there was contact with the following referral source on the day of admission: only ED, 1853 (18%); only GP, 3384 (32%); and only OOH, 823 (8%). Additionally, 2165 (20%) had contact with more than one referral source, and 1037 (10%) had contact with referral source(s) on the day before the admission. When all 92 229 SSAs were considered, those with an ED referrer were more likely to be for older children, of white ethnicity, living in more deprived communities and diagnosed with asthma, convulsions or croup. The odds ratio for an SSA for a given condition differed by referral source and ranged from 0.07 to 1.9 (with reference to ED referrals). CONCLUSION: This study yielded insights and potential limitations regarding data linkage in a healthcare setting. Data coverage, particularly from primary care, needs to improve further. Evidence from data linkage studies can inform future intervention designed to provide safe integrated care pathways.

Identifying and prioritising future interventions with stakeholders to improve paediatric urgent care pathways in Scotland, UK: a mixed-methods study.

OBJECTIVES: To identify and prioritise interventions, from the perspectives of parents and health professionals, which may be alternatives to current unscheduled paediatric urgent care pathways. DESIGN: FLAMINGO (FLow of AdMissions in chIldren and youNG peOple) is a sequential mixed-methods study, with public and patient involvement (PPI) throughout. Data linkage for urgent admissions and three referral sources: emergency department, out of hours service and general practice, was followed by qualitative interviews with parents and professionals. Findings were presented and discussed at a stakeholder intervention prioritisation event. SETTING: National Health Service in Scotland, UK. PARTICIPANTS: Quantitative data: children with urgent medical admission to hospital from 2015 to 2017. Qualitative interviews: parents and health professionals with experiences of urgent short stay hospital admissions of children. PPI engagement was conducted with nine parent-toddler groups and a university-based PPI advisory group. Stakeholder event: parents, health professionals and representatives from Scottish Government, academia, charities and PPI attended. RESULTS: Data for 171 039 admissions which included 92 229 short stay admissions were analysed and 48 health professionals and 21 parents were interviewed. The stakeholder event included 7 parents, 12 health professionals and 28 other stakeholders. Analysis and synthesis of all data identified seven interventions which were prioritised at the stakeholder event: (1) addressing gaps in acute paediatric skills of health professionals working in community settings; (2) assessment and observation of acutely unwell children in community settings; (3) creation of holistic children's 'hubs'; (4) adoption of 'hospital at home' models; and three specialised care pathways for subgroups of children; (5) convulsions; (6) being aged <2 years old; and (7) wheeze/bronchiolitis. Stakeholders prioritised interventions 1, 2 and 3; these could be combined into a whole population intervention. Barriers to progressing these include resources, staffing and rurality. CONCLUSIONS: Health professionals and families want future interventions that are patient-centred, community-based and aligned to outcomes that matter to them.

Text message conversations between peer supporters and women to deliver infant feeding support using behaviour change techniques: A qualitative analysis.

OBJECTIVE: To analyse text message conversations between peer supporters (called Infant Feeding Helpers - IFHs) and new mothers using qualitative methods to understand how peer support can influence and support women's feeding experiences. DESIGN: Qualitative analysis of text messages conversations using both inductive thematic and deductive content approaches to coding. Thematic analysis of the text message transcripts and deductive content analysis was used to code if Behaviour Change Techniques (BCTs) were employed by IFHs in their interactions with women. BCTs coded in text messages were then compared with those tabulated from antenatal meeting recordings and documented in interview transcripts. PARTICIPANTS AND SETTING: 18 primiparous women and 7 Infant Feeding Helpers from one community site in South-West England. FINDINGS: Three key themes were identified in the18 text message conversations (1679 texts): 'breastfeeding challenges', 'mother-centred conversations', and 'emotional and practical support'. The core BCTs of 'social support' and 'changing the social environment' were found at least once in 17 (94 %) and 18 (100 %) text message conversations respectively. Meanwhile, 'instruction to perform the behaviour' was used at least once in over 50 % of conversations. Generally, the use of BCTs was greatest between birth and two weeks during a period of daily texts when women reported many feeding challenges. The number and range of BCTs used in text messages were similar to those documented in audio-recorded meetings and interview accounts. CONCLUSION AND IMPLICATIONS: Infant Feeding Helpers were able to provide engaging and successful breastfeeding peer support through text messages. Messaging was shown to be an appropriate and accessible method of delivering BCTs focussing on 'social support' and 'changing the social environment'. Peer supporters delivering BCTs via text messages is acceptable and appropriate to use if in-person support is limited due to unforeseen circumstances such as the COVID-19 pandemic.

Regional variations in short stay urgent paediatric hospital admissions: a sequential mixed-methods approach exploring differences through data linkage and qualitative interviews.

OBJECTIVES: The aim of this sequential mixed-methods study was to describe and understand how paediatric short stay admission (SSA) rates vary across Health Board regions of Scotland. DESIGN: Exploratory sequential mixed-methods study. Routinely acquired data for the annual (per capita) SSA to hospital were compared across the 11 regions. Five diverse regions with different SSA per capita formed cases for qualitative interviews with health professionals and parents to explore how care pathways, service features and geography may influence decisions to admit. SETTING: Scotland. PARTICIPANTS: All children admitted to hospital 2015-2017. Healthcare staff (n=48) and parents (n=15) were interviewed. RESULTS: Of 171 039 urgent hospital admissions, 92 229 were SSAs, with a fivefold variation between 14 and 69/1000 children/year across regions. SSAs were higher for children in the most deprived compared with the least deprived communities. When expressed as a ratio of highest to lowest SSA/1000 children/year for diagnosed conditions between regions, the ratio was highest (10.1) for upper respiratory tract infection and lowest (2.8) for convulsions. Readmissions varied between 0.80 and 2.52/1000/year, with regions reporting higher SSA rates more likely to report higher readmission rates (r=0.70, p=0.016, n=11). Proximity and ease of access to services, local differences in service structure and configuration, national policy directives and disparities in how an SSA is defined were recognised by interviewees as explaining the observed regional variations in SSAs. Socioeconomic deprivation was seldom spontaneously raised by professionals when reflecting on reasons to refer or admit a child. Instead, greater emphasis was placed on the wider social circumstances and parents' capacity to cope with and manage their child's illness at home. CONCLUSION: SSA rates for children vary quantitatively by region, condition and area deprivation and our interviews identify reasons for this. These findings can usefully inform future care pathway interventions.