Sophie Reale

Background: The National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how future implementation of NICE recommendations within the NHS was explored during complex intervention development to enable evaluation of a lifestyle intervention. Methods: Two stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored barriers and facilitators for embedding SLI into the context of the NHS, with delivery partner Nuffield Health, in the future. Results: Workshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI including patients (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of the SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner. Conclusions: Application of NPT within two stakeholder workshops enhanced complex intervention development. Context-specific strategies to support implementation of SLI within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT. Trial registration: (ISRCTN: 46385239). Registered on July 30, 2020.

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.

Background The National Institute for Health and Care Excellence (NICE) recommend that men with prostate cancer on androgen deprivation therapy (ADT) are offered twice weekly supervised aerobic and resistance exercise to address side effects of treatment. However, supervised exercise is not routinely offered in standard clinical practice. The STAMINA programme grant for applied research (PGfAR) has been designed to evaluate whether this recommendation can be delivered within standard NHS care. This paper describes how implementation of NICE recommendations within a trial context was explored during complex intervention development to enable evaluation of a lifestyle intervention. Methods Two stakeholder workshops were conducted to explore factors pertinent to future implementation of the STAMINA Lifestyle intervention (SLI). Normalisation Process Theory (NPT) provided the theoretical framework for discussion and analysis. Stakeholder workshop 1 focussed on intervention coherence and buy-in. Stakeholder workshop 2 explored strategies for embedding SLI into the context of the NHS with delivery partner Nuffield Health. Results Workshops were attended by healthcare professionals (n = 16), exercise professionals (n = 17), members of public involved in PPI (n = 12), health psychologists (n = 2), clinical commissioners (n = 4), cancer charities (n = 3), a cancer alliance (n = 1) and health economist (n = 1). Stakeholders agreed that professional training packages should emphasise the uniqueness of SLI and underpinning theory and evidence (Coherence). To further engagement, the use of STAMINA champions and information about the delivery partner were recommended to enhance confidence and knowledge (Cognitive participation). Furthermore, a simple communication (Collective Action) and progress reporting system (Reflexive Monitoring) was suggested to fit into existing infrastructure within the NHS and community partner. Conclusions Application of NPT within two stakeholder workshops optimised complex intervention development. Context-specific strategies to support implementation of the STAMINA Lifestyle Intervention within the context of a trial were proposed, sensed-checked, and considered acceptable. The organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out were considered (if proven to be effective) and will be explored in the qualitative component of a process evaluation underpinned by NPT. Trial registration (ISRCTN: 46385239).

Study aimed to evaluate the impact of integrating family planning with maternal, newborn, and child health (FP-MNCH) on uptake of modern contraceptive methods and related health outcomes in two districts of the province of Sindh, Pakistan. Impact of intervention was evaluated using a quasi-experimental control before-after study design. Intervention included capacity building of healthcare providers and outreach workers, ensuring sustained supplies of family planning commodities, data-driven decision-making, and community engagement activities. Data was collected through household surveys at baseline (December2020) and endline (December 2022). The sample size was estimated as 880 married women of reproductive age (MWRA) in each district. The Difference and Difference(DiD) analytical method was used to estimate the impact of intervention adjusted for potential confounding factors. There was statistically significant increase of 11.3% in the current use of MCM in the intervention group compared to the control group (p value <0.001), with increases observed in the uptake of injection , implants, and condoms. Additionally, there was an increase in the proportion of women who had ANC visits (DiD 10.5% p value 0.003), FP counselling during ANC (DiD 15.6% p value < 0.001), LHW visits during pregnancy (DiD 15.1% p value 0.021), PNC check-ups for mother (DiD 25.2% p value <0.001), LHW visits after delivery (DiD 20.4% p value <0.001), and LHW advised for family planning at PNC visit n (DiD 14.5% p value 0.030). This study provides strong evidence for the scaling-up of integrated interventions through existing health care platforms utilizing human resources deployed by the government. This FP-MNCH model has the potential to be adopted in other provinces and at federally administered areas for both health and population planning. This model should be considered for replication in other districts of Sindh to accelerate current level of integration already existing.

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

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 RR2-10.2196/35291

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

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. CLINICALTRIAL ClinicalTrials.gov NCT05045599; https://clinicaltrials.gov/ct2/show/NCT05045599 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/35291

Summary: 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.

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.