Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for persistent taxane-induced peripheral neuropathy (B-HAPI study): a randomized controlled trial.

BACKGROUND: Evaluation publications typically summarize the results of studies to demonstrate the effectiveness of an intervention, but little is shared concerning any changes implemented during the study. We present a process evaluation protocol of a home-based gait, balance, and resistance exercise intervention to ameliorate persistent taxane-induced neuropathy study according to 7 key elements of process evaluation. METHODS: The process evaluation is conducted parallel to the longitudinal, randomized control clinical trial examining the effects of the home-based gait, balance, and resistance exercise program for women with persistent peripheral neuropathy following treatment with taxanes for breast cancer (IRB approval: Pro00040035). The flowcharts clarify how the intervention should be implemented in comparable settings, fidelity procedures help to ensure the participants are comfortable and identify their individual needs, and the process evaluation allows for the individual attention tailoring and focus of the research to avoid protocol deviation. CONCLUSIONS: The publication of the evaluation protocol plan adds transparency to the findings of clinical trials and favors process replication in future studies. The process evaluation enables the team to systematically register information and procedures applied during recruitment and factors that impact the implementation of the intervention, thereby allowing proactive approaches to prevent deviations from the protocol. When tracking an intervention continuously, positive or negative intervention effects are revealed early on in the study, giving valuable insight into inconsistent results. Furthermore, a process evaluation adds a participant-centered element to the research protocols, which allows a patient-centered approach to be applied to data collection. TRIAL REGISTRATION: ClinicalTrials.gov NCT04621721, November 9, 2020, registered prospectively. PROTOCOL VERSION: April 27, 2020, v2.

Protocol for the STEADY intervention for type 1 diabetes and disordered eating: Safe management of people with Type 1 diabetes and EAting Disorders studY.

This paper describes the protocol to test the feasibility of the Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY) intervention. STEADY is a novel complex intervention for people with type 1 diabetes and disordered eating (T1DE) of mild to moderate severity. The STEADY intervention integrates cognitive behavioural therapy (CBT) with diabetes education, and was developed using Experience-Based Co-Design. METHODS: The feasibility of STEADY will be tested using a randomised controlled feasibility trial. Forty adults with T1DE will be recruited and randomised into the STEADY intervention or treatment as usual control group. We will collect demographic, biomedical and psychometric data, routine glucose metrics and conduct the Structured Clinical Interview for DSM-5. Participants randomised to the STEADY intervention will receive 12 STEADY therapy sessions with a diabetes specialist nurse trained in CBT, delivered via videoconference and an optional smartphone app. The main outcome at 6 months will be the feasibility of STEADY (recruitment, dropout rates, feasibility of delivery). The secondary outcomes are biomedical (HbA1c and glucose time in range) and psychological (person-reported outcome measures in disordered eating, diabetes distress, depression and anxiety). A process evaluation will evaluate the fidelity, feasibility, acceptability and appropriateness of STEADY, and participant experiences. ETHICS AND DISSEMINATION: The protocol was approved by the East of England-Essex Research Ethics Committee (21/EE/0235). Study findings will be shared with study participants and disseminated through peer-reviewed publications and conference presentations.

Sustaining the benefits of structured education: Participants' experiences of receiving structured individual support during a programme (DAFNEplus) informed by behavioural science.

AIMS: The DAFNEplus programme seeks to promote sustained improvements in glycaemic management by incorporating techniques from behavioural science. It includes five sessions of structured individual support delivered over 12 months following group education. As part of a broader evaluation, and to inform decision-making about roll-out in routine care, we explored participants' experiences of, and engagement with, that individual support. METHODS: We interviewed DAFNEplus participants (n = 28) about their experiences of receiving individual support and the impact they perceived it as having on their self management practices. We analysed data thematically. RESULTS: Participants described several important ways individual support had helped strengthen their self management, including: consolidating and expanding their understandings of flexible intensive insulin therapy; promoting ongoing review and refinement of behaviour; encouraging continued and effective use of data; and facilitating access to help from healthcare professionals to pre-empt or resolve emergent difficulties. Participants characterised themselves as moving towards independence in self management over the time they received individual support, with their accounts suggesting three key stages in that journey: 'Working with healthcare professionals'; 'Growing sense of responsibility'; and, 'Taking control'. Whilst all portrayed themselves as changed, participants' progress through those stages varied; a few continued to depend heavily on DAFNEplus facilitators for advice and/or direction at 12 months. CONCLUSIONS: While all participants benefited from individual support, our findings suggest that some may need, or gain further benefit from, longer-term, tailored support. This has important implications for decision-making about roll-out of DAFNEplus post-trial and for the development of future programmes seeking to bring about sustainable changes in self management practices.

From efficacy to effectiveness: a comprehensive framework for monitoring, evaluating and optimizing seasonal malaria chemoprevention programmes.

BACKGROUND: Seasonal Malaria Chemoprevention (SMC) is a highly effective intervention for preventing malaria, particularly in areas with highly seasonal transmission. Monitoring and evaluating (M&E) SMC programmes are complex due to the scale, time-sensitive delivery of the programme, and influence of external factors. This paper describes the process followed to develop a comprehensive M&E framework tailored specifically for the SMC context. METHODS: The Framework was developed through a literature and programme review, and stakeholder dialogues across three implementing countries-Burkina Faso, Chad, and Nigeria. Expert consultation further refined the Framework through an iterative approach drawing upon data collected through the three sources. The Framework was designed using the Logical Framework Approach incorporating external factors and intentionally aligned with global malaria M&E standards. RESULTS: An overall aim and seven programme objectives were developed measured by 70 indicators. The indicators also capture the causal links between the implementation and results of the programme. The Framework leverages the use of current data sources and existing mechanisms, ensuring efficient data use without requiring a significant increase in resources for overall programme optimization. It also promotes the use of data triangulation, and stratification for a more nuanced understanding of factors affecting programme performance and timely data informed decision-making. CONCLUSIONS: The SMC M&E Framework presented here provides a standardized approach for programme implementers to enhance decision-making for optimal programme performance. This is an essential tool as the scope of SMC programmes expands to new geographies and target age groups.

Using formative process evaluation to improve program implementation and accessibility of competitive group-based physical activity in the TEAM-PA trial.

BACKGROUND: This study demonstrates how formative process evaluation was used to assess implementation and improve dose and fidelity in the Together Everyone Achieves More Physical Activity (TEAM-PA) randomized controlled trial. TEAM-PA uses a randomized group cohort design to evaluate the efficacy of a group-based intervention for increasing physical activity among African American women. METHODS: Intervention groups met for 10 weeks and were co-led by female African American facilitators, with intervention sessions consisting of group feedback, a health curriculum, group-based physical activity games, and group-based goal-setting. Drawing from a multi-theoretical framework, the intervention targeted social affiliation using collaborative and competitive group strategies, including essential elements focused on group-based behavioral skills, peer-to-peer positive communication, collectivism, optimal challenge, social facilitation, and peer to peer challenges. Formative process evaluation was used to monitor reach, dose, and fidelity, and implement feedback and solutions. RESULTS: Across two cohorts, four groups (n = 54) were randomized to the TEAM-PA intervention. On average 84.8% of participants attended each week, which exceeded the a priori criteria. Results from the systematic observations indicated that on average 93% of the dose items were completed in each session and adequate levels of fidelity were achieved at both the facilitator and group-levels. Participants were compliant with wearing the FitBits (6.73 ± 0.42 days/week) and most participants successfully contributed to meeting the group-based goals. The use of open-ended items also revealed the need for additional modifications to the group-based PA games, including allowing for individuals to take breaks, incorporating a broader range of exercises, minimizing activities that required bending/reaching down without assistance, and providing facilitators with additional training for implementing the games. Initial evidence suggests that these changes were successful in increasing participants' comprehension of the games from Cohort 1 (M = 1.83, SD = 0.71) to Cohort 2 (M = 3.33, SD = 0.69). CONCLUSION: Findings from this study demonstrated high levels of reach, dose, and fidelity, while also highlighting strategies for implementing competitive group-based PA games that are accessible across physical fitness levels. Formative process evaluation, including open-ended items and collaborative brainstorming, holds tremendous potential for improving future interventions. TRIAL REGISTRATION: This study was registered on Clinicaltrials.gov (# NCT05519696) on August 22, 2022 prior to the enrollment of the first participant on September 12, 2022 ( https://clinicaltrials.gov/study/NCT05519696?term=NCT05519696&rank=1 ).

Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation.

BACKGROUND: POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention. METHODS: We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy. RESULTS: Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context. CONCLUSIONS: Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses' results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness. TRIAL REGISTRATION: Number NCT02765009.

A process evaluation of the NIDUS-Professional dementia training intervention for UK homecare workers.

INTRODUCTION: This process evaluation was conducted in parallel to the randomised controlled feasibility trial of NIDUS-Professional, a manualised remote dementia training intervention for homecare workers (HCWs), delivered alongside an individualised intervention for clients living with dementia and their family carers (NIDUS-Family). The process evaluation reports on: (i) intervention reach, dose and fidelity; (ii) contexts influencing agency engagement and (iii) alignment of findings with theoretical assumptions about how the intervention might produce change. METHODS: We report proportions of eligible HCWs receiving any intervention (reach), number of sessions attended (dose; attending ≥4/6 main sessions was predefined as adhering), intervention fidelity and adherence of clients and carers to NIDUS-Family (attending all 6-8 planned sessions). We interviewed HCWs, managers, family carers and facilitators. We integrated and thematically analysed, at the homecare agency level, qualitative interview and intervention recording data. RESULTS: 32/141 (23%) of eligible HCWs and 7/42 (17%) of family carers received any intervention; most who did adhered to the intervention (89% and 71%). Intervention fidelity was high. We analysed interviews with 20/44 HCWs, 3/4 managers and 3/7 family carers, as well as intervention recordings involving 32/44 HCWs. All agencies reported structural challenges in supporting intervention delivery. Agencies with greater management buy-in had higher dose and reach. HCWs valued NIDUS-Professional for enabling group reflection and peer support, providing practical, actionable care strategies and increasing their confidence as practitioners. CONCLUSION: NIDUS-Professional was valued by HCWs. Agency management, culture and priorities were key barriers to implementation; we discuss how to address these in a future trial.

Monthly engagement with EIP keyworkers was associated with a five-fold increase in the odds of engagement with psychosocial interventions.

BACKGROUND: Early intervention in psychosis (EIP) supports people who are experiencing their first episode of psychosis (FEP). A new Model of Care (MoC) for EIP services was launched in Ireland in 2019. Three EIP demonstration sites were chosen to test this MoC through a 'hub and spoke' approach. These services were a new way of organising care for people experiencing FEP, based upon a recovery model of care, and which sought to standardise care, improve access by clinically led multidisciplinary teams. This included newly created EIP keyworker roles whereby keyworkers assumed responsibilities regarding assessment, comprehensive individual care planning and coordination of care. METHODS: A mixed methods design utilising the UK Medical Research Council's process evaluation framework. Purposive sampling techniques were utilised. Descriptive analyses and logistic regression were performed to examine how increased keyworker engagement influenced the use of other psychosocial interventions within the EIP demonstration sites. Thematic analyses was used for qualitative data. RESULTS: There was a strong positive relationship between keyworker contacts and psychosocial interventions offered. Specifically, the odds of achieving at least monthly engagement with cognitive behavioural therapy for psychosis (CBTp; (5.76 (2.43-13.64), p < 0.001), and behavioural family therapy (BFT; (5.52(1.63-18.69, p < 0.006)) increased by fivefold with each additional monthly keyworker contact. For individual placement support (IPS) each additional monthly keyworker contact was associated with a three-fold increase in the odds of achieving monthly attendance with IPS (3.73 (1.64-8.48), p < 0.002). Qualitative results found that the EIP keyworker role as viewed by both service users and staff as a valuable nodal point, with a particular emphasis on care coordination and effective communication. CONCLUSIONS: This study advances the understanding of keyworker effects through qualitative evidence of keyworkers functioning as a "linchpin" to the service, while the positive response association between keyworker contacts and engagement with other services provides quantitative support for keyworkers reducing the organisational or structural barriers to service access. Given the importance of these positions, health systems should ensure that EIP programmes identify qualified and experienced staff to fill these roles, as well as allocate the appropriate funding and protected time to support keyworker engagement and impact.

Strengthening national salt reduction strategies using multiple methods process evaluations: case studies from Malaysia and Mongolia.

OBJECTIVE: To understand the extent to which national salt reduction strategies in Malaysia and Mongolia were implemented and achieving their intended outcomes. DESIGN: Multiple methods process evaluations conducted at the mid-point of strategy implementation, guided by theoretical frameworks. SETTING: Malaysia (2018-2019) and Mongolia (2020-2021). PARTICIPANTS: Desk-based reviews of related documents, interviews with key stakeholders (n 12 Malaysia, n 10 Mongolia), focus group discussions with health professionals in Malaysia (n 43) and health provider surveys in Mongolia (n 12). RESULTS: Both countries generated high-quality local evidence about salt intake and levels in foods and culturally specific education resources. In Malaysia, education and reformulation activities were delivered with moderate dose (quantity) but reach among the population was low. Within 5 years, Mongolia implemented education among schools, health professionals and food producers on salt reduction with high reach, but with moderate dose (quantity) and reach among the general population. Both countries faced challenges in implementing legislative interventions (mandatory salt labelling and salt limits in packaged foods) and both could improve the scaling up of their reformulation and education activities. CONCLUSIONS: In the first half of Malaysia's and Mongolia's strategies, both countries generated necessary evidence and education materials, mobilised health professionals to deliver salt reduction education and achieved small-scale reformulation in foods. Both subsequently should focus on implementing regulatory policies and achieving population-wide reach and impact. Process evaluations of existing salt reduction strategies can help strengthen intervention delivery, aiding achievement of WHO's 30 % reduction in salt intake by 2025 target.

The role of a community health worker-delivered preconception and pregnancy intervention in achieving a more positive pregnancy experience: the Bukhali trial in Soweto, South Africa.

BACKGROUND: A patient-centered, human-rights based approach to maternal care moves past merely reducing maternal mortality and morbidity, towards achieving a positive pregnancy experience. When evaluating an intervention, particularly in the context of the complex challenges facing maternal care in South Africa, it is therefore important to understand how intervention components are experienced by women. We aimed to qualitatively explore (i) factors influencing the pregnancy and postpartum experience amongst young women in Soweto, South Africa, and (ii) the influence of Bukhali, a preconception, pregnancy, and early childhood intervention delivered by community health workers (CHWs), on these experiences. METHODS: Semi-structured, in-depth interviews were conducted with 15 purposively sampled participants. Participants were 18-28-year-old women who (i) were enrolled in the intervention arm of the Bukhali randomized controlled trial; (ii) were pregnant and delivered a child while being enrolled in the trial; and (iii) had at least one previous pregnancy prior to participation in the trial. Thematic analysis, informed by the positive pregnancy experiences framework and drawing on a codebook analysis approach, was used. RESULTS: The themes influencing participants' pregnancy experiences (aim 1) were participants' feelings about being pregnant, the responsibilities of motherhood, physical and mental health challenges, unstable social support and traumatic experiences, and the pressures of socioeconomic circumstances. In terms of how support, information, and care practices influenced these factors (aim 2), four themes were generated: acceptance and mother/child bonding, growing and adapting in their role as mothers, receiving tools for their health, and having ways to cope in difficult circumstances. These processes were found to be complementary and closely linked to participant context and needs. CONCLUSION: Our findings suggest that, among women aged 18-28, a CHW-delivered intervention combining support, information, and care practices has the potential to positively influence women's pregnancy experience in South Africa. In particular, emotional support and relevant information were key to better meeting participant needs. These findings can help define critical elements of CHW roles in maternal care and highlight the importance of patient-centred solutions to challenges within antenatal care. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201903750173871, 27/03/2019.

A sports-related injury prevention program for Dutch youth volleyball players: Process evaluation alongside a quasi-randomized controlled trial.

OBJECTIVE: This process evaluation aimed to gain insight into the implementation of the VolleyVeilig Youth program by Dutch volleyball clubs within the context of an effectiveness trial. METHODS: We applied the UK Medical Research Council framework for process evaluations and assessed the context, implementation and mechanisms of impact. Trainers participating in the effectiveness trial were asked to complete a questionnaire at the end of the study. A subsample of the trainers based on the self-reported adherence score was invited to participate in an interview accordingly. We used a thematic analysis to present the data. RESULTS: Thirty-one trainers (100%) completed the questionnaire, and seven agreed to participate in an interview. Although adherence gradually decreased over the volleyball season, most trainers reported partially adhere with the program until the end of the study. The main themes included factors associated with the (1) VolleyVeilig Youth program, (2) trainer, (3) players, and (4) volleyball club. CONCLUSION: Although (partial) adherence to the VolleyVeilig Youth program was high in this study, implementation strategies must be developed to target the barriers reported by the trainers before the program can be successfully implemented nationwide in the Netherlands.

A qualitative evaluation of a co-design process involving young people at risk of suicide.

BACKGROUND: Co-design is becoming common practice in the development of mental health services, however, little is known about the experience of such practices, particularly when young people are involved. OBJECTIVE: The aim of this study was to conduct a process evaluation of the co-design which was undertaken for the development of an intervention for youth and adolescents at risk of suicide. This paper briefly outlines the co-design process undertaken during a COVID-19 lockdown and then focuses on a qualitative evaluation of the experience of taking part in a co-design process. SETTING AND PARTICIPANTS: The evaluation involved young consumers of a public youth mental health service, their carers/parents and service delivery staff who had taken part in the co-design process. METHOD: This study used follow-up semistructured interviews with the co-design participants to explore their experience of the co-design process. Inductive thematic analysis was used to draw out common themes from the qualitative data. RESULTS: It was found that despite the practical efforts of the project team to minimise known issues in co-design, challenges centred around perceptions regarding power imbalance, the need for extensive consultation and time constraints still arose. DISCUSSION: Despite these challenges, the study found that the co-design provided a human-centred, accessible and rewarding process for young people, parents and staff members, leaving them with the feeling that they had made a worthwhile contribution to the design of the new service, as well as contributing to changing practice in service design. CONCLUSION: With sensitivity and adaptation to usual practice, it is possible to include young people with suicidal ideation, their parents/carers and professional staff in a safe and effective co-design process. PATIENT AND PUBLIC CONTRIBUTION: The authors would like to thank and acknowledge the young people with a lived experience and their carers who participated in the co-design process and research evaluation component of this study. We also wish to thank the clinical staff, peer workers and family peer workers who participated in this research.

Facilitators and barriers to implementing a specialized care unit for persons with cognitive impairment in an acute geriatric hospital: a process evaluation.

BACKGROUND: Implementing dementia care interventions in an acute hospital poses multiple challenges. To understand factors influencing the implementation, in-depth knowledge about specific facilitators and barriers is necessary. The aim of this study was to identify facilitators and barriers to implementing an interprofessional, multicomponent intervention of a specialized unit for persons with cognitive impairment in an acute geriatric hospital. METHODS: We conducted a process evaluation as part of a participatory action research study. For data collection, semi-structured individual interviews with fifteen professionals involved in the implementation of the specialized unit. We further conducted two focus groups with twelve professionals working on other units of the geriatric hospital. We performed a qualitative content analysis following Kuckartz's content-structuring analysis scheme. RESULTS: We identified the following barriers to implementing the specialized unit: uncontrollable contextual changes (e.g., COVID-19 pandemic), staff turnover in key functions, high fluctuation in the nursing team, traditional work culture, entrenched structures, inflexible and efficiency-oriented processes, monoprofessional attitude, neglect of project-related communication, and fragmentation of interprofessional cooperation. An established culture of interprofessionalism, an interprofessionally composed project group, cooperation with a research partner, as well as the project groups' motivation and competence of managing change facilitated the implementation. CONCLUSIONS: The implementation faced numerous barriers that can be described using the key constructs of the i-PARIHS framework: context, recipients, innovation, and facilitation. Overcoming these barriers requires an organizational development approach, extended project duration and increased process orientation. Furthermore, strategically planned, precise and ongoing communication towards all persons involved seems crucial. Differences between the work cultures of the professions involved deserve particular attention with regard to project-related roles and processes.

Process evaluation of the Yéego! Program to increase healthy eating and gardening among American Indian elementary school children.

BACKGROUND: American Indian children are at increased risk for obesity and diabetes. School-based health promotion interventions are one approach to promoting healthy behaviors to reduce this risk, yet few studies have described their implementation and fidelity. We conducted a qualitative process evaluation of the Yéego! Healthy Eating and Gardening Program, a school-based intervention to promote healthy eating among Navajo elementary school children. The intervention included a yearlong integrated curriculum, as well as the construction and maintenance of a school-based garden. METHODS: Our process evaluation included fidelity checklists completed by program staff and qualitative interviews with program staff and classroom teachers after the intervention was implemented. We used content analysis to identify themes. RESULTS: We identified several themes related to evidence of delivery adherence, program satisfaction, and lessons learned about delivery. Intervention staff followed similar procedures to prepare for and deliver lessons, but timing, teaching styles, and school-level factors also impacted overall implementation fidelity. Teachers and students had positive perceptions of the program, especially lessons that were highly visual, experiential, and connected to Navajo culture and the surrounding community. Teachers and program staff identified ways to enhance the usability of the curriculum by narrowing the scope, relating content to student experiences, and aligning content with school curriculum standards. CONCLUSIONS: The program was implemented with moderately high fidelity across contexts. We identified areas where modifications could improve engagement, acceptability, efficacy, and sustainability of the program. Our results have implications for the evaluation and dissemination of school-based health interventions to promote healthy eating among children, especially in American Indian communities.

How the Plants for Joints multidisciplinary lifestyle intervention achieved its effects: a mixed methods process evaluation.

BACKGROUND: Plants for Joints (PFJ) is a multidisciplinary intervention centered around a whole-food plant-based diet, physical activity, and sleep and stress management. The PFJ intervention successfully improved disease activity and symptoms in people with rheumatoid arthritis (RA) or osteoarthritis (OA), respectively, and metabolic health. To investigate how these effects were achieved a mixed methods process evaluation was conducted to understand the context, implementation, and mechanism of impact of the PFJ intervention. Also, the relationship between degree of implementation and lifestyle changes was explored. METHODS: Quantitative and qualitative data were collected across the evaluation domains context (i.e. reach), implementation (i.e. recruitment and delivery), and mechanism of impact (i.e. responsiveness) of both the participants and coaches (incl. dietitians, sport coaches) according to the UK MRC guidelines for process evaluations. Data was collected from the participants via focus groups and questionnaires after the intervention, and interviews with coaches. Qualitative data were analyzed thematically, and quantitative data were assessed with descriptive statistics and linear regression analyses. Degree of implementation was quantified using a theory-driven implementation index score composed of different process evaluation constructs. RESULTS: Of the 155 participants who participated in the PFJ intervention, 106 (68%) took part in the questionnaire and 34 (22%) attended a focus group. Participants felt the intervention was complete, coherent, and would recommend the intervention to others (mean score 9.2 (SD 1.4) out of 10). Participants felt heard and empowered to take control of their lifestyle and health outcomes. Components perceived as most useful were self-monitoring, social support, practical and theoretical information, and (individual) guidance by the multidisciplinary team. Participants perceived the intervention as feasible, and many indicated it effectively improved their health outcomes. In an explorative analysis there was no significant difference in healthy lifestyle changes across implementation index score groups. CONCLUSION: This process evaluation offers important insights into why the PFJ intervention works and how the intervention can be optimized for future implementation. Results indicating the intervention's high satisfaction, feasibility, and perceived effectiveness, further support the use of plant-based lifestyle interventions as an additional treatment option for patients with RA, OA, or other chronic diseases. TRIAL REGISTRATION: International Clinical Trial Registry Platform numbers: NL7800, NL7801, and NL7802, all registered 17-06-2019.

Process evaluation of implementation of the early stages of a whole systems approach to obesity in a small Island.

BACKGROUND: The small Atlantic island of St Helena is a United Kingdom Overseas Territory (UKOT) with a high prevalence of childhood obesity (over a quarter of 4-5 and 10-11 year olds) and, anecdotally, adulthood obesity and its associated health detriments. St Helena have taken a whole systems approach to obesity (WSAO) to address the issue. A WSAO recognises the factors that impact obesity as a complex system and requires a 'health in all policies' approach. UK academic and public health technical support was provided to the local St Helena delivery team. This process evaluation sought to explore the early stages of the WSAO implementation and implications for the transferability of the approach to other small island developing states and UKOT. METHODS: Data was collected via eight semi-structured interviews, paper based and online surveys, and document analysis. Thematic analysis was used to analyse the data. RESULTS: The analysis identified three factors which aided the first phase of WSAO implementation: (1) senior leaders support for the approach; (2) the academic support provided to establish and develop the approach; and (3) effective adaptation of UK Government resources to suit the local context. Key challenges of early implementation included: maintaining and broadening stakeholder engagement; limited local workforce capacity and baseline knowledge related to obesity and systems thinking; and limited capacity for support from the UK-based academic team due to contract terms and COVID-19 restrictions. CONCLUSIONS: Early stages of implementation of a WSAO in a UKOT can be successful when using UK's resources as a guide and adapting them to a small island context. All participants recommended other small islands adopt this approach. Continued senior support, dedicated leadership, and comprehensive community engagement is needed to progress implementation and provide the foundation for long-term impact. Small island developing states considering adopting a WSAO should consider political will, senior level buy-in and support, funding, and local workforce knowledge and capacity to enable the best chances of successful and sustainable implementation.

Process evaluation of school-based high-intensity interval training interventions for children and adolescents: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Several systematic reviews have been published to investigate the effectiveness of high-intensity interval training (HIIT) in schools. However, there has been limited attention given to understanding the functioning of the intervention processes, which is of paramount importance for interpreting and translating the intervention effectiveness. The aim of this systematic review is to determine the extent to which process evaluation is measured in school-based HIIT interventions and to explore the effects of process evaluation and intervention characteristics on cardiorespiratory fitness (CRF), body composition, muscular strength, and blood pressure. METHODS: A comprehensive search was conducted in SPORT Discus (EBSCOhost), Web of Science, Scopus, Medline (Ovid) and Cochrane Central Register of Controlled Trials. The extent to which process evaluation is measured was narratively reported, alongside with the guidance of process evaluation of complex interventions by UK Medical Research Council. Meta-analyses and meta-regressions were conducted to determine the effects of process evaluation and intervention characteristics to the intervention outcomes. RESULTS: The literature search identified 77 studies reporting on 45 school-based HIIT interventions. In total, five interventions reported process evaluation in a section or in a separate study, and only one intervention adopted a process evaluation framework. On average, 6 out of 12 process evaluation measures were reported in all interventions. Subgroup analyses did not indicate any beneficial treatment effects for studies with process evaluation group, whereas all pooled data and studies without process evaluation group showed significant improvement for CRF and body composition. CONCLUSION: Process evaluation is frequently omitted in the literature of school-based HIIT in children and adolescents. Although reporting of process evaluation measures may not directly associate with better intervention outcomes, it allows accurate interpretation of intervention outcomes, thereby enhancing the generalisability and dissemination of the interventions.

Process evaluation of the 'Lafiyan Yara' project on enhancing access to HIV testing services using existing community structures in Nigeria.

BACKGROUND: The Lafiyan Yara Project aimed to increase demand for HIV counselling, testing, treatment, and prevention services among pregnant women and children in Taraba State, Nigeria. Implemented from 2019 to 2021, the project utilized existing community structures, including traditional birth attendants, village health workers, and patent and proprietary medicine vendors, for mobilization. This study assessed the project's activities, contributors, relevance, effectiveness, and efficiency. METHODS: The process evaluation was conducted using focus group discussions and key informant interviews with beneficiaries, community leaders, project staff, health facility personnel, and government officials. Data analysis employed framework analysis. RESULTS: The Lafiyan Yara project was reported to have achieved notable successes, including increased HIV testing rates among children and pregnant women, improved linkage to care services, reduced mother-to-child transmission of HIV, increased HIV/AIDS awareness and knowledge, and enhanced community engagement and support. Challenges identified included insufficient funding for community mobilizers, training needs for health workers, and inadequate availability of test kits at health facilities. Confidentiality and stigma issues arose during community mobilizations. A key lesson learned was the importance of a comprehensive HIV care approach, emphasizing testing and ensuring support for individuals testing positive. CONCLUSIONS: The project's approach of leveraging community structures to create demand for HIV services among women and children proved effective, provided proper linkage to care for those testing positive. Addressing stigma and involving husbands/fathers in the community approach are crucial for improving outcomes. TRIAL REGISTRATION: IPHOAU/12/1384.

Process evaluation of a parent-child communication intervention for adolescent sexual and reproductive health in Uganda.

BACKGROUND: Previous initiatives concerning adolescent sexual and reproductive health (SRH) education in Low-or-Middle Income Countries (LMICs) have been limited by cultural norms and misinformation perpetuated within families. Responding to the paucity of research on the implementation of SRH interventions in LMICs and limited knowledge regarding their mechanisms, this study undertakes a process evaluation of a parent-focused intervention to promote parent-adolescent communication about SRH in Uganda. METHODS: This paper explores the implementation, contextual factors and mechanisms of impact of the intervention, using the Medical Research Council (MRC) guidelines for process evaluations. Implementation was evaluated through indicators of dose, fidelity and adaptations, acceptability and feasibility. The contextual factors and mechanisms of impact were evaluated to refine the intervention's causal assumptions. Data was collected during April - October 2021 in South-Western Uganda using a mixed-methods approach, including document analysis, intervention observations, interviews, focus group discussions and most significant change stories. RESULTS: The acceptability of the intervention was related to its community engagement, the strong rapport with delivery agents, and individual characteristics of participants. Five contextual factors influencing implementation were highlighted; (i) cultural norms, (ii) perceptions about youth SRH, (iii) poverty, (iv) Covid-19 pandemic, and (v) prior research projects in the community. When considering the intervention's mechanisms of impact, four causal pathways were identified; (i) Awareness of SRH needs helped parents overcome stigma, (ii) Parenting skills training improved SRH communication, (iii) Group learning stimulated shared parenting, and (iv) Group learning improved co-parenting. CONCLUSION: The paper presented three key learnings and corresponding recommendations for future research. Firstly, implementation success was credited to meaningful community engagement which improved acceptability and uptake. Secondly, the complex influences of contextual factors highlighted the need for contextual analysis in research studies to inform intervention design. Finally, this evaluation recognised the interplay between mechanisms of impact and suggested further research consider such combined impacts when designing intervention content.

Impact and process evaluation of a primary-school Food Education and Sustainability Training (FEAST) program in 10-12-year-old children in Australia: pragmatic cluster non-randomized controlled trial.

BACKGROUND: Environmentally sustainable food initiatives accompanying nutrition education, such as the Food Education and Sustainability Training (FEAST) program, have gained traction in school settings. The aim of this trial was to conduct an impact and process evaluation of FEAST, to evaluate its effect on children's fruit and vegetable (F&V) intakes, and secondary outcomes: F&V variety consumed, nutrition knowledge, food preparation/cooking skills, self-efficacy and behaviours, food waste knowledge and behaviours, and food production knowledge. METHODS: FEAST was a 10-week curriculum-aligned program, designed to educate children about healthy eating, food waste, and sustainability, while teaching cooking skills. It was implemented by classroom teachers, face-to-face and online, during COVID-19 school closures, in Australia in 2021. A custom designed survey was used to collect baseline and post-intervention data from students. Generalised linear mixed models (GLMM) estimated group differences in pre-post changes for primary and secondary outcomes. Surveys were also administered to students and teachers to evaluate intervention implementation. RESULTS: Twenty schools participated and self-selected to be either intervention schools (n = 10) or wait-list control (WLC) schools (n = 10). A total of 977, 5th and 6th grade children participated in the trial with a mean age of 11.1 years (SD ± 0.7). The FEAST intervention, compared to WLC, did not result in significant increases in primary outcomes nor secondary outcomes. The process evaluation revealed FEAST was well-received by students and teachers, but COVID-19 school closures hindered implementation fidelity with a less intense program delivered under the constraints of pandemic lockdowns. CONCLUSIONS: This is the first cluster non-randomized controlled trial designed to independently evaluate FEAST in the primary-school setting. No evidence was found for improved F&V intakes in children, nor secondary outcomes. However, the positive process evaluation results suggest that further trials of the program are warranted. If implemented as originally designed (pre-pandemic), with increased duration and complemented by supporting school policies, such programs have the potential to improve children's daily F&V intakes, cooking skills and food waste behaviours. This would support the Australian curriculum and contribute to: health promotion within schools and sustainable schools initiatives, the national agenda to reduce food waste and sustainable development goals. AUSTRALIAN AND NEW ZEALAND CLINICAL TRIALS REGISTRY: [ACTRN12620001347954]- Registered prospectively on 14/12/2020.