Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial.

OBJECTIVE: To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services. DESIGN: Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phase 3 (CPIT III)). SETTING: Seven UK stop smoking services provided in primary and secondary care facilities in Scotland, Northern Ireland, and England. PARTICIPANTS: 944 pregnant women (age ≥16 years) who self-reported as being smokers (at least one cigarette in the past week) when asked at first maternity visit, less than 24 weeks' gestation, and notified to the trial team by routine stop smoking services. INTERVENTIONS: Participants in the control group were offered the standard stop smoking services, which includes the offer of counselling by specially trained workers using withdrawal orientated therapy and the offer of free nicotine replacement therapy. The intervention was the offer of usual support from the stop smoking services and the addition of up to £400 ($440; €455) of LoveToShop financial voucher incentives for engaging with current stop smoking services or to stop smoking, or both, during pregnancy. MAIN OUTCOME MEASURES: Self-reported smoking cessation in late pregnancy (between 34 and 38 weeks' gestation) corroborated by saliva cotinine (and anabasine if using nicotine replacement products). Results were adjusted for age, smoking years, index of multiple deprivation, Fagerström score, before or after covid, and recruitment site. Secondary outcomes included point and continuous abstinence six months after expected date of delivery, engagement with stop smoking services, biochemically validated abstinence from smoking at four weeks after stop smoking date, birth weight of baby, cost effectiveness, generalisability documenting formats of stop smoking services, and acceptability to pregnant women and their carers. RESULTS: From 9 January 2018 to 4 April 2020, of 4032 women screened by stop smoking services, 944 people were randomly assigned to the intervention group (n=471) or the control group (n=470). Three people asked for their data to be removed. 126 (27%) of 471 participants stopped smoking from the intervention group and 58 (12%) of 470 from the control group (adjusted odds ratio 2.78 (1.94 to 3.97) P<0.001). Serious adverse events were miscarriages and other expected pregnancy events requiring hospital admission; all serious adverse events were unrelated to the intervention. Most people who stopped smoking from both groups relapsed after their baby was born. CONCLUSIONS: The offer of up to £400 of financial voucher incentives to stop smoking during pregnancy as an addition to current UK stop smoking services is highly effective. This bolt-on intervention supports new guidance from the UK National Institute for Health and Care Excellence, which includes the addition of financial incentives to support pregnant women to stop smoking. Continuing incentives to 12 months after birth is being examined to prevent relapse. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15236311.

Effectiveness and cost-effectiveness of text messages with or without endowment incentives for weight management in men with obesity (Game of Stones): study protocol for a randomised controlled trial.

BACKGROUND: Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity. METHODS: A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies. DISCUSSION: The trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men's experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services. TRIAL REGISTRATION: ISRCTN 91974895 . Registered on 14/04/2021.

Usual care in a multicentre randomised controlled trial of financial incentives for smoking cessation in pregnancy: qualitative findings from a mixed-methods process evaluation.

OBJECTIVES: Financial incentives are recommended by the UK's National Institute for Health and Care Excellence to aid smoking cessation in pregnancy. However, little is known about how implementation contexts might impact on their effectiveness. Variations in smoking cessation support (usual care) for pregnant women who smoke were examined qualitatively as part of a prospective process evaluation of the Cessation in Pregnancy Incentives Trial (CPIT III). DESIGN: Longitudinal case studies of five CPIT III trial sites informed by realist evaluation. SETTING: A stop smoking service (SSS) serving a maternity hospital constituted each case study, located in three UK countries. PARTICIPANTS: Data collection included semistructured interviews with trial participants (n=22), maternity (n=12) and SSS staff (n=17); and site observations and perspectives recorded in fieldnotes (n=85). RESULTS: Cessation support (usual care) for pregnant women varied in amount, location, staff capacity, flexibility and content across sites. SSS staff capacity was important to avoid gaps in support. Colocation and good working relationships between maternity and SSS professionals enabled prioritisation and reinforced the importance of smoking cessation. Sites with limited use of carbon monoxide (CO) monitoring reduced opportunities to identify smokers while inconsistency around automatic referral processes prevented the offer of cessation support. SSS professionals colocated within antenatal clinics were available to women they could not otherwise reach. Flexibility around location, timing and tailoring of approaches for support, facilitated initial and sustained engagement and reduced the burden on women. CONCLUSIONS: Trial sites faced varied barriers and facilitators to delivering cessation support, reflecting heterogeneity in usual care. If financial incentives are more effective with concurrent smoking cessation support, sites with fewer barriers and more facilitators regarding this support would be expected to have more promising trial outcomes. Future reporting of trial outcomes will assist in understanding incentives' generalisability across a wide range of usual care settings. TRIAL REGISTRATION NUMBER: ISRCTN15236311.

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial.

BACKGROUND: Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? METHODS: The Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n = 940) are pregnant smokers (age > 16 years, < 24 weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6 months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6 months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK? DISCUSSION: This phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial.

BACKGROUND: Being overweight or obese following breast cancer diagnosis can increase cancer recurrence and mortality, so effective interventions for weight loss in this group could enhance survival. A pilot randomised controlled trial was conducted to assess whether a weight loss programme comprising generic Weight Watchers® referral offered to women treated for breast cancer with or without additional breast cancer-tailored dietetic support is feasible and shows promise for improving weight and quality of life (QoL). METHODS: Participants were randomly allocated to 3 groups: Weight Watchers® referral (for 12 sessions of meetings and digital tools) plus 5 breast cancer-tailored dietitian-led group support sessions (WW Plus: n = 14), Weight Watchers® referral only (WW: n = 16) or control (Weight Watchers® referral after 3 months, n = 15). Feasibility was assessed based on retention rate, recruitment and randomisation process, meeting attendance, suitability of the setting and outcome measurement tools, unintended consequences, cost and observations of the dietetic sessions. Outcomes were measured at 0, 3 ('trial exit') and 12 months post intervention. RESULTS: The response rate to the invitation was 43% (140/327) of whom 58 were eligible and 45 (median age 61.0 years; body mass index 30.2 kg/m2) were randomised. Data from 38 (84%) and 30 (67%) participants were available at trial exit and 12 months respectively. Feasibility issues included slow recruitment process, lack of blinding throughout, weighing scales not measuring > 150 kg, lack of clear instructions for completing QoL questionnaire and workload and time pressures in delivering dietetic sessions. Participants had good attendance rate at group meetings and no serious unintended consequences were reported. WW Plus was most expensive to run. Mean (95% CI) weight change at trial exit was - 3.67 kg (- 5.67, - 2.07) in WW Plus, - 6.03 kg (- 7.61, - 4.44) in WW group and + 0.19 kg (- 1.45, + 1.83) in control group. About 40% of the WW Plus, 64% of the WW group and 56% of the control group lost ≥ 5% of their baseline weight by 12 months. All groups showed promise for improving QoL at trial exit but only the WW group maintained significant improvements from baseline at 12 months. CONCLUSIONS: The trial procedures were feasible, with some modifications. This pilot trial indicates the benefits of providing free WW vouchers for weight loss maintenance and improving QoL but provided no evidence that including additional dietetic support would add any extra value. Further research with WW with long-term follow-up should be undertaken to assess weight loss sustainability and benefit on health outcomes in this patient group. TRIAL REGISTRATION: ISRCTN-29623418.

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.

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.

Public acceptability of financial incentives to reward pregnant smokers who quit smoking: a United Kingdom-France comparison.

A substantial amount of research has been conducted on financial incentives to increase abstinence from smoking among pregnant smokers. If demonstrated to be effective, financial incentives could be proposed as part of health care interventions to help pregnant smokers quit. Public acceptability is important; as such interventions could be publicly funded. Concerns remain about the acceptability of these interventions in the general population. We aimed to assess the acceptability of financial incentives to reward pregnant smokers who stop smoking using a survey conducted in the UK and then subsequently in France, two developed countries with different cultural and social backgrounds. More French than British respondents agreed with financial incentives for rewarding quitting smoking during pregnancy, not smoking after delivery, keeping a smoke-free household, health service payment for meeting target and the maximum amount of the reward. However, fully adjusted models showed significant differences only for the two latter items. More British than French respondents were neutral toward financial incentives. Differences between the representative samples of French and British individuals demonstrate that implementation of financial incentive policies may not be transferable from one country to another.

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.

Combining PPI with qualitative research to engage 'harder-to-reach' populations: service user groups as co-applicants on a platform study for a trial.

PLAIN ENGLISH SUMMARY: It is recommended that research studies are carried out with or by patients and the public through their involvement from the beginning and in as many stages as possible (known as PPI). Some studies formally invite patients and the public to participate in interviews and focused group discussions to collect views about topics (known as qualitative research). In our study on financial incentives for giving up smoking in pregnancy and breastfeeding, we combined both PPI and qualitative research to include the views of women with a range of experiences of smoking and breastfeeding. We involved two mother and baby groups in disadvantaged areas of North East Scotland and North West England as research partners on our team. First, we asked members to comment on our research plans and documents, which is standard PPI. Second, we asked members to participate in voice recorded discussions, contributing to qualitative research data. These discussions revealed different views from those that we heard through research interviews. They allowed us to develop more relevant research tools and resources. Members also helped us to identify people outside the groups who we could interview. Combining involvement and participation helped us to include the views of a wide range of women from 'harder-to-reach' groups who don't usually take part in research. This was important because the research was intended for women who could benefit from incentives to stop smoking in pregnancy and breastfeed, often present in such groups. Positive continuing relationships and trust improved on involvement or participation alone. ABSTRACT: ᅟ. BACKGROUND: Patient and public involvement (PPI) in all research studies is recommended from the earliest point and in as many stages as possible. Qualitative research is also recommended in the early stages of designing complex intervention trials. Combining both together might enable inclusion of 'harder-to-reach' perspectives from the target population(s), particularly when the research is intended for their benefit. However, the interface between PPI and qualitative research has received little attention. In a multi-disciplinary, mixed methods study to inform the design of incentive trials for smoking cessation in pregnancy and breastfeeding, we combined PPI and qualitative research, with some overlap. Mother and baby groups from two geographically separate disadvantaged areas, with diverse experiences of the smoking and breastfeeding, but no training or previous involvement in research, were recruited as PPI research grant co-applicants. An iterative partnership approach facilitated involvement in research conduct and design across all project phases. Group PPI members were also invited to contribute to more formal qualitative data collection, as and when indicated by the research questions, and emerging analysis. RESULTS: We engaged with 'harder-to-reach' women in mother and baby group settings, rather than in academic or home environments. These settings were relaxed and informal, which facilitated rapport-building, disclosures of unexpected information and maintained trust. Twenty-one women participated in standard PPI activities: feedback on study protocols and documents; piloting questionnaires and interview schedules. PPI members voiced some different perspectives from those captured within the qualitative dataset. Nineteen participated in focused qualitative research. Novel aspects were audio recorded PPI discussions, which contributed qualitative data; first, to interpret systematic review findings and construct intervention vignettes for use in the qualitative research; second, to assist with recruitment to improve sample diversity in the formal qualitative dataset; and third, to translate theory and findings presented in a researcher generated logic model into a lay tool. This had face validity for potential trial participants and used the metaphor of a ladder. CONCLUSIONS: Combining and overlapping PPI and qualitative research added 'harder-to-reach' contributions, sample diversity, trust and engagement in creative approaches beyond what could be achieved through PPI or qualitative research alone.

Perspectives on financial incentives to health service providers for increasing breast feeding and smoking quit rates during pregnancy: a mixed methods study.

OBJECTIVE: To explore the acceptability, mechanisms and consequences of provider incentives for smoking cessation and breast feeding as part of the Benefits of Incentives for Breastfeeding and Smoking cessation in pregnancy (BIBS) study. DESIGN: Cross-sectional survey and qualitative interviews. SETTING: Scotland and North West England. PARTICIPANTS: Early years professionals: 497 survey respondents included 156 doctors; 197 health visitors/maternity staff; 144 other health staff. Qualitative interviews or focus groups were conducted with 68 pregnant/postnatal women/family members; 32 service providers; 22 experts/decision-makers; 63 conference attendees. METHODS: Early years professionals were surveyed via email about the acceptability of payments to local health services for reaching smoking cessation in pregnancy and breastfeeding targets. Agreement was measured on a 5-point scale using multivariable ordered logit models. A framework approach was used to analyse free-text survey responses and qualitative data. RESULTS: Health professional net agreement for provider incentives for smoking cessation targets was 52.9% (263/497); net disagreement was 28.6% (142/497). Health visitors/maternity staff were more likely than doctors to agree: OR 2.35 (95% CI 1.51 to 3.64; p<0.001). Net agreement for provider incentives for breastfeeding targets was 44.1% (219/497) and net disagreement was 38.6% (192/497). Agreement was more likely for women (compared with men): OR 1.81 (1.09 to 3.00; p=0.023) and health visitors/maternity staff (compared with doctors): OR 2.54 (95% CI 1.65 to 3.91; p<0.001). Key emergent themes were 'moral tensions around acceptability', 'need for incentives', 'goals', 'collective or divisive action' and 'monitoring and proof'. While provider incentives can focus action and resources, tensions around the impact on relationships raised concerns. Pressure, burden of proof, gaming, box-ticking bureaucracies and health inequalities were counterbalances to potential benefits. CONCLUSIONS: Provider incentives are favoured by non-medical staff. Solutions which increase trust and collaboration towards shared goals, without negatively impacting on relationships or increasing bureaucracy are required.

Benefits of Incentives for Breastfeeding and Smoking cessation in pregnancy (BIBS): a mixed-methods study to inform trial design.

BACKGROUND: Smoking in pregnancy and/or not breastfeeding have considerable negative health outcomes for mother and baby. AIM: To understand incentive mechanisms of action for smoking cessation in pregnancy and breastfeeding, develop a taxonomy and identify promising, acceptable and feasible interventions to inform trial design. DESIGN: Evidence syntheses, primary qualitative survey, and discrete choice experiment (DCE) research using multidisciplinary, mixed methods. Two mother-and-baby groups in disadvantaged areas collaborated throughout. SETTING: UK. PARTICIPANTS: The qualitative study included 88 pregnant women/recent mothers/partners, 53 service providers, 24 experts/decision-makers and 63 conference attendees. The surveys included 1144 members of the general public and 497 health professionals. The DCE study included 320 women with a history of smoking. METHODS: (1) Evidence syntheses: incentive effectiveness (including meta-analysis and effect size estimates), delivery processes, barriers to and facilitators of smoking cessation in pregnancy and/or breastfeeding, scoping review of incentives for lifestyle behaviours; (2) qualitative research: grounded theory to understand incentive mechanisms of action and a framework approach for trial design; (3) survey: multivariable ordered logit models; (4) DCE: conditional logit regression and the log-likelihood ratio test. RESULTS: Out of 1469 smoking cessation and 5408 breastfeeding multicomponent studies identified, 23 smoking cessation and 19 breastfeeding studies were included in the review. Vouchers contingent on biochemically proven smoking cessation in pregnancy were effective, with a relative risk of 2.58 (95% confidence interval 1.63 to 4.07) compared with non-contingent incentives for participation (four studies, 344 participants). Effects continued until 3 months post partum. Inconclusive effects were found for breastfeeding incentives compared with no/smaller incentives (13 studies) but provider commitment contracts for breastfeeding show promise. Intervention intensity is a possible confounder. The acceptability of seven promising incentives was mixed. Women (for vouchers) and those with a lower level of education (except for breastfeeding incentives) were more likely to disagree. Those aged ≤ 44 years and ethnic minority groups were more likely to agree. Agreement was greatest for a free breast pump and least for vouchers for breastfeeding. Universal incentives were preferred to those targeting low-income women. Initial daily text/telephone support, a quitting pal, vouchers for > £20.00 per month and values up to £80.00 increase the likelihood of smoking cessation. Doctors disagreed with provider incentives. A 'ladder' logic model emerged through data synthesis and had face validity with service users. It combined an incentive typology and behaviour change taxonomy. Autonomy and well-being matter. Personal difficulties, emotions, socialising and attitudes of others are challenges to climbing a metaphorical 'ladder' towards smoking cessation and breastfeeding. Incentive interventions provide opportunity 'rungs' to help, including regular skilled flexible support, a pal, setting goals, monitoring and outcome verification. Individually tailored and non-judgemental continuity of care can bolster women's capabilities to succeed. Rigid, prescriptive interventions placing the onus on women to behave 'healthily' risk them feeling pressurised and failing. To avoid 'losing face', women may disengage. LIMITATIONS: Included studies were heterogeneous and of variable quality, limiting the assessment of incentive effectiveness. No cost-effectiveness data were reported. In surveys, selection bias and confounding are possible. The validity and utility of the ladder logic model requires evaluation with more diverse samples of the target population. CONCLUSIONS: Incentives provided with other tailored components show promise but reach is a concern. Formal evaluation is recommended. Collaborative service-user involvement is important. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012001980. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Incentives to promote breastfeeding: a systematic review.

BACKGROUND AND OBJECTIVES: Few women in industrialized countries achieve the World Health Organization's recommendation to breastfeed exclusively for 6 months. Governments are increasingly seeking new interventions to address this problem, including the use of incentives. The goal of this study was to assess the evidence regarding the effectiveness of incentive interventions, delivered within or outside of health care settings, to individuals and/or their families seeking to increase and sustain breastfeeding in the first 6 months after birth. METHODS: Searches of electronic databases, reference lists, and grey literature were conducted to identify relevant reports of published, unpublished, and ongoing studies. All study designs published in English, which met our definition of incentives and that were from a developed country, were eligible for inclusion. Abstract and full-text article review with sequential data extraction were conducted by 2 independent authors. RESULTS: Sixteen full reports were included in the review. The majority evaluated multicomponent interventions of varying frequency, intensity, and duration. Incentives involved providing access to breast pumps, gifts, vouchers, money, food packages, and help with household tasks, but little consensus in findings was revealed. The lack of high-quality, randomized controlled trials identified by this review and the multicomponent nature of the interventions prohibited meta-analysis. CONCLUSIONS: This review found that the overall effect of providing incentives for breastfeeding compared with no incentives is unclear due to study heterogeneity and the variation in study quality. Further evidence on breastfeeding incentives offered to women is required to understand the possible effects of these interventions.

Incentives for breastfeeding and for smoking cessation in pregnancy: an exploration of types and meanings.

Financial or tangible incentives are a strategy for improving health behaviours. The mechanisms of action of incentives are complex and debated. Using a multidisciplinary integrated mixed methods study, with service-user collaboration throughout, we developed a typology of incentives and their meanings for initiating and sustaining smoking cessation in pregnancy and breastfeeding. The ultimate aim was to inform incentive intervention design by providing insights into incentive acceptability and mechanisms of action. Systematic evidence syntheses of incentive intervention studies for smoking cessation in pregnancy or breastfeeding identified incentive characteristics, which were developed into initial categories. Little published qualitative data on user perspectives and acceptability was available. Qualitative interviews and focus groups conducted in three UK regions with a diverse socio-demographic sample of 88 women and significant others from the target population, 53 service providers, 24 experts/decision makers, and conference attendees identified new potential incentives and providers, with and without experience of incentives. Identified incentives (published and emergent) were classified into eight categories: cash and shopping vouchers, maternal wellbeing, baby and pregnancy-related, behaviour-related, health-related, general utility, awards and certificates, and experiences. A typology was refined iteratively through concurrent data collection and thematic analysis to explore participants' understandings of 'incentives' and to compare and contrast meanings across types. Our typology can be understood in three dimensions: the degree of restriction, the extent to which each is hedonic and/or utilitarian, and whether each has solely monetary value versus monetary with added social value. The layers of autonomy, meanings and the social value of incentive types influence their acceptability and interact with structural, social, and personal factors. Dimensions of incentive meaning that go beyond the simple incentive description should inform incentive programme design and are likely to influence outcomes.

Unintended consequences of incentive provision for behaviour change and maintenance around childbirth.

Financial (positive or negative) and non-financial incentives or rewards are increasingly used in attempts to influence health behaviours. While unintended consequences of incentive provision are discussed in the literature, evidence syntheses did not identify any primary research with the aim of investigating unintended consequences of incentive interventions for lifestyle behaviour change. Our objective was to investigate perceived positive and negative unintended consequences of incentive provision for a shortlist of seven promising incentive strategies for smoking cessation in pregnancy and breastfeeding. A multi-disciplinary, mixed-methods approach included involving two service-user mother and baby groups from disadvantaged areas with experience of the target behaviours as study co-investigators. Systematic reviews informed the shortlist of incentive strategies. Qualitative semi-structured interviews and a web-based survey of health professionals asked open questions on positive and negative consequences of incentives. The participants from three UK regions were a diverse sample with and without direct experience of incentive interventions: 88 pregnant women/recent mothers/partners/family members; 53 service providers; 24 experts/decision makers and interactive discussions with 63 conference attendees. Maternity and early years health professionals (n = 497) including doctors, midwives, health visitors, public health and related staff participated in the survey. Qualitative analysis identified ethical, political, cultural, social and psychological implications of incentive delivery at population and individual levels. Four key themes emerged: how incentives can address or create inequalities; enhance or diminish intrinsic motivation and wellbeing; have a positive or negative effect on relationships with others within personal networks or health providers; and can impact on health systems and resources by raising awareness and directing service delivery, but may be detrimental to other health care areas. Financial incentives are controversial and generated emotive and oppositional responses. The planning, design and delivery of future incentive interventions should evaluate unexpected consequences to inform the evidence for effectiveness, cost-effectiveness and future implementation.

Public acceptability of financial incentives for smoking cessation in pregnancy and breast feeding: a survey of the British public.

OBJECTIVE: To survey public attitudes about incentives for smoking cessation in pregnancy and for breast feeding to inform trial design. DESIGN: Cross-sectional survey. SETTING AND PARTICIPANTS: British general public. METHODS: Seven promising incentive strategies had been identified from evidence syntheses and qualitative interview data from service users and providers. These were shopping vouchers for: (1) validated smoking cessation in pregnancy and (2) after birth; (3) for a smoke-free home; (4) for proven breast feeding; (5) a free breast pump; (6) payments to health services for reaching smoking cessation in pregnancy targets and (7) breastfeeding targets. Ipsos MORI used area quota sampling and home-administered computer-assisted questionnaires, with randomised question order to assess agreement with different incentives (measured on a five-point scale). Demographic data and target behaviour experience were recorded. Analysis used multivariable ordered logit models. RESULTS: Agreement with incentives was mixed (ranging from 34% to 46%) among a representative sample of 1144 British adults. Mean agreement score was highest for a free breast pump, and lowest for incentives for smoking abstinence after birth. More women disagreed with shopping vouchers than men. Those with lower levels of education disagreed more with smoking cessation incentives and a breast pump. Those aged 44 or under agreed more with all incentive strategies compared with those aged 65 and over, particularly provider targets for smoking cessation. Non-white ethnic groups agreed particularly with breastfeeding incentives. Current smokers with previous stop attempts and respondents who had breast fed children agreed with providing vouchers for the respective behaviours. Up to £40/month vouchers for behaviour change were acceptable (>85%). CONCLUSIONS: Women and the less educated were more likely to disagree, but men and women of childbearing age to agree, with incentives designed for their benefit. Trials evaluating reach, impact on health inequalities and ethnic groups are required prior to implementing incentive interventions. TRIAL REGISTRATION NUMBER: CRD42012001980.

Seeing other women breastfeed: how vicarious experience relates to breastfeeding intention and behaviour.

Vicarious experience gained through seeing women breastfeed may influence infant feeding decisions and self-efficacy. Our aim was to measure the attributes of seeing breastfeeding and to investigate how these relate to feeding intention (primary outcome) and behaviour (secondary outcome). First, we developed a Seeing Breastfeeding Scale (SBS), which consisted of five attitudes (Cronbach's alpha of 0.86) to most recently observed breastfeeding: 'I felt embarrassed'; 'I felt uncomfortable'; 'I did not know where to look'; and 'It was lovely' and 'It didn't bother me'. Test-retest reliability showed agreement (with one exception, kappas ranged from 0.36 to 0.71). Second, we conducted a longitudinal survey of 418 consecutive pregnant women in rural Scotland. We selected the 259 women who had never breastfed before for further analysis. Following multiple adjustments, women who agreed that 'It was lovely to see her breastfeed' were more than six times more likely to intend to breastfeed compared with women who disagreed with the statement [odds ratio (OR) 6.72, 95% confidence interval (CI) 2.85-15.82]. Women who completed their full-time education aged 17 (OR 3.09, 95% CI 1.41-6.77) or aged 19 (OR 7.41 95% CI 2.51-21.94) were more likely to initiate breastfeeding. Women who reported seeing breastfeeding within the preceding 12 months were significantly more likely to agree with the statement 'It was lovely to see her breastfeed' (P = 0.02). Positive attitudes to recently seen breastfeeding are more important determinants of feeding intention than age of first seeing breastfeeding, the relationship to the person seen and seeing breastfeeding in the media.