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.

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.

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

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

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.

Preconception knowledge, beliefs and behaviours among people of reproductive age: A systematic review of qualitative studies.

BACKGROUND: The health of parents before pregnancy influences the short- and long-term health of their offspring. This systematic review explored the preconception knowledge, beliefs and behaviours held by women and men of childbearing age. METHODS: Databases were searched from 2009 to 2022 (MEDLINE, CINAHL Full-text, PsycINFO, EMBASE). Inclusion criteria specified qualitative research papers which recruited individuals of reproductive age (16-45 years) without existing chronic illnesses. Data were quality assessed and analysed using thematic synthesis. RESULTS: Twelve papers met inclusion criteria. Six themes were identified (cultural context, pregnancy planning, knowledge, gender roles and responsibility, information seeking, prior health behaviours) which relate to individual, social, psychological and cultural factors. Cultural context was related to all other themes. Pregnancy planners had greater motivation to optimise their health whereas those not actively planning were focused more on becoming financially stable. Women and men's knowledge of how and why to engage in health protective behaviours was limited, with health risks and behaviour change discussed in the context of pregnancy rather than preconception. Gender roles influenced individual responsibility for preparation for pregnancy, which in turn influenced information seeking behaviours and engagement in health behaviours. Online sources of support and information were seen as desirable, regardless of pregnancy planning stage. CONCLUSIONS: Our findings indicate that behaviour change interventions designed to support people to optimise health before conception should address cultural, individual, social and psychological factors to facilitate behaviour change. Development of online resources may help to increase accessibility for people across different cultural contexts and stages of pregnancy planning.

Exploring the views and experiences of people recovering from a stroke about a new text message intervention to promote physical activity after rehabilitation-Keeping Active with Texting After Stroke: A qualitative study.

BACKGROUND: Participating in exercise following a stroke is essential for recovery. When community-based rehabilitation services end, some people struggle to remain active. We codesigned Keeping Active with Texting After Stroke (KATS), a text message intervention to support home-based, self-directed plans to continue exercising. KATS delivers a series of automated text messages over a 12-week period from the point of discharge from National Health Service-funded therapy. The aim of this study was to explore the views and experiences of the first cohort of participants to complete the KATS intervention about the meaning, engagement, workability and worth of the intervention. METHODS: We undertook a qualitative study, theoretically informed by Normalisation Process Theory. We conducted semi-structured telephone interviews with people with stroke from two Health Boards in Scotland. Data collection took place over two phases, with each participant being interviewed twice: first, halfway through intervention delivery (Week 6) and then again at the end of the intervention (Week 12). All interviews were audio-recorded, transcribed and analysed thematically. RESULTS: A total of 24 interviews were conducted with 12 participants. Our findings were organised around four overarching analytical themes: (1) making sense of KATS: timing and complementarity in the rehabilitation journey; (2) engaging with KATS: connection and identification with others; (3) making KATS work: flexibility and tailorable guidance; (4) appraising the worth of KATS: encouragement and friendliness. Participants differentiated KATS from current rehabilitation practice, finding it relevant, fitting and worthwhile. Variations were reported in engagement with behaviour change techniques, but participants were able to tailor KATS use, making it work for them in different ways. CONCLUSIONS: Perceived benefits went beyond promoting physical activity, including feeling supported and connected. Future research will test the effectiveness of KATS in promoting physical activity and explore any associations with relevant social and emotional secondary outcomes. PATIENT OR PUBLIC CONTRIBUTION: A research funding proposal was developed in collaboration with five people with stroke and three spouses. After securing funding, six people with stroke were invited to join the project's Collaborative Working Group, alongside health professionals and stroke rehabilitation experts, to codevelop the intervention and support the feasibility study.

Keeping Active with Texting after Stroke (KATS): development of a text message intervention to promote physical activity and exercise after stroke.

BACKGROUND: Post-stroke physical activity reduces disability and risk of further stroke. When stroke rehabilitation ends, some people feel abandoned by services and struggle to undertake physical activities that support recovery and health. The aim of this study was to codesign a novel text message intervention to promote physical activity among people with stroke and provide support when formal rehabilitation ends. This manuscript describes the intervention development processes that will inform future pilot and feasibility studies. METHODS: The planned intervention was a series of text messages to be sent in a predetermined sequence to people with stroke at the end of rehabilitation. The intervention, underpinned by behaviour change theory and using salient behaviour change techniques, would provide daily messages offering encouragement and support for the uptake and maintenance of physical activity following stroke. The intervention was codesigned by a Collaborative Working Group, comprised of people with stroke, rehabilitation therapists, representatives from stroke charities and academics. A four-step framework was used to design the intervention: formative research on physical activity post-stroke, creation of the behaviour change text message intervention, pre-testing and refinement. Formative research included a review of the scientific evidence and interviews with community-dwelling people with stroke. Data generated were used by the Collaborative Working Group to identify topics to be addressed in the intervention. These were mapped to constructs of the Health Action Process Approach, and salient behaviour change techniques to deliver the intervention were identified. The intervention was rendered into a series of text messages to be delivered over 12 weeks. The draft intervention was revised and refined through an iterative process including review by people with stroke, their spouses, rehabilitation therapists and experts in the field of stroke. The messages encourage regular physical activity but do not prescribe exercise or provide reminders to exercise at specific times. They use conversational language to encourage engagement, and some are personalised for participants. Quotes from people with stroke provide encouragement and support and model key behaviour change techniques such as goal setting and coping planning. DISCUSSION: Co-design processes were critical in systematically developing this theory and evidence-based intervention. People with stroke and rehabilitation therapists provided insights into perceived barriers post-rehabilitation and identified strategies to overcome them. The structured multistep approach highlighted areas for improvement through successive rounds of review. The intervention will be tested for acceptability, feasibility and effectiveness in future studies. This co-design approach could be used for interventions for other heath behaviours and with different populations.

Informing interventions to improve uptake of adjuvant endocrine therapy in women with breast cancer: a theoretical-based examination of modifiable influences on non-adherence.

PURPOSE: To inform intervention development, we measured the modifiable determinants of endocrine therapy (ET) non-adherence in women with breast cancer, using the Theoretical Domains Framework (TDF) and examined inter-relationships between these determinants and non-adherence using the Perceptions and Practicalities Approach (PAPA). METHODS: Women with stages I-III breast cancer prescribed ET were identified from the National Cancer Registry Ireland (N = 2423) and invited to complete a questionnaire. A theoretically based model of non-adherence was developed using PAPA to examine inter-relationships between the 14 TDF domains of behaviour change and self-reported non-adherence. Structural equation modelling (SEM) was used to test the model. RESULTS: A total of 1606 women participated (response rate = 66%) of whom 395 (25%) were non-adherent. The final SEM with three mediating latent variables (LVs) (PAPA Perceptions: TDF domains, Beliefs about Capabilities, Beliefs about Consequences; PAPA Practicalities: TDF domain, Memory, Attention, Decision Processes and Environment) and four independent LVs (PAPA Perceptions: Illness intrusiveness; PAPA Practicalities: TDF domains, Knowledge, Behaviour Regulation; PAPA External Factors: TDF domain, Social Identity) explained 59% of the variance in non-adherence and had an acceptable fit (χ2(334) = 1002, p < 0.001; RMSEA = 0.03; CFI = 0.96 and SRMR = 0.07) Knowledge had a significant mediating effect on non-adherence through Beliefs about Consequences and Beliefs about Capabilities. Illness intrusiveness had a significant mediating effect on non-adherence through Beliefs about Consequences. Beliefs about Consequences had a significant mediating effect on non-adherence through Memory, Attention, Decision Processesg and Environment. CONCLUSIONS: By underpinning future interventions, this model has the potential to improve ET adherence and, hence, reduce recurrence and improve survival in breast cancer.

WeWalk: walking with a buddy after stroke-a pilot study evaluating feasibility and acceptability of a person-centred dyadic behaviour change intervention.

BACKGROUND: Evidence for benefits of physical activity after stroke is unequivocal. However, many people with stroke are inactive, spending > 80% of waking hours sedentary even when they have physical capacity for activity, indicating barriers to physical activity participation that are not physical. WeWalk is a 12-week person-centred dyadic behaviour change intervention in which a person with stroke (PWS) and a walking buddy form a dyad to work together to support the PWS to increase their physical activity by walking outdoors. This pilot study examined the feasibility of recruiting dyads, explored their perceptions of acceptability and their experiences using WeWalk, to identify required refinements before progression to a clinical trial. METHODS: Design: A single-arm observational pilot study with qualitative evaluation. INTERVENTION: WeWalk involved facilitated face-to-face and telephone sessions with a researcher who was also a behaviour change practitioner, supported by intervention handbooks and diaries, in which dyads agreed walking goals and plans, monitored progress, and developed strategies for maintaining walking. EVALUATION: Descriptive data on recruitment and retention were collected. Interview data were collected through semi-structured interviews and analysed using thematic analysis, guided by a theoretical framework of acceptability. RESULTS: We recruited 21 dyads comprising community dwelling PWS and their walking buddies. Ten dyads fully completed WeWalk before government-imposed COVID-19 lockdown. Despite lockdown, 18 dyads completed exit interviews. We identified three themes: acceptability evolves with experience, mutuality, and person-centredness with personally relevant tailoring. As dyads recognised how WeWalk components supported walking, perceptions of acceptability grew. Effort receded as goals and enjoyment of walking together were realised. The dyadic structure provided accountability, and participants' confidence developed as they experienced physical and psychological benefits of walking. WeWalk worked best when dyads exhibited relational connectivity and mutuality in setting and achieving goals. Tailoring intervention components to individual circumstances and values supported dyads in participation and achieving meaningful goals. CONCLUSION: Recruiting dyads was feasible and most engaged with WeWalk. Participants viewed the dyadic structure and intervention components as acceptable for promoting outdoor walking and valued the personally tailored nature of WeWalk. Developing buddy support skills and community delivery pathways are required refinements. ISCTRN number: 34488928.

Handwashing adherence during the COVID-19 pandemic: A longitudinal study based on protection motivation theory.

RATIONALE: The associations between the number of COVID-19 cases/deaths and subsequent uptake of protective behaviors may reflect cognitive and behavioral responses to threat-relevant information. OBJECTIVE: Applying protection motivation theory (PMT), this study explored whether the number of total COVID-19 cases/deaths and general anxiety were associated with cross-situational handwashing adherence and whether these associations were mediated by PMT-specific self-regulatory cognitions (threat appraisal: perceived vulnerability, perceived illness severity; coping appraisal: self-efficacy, response efficacy, response costs). METHOD: The study (#NCT04367337) was conducted in March-September 2020 among 1256 adults residing in 14 countries. Self-reports on baseline general anxiety levels, handwashing adherence across 12 situations, and PMT-related constructs were collected using an online survey at two points in time, four weeks apart. Values of COVID-19 cases and deaths were retrieved twice for each country (one week prior to the individual data collection). RESULTS: Across countries and time, levels of adherence to handwashing guidelines were high. Path analysis indicated that smaller numbers of COVID-19 cases/deaths (Time 0; T0) were related to stronger self-efficacy (T1), which in turn was associated with higher handwashing adherence (T3). Lower general anxiety (T1) was related to better adherence (T3), with this effect mediated by higher response efficacy (T1, T3) and lower response cost (T3). However, higher general anxiety (T1) was related to better adherence via higher illness severity (T1, T3). General anxiety was unrelated to COVID-19 indicators. CONCLUSIONS: We found a complex pattern of associations between the numbers of COVID-19 cases/deaths, general anxiety, PMT variables, and handwashing adherence at the early stages of the pandemic. Higher general anxiety may enable threat appraisal (perceived illness severity), but it may hinder coping appraisal (response efficacy and response costs). The indicators of the trajectory of the pandemic (i.e., the smaller number of COVID-19 cases) may be indirectly associated with higher handwashing adherence via stronger self-efficacy.

Reducing patient delay in acute coronary syndrome: Randomized controlled trial testing effect of behaviour change intervention on intentions to seek help.

OBJECTIVES: The aim of this study was to evaluate the efficacy of a behaviour change intervention to reduce patient delay with symptoms of acute coronary syndrome. DESIGN: A 3-arm web-based, parallel randomized controlled trial. METHODS: The intervention comprised 12 behaviour change techniques (BCTs) embedded in a text-only or text+visual narrative (the techniques were systematically identified through systematic review and a consensus exercise). Between February and November 2017, n = 145 people who had recently experienced acute coronary syndrome were randomly allocated to intervention ('text+visual' or 'text-only') or control. Intentions to phone an ambulance immediately for acute coronary syndrome symptoms were assessed before and after the intervention using symptom scenarios, and the change in intention was compared across the three groups. RESULTS: Significant increases in intention to phone an ambulance immediately for ACS symptoms were seen following the 'text+visual' intervention but not following 'text-only' or control. However, the study was underpowered to detect any significant changes in intention between the 3 groups. There were no unintended effects on intentions for non-urgent symptoms. CONCLUSIONS: A 'text+visual' BCT-based intervention may significantly increase intention to phone an ambulance with symptoms of ACS. Further testing of the effect of the intervention on actual behaviour is required.

Effectiveness of general practitioner-delivered nutrition care interventions on dietary and health outcomes in adults with diet-related chronic conditions: a systematic review protocol.

OBJECTIVE: This systematic review will evaluate the effectiveness of nutrition care interventions delivered by general practitioners versus usual care or no care on dietary and health outcomes in adults with diet-related chronic conditions or risk states. INTRODUCTION: General practitioners are usually the first contacts in the health care system for patients with diet-related chronic conditions. While there is some evidence that general practitioners can be effective in delivering nutrition care for a number of outcomes, to inform future care, an update of the evidence is required as well as an examination of which components are associated with positive outcomes. INCLUSION CRITERIA: Published studies will be included if they report on adults with or at risk of diet-related chronic conditions; one-on-one nutrition care interventions individually delivered by general practitioners during primary care consultations; usual or no care as comparators; dietary and/or health outcomes with a minimum three-month follow-up; and randomized controlled trials. Included studies will be available in, or able to be translated into, English and will have no date restrictions. METHODS: The databases to be searched will include CINAHL, Embase, MEDLINE, and ProQuest Nursing and Allied Health. Following deduplication, two reviewers will independently screen the titles and abstracts in Covidence, followed by the full texts of potentially relevant studies. Disagreements will be resolved through discussion or with a third reviewer. Included studies will be critically appraised and data will be extracted using a modified JBI tool. Findings will be reported in tables and narrative synthesis, and pooled with statistical meta-analysis, where possible. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42021289011.

Examining the role of sex on the benefits of muscle-strengthening activities for people living with obesity: A cross-sectional study.

Aims: To investigate the correlations between meeting the muscle-strengthening activities guideline, body fat %, and mortality for individuals living with obesity and to explore if these correlations are moderated by sex. Methods: Data from 3915 adults (51.9% women; 48.1% men ) living with obesity (body fat % ≥25 for men and ≥35 for women) from two cycles of the National Health and Nutrition Examination Survey (NHANES 2003-04/2005-06) were analyzed. Muscle-strengthening activities were self-reported via a questionnaire, body fat % was measured via Dual Energy X-ray, and mortality was obtained via administrative data for an average of 10 years. Results: 18.7% of men and 15.2% of women living with obesity met the muscle-strengthening activities guideline (p = 0.021) . Sex was correlated with body fat %; (ß (SE)= 11.34 (0.18); p ≤ 0.001) and risk of mortality (hazard ratio (95% confidence interval) = 0.36 (0.24-0.54); p ≤ 0.001), once adjusted for confounders (weekly aerobic activities, ethnicity, education, household income, smoking, and the sum of chronic conditions). The interaction between sex and meeting the muscle-strengthening activities guideline was not significantly correlated with the studied outcomes. Conclusion: Performing muscle-strengthening activities a minimum of two times per week does not impact body fat % or risk of mortality (over 10 years) differently in men or women living with obesity.

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.

We Walk: a person-centred, dyadic behaviour change intervention to promote physical activity through outdoor walking after stroke-an intervention development study.

OBJECTIVES: To develop We Walk, a theoretically informed, 12-week person-centred dyadic behaviour change intervention to increase physical activity (PA) in community-dwelling people with stroke (PWS) through outdoor walking. DESIGN: Three-phase intervention development study. Phase 1: we reviewed literature on barriers and facilitators to PA after stroke and mapped them to the Behaviour Change Wheel and Theoretical Domains Framework to define intervention components. The Health Action Process Approach determined intervention structure underpinned by person-centred principles. Phase 2: stakeholder focus groups involving PWS, their companions and health professionals reviewed the draft intervention, and experts in behaviour change were consulted. Phase 3: informed by phases 1 and 2, the intervention and form of delivery were refined, with final review through patient and public involvement. SETTING: Three Scottish community rehabilitation stroke services. PARTICIPANTS: Twenty-three ambulatory community-dwelling PWS and their companions, thirty-seven health and exercise professionals, seven behaviour change experts. RESULTS: Phase 1 determined key intervention components: information about benefits of walking; developing motivation and confidence to walk; facilitating dyadic goal setting and making plans together; monitoring walking, overcoming challenges; and maintaining walking behaviour. Phase 2 review by stakeholder focus groups and behaviour change experts endorsed intervention components and structure, emphasising dyadic relational aspects as central to potential success. In phase 3, intervention content and handbooks for PWS and buddies were finalised. Healthcare professionals proposed third-sector delivery as most appropriate for intervention delivery. A detailed delivery manual was developed. Participants preferred facilitated face-to-face and telephone delivery. CONCLUSIONS: Our multilens intervention development approach ensured this novel intervention was evidence-informed, person-centred, theoretically coherent provided appropriate social support, and addressed issues of concern to PWS. This study established intervention components and structure and identified operational issues critical to future success. Future research will pilot and refine We Walk and evaluate acceptability, feasibility, effectiveness and cost-effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN34488928.

Examining dietary self-talk content and context for discretionary snacking behaviour: a qualitative interview study.

Background: Consuming discretionary snack foods high in calories, salt, sugar or fat in between regular meals can have a negative impact on weight management and health. Despite the intention to refrain from discretionary snacking, individuals often report feeling tempted by snack foods. A cognitive process to resolve food choice related tension may be dietary self-talk which is one's inner speech around dietary choice. This study aimed to understand the content and context of dietary self-talk before consuming discretionary snack foods. Methods: Qualitative semi-structured interviews based on Think-Aloud methods were conducted remotely. Participants answered open-ended questions and were presented with a list of 37 dietary self-talk items. Interview transcripts were analyzed thematically. Results: Interviews (n = 18, age: 19-54 years, 9 men, 9 women) confirmed the frequent use of dietary self-talk with all 37 content items endorsed. Reported use was highest for the self-talk items: 'It is a special occasion'; 'I did physical activity/exercise today'; and 'I am hungry'. Three new items were developed, eight items were refined. Identified key contextual themes were: 'reward', 'social', 'convenience', 'automaticity', and 'hunger'. Conclusions: This study lists 40 reasons people use to allow themselves to consume discretionary snack foods and identifies contextual factors of dietary-self talk. All participants reported using dietary self-talk, with variation in content, frequency and degree of automaticity. Recognising and changing dietary self-talk may be a promising intervention target for changing discretionary snacking behaviour.

The Interplay Between Strictness of Policies and Individuals' Self-Regulatory Efforts: Associations with Handwashing During the COVID-19 Pandemic.

BACKGROUND: Patterns of protective health behaviors, such as handwashing and sanitizing during the COVID-19 pandemic, may be predicted by macro-level variables, such as regulations specified by public health policies. Health behavior patterns may also be predicted by micro-level variables, such as self-regulatory cognitions specified by health behavior models, including the Health Action Process Approach (HAPA). PURPOSE: This study explored whether strictness of containment and health policies was related to handwashing adherence and whether such associations were mediated by HAPA-specified self-regulatory cognitions. METHODS: The study (NCT04367337) was conducted among 1,256 adults from Australia, Canada, China, France, Gambia, Germany, Israel, Italy, Malaysia, Poland, Portugal, Romania, Singapore, and Switzerland. Self-report data on cross-situational handwashing adherence were collected using an online survey at two time points, 4 weeks apart. Values of the index of strictness of containment and health policies, obtained from the Oxford COVID-19 Government Response Tracker database, were retrieved twice for each country (1 week prior to individual data collection). RESULTS: Across countries and time, levels of handwashing adherence and strictness of policies were high. Path analysis indicated that stricter containment and health policies were indirectly related to lower handwashing adherence via lower self-efficacy and self-monitoring. Less strict policies were indirectly related to higher handwashing adherence via higher self-efficacy and self-monitoring. CONCLUSIONS: When policies are less strict, exposure to the SARS-CoV-2 virus might be higher, triggering more self-regulation and, consequently, more handwashing adherence. Very strict policies may need to be accompanied by enhanced information dissemination or psychosocial interventions to ensure appropriate levels of self-regulation.

The trajectory of COVID-19 pandemic and handwashing adherence: findings from 14 countries.

BACKGROUND: The COVID-19 pandemic has affected people's engagement in health behaviors, especially those that protect individuals from SARS-CoV-2 transmission, such as handwashing/sanitizing. This study investigated whether adherence to the World Health Organization's (WHO) handwashing guidelines (the outcome variable) was associated with the trajectory of the COVID-19 pandemic, as measured by the following 6 indicators: (i) the number of new cases of COVID-19 morbidity/mortality (a country-level mean calculated for the 14 days prior to data collection), (ii) total cases of COVID-19 morbidity/mortality accumulated since the onset of the pandemic, and (iii) changes in recent cases of COVID-19 morbidity/mortality (a difference between country-level COVID-19 morbidity/mortality in the previous 14 days compared to cases recorded 14-28 days earlier). METHODS: The observational study (#NCT04367337) enrolled 6064 adults residing in Australia, Canada, China, France, Gambia, Germany, Israel, Italy, Malaysia, Poland, Portugal, Romania, Singapore, and Switzerland. Data on handwashing adherence across 8 situations (indicated in the WHO guidelines) were collected via an online survey (March-July 2020). Individual-level handwashing data were matched with the date- and country-specific values of the 6 indices of the trajectory of COVID-19 pandemic, obtained from the WHO daily reports. RESULTS: Multilevel regression models indicated a negative association between both accumulation of the total cases of COVID-19 morbidity (B = -.041, SE = .013, p = .013) and mortality (B = -.036, SE = .014 p = .002) and handwashing. Higher levels of total COVID-related morbidity and mortality were related to lower handwashing adherence. However, increases in recent cases of COVID-19 morbidity (B = .014, SE = .007, p = .035) and mortality (B = .022, SE = .009, p = .015) were associated with higher levels of handwashing adherence. Analyses controlled for participants' COVID-19-related situation (their exposure to information about handwashing, being a healthcare professional), sociodemographic characteristics (gender, age, marital status), and country-level variables (strictness of containment and health policies, human development index). The models explained 14-20% of the variance in handwashing adherence. CONCLUSIONS: To better explain levels of protective behaviors such as handwashing, future research should account for indicators of the trajectory of the COVID-19 pandemic. TRIAL REGISTRATION: Clinical Trials.Gov, # NCT04367337.

Barriers to nutritional pregnancy preparation and support needs in women and men: Qualitative study based on the Theoretical Domains Framework.

PURPOSE: Eating behaviours prior to conception may impact the health of the offspring at birth and throughout life. Women and men of childbearing age often follow a nutritionally poor preconception diet. Nutritional support before pregnancy has the potential to improve the health of future offspring. This study examined barriers to nutritional preparation for pregnancy and perceived support needs of women and men of childbearing age. DESIGN: Qualitative interviews based on the Theoretical Domains Framework. SETTING: Online. PARTICIPANTS: Eligible individuals were (1) New Brunswick residents (all genders), (2) over 19 years old, and (3) intended to have offspring in the future. METHODS: Interviews were conducted via online instant messenger and analysed thematically. RESULTS: Interviews of participants (n = 19, age = 19-23 years, 14 women, 5 men) gave rise to five key theoretical domains: lack of knowledge; lack of beliefs about capabilities; suboptimal environmental context and resources; unfavourable social influences; and restrictive social roles. Suggestions to address pregnancy preparation support needs included healthcare professional consultations; accessible and credible references; increasing access to healthy food; proactive engagement; and gender-specific support. CONCLUSION: Women and men called for various types of preconception support to address identified barriers, ranging from healthcare professional advice and credible informational resources to broader interventions such as making healthy food more affordable and normalizing discussion of preconception health throughout the life course.

Identifying ways to maximise cervical screening uptake: a qualitative study of GPs' and practice nurses' cervical cancer screening-related behaviours.

Background:  Cervical screening uptake is declining in several countries. Primary care practitioners could play a greater role in maximising uptake, but better understanding is needed of practitioners' cervical screening-related behaviours. Among general practitioners (GPs) and practice nurses, we aimed to identify cervical screening-related clinical behaviours; clarify practitioners' roles/responsibilities; and determine factors likely to influence clinical behaviours. Methods: Telephone interviews were conducted with GPs and practice nurses in Ireland. Interview transcripts were analysed using the Theoretical Domains Framework (TDF), a comprehensive psychological framework of factors influencing clinical behaviour. Results: 14 GPs and 19 practice nurses participated. Key clinical behaviours identified were offering smears and encouraging women to attend for smears. Smeartaking responsibility was considered a predominantly female role. Of 12 possible theoretical domains, 11 were identified in relation to these behaviours. Those judged to be the most important were beliefs about capabilities; environmental context and resources; social influences; and behavioural regulation. Difficulties in obtaining smears from certain subgroups of women and inexperience of some GPs in smeartaking arose in relation to beliefs about capabilities. The need for public health education and reluctance of male practitioners to discuss cervical screening with female patients emerged in relation to social influences.   Conclusions: We identified - for the first time - primary care practitioners' cervical-screening related clinical behaviours, their perceived roles and responsibilities, and factors likely to influence behaviours. The results could inform initiatives to enable practitioners to encourage women to have smear tests which in turn, may help increase cervical screening uptake.