Effectiveness of the Walking in ScHools (WISH) Study, a peer-led walking intervention for adolescent girls: results of a cluster randomised controlled trial.

BACKGROUND: Most adolescent girls fail to meet current physical activity guidelines. Physical activity behaviours track from childhood into adulthood and providing adolescent girls with opportunities to be physically active may have health benefits beyond childhood. The effects of walking interventions on adult cardiometabolic health are known, however less is understood about the potential of walking to promote physical activity in adolescents. Following the Walking In ScHools (WISH) feasibility study, this definitive trial aimed to evaluate the effectiveness of a novel, low-cost, school-based walking intervention at increasing physical activity levels of adolescent girls (aged 12-14 years). METHODS: Female pupils were recruited from eighteen schools across the border region of Ireland and in Northern Ireland. In intervention schools (n = 9), girls aged 15-18 years, were trained as walk leaders, and led the younger pupils in 10-15 min walks before school, at break and lunch recess. All walks took place in school grounds and pupils were encouraged to participate in as many walks as possible each week. The primary outcome measure was accelerometer determined total physical activity (counts per minutes, cpm). RESULTS: In total, 589 pupils were recruited to the study. At baseline, pupils engaged in a median (interquartile range (IQR)) 35.7 (21.2) mins moderate-vigorous physical activity (MVPA) per day and only 12% (n = 66) of participants met physical activity guidelines (60 min MVPA per day). The intervention was delivered for a mean (standard deviation (SD)) 19.9 ± 0.97 weeks. The mean post-intervention total physical activity for the intervention group was 676 cpm and 710 cpm in the control group. Post-intervention total physical activity did not statistically differ between groups when adjusted for age, body mass index z-scores and baseline physical activity (mean difference, -33.5, 95% CI = -21.2 to 88.1; p = 0.213). CONCLUSIONS: 'Scaling-up' physical activity interventions is challenging and despite a promising feasibility study, the results of this fully powered trial suggest that in this context, the WISH intervention did not increase device measured physical activity. Since the COVID-19 pandemic, school environments have changed and although pupils enjoyed the programme, attendance at walks was low, indicating that there is a need to better understand how to implement interventions within schools. TRIAL REGISTRATION: ISRCTN; ISRCTN12847782; Registered 2nd July 2019.

A peer-led walking intervention for adolescent girls (the WISH study): a cluster-randomised controlled trial.

BACKGROUND: Adolescent girls in the UK and Ireland fail to meet physical activity (PA) guidelines. PA behaviours track from childhood into adulthood. The effects of walking interventions on adult health are known; however, the potential of walking to promote PA in adolescents is less known. This study evaluated the effectiveness of a novel, school-based walking intervention aimed at increasing PA levels of adolescent girls. METHODS: In this cluster-randomised controlled trial, female pupils aged 12-14 years were recruited from 18 (mixed or single-sex) schools across the border region of Ireland and Northern Ireland. Schools were randomly assigned to either the control group (usual physical activity; n=9) or the intervention group (n=9) by independent faculty staff using an online randomisation tool (randomization.com). In intervention schools, female pupils aged 15-18 years were trained as walk leaders and led the younger pupils in 10-15 min walks before school, at break, and at lunchtime. Walks were in school grounds and pupils were encouraged to join as many walks as possible. The intervention was delivered for a full school year excluding holidays (for a total of 18-21 weeks). Accelerometers measured PA, and the primary outcome was total PA (counts per minute [cpm]). Ethics approval was granted by Ulster University Research Ethics Committee and written informed consent (parent or guardian) and assent (pupils) was obtained. This study is registered with the ISRCTN Registry, 12847782. FINDINGS: The study took place from Sept 1, 2021, to May 31, 2023. In total, 589 pupils were recruited (n=286 in intervention group; n=303 in control group). Median moderate-vigorous PA (MVPA) at baseline was 36·1 min/day (IQR 23·0) for the intervention group and 35·3 min/day (19·8) for the control group. Only 37 (15%) girls in the intervention group and 29 (10%) girls in the control group met PA guidelines (60 min/day of MVPA). The mean total PA after intervention was 676 cpm (SD 18·7) for the intervention group and 710 cpm (SD 17·7) for the control group. Post-intervention total PA did not differ between groups when adjusted for age, body-mass index, z-scores, and baseline PA (mean difference -33·5, 95% CI -21·2 to 88·1; p=0·213). INTERPRETATION: Scaling up PA interventions is challenging. Despite a promising feasibility study, the results of this fully powered trial indicate that in this context, the walking programme did not increase PA. Since the COVID-19 pandemic, school environments have changed, and although pupils enjoyed the programme, attendance at walks was low. There is a need to better understand the implementation of interventions such as this within schools. FUNDING: Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN).

'Including us, talking to us and creating a safe environment'-Youth patient and public involvement and the Walking In ScHools (WISH) Study: Lessons learned.

BACKGROUND: Young people have the right to be informed and consulted about decisions affecting their lives. Patient and public involvement (PPI) ensures that research is carried out 'with' or 'by' young people rather than 'to', 'about' or 'for' them. The aim of this paper is to outline how youth PPI can be embedded within a physical activity intervention, reflect on the impact of PPI and provide recommendations for future PPI in a similar context. METHODS: A Youth Advisory Group (YAG) was set up within the Walking In ScHools (WISH) Study to involve adolescent girls in the delivery, implementation and dissemination of a physical activity intervention targeted at adolescents. Schools invited pupils aged 12-14 years and 15-18 years to YAG meetings (n3, from 2019 to 2023). Participative methods were used to inform recruitment strategies and data collection methods for the WISH Study. RESULTS: Across the three YAG meetings, n51 pupils from n8 schools were involved. Pupils enjoyed the YAG meetings, felt that their feedback was valued and considered the meetings a good way to get young people involved in research. The YAG advised on specific issues and although measuring impact was not the primary aim of the YAG meetings, over the course of the study there were many examples of the impact of PPI. Recruitment targets for the WISH Study were exceeded, the attrition rate was low and pupils were engaged in data collection. CONCLUSION: Youth PPI is a developing field and there are few physical activity studies that report the PPI work undertaken. Within the WISH Study, three YAG meetings were held successfully, and the views of adolescent girls were central to the development of the study. Considering the specific issues that the YAG advised on (study recruitment, attrition and data collection), there was evidence of a positive impact of PPI. PATIENT OR PUBLIC CONTRIBUTION: Pupils from post-primary schools interested/participating in the WISH Study were invited to attend YAG meetings. YAG meetings were set up to consult adolescent girls on the delivery, implementation and dissemination of the WISH intervention.

A 2-Year Randomized Controlled Trial With Low-Dose B-Vitamin Supplementation Shows Benefits on Bone Mineral Density in Adults With Lower B12 Status.

Folate, vitamins B12, B6, and riboflavin are required for one-carbon metabolism and may affect bone health, but no previous randomized trial has investigated all four nutrients in this context. We investigated the effect of low-dose B-vitamins for 2 years on bone mineral density (BMD) in a dual-centered, 2-year randomized controlled trial (RCT) in adults aged ≥50 years. Eligible participants not consuming B-vitamin supplements or fortified foods >4 times weekly were randomized to receive daily either combined folic acid (200 µg), vitamin B12 (10 µg), vitamin B6 (10 mg), and riboflavin (5 mg), or "active" placebo, whereby both the intervention and placebo groups received vitamin D (10 µg). BMD was assessed before and after intervention using dual-energy X-ray absorptiometry (DXA) scanning of the total hip, femoral neck, and lumbar spine (L1 to L4). Of 205 eligible participants randomized, 167 completed the trial in full. B-vitamin intervention resulted in increases in serum folate (p < 0.001), serum B12 (p < 0.001), and plasma pyridoxal-5-phosphate (p < 0.001) and decreases in functional biomarkers of B-vitamin status, erythrocyte glutathione reductase activation coefficient (p < 0.001), serum methylmalonic acid (MMA; p < 0.001), and serum total homocysteine (p < 0.001). B-vitamin intervention had no overall effect on BMD, which declined in both treatment groups by approximately 1% (ranging from -0.7% to -1.4%). However, in participants with lower baseline B12 status (serum B12 <246 pmol/L or MMA ≥0.22 µmol/L), B-vitamin intervention reduced the 2-year BMD decline versus placebo: adjusted mean (95% confidence interval [CI]) change of -0.003 (-0.008, 0.002) versus -0.015 (-0.021, -0.010) g/cm2 at the total hip and -0.004 (-0.010, 0.001) versus -0.013 (-0.018, -0.007) g/cm2 at the femoral neck. In conclusion, the findings indicate that although low-dose B-vitamin intervention for 2 years had no overall effect on BMD, improving B-vitamin status appears to have specific benefits for bone health in adults with lower B12 status. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Effectiveness of a fortified drink in improving B vitamin biomarkers in older adults: a controlled intervention trial.

BACKGROUND: Older adults are reported to have sub-optimal B vitamin status; targeted food-based solutions may help to address this. The objectives of the OptiAge food intervention study were to develop and investigate the effectiveness of a B vitamin-fortified drink in improving B vitamin biomarkers in older Irish adults with a primary outcome of change in the B vitamin biomarker status. METHODS: A double-blinded randomised controlled trial was performed in parallel at University College Dublin and Ulster University. Participants aged > 50 years were recruited following screening for exclusion criteria (i.e. taking medications known to interfere with B vitamin metabolism, supplements containing B vitamins, consuming > 4 portions of B vitamin-fortified foods per week or diagnosed with gastrointestinal, liver or pulmonary disease). Recruited participants meeting the inclusion criteria were randomised (by sex and study centre) to receive daily for 16 weeks either B vitamin-fortified or placebo drinks as developed by Smartfish, Norway. Each B vitamin-fortified drink (200 ml) contained 200 µg folic acid, 10 µg vitamin B12, 10 mg vitamin B6 and 5 mg riboflavin, while the placebo was an identical, isocaloric formulation without added B vitamins. Fasting blood samples were collected pre- and post-intervention which were used to measure the primary outcome of change in B vitamin biomarker levels. RESULTS: A total of 95 participants were randomised, of which 81 commenced the trial. Of these, 70 completed (37 in the active and 33 in the placebo groups). Intention to treat (ITT) analysis of the B vitamins demonstrated a significant improvement in all B vitamin biomarkers in the active compared to placebo groups: p < 0.01 for each of serum folate, serum vitamin B12 and plasma pyridoxal 5'-phosphate (vitamin B6) and the functional riboflavin biomarker, erythrocyte glutathione reductase activation coefficient (EGRac). Correspondingly, a significant lowering of serum homocysteine from 11.9 (10.3-15.1) µmol/L to 10.6 (9.4-13.0) µmol/L was observed in response to the active treatment (P < 0.001). Similar results were seen in a per-protocol analysis. CONCLUSIONS: The results demonstrate that a B vitamin-fortified drink was effective in optimising B vitamin status, making this a useful intervention option to improve B vitamin status in older adults. Trial registration ISRCTN, ISRCTN61709781-Retrospectively registered, https://www.isrctn.com/ISRCTN61709781.

Inadequate Communication Exacerbates the Support Needs of Current and Bereaved Caregivers in Advanced Heart Failure and Impedes Shared Decision-making.

BACKGROUND: Clinicians face considerable challenges in identifying patients with advanced heart failure who experience significant symptom burden at the end of life. Often, these patients are cared for in the community by a loved one who has limited access to support from specialist services, including palliative care. AIM: The aims of this study were to explore caregivers' experience when caring for a loved one with advanced heart failure at the end of life and to identify any unmet psychosocial needs. METHODS: This article reports findings of a qualitative study, using semistructured, one-to-one interviews with current and bereaved caregivers, who participated in a larger mixed-methods study. Interviews were conducted by a trained researcher, digitally recorded, transcribed verbatim, and imported to NVivo 11 for data management and coding. Data were analyzed using thematic analysis and an inductive approach. RESULTS: The 30 interviews included 20 current caregivers and 10 bereaved caregivers. The central feature of the caregivers' experience was identified as being "a physical and emotional rollercoaster." There were 3 main themes identified: poor communication, living with uncertainty, and lack of service provision. These themes were supported by 6 subthemes: inadequate understanding of palliative care, a 24/7 physical burden, emotional burden, inability to plan, no care continuity, and dying lonely and unsupported. CONCLUSIONS: Caregivers in advanced heart failure need clearer communication regarding diagnosis and prognosis of their loved one's condition to help with the uncertainty of their situation. Improved identification of palliative care needs and more coordinated service provision are urgently required to address their physical and emotional challenges from diagnosis through bereavement.

Inflammatory response following in vitro exposure to methylmercury with and without n-3 long chain polyunsaturated fatty acids in peripheral blood mononuclear cells from systemic lupus erythematosus patients compared to healthy controls.

Methylmercury (MeHg) is a proposed environmental stimulus in systemic lupus erythematosus (SLE). Humans are primarily exposed to MeHg through fish consumption. Fish are also important sources of n-3 long chain polyunsaturated fatty acids (n-3 LCPUFA). This in vitro study investigated the inflammatory response of isolated peripheral blood mononuclear cells (PBMCs), when exposed to either MeHg alone or with added n-3 LCPUFA, from SLE patients (N = 12) compared to healthy sex matched controls (N = 12). The PBMCs were isolated and exposed to 200 nM of MeHg for 24 h with or without pre-exposure to eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) at a concentration of 100 µM each. Supernatants were analyzed for the inflammatory markers. Following exposure to MeHg, mean TNF-α concentrations were significantly higher in SLE patients (2226.01 ±â€¯348.98pg/ml) compared to controls (701.40 ±â€¯680.65 pg/ml) (P = .008). Pre-exposure of cells with MeHg and EPA resulted in a significantly higher concentration of IL-8 in supernatants from SLE patients (2137.83 ±â€¯1559.01 pg/ml) compared to that of the controls (879.26 ±â€¯979.49 pg/ml) (P = .030). EPA and DHA attenuated the pro-inflammatory inducing effects of MeHg in SLE and control cells. In summary, exposure to MeHg stimulated a higher TNF-α response in SLE patients compared with healthy controls; nevertheless the presence of n-3 LCPUFA reduced the overall inflammatory response, albeit to a lesser degree in SLE patients.

'The importance of planning for the future': Burden and unmet needs of caregivers' in advanced heart failure: A mixed methods study.

BACKGROUND: While studies have evaluated caregiver outcomes in heart failure, the burden and support needs when caring for someone with advanced heart failure at the end of life have yet to be outlined. AIM: To identify psychosocial factors associated with caregiver burden and evaluate the support needs of caregivers in advanced heart failure. DESIGN: A sequential mixed methods study comprising two phases: (1) postal survey with advanced heart failure patients and their caregivers and (2) interviews with current and bereaved caregivers. Correlation, chi-square, t test, regression and thematic analysis were undertaken on the data. PARTICIPANTS: Advanced heart failure patients ( n = 112) and their caregivers ( n = 84) were recruited from secondary care settings across the United Kingdom and Ireland. For phase 2 interviews, current caregivers ( n = 20) were purposively recruited from phase 1, and bereaved caregivers ( n = 10) were purposively recruited via voluntary organisation, social media and email. RESULTS: More than half the caregivers (53%) had levels of distress associated with depression (Zarit Burden score >24). Caregiver depression score, preparedness for caregiving and patients' depression score predicted caregiver burden. Qualitative analysis identified an overarching theme of lack of future care planning and four subthemes: (1) seeking emotional support from someone who understands, (2) want information on prognostication, (3) lack of knowledge on how to and where to get support and (4) require knowledge on what to expect at the end of life. CONCLUSION: Caregivers have unmet needs and feel unprepared for the future. Implementation of future care planning by clinical teams should address patient and caregiver support needs and in turn alleviate caregiver burden.

Carers' needs in advanced heart failure: A systematic narrative review.

BACKGROUND: Informal caregivers play a pivotal role in the care of people living with advanced heart failure, however, carers' needs have not been clearly identified. AIM: The aim of this study is to explore the evidence on palliative care needs expressed by carers of people with heart failure. METHODS: Five electronic databases (CINAHL PLUS, EMBASE, Medline, PsychInfo and SCOPUS) were systematically searched and articles published January 2003-June 2014 with a qualitative methodology focusing on the palliative care needs of carers of people living with heart failure were included. RESULTS: Data was systematically extracted from 15 articles using an inductive methodology for the thematic analysis. Ten broad categories emerged from which three key areas of support needs were identified; psychosocial support to maintain a sense of normalcy; support with daily living; support navigating the healthcare system. The articles were predominantly published in the UK and USA with a total sample size across all articles of 270, the majority of which were older female spouses. Results included a combination of carers, patients and professionals thoughts, however data was extracted for carers only. CONCLUSIONS: Carer's needs initiate when the patient is diagnosed and continue throughout the disease into bereavement. These needs are continuously prioritised and reprioritised depending on the patients' medical stability. A holistic approach is needed to support these carers, incorporating heart failure and palliative care specialties. Further research is warranted to explore different methods of delivering support and information and to evaluate whether these reduce carer burden.