Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation.

BACKGROUND: UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention offers a system-level change to clinical care delivery addressing barriers to long-term behaviour change and implementation of new prostate cancer care pathways. This trial aims to establish whether STAMINA is clinically and cost-effective in improving cancer-specific quality of life and/or reducing fatigue compared to optimised usual care. The process evaluation aims to inform the interpretation of results and, if the intervention is shown to benefit patients, to inform the implementation of the intervention into the NHS. METHODS: Men with prostate cancer on androgen deprivation therapy (n = 697) will be identified from a minimum of 12 UK NHS trusts to participate in a multi-centre, two-arm, individually randomised controlled trial. Consenting men will have a 'safety to exercise' check and be randomly allocated (5:4) to the STAMINA lifestyle intervention (n = 384) or optimised usual care (n = 313). Outcomes will be collected at baseline, 3-, 6- and 12-month post-randomisation. The two primary outcomes are cancer-specific quality of life and fatigue. The parallel process evaluation will follow a mixed-methods approach to explore recruitment and aspects of the intervention including, reach, fidelity, acceptability, and implementation. An economic evaluation will estimate the cost-effectiveness of the STAMINA lifestyle intervention versus optimised usual care and a discrete choice experiment will explore patient preferences. DISCUSSION: The STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services. TRIAL REGISTRATION: ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

Effective strategies for increasing the uptake of modern methods of family planning in South Asia: a systematic review and meta-analysis.

BACKGROUND: Family planning (FP) interventions have improved the use of modern contraceptives, yet a high unmet need for contraception still exists in South Asia. This systematic review of existing research was conducted to identify effective FP interventions that led to an increase in the uptake of modern methods of contraception in South Asia. METHODS: Five electronic databases were searched for relevant studies published between January 1st, 2000 and May 4, 2023. Experimental studies that reported data on the impact of FP interventions on modern contraceptive use among women of reproductive age (15-49 years) in the South Asian region were included. A random-effects Inverse Variance weighted model was employed to pool the adjusted odds ratio (OR) on modern contraceptive use and unmet need for contraception. In addition, we computed subgroup meta-estimates based on intervention type and the urban-rural divide. RESULTS: Among 643 studies identified, 21 met the inclusion criteria. The overall pooled odds ratio for modern contraceptive use was significantly higher (OR 1.51; 95% CI 1.35-1.70; heterogeneity; I2 = 81%) for FP interventions with a significant reduction in unmet need for contraception (OR 0.86; 95% CI 0.78-0.94, I2 = 50%). The subgroup analysis revealed demand-generation (OR 1.61; 95% CI 1.32-1.96), health system integrated (OR 1.53; 95% CI 1.07-2.20), and franchised FP clinic interventions (OR 1.32; 95% CI 1.21-1.44) had promoted the modern contraceptive uptake. Further, FP interventions implemented in urban settings showed a higher increase in modern contraceptive use (OR 1.73; 95% CI 1.44-2.07) compared to rural settings (OR 1.46; 95% CI 1.28-1.66). Given the considerable heterogeneity observed across studies and the low degree of certainty indicated by the GRADE summary for the primary outcome, caution is advised when interpreting the results. CONCLUSION: The review collated experimentally evaluated FP interventions that increased modern contraception use and reduced the unmet need in South Asia. The demand generation interventions were the most effective in increasing the uptake of modern contraceptive methods. Furthermore, the urban environment provides a conducive environment for interventions to improve contraceptive usage. However, further studies should assess which aspects were most effective on attitudes towards contraception, selection of more effective methods, and contraceptive behaviors.

Community and Health Care Provider Perspectives on Barriers to and Enablers of Family Planning Use in Rural Sindh, Pakistan: Qualitative Exploratory Study.

BACKGROUND: Unmet need for family planning in Pakistan is high, with 17% of all married women wanting to avoid or delay pregnancy. However, they cannot owing to a lack of access to modern contraception and sociocultural hindrances. With the modern contraceptive prevalence rate stagnant at approximately 25% over the last 5 years, it is important to explore barriers and enablers to modern contraception uptake to reduce maternal and child mortality and improve reproductive health outcomes for young girls and women. OBJECTIVE: A formative research approach was taken to explore community member and health care provider perspectives on access to and use of family planning methods in 2 rural districts of Sindh, Pakistan. The broader goal of this study was to provide evidence to design and implement a socioculturally appropriate family planning intervention within the existing service delivery platforms to increase modern contraceptive uptake in the context of rural Sindh. METHODS: A qualitative exploratory design was used. Between October 2020 and December 2020, 11 focus group discussions and 11 in-depth interviews were conducted. Focus group discussions were held with men and women from the community, including adolescents, to build an understanding of community beliefs and concepts regarding modern contraceptive methods. In-depth interviews were conducted with health care workers and explored intersections between family planning and reproductive health service delivery at the facility and outreach levels. RESULTS: The findings revealed that limited financial autonomy, restricted women's mobility, discriminatory gender norms, and cultural practices left women with little opportunity for independent decision-making on the use of modern contraceptive methods. Furthermore, facility-level and supply-side barriers, including frequent stock-outs of modern contraceptives combined with a lack of capacity of health workers to provide quality family planning services and counseling, played an important role in demotivating women from seeking services. In addition, a lack of integration of family planning with maternal and child health service delivery at the health system level was emphasized as a major missed opportunity for contraceptive uptake. Several demand-side barriers to family planning uptake were also highlighted. These included husbands' or in-laws' disapproval, social stigma, and perceived fear of side effects regarding modern family planning method use. More importantly, a lack of adolescent-friendly reproductive health services and spaces for counseling was identified as a critical intervention area. CONCLUSIONS: This study provides qualitative evidence on issues related to the effectiveness of family planning interventions, specifically in the context of rural Sindh. The findings emphasize the need to design socioculturally appropriate and health system-relevant family planning interventions-the effectiveness of which can be improved through their integration with maternal and child health service delivery mechanisms, consistent service provision, and opportunities for the capacity building of the health care workforce. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/35291.

Effects of Integrating Family Planning With Maternal, Newborn, and Child Health Services on Uptake of Voluntary Modern Contraceptive Methods in Rural Pakistan: Protocol for a Quasi-experimental Study.

BACKGROUND: The uptake of modern contraceptive methods (MCMs) remains low, with 25% of women reporting their use in Pakistan. The overarching interventions covering service delivery platforms at facility and community levels necessitate the integration of family planning (FP) with maternal, newborn, and child health (MNCH) services. OBJECTIVE: The main aim of this study is to evaluate the impact of an integrated FP-MNCH service delivery model to increase coverage of MCMs in rural Pakistan. Moreover, we aim to measure the level of effectiveness of interventions regarding the uptake of MCMs. METHODS: A quasi-experimental, sequential, mixed methods study design with pre- and postevaluation will be adopted to evaluate the impact of integration of FP with MNCH services. The interventions include the following: (1) capacity strengthening of health care providers, including technical trainings; training in counseling of women who attend immunization centers, antenatal care (ANC) clinics, and postnatal care (PNC) clinics; and provision of job aids; (2) counseling of women and girls attending ANC, PNC, and pediatric clinics; (3) ensuring sustained provision of supplies and commodities; (4) community engagement, including establishing adolescent-friendly spaces; and (5) use of District Health Information System data in decision-making. Descriptive statistics will be used to estimate prevalence (ie, proportions) and frequencies of outcome indicators. A univariate difference-in-difference analytical approach will be used to estimate the effect of the interventions. In addition, a Blinder-Oaxaca decomposition analysis will be conducted to identify and quantify determinants of the modern contraceptive prevalence rate. RESULTS: The intervention phase began in July 2021 and will run until June 2022. The impact assessment will be conducted from July to September 2022. CONCLUSIONS: This project will evaluate the impact of integrating FP with MNCH services. Furthermore, this study will identify the drivers and barriers in uptake of MCMs and will simultaneously help in modifying the interventional strategies that can be scaled up through existing service delivery platforms within the public and private sectors, according to the local sociocultural and health system context. TRIAL REGISTRATION: ClinicalTrials.gov NCT05045599; https://clinicaltrials.gov/ct2/show/NCT05045599. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35291.

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial).

Lifestyle interventions involving exercise training offset the adverse effects of androgen deprivation therapy in men with prostate cancer. Yet provision of integrated exercise pathways in cancer care is sparse. This study assessed the feasibility and acceptability of an embedded supervised exercise training intervention into standard prostate cancer care in a single-arm, multicentre prospective cohort study. Feasibility included recruitment, retention, adherence, fidelity and safety. Acceptability of behaviourally informed healthcare and exercise professional training was assessed qualitatively. Despite the imposition of lockdown for the COVID-19 pandemic, referral rates into and adherence to, the intervention was high. Of the 45 men eligible for participation, 79% (n = 36) received the intervention and 47% (n = 21) completed the intervention before a government mandated national lockdown was enforced in the United Kingdom. Patients completed a mean of 27 min of aerobic exercise per session (SD = 3.48), at 77% heart rate maximum (92% of target dose), and 3 sets of 10 reps of 3 resistance exercises twice weekly for 12 weeks, without serious adverse event. The intervention was delivered by 26 healthcare professionals and 16 exercise trainers with moderate to high fidelity, and the intervention was deemed highly acceptable to patients. The impact of societal changes due to the pandemic on the delivery of this face-to-face intervention remain uncertain but positive impacts of embedding exercise provision into prostate cancer care warrant long-term investigation.

The development of a theory and evidence-based intervention to aid implementation of exercise into the prostate cancer care pathway with a focus on healthcare professional behaviour, the STAMINA trial.

BACKGROUND: Twice-weekly supervised aerobic and resistance exercise for 12 weeks reduces fatigue and improves quality of life in men on Androgen Deprivation Therapy for prostate cancer. Despite the National Institute for Health and Care Excellence (NICE) proposing this as standard of care, it does not routinely take place in practice. Healthcare professionals are in a prime position to deliver and integrate these recommendations. A change in the behaviour of clinical teams is therefore required. In this paper, we describe the development of a training package for healthcare professionals using theory and evidence to promote delivery of such recommendations as standard care. METHODS: The intervention development process was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. Target behaviours were identified from the literature and thirty-five prostate cancer care healthcare professionals (including oncologists, consultant urologists, clinical nurse specialists, physiotherapists, general practitioners and commissioners) were interviewed to understand influences on these behaviours. The Theoretical Domains Framework was used to identify theoretical constructs for change. Behaviour change techniques were selected based on theory and evidence and were translated into intervention content. The intervention was refined with the input of stakeholders including healthcare professionals, patients, and exercise professionals in the form of rehearsal deliveries, focus groups and a workshop. RESULTS: Seven modifiable healthcare professional target behaviours were identified to support the delivery of the NICE recommendations including identifying eligible patients suitable for exercise, recommending exercise, providing information, exercise referral, providing support and interpret and feedback on progress. Ten domains from the Theoretical Domain's Framework were identified as necessary for change, including improving knowledge and skills, addressing beliefs about consequences, and targeting social influences. These were targeted through twenty-two behaviour change techniques delivered in a half-day, interactive training package. Based on initial feedback from stakeholders, the intervention was refined in preparation for evaluation. CONCLUSIONS: We designed an intervention based on theory, evidence, and stakeholder feedback to promote and support the delivery of NICE recommendations. Future work will aim to test this training package in a multi-centre randomised trial. If proven effective, the development and training package will provide a template for replication in other clinical populations, where exercise has proven efficacy but is insufficiently implemented.

Towards implementing exercise into the prostate cancer care pathway: development of a theory and evidence-based intervention to train community-based exercise professionals to support change in patient exercise behaviour (The STAMINA trial).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommend that men on androgen deprivation therapy (ADT) for prostate cancer should receive supervised exercise to manage the side-effects of treatment. However, these recommendations are rarely implemented into practice. Community-based exercise professionals (CBEPs) represent an important target group to deliver the recommendations nationally, yet their standard training does not address the core competencies required to work with clinical populations, highlighting a need for further professional training. This paper describes the development of a training package to support CBEPs to deliver NICE recommendations. METHODS: Development of the intervention was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. In step one, target behaviours, together with their barriers and facilitators were identified from a literature review and focus groups with CBEPs (n = 22) and men on androgen deprivation therapy (n = 26). Focus group outputs were mapped onto the Theoretical Domains Framework (TDF) to identify theoretical constructs for change. In step two, behaviour change techniques and their mode of delivery were selected based on psychological theories and evidence to inform intervention content. In step three, the intervention was refined following delivery and subsequent feedback from intervention recipients and stakeholders. RESULTS: Six modifiable CBEPs target behaviours were identified to support the delivery of the NICE recommendations. Nine domains of the TDF were identified as key determinants of change, including: improving knowledge and skills and changing beliefs about consequences. To target the domains, we included 20 BCTs across 8 training modules and took a blended learning approach to accommodate different learning styles and preferences. Following test delivery to 11 CBEPs and feedback from 28 stakeholders, the training package was refined. CONCLUSION: Established intervention development approaches provided a structured and transparent guide to intervention development. A training package for CBEPs was developed and should increase trust amongst patients and health care professionals when implementing exercise into prostate cancer care. Furthermore, if proven effective, the development and approach taken may provide a blueprint for replication in other clinical populations where exercise has proven efficacy but is insufficiently implemented.

Grandparental dietary provision, feeding practices and feeding styles when caring for preschool-aged grandchildren: A systematic mixed methods review.

Grandparents are frequently relied upon to care for their preschool-aged grandchildren. These early years are a crucial age in the development of dietary habits and preferences. This review aims to determine grandparental dietary provision, feeding practices and feeding styles when caring for their preschool-aged grandchildren. Medline, PsycInfo and Web of Science were searched in January 2020. A systematic mixed methods approach was used to synthesize the qualitative (n = 13) and quantitative (n = 7) articles describing grandparents' feeding styles (n = 9), feeding practices (n = 14) and dietary provision (n = 18). Grandparents are serving large portion sizes and encouraging their grandchildren to eat frequently. Results are mixed for the types of foods provided; grandparents provide discretionary foods high in sugar and fat, and some also choose more expensive core foods as treats (e.g., berries). Grandparents engage in feeding practices that promote healthy eating (e.g., creating a healthy feeding environment) and promote autonomy and independence (e.g., considering their grandchild's preferences). However, they also use some coercive feeding practices (e.g., using food as a reward) and may be using indulgent feeding styles, which can be conducive to obesogenic dietary intakes. Interventions targeting grandparents could be an effective way to improve dietary-related health outcomes in young children.

Maternal Decisions on Portion Size and Portion Control Strategies for Snacks in Preschool Children.

Caregivers are responsible for the type and amount of food young children are served. However, it remains unclear what considerations caregivers make when serving snacks to children. The aim of the study was to explore mothers' decisions and portion control strategies during snack preparation in the home environment. Forty mothers of children aged 24-48 months participated in the study. Mothers prepared five snack foods for themselves and their child whilst verbalizing their actions and thoughts. Mothers were then asked about their portion size decisions in a semi-structured interview. Transcripts were imported into NVivo and analyzed thematically. Three key themes were identified: (1) portion size considerations, (2) portion control methods, and (3) awareness and use of portion size recommendations. Transient, food-related situational influences influenced mothers and disrupted planning and portion control. Food packaging and dishware size were used as visual cues for portion control; however, these vary widely in their size, thus emphasizing mothers' uncertainty regarding appropriate portion sizes. Mothers called for portion size information to be accessible, child-centered, and simple. These findings reveal multiple considerations when deciding on the correct snack portion sizes for children. These decisions are complex and vary across situations and time, and according to the types of snacks offered.

Snack Portion Sizes for Preschool Children Are Predicted by Caregiver Portion Size, Caregiver Feeding Practices and Children's Eating Traits.

Caregivers are mostly responsible for the foods young children consume; however, it is unknown how caregivers determine what portion sizes to serve. This study examined factors which predict smaller or larger than recommended snack portion sizes in an online survey. Caregivers of children aged 2 to 4 years were presented with 10 snack images, each photographed in six portion sizes. Caregivers (n = 659) selected the portion they would usually serve themselves and their child for an afternoon snack. Information on child eating traits, parental feeding practices and demographics were provided by caregivers. Most caregivers selected portions in line with recommended amounts for preschool children, demonstrating their ability to match portion sizes to their child's energy requirements. However, 16% of caregivers selected smaller than recommended low energy-dense (LED, e.g., fruits and vegetables) snacks for their child which was associated with smaller caregiver's own portion size, reduced child food liking and increased satiety responsiveness. In contrast, 28% of caregivers selected larger than recommended amounts of high energy-dense (HED, e.g., cookies, crisps) snacks for their child which were associated with larger caregiver's own portion size, greater frequency of consumption, higher child body mass index (BMI), greater pressure to eat and lower child food liking. These findings suggest that most caregivers in this study select portions adjusted to suit their child's age and stage of development. Future interventions could provide support to caregivers regarding the energy and nutrient density of foods given the relatively small portion sizes of LED and large portions of HED snacks offered to some children.

The Feasibility and Acceptability of Two Methods of Snack Portion Control in United Kingdom (UK) Preschool Children: Reduction and Replacement.

Large portions of high energy dense (HED) snacks are offered to children from a young age and are pervasive in our food environment. This study aimed to explore the feasibility, acceptability, and preliminary efficacy of two strategies of snack portion control: reduction and replacement. Forty-six mother-child dyads aged 22⁻56 months (36.6 ± 9.5 m, 48% female) completed a three-week intervention. In week 1 (baseline) no changes were made to the child's diet; week 2 (acclimation) children received a standardised selection of HED snacks, and in week 3 (intervention) participants were randomly assigned to snack replacement (n = 24) or snack reduction (n = 22). Snack replacement involved swapping HED snacks for fruits and vegetables, whilst snack reduction involved reducing the size of HED snacks by 50%. Food and energy intake were measured using a weighed food diary for four consecutive days. Snack replacement resulted in more positive changes to children's diets; vegetable intake increased (p < 0.01), and total daily energy intake decreased when compared to snack reduction (p < 0.05). Mothers expressed a more favourable attitude to snack replacement, although snack reduction was also well received by mothers. Despite increased preliminary efficacy of snack replacement on dietary intake, both strategies were feasible and acceptable. The current pilot study provides the necessary information to inform the design of future interventions.

Weight stigma in frequent exercisers: Overt, demeaning and condescending.

The aim of this study was to qualitatively examine weight stigma in individuals who exercise frequently. In total, six focus groups, comprising 30 participants aged 18-25 years, were conducted using convenience sampling. All participants were frequent exercisers. Five themes emerged in the data with participants discussing bullying, the consequences of obesity, causes of obesity, lack of willpower and interventions to reduce obesity. This study is the first qualitative examination of weight stigmatisation in frequent exercisers, where the beliefs reported by focus group participants suggest that frequent exercisers stigmatise, discriminate and dehumanise obese people. Future research to examine the impact of weight stigma on exercise motivation and behaviour of obese people appears warranted.

Menu labelling and food choice in obese adults: a feasibility study.

BACKGROUND: To date research examining the benefits of menu labelling in the UK is sparse. The aim of the present study was to examine the impact of menu labelling in a UK obese population. METHODS: Using a repeated measures design, 61 patients at a tier 3 weight management service completed four questionnaires to assess their food choice (control) and behaviour change when presented with 3 menu labelling formats (calorie content; nutrient content; and energy expenditure). RESULTS: All three forms of labelling increased participants weight control concerns compared to the control condition. There was a significant difference in content of food ordered in the three menu labelling formats compared to the control condition. The calorie condition had the largest percentage decrease in calories selected followed by energy expenditure and nutrient content. However, no difference was observed between the three conditions in the desire for menu labelling in restaurants to be introduced in the UK. CONCLUSIONS: The findings suggest that menu labelling should be enforced in the UK as it is both beneficial to promoting healthy eating and in demand. This study is the first to examine menu labelling in a UK obese population using energy expenditure equivalents to provide nutritional information.