Bisphosphonate alternative regimens for the prevention of osteoporotic fragility fractures: BLAST-OFF, a mixed-methods study.

Background: Bisphosphonates are a class of medication commonly used to treat osteoporosis. Alendronate is recommended as the first-line treatment; however, long-term adherence (both treatment compliance and persistence) is poor. Alternative bisphosphonates are available, which can be given intravenously and have been shown to improve long-term adherence. However, the most clinically effective and cost-effective alternative bisphosphonate regimen remains unclear. What is the most cost-effective bisphosphonate in clinical trials may not be the most cost-effective or acceptable to patients in everyday clinical practice. Objectives: 1. Explore patient, clinician and stakeholder views, experiences and preferences of alendronate compared to alternative bisphosphonates. 2. Update and refine the 2016 systematic review and cost-effectiveness analysis of bisphosphonates, and estimate the value of further research into their benefits. 3. Undertake stakeholder/consensus engagement to identify important research questions and further rank research priorities. Methods: The study was conducted in two stages, stages 1A and 1B in parallel, followed by stage 2: • Stage 1A - we elicited patient and healthcare experiences to understand their preferences of bisphosphonates for the treatment of osteoporosis. This was undertaken by performing a systematic review and framework synthesis of qualitative studies, followed by semistructured qualitative interviews with participants. • Stage 1B - we updated and expanded the existing Health Technology Assessment systematic review and clinical and cost-effectiveness model, incorporating a more comprehensive review of treatment efficacy, safety, side effects, compliance and long-term persistence. • Stage 2 - we identified and ranked further research questions that need to be answered about the effectiveness and acceptability of bisphosphonates. Results: Patients and healthcare professionals identified a number of challenges in adhering to bisphosphonate medication, balancing the potential for long-term risk reduction against the work involved in adhering to oral alendronate. Intravenous zoledronate treatment was generally more acceptable, with such regimens perceived to be more straightforward to engage in, although a portion of patients taking alendronate were satisfied with their current treatment. Intravenous zoledronate was found to be the most effective, with higher adherence rates compared to the other bisphosphonates, for reducing the risk of fragility fracture. However, oral bisphosphonates are more cost-effective than intravenous zoledronate due to the high cost of zoledronate administration in hospital. The importance of including patients and healthcare professionals when setting research priorities is recognised. Important areas for research were related to patient factors influencing treatment selection and effectiveness, how to optimise long-term care and the cost-effectiveness of delivering zoledronate in an alternative, non-hospital setting. Conclusions: Intravenous zoledronate treatment was generally more acceptable to patients and found to be the most effective bisphosphonate and with greater adherence; however, the cost-effectiveness relative to oral alendronate is limited by its higher zoledronate hospital administration costs. Future work: Further research is needed to support people to make decisions influencing treatment selection, effectiveness and optimal long-term care, together with the clinical and cost-effectiveness of intravenous zoledronate administered in a non-hospital (community) setting. Limitations: Lack of clarity and limitations in the many studies included in the systematic review may have under-interpreted some of the findings relating to effects of bisphosphonates. Trial registration: This trial is registered as ISRCTN10491361. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127550) and is published in full in Health Technology Assessment; Vol. 28, No. 21. See the NIHR Funding and Awards website for further award information.

Bisphosphonates are drug treatments commonly used to treat osteoporosis. Alendronate is the most used and is taken by mouth, weekly at a specific time of the week, which can be challenging. Less than one in four people continue this treatment beyond 2 years. Alternative bisphosphonates are available, which vary in frequency and how they are administered. The most acceptable and best value-for-money regimen is unclear. Our aim was to determine how effective alternative bisphosphonates are compared to alendronate at preventing fractures and whether reduction in fracture risk was achieved at a reasonable financial cost, but acceptable to patients. The study was conducted in two stages, stages 1A and 1B in parallel, followed by stage 2: Stage 1A: a review of the published evidence on patients' and doctors' views, experiences and preferences regarding different bisphosphonate treatment regimens, followed by interviews with patients and healthcare professionals. Stage 1B: an update of an existing study on how effective bisphosphonates are in preventing fragility fractures caused by osteoporosis and whether they are good value for money. Stage 2: identification of questions that need to be answered about the effectiveness and acceptability of bisphosphonate treatments. Taking bisphosphonate medication often involves quite a lot of effort by patients, particularly when taking alendronate tablets. A yearly infusion of zoledronate treatment was more acceptable, easier to engage with and the most effective treatment compared to alendronate. However, the cost of administering zoledronate in hospital made alendronate better value for money. Bisphosphonates are effective in reducing the risk of fracture, but 'continuing with treatment', particularly alendronate tablets, remains a challenge. A yearly infusion of zoledronate offers an acceptable and effective treatment, but further research is needed to support patients and healthcare professionals in making decisions about the various treatments, benefits and cost savings of administering zoledronate outside of hospital and in the community.

The effectiveness of cognitive behavioural therapy for depression in women with breast cancer: a systematic review and meta-analysis.

BACKGROUND: Depression is a common co-morbidity in women with breast cancer. Previous systematic reviews investigating cognitive behavioural therapy (CBT) for depression in this population based their conclusions on findings from studies with varying and often limited specificity, quality and/or quantity of CBT within their interventions. AIM: To determine the effectiveness of a specific, well-evidenced CBT protocol for depression in women with breast cancer. METHOD: Online databases were systematically searched to identify randomised controlled trials (RCTs) testing CBT (aligned to Beck's protocol) as a treatment for depression in women with breast cancer. Screening, data extraction and risk of bias assessment were independently undertaken by two study authors. Both narrative synthesis and meta-analysis were used to analyse the data. The meta-analysis used a random effects model to compare CBT with non-active/active controls of depression using validated, self-report measures. RESULTS: Six RCTs were included in the narrative synthesis, and five in the meta-analysis (n = 531 participants). Overall, CBT demonstrated an improvement in depression scores in the CBT condition versus active and non-active controls at post-intervention (SMD = -0.93 [95% CI -1.47, -0.40]). Narratively, five out of six RCTs reported statistically significant improvements in depression symptoms for CBT over control conditions for women with breast cancer. CONCLUSION: CBT aligned to Beck's protocol for depression appears effective for treating depression in women with breast cancer. However, further research is needed for women with stage IV breast cancer. The clinical recommendation is that therapists utilise Beck's CBT protocol for depression, whilst considering the complex presentation and adapt their practice accordingly.

Adequacy of thyroid hormone replacement for people with hypothyroidism in real-world settings: A systematic review and meta-analysis of observational studies.

OBJECTIVE: Thyroid hormone under-replacement and over-replacement are associated with adverse health outcomes. This systematic review aimed to evaluate the extent of thyroid hormone replacement adequacy for patients with known hypothyroidism in real-word settings, excluding those receiving thyroid hormone suppressive therapy as thyroid cancer treatment. DESIGN: Four electronic databases (Embase [Ovid], Medline [Ovid], PubMed and SCOPUS) were searched for published and unpublished observational studies until 12 December 2022. The results of the studies were meta-analysed to calculate pooled prevalence estimates for thyroid hormone supplementation adequacy, over-replacement and under-replacement. Quality assessment of studies was performed using the Joanna-Briggs appraisal tool for prevalence studies. RESULTS: Seven studies with a total of 4230 patients were eligible for quantitative synthesis. The pooled prevalence estimates of adequate thyroid replacement, over-replacement and under-replacement were 0.55 (95% confidence interval [CI]: 0.49-0.60, p = .001), 0.20 (95% CI: 0.14-0.27, p = .001) and 0.24 (95% CI: 0.13-0.36, p = .001), respectively. Four studies subclassified hypothyroidism and hyperthyroidism into overt and subclinical. The pooled prevalence of overt and subclinical hyperthyroidism was 0.04 (95% CI: 0.00-0.11, p = .01) and 0.17 (95% CI: 0.09-0.27 p = .001), respectively. For overt and subclinical hypothyroidism, the pooled prevalence was 0.02 (95% CI: 0.01-0.03, p = .001) and 0.20 (95% CI: 0.12-0.29, p = .001), respectively. CONCLUSIONS: On average, approximately half of patients with hypothyroidism are only treated to target euthyroidism. In real-world practice, a significant number of patients are over-treated or under-treated, leading to adverse healthcare outcomes. It is imperative that more effective thyroid monitoring strategies be implemented, with an emphasis on primary care thyroid function monitoring, to minimise inappropriate thyroid replacement treatments and optimise healthcare outcomes at a population level.

Clinicians' views of prescribing oral and intravenous bisphosphonates for osteoporosis: a qualitative study.

BACKGROUND: Bisphosphonate medications, including alendronate, ibandronate and risedronate administered orally and zoledronate, administered intravenously, are commonly prescribed for the treatment of osteoporosis based on evidence that, correctly taken, bisphosphonates can improve bone strength and lead to a reduction in the risk of fragility fractures. However, it is currently unclear how decisions to select between bisphosphonate regimens, including intravenous regimen, are made in practice and how clinicians support patients with different treatments. METHODS: This was an interpretivist qualitative study. 23 semi-structured telephone interviews were conducted with a sample of general practitioners (GPs), secondary care clinicians, specialist experts as well as those providing and leading novel treatments including participants from a community intravenous (IV) zoledronate service. Data analysis was undertaken through a process of iterative categorisation. RESULTS: The results report clinicians varying experiences of making treatment choices, as well as wider aspects of osteoporosis care. Secondary care and specialist clinicians conveyed some confidence in making treatment choices including on selecting IV treatment. This was aided by access to diagnostic testing and medication expertise. In contrast GPs reported a number of challenges in prescribing bisphosphonate medications for osteoporosis and uncertainty about treatment choice. Results also highlight how administering IV zoledronate was seen as an opportunity to engage in broader care practices. CONCLUSION: Approaches to making treatment decisions and supporting patients when prescribing bisphosphonates for osteoporosis vary in practice. This study points to the need to co-ordinate osteoporosis treatment and care across different care providers.

Research priorities regarding the use of bisphosphonates for osteoporosis: a UK priority setting exercise.

PURPOSE: Worldwide, many people who would benefit from osteoporosis drugs are not offered or receiving them, resulting in an osteoporosis care gap. Adherence with bisphosphonates is particularly low. This study aimed to identify stakeholder research priorities relating to bisphosphonate treatment regimens for prevention of osteoporotic fractures. METHODS: A three-step approach based on the James Lind Alliance methodology for identification and prioritisation of research questions was used. Research uncertainties were gathered from a large programme of related research studies about bisphosphonate regimens and from recent published international clinical guidelines. Clinical and public stakeholders refined the list of uncertainties into research questions. The third step prioritised the questions using a modified nominal group technique. RESULTS: In total, 34 draft uncertainties were finalised into 33 research questions by stakeholders. The top 10 includes questions relating to which people should be offered intravenous bisphosphonates first line (1); optimal duration of treatment (2); the role of bone turnover markers in treatment breaks (3); support patient need for medicine optimisation (4); support primary care practitioner need regarding bisphosphonates (5); comparing zoledronate given in community vs hospital settings (6); ensuring quality standards are met (7); the long-term model of care (8); best bisphosphonate for people aged under 50 (9); and supporting patient decision-making about bisphosphonates (10). CONCLUSION: This study reports, for the first time, topics of importance to stakeholders in the research of bisphosphonate osteoporosis treatment regimens. These findings have implications for research into implementation to address the care gap and education of healthcare professionals. Using James Lind Alliance methodology, this study reports prioritised topics of importance to stakeholders in the research of bisphosphonate treatment in osteoporosis. The priorities address how to better implement guidelines to address the care gap, understanding patient factors influencing treatment selection and effectiveness, and how to optimise long-term care.

Long-Term Effect of Weight Regain Following Behavioral Weight Management Programs on Cardiometabolic Disease Incidence and Risk: Systematic Review and Meta-Analysis.

BACKGROUND: Behavioral weight management programs (BWMPs) enhance weight loss in the short term, but longer term cardiometabolic effects are uncertain as weight is commonly regained. We assessed the impact of weight regain after BWMPs on cardiovascular risk factors, diabetes, and cardiovascular disease. METHODS: Trial registries, 11 databases, and forward-citation searching (latest search, December 19) were used to identify articles published in English, from any geographical region. Randomized trials of BWMPs in adults with overweight/obesity reporting cardiometabolic outcomes at ≥12 months at and after program end were included. Differences between more intensive interventions and comparator groups were synthesized using mixed-effects, meta-regression, and time-to-event models to assess the impact of weight regain on cardiovascular disease incidence and risk. RESULTS: One hundred twenty-four trials reporting on ≥1 cardiometabolic outcomes with a median follow-up of 28 (range, 11-360) months after program end were included. Median baseline participant body mass index was 33 kg/m2; median age was 51 years. Eight and 15 study arms (7889 and 4202 participants, respectively) examined the incidence of cardiovascular disease and type 2 diabetes, respectively, with imprecise evidence of a lower incidence for at least 5 years. Weight regain in BWMPs relative to comparators reduced these differences. One and 5 years after program end, total cholesterol/HDL (high-density lipoprotein) ratio was 1.5 points lower at both times (82 studies; 19 003 participants), systolic blood pressure was 1.5 mm mercury and 0.4 mm lower (84 studies; 30 836 participants), and HbA1c (%) 0.38 lower at both times (94 studies; 28 083 participants). Of the included studies, 22% were judged at high risk of bias; removing these did not meaningfully change results. CONCLUSIONS: Despite weight regain, BWMPs reduce cardiometabolic risk factors with effects lasting at least 5 years after program end and dwindling with weight regain. Evidence that they reduce the incidence of cardiovascular disease or diabetes is less certain. Few studies followed participants for ≥5 years. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42018105744.

Weight regain and mental health outcomes following behavioural weight management programmes: A systematic review with meta-analyses.

Behavioural weight management programmes (BWMPs) lead to weight loss but subsequent weight regain may harm mental health outcomes. We searched for randomised trials of BWMPs in adults with overweight/obesity with follow-up ≥12 months from baseline that measured weight change both at and after programme-end. We included only studies reporting mental health at or after programme-end. We meta-analysed changes in various mental health outcomes using a random-effects model by nature of the comparator group and by time since programme end. Subgroup analysis explored heterogeneity. We used mixed models and meta-regression to analyse the association between change in weight and change in depression and/or anxiety over time, with higher scores indicating greater depression and/or anxiety. We included 47 studies. When comparing BWMPs (diet and/or exercise) to control, most estimates included the possibility of no difference, but pooled estimates for psychological wellbeing, self-esteem and mental-health composite scores at programme-end, anxiety at 1-6 months, and depression at 7-12 months after programme-end suggested improvements in intervention arms relative to control, with 95% CIs excluding no difference. Pooled estimates found no evidence that BWMPs harmed mental health at programme end or beyond. Mental health composite scores at programme-end favoured diet and exercise interventions over diet alone, with 95% CIs excluding no difference. All other measures and timepoints included the possibility of no difference or could not be meta-analysed due to high heterogeneity or a paucity of data. Mixed models and meta-regression of the association between change in depression and/or anxiety scores over time, and change in weight, were inconclusive. Despite weight regain after BWMPs, our meta-analyses found no evidence of mental health harm and some evidence that BWMPs may improve some dimensions of mental health at and after programme-end.

Weight regain after behavioural weight management programmes and its impact on quality of life and cost effectiveness: Evidence synthesis and health economic analyses.

AIMS: We used data from a recent systematic review to investigate weight regain after behavioural weight management programmes (BWMPs, sometimes referred to as lifestyle modification programmes) and its impact on quality-of-life and cost-effectiveness. MATERIALS AND METHODS: Trial registries, databases and forward-citation searching (latest search December 2019) were used to identify randomized trials of BWMPs in adults with overweight/obesity reporting outcomes at ≥12 months, and after programme end. Two independent reviewers screened records. One reviewer extracted data and a second checked them. The differences between intervention and control groups were synthesized using mixed-effect, meta-regression and time-to-event models. We examined associations between weight difference and difference in quality-of-life. Cost-effectiveness was estimated from a health sector perspective. RESULTS: In total, 155 trials (n > 150 000) contributed to analyses. The longest follow-up was 23 years post-programme. At programme end, intervention groups achieved -2.8 kg (95%CI -3.2 to -2.4) greater weight loss than controls. Weight regain after programme end was 0.12-0.32 kg/year greater in intervention relative to control groups, with a between-group difference evident for at least 5 years. Quality-of-life increased in intervention groups relative to control at programme end and thereafter returned to control as the difference in weight between groups diminished. BWMPs with this initial weight loss and subsequent regain would be cost-effective if delivered for under £560 (£8.80-£3900) per person. CONCLUSIONS: Modest rates of weight regain, with persistent benefits for several years, should encourage health care practitioners and policymakers to offer obesity treatments that cost less than our suggested thresholds as a cost-effective intervention to improve long-term weight management. REGISTRATION: The review is registered on PROSPERO, CRD42018105744.

The effectiveness of psychological interventions on mental health and quality of life in people living with type 1 diabetes: a systematic review and meta-analysis.

Background: Living with type 1 diabetes can be associated with significant psychological morbidity, poor glycaemic control, and increased risk for microvascular complications. This systematic review sought to investigate the effects of psychological interventions on depression, anxiety, diabetes-related distress, quality of life, and glycaemic control in people with type 1 diabetes. Methods: Eight electronic databases were searched for published and unpublished randomised controlled trials. Screening, data extraction, and risk of bias assessment (using the Cochrane Collaboration tool for assessing risk of bias 2.0) were independently undertaken by two study authors. The results of the studies were meta-analysed, implementing a random-effects model. The Grading of Recommendations Assessment and Development and Evaluation (GRADE) system was used to determine the confidence in the effect estimates. Results: Twenty studies were identified. Non-significant standardised mean differences (SMD) were found for depression symptoms (SMD = - 0.17, 95% CI [- 0.41, 0.07], p = 0.16) and diabetes-related distress (SMD = - 0.12, 95% CI [- 0.27, 0.04], p = 0.13). Significant SMD was found for quality of life (SMD = 0.27, 95% CI [0.11, 0.42], p = 0.0007). Significant mean difference (MD) was found for HbA1c (MD = - 0.26, 95% CI [- 0.51, - 0.01], p = 0.04). Prespecified subgroup analysis for cognitive behaviour-based interventions showed significant improvement for HbA1c (MD = - 0.23, 95% CI [- 0.44, - 0.02], p = 0.03). Conclusions: Psychological interventions were found to significantly increase quality of life and promote glucose control in people with type 1 diabetes. Depending on their cost-effectiveness, psychological interventions could be incorporated in routine clinical practice for people with type 1 diabetes and concomitant psychological morbidity. Supplementary Information: The online version contains supplementary material available at 10.1007/s13340-021-00564-9.

The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vertebral fragility fractures.

INTRODUCTION: Vertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals.A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients. METHOD: A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data. ETHICS AND DISSEMINATION: Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority (reference IRAS 293210) and is sponsored by Nottingham University Hospitals NHS Trust (reference 21HC001). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion. TRIAL REGISTRATION NUMBER: ISRCTN18334053.

Assessing the Effectiveness of Bisphosphonates for the Prevention of Fragility Fractures: An Updated Systematic Review and Network Meta-Analyses.

Bisphosphonates have been found to be effective in preventing fragility fractures. However, their comparative effectiveness in populations at risk has yet to be defined. In light of recent clinical trials, we aimed to compare four bisphosphonates (alendronate, ibandronate, risedronate, and zoledronate) and to identify which are the most effective for the prevention of fragility fractures. This is an update of a systematic review previously published as part of a NICE HTA report. We conducted a systematic review and network meta-analysis, updating the estimates regarding the comparative effectiveness of the aforementioned bisphosphonates. Studies identified from published and unpublished sources between 2014 and 2021 were added to the studies identified in the previous review. Screening, data extraction and risk of bias assessment were independently undertaken by two reviewers. Outcomes were fractures, femoral neck bone mineral density (BMD), mortality, and adverse events. We identified 25 additional trials, resulting in a total population of 47,007 participants. All treatments had beneficial effects on fractures versus placebo with zoledronate being the most effective treatment in preventing vertebral fractures (hazard ratio [HR] 0.38; 95% credibility interval [CrI], 0.28-0.49). Zoledronate (HR 0.71; 95% CrI, 0.61-0.81) and risedronate (HR 0.70; 95% CrI, 0.53-0.84) were found to be the most effective treatments in preventing nonvertebral fractures. All treatments were associated with increases in femoral neck BMD versus placebo with zoledronate being the most effective treatment mean difference (MD 4.02; 95% CrI, 3.2-4.84). There was a paucity of data regarding hip and wrist fractures. Depending on its cost-effectiveness, zoledronate could be considered a first-line option for people at increased risk of fragility fractures. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

The Impact of Environmental Sustainability Labels on Willingness-to-Pay for Foods: A Systematic Review and Meta-Analysis of Discrete Choice Experiments.

Food production is a major contributor to environmental damage. More environmentally sustainable foods could incur higher costs for consumers. In this review, we explore whether consumers are willing to pay (WTP) more for foods with environmental sustainability labels ('ecolabels'). Six electronic databases were searched for experiments on consumers' willingness to pay for ecolabelled food. Monetary values were converted to Purchasing Power Parity dollars and adjusted for country-specific inflation. Studies were meta-analysed and effect sizes with confidence intervals were calculated for the whole sample and for pre-specified subgroups defined as meat-dairy, seafood, and fruits-vegetables-nuts. Meta-regressions tested the role of label attributes and demographic characteristics on participants' WTP. Forty-three discrete choice experiments (DCEs) with 41,777 participants were eligible for inclusion. Thirty-five DCEs (n = 35,725) had usable data for the meta-analysis. Participants were willing to pay a premium of 3.79 PPP$/kg (95%CI 2.7, 4.89, p ≤ 0.001) for ecolabelled foods. WTP was higher for organic labels compared to other labels. Women and people with lower levels of education expressed higher WTP. Ecolabels may increase consumers' willingness to pay more for environmentally sustainable products and could be part of a strategy to encourage a transition to more sustainable diets.

The Effects of Environmental Sustainability Labels on Selection, Purchase, and Consumption of Food and Drink Products: A Systematic Review.

This review assessed the effects of environmental labels on consumers' demand for more sustainable food products. Six electronic databases were searched for experimental studies of ecolabels and food choices. We followed standard Cochrane methods and results were synthesized using vote counting. Fifty-six studies (N = 42,768 participants, 76 interventions) were included. Outcomes comprised selection (n = 14), purchase (n = 40) and consumption (n = 2). The ecolabel was presented as text (n = 36), logo (n = 13) or combination (n = 27). Message types included: organic (n = 25), environmentally sustainable (n = 27), greenhouse gas emissions (n = 17), and assorted "other" message types (n = 7). Ecolabels were tested in actual (n = 15) and hypothetical (n = 41) environments. Thirty-nine studies received an unclear or high RoB rating. Sixty comparisons favored the intervention and 16 favored control. Ecolabeling with a variety of messages and formats was associated with the selection and purchase of more sustainable food products.

Association between characteristics of behavioural weight loss programmes and weight change after programme end: systematic review and meta-analysis.

OBJECTIVE: To determine if the characteristics of behavioural weight loss programmes influence the rate of change in weight after the end of the programme. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Trial registries, 11 electronic databases, and forward citation searching (from database inception; latest search December 2019). Randomised trials of behavioural weight loss programmes in adults with overweight or obesity, reporting outcomes at ≥12 months, including at the end of the programme and after the end of the programme. REVIEW METHODS: Studies were screened by two independent reviewers with discrepancies resolved by discussion. 5% of the studies identified in the searches met the inclusion criteria. One reviewer extracted the data and a second reviewer checked the data. Risk of bias was assessed with Cochrane's risk of bias tool (version 1). The rate of change in weight was calculated (kg/month; converted to kg/year for interpretability) after the end of the programme in the intervention versus control groups by a mixed model with a random intercept. Associations between the rate of change in weight and prespecified variables were tested. RESULTS: Data were analysed from 249 trials (n=59 081) with a mean length of follow-up of two years (longest 30 years). 56% of studies (n=140) had an unclear risk of bias, 21% (n=52) a low risk, and 23% (n=57) a high risk of bias. Regain in weight was faster in the intervention versus the no intervention control groups (0.12-0.32 kg/year) but the difference between groups was maintained for at least five years. Each kilogram of weight lost at the end of the programme was associated with faster regain in weight at a rate of 0.13-0.19 kg/year. Financial incentives for weight loss were associated with faster regain in weight at a rate of 1-1.5 kg/year. Compared with programmes with no meal replacements, interventions involving partial meal replacements were associated with faster regain in weight but not after adjustment for weight loss during the programme. Access to the programme outside of the study was associated with slower regain in weight. Programmes where the intensity of the interaction reduced gradually were also associated with slower regain in weight in the multivariable analysis, although the point estimate suggested that the association was small. Other characteristics did not explain the heterogeneity in regain in weight. CONCLUSION: Faster regain in weight after weight loss was associated with greater initial weight loss, but greater initial weight loss was still associated with reduced weight for at least five years after the end of the programme, after which data were limited. Continued availability of the programme to participants outside of the study predicted a slower regain in weight, and provision of financial incentives predicted faster regain in weight; no other clear associations were found. STUDY REGISTRATION: PROSPERO CRD42018105744.

The effect of physical activity on anxiety in children and young people: a systematic review and meta-analysis.

BACKGROUND: There is emerging evidence that physical activity can have beneficial effects on anxiety. A comprehensive synthesis of the evidence of the anxiolytic effects of physical activity from randomised controlled trials (RCTs) in children and young people (CYP) is warranted. METHODS: A search of 13 databases was conducted to identify RCTs testing the effects of physical activity on anxiety symptoms in children and young people (up to 25 years). Screening, data extraction and risk of bias assessment (using the Cochrane Collaboration tool for assessing risk of bias) were independently undertaken by two study authors. The primary analysis used a random effects model to compare the effect of physical activity interventions to no intervention or minimal intervention control conditions on state anxiety, assessed using validated, self-report measures. RESULTS: Of the 3590 articles retrieved, 22 RCTs were included, with nine included in the primary meta-analysis. The overall standardised mean difference was 0.54 (95% CI -0.796, -0.28), representing a moderate improvement in state anxiety, compared to no intervention or minimal intervention control conditions. Physical activity was also found to produce significantly superior effects on state anxiety when compared to a time and attention-controlled group. LIMITATIONS: The studies are of low quality overall, and there are a limited number of studies included in the meta-analyses therefore limiting the precision of results. CONCLUSIONS: Physical activity may be a useful approach to addressing anxiety symptoms in children and young people, however, further trials of clinical populations are required to determine the effectiveness of physical activity as a treatment of anxiety disorders.

The effectiveness of exercise-based interventions for preventing or treating postpartum depression: a systematic review and meta-analysis.

Postpartum depression can have detrimental effects on both a mother's physical and mental health and on her child's growth and emotional development. The aim of this study is to assess the effectiveness of exercise/physical activity-based interventions in preventing and treating postpartum depressive symptoms in primiparous and multiparous women to the end of the postnatal period at 52 weeks postpartum. Electronic databases were searched for published and unpublished randomised controlled trials of exercise/physical activity-based interventions in preventing and treating depressive symptoms and increasing health-related quality of life in women from 4 to 52 weeks postpartum. The results of the studies were meta-analysed and effect sizes with confidence intervals were calculated. The Grading of Recommendations Assessment and Development and Evaluation (GRADE) system was used to determine the confidence in the effect estimates. Eighteen trials conducted across a range of countries met the inclusion criteria. Most of the exercise interventions were aerobic and coaching compared to usual care, non-intervention and active controls. Small effect sizes of exercise-based interventions in reducing depressive symptoms were observed collectively and the quality of evidence was low across the individual studies. Although exercise-based interventions could create an alternative therapeutic approach for preventing major depression in postpartum women who experience subthreshold elevated depressive symptoms, the clinical effectiveness and the cost-effectiveness of exercise-based and physical activity interventions need to be better established. There is a need for further more rigorous testing of such interventions in high-quality randomised controlled trials against active control conditions before large-scale roll-out of these interventions in clinical practice is proposed.

The effectiveness of the Penn Resiliency Programme (PRP) and its adapted versions in reducing depression and anxiety and improving explanatory style: A systematic review and meta-analysis.

Mental health problems in children can be precursors of psychosocial problems in adulthood. The aim of this study is to assess the effectiveness of the universal application of a resilience intervention (PRP and derivatives), which has been proposed for large scale roll-out. Electronic databases were searched for published randomized controlled trials of PRP and derivatives to prevent depression and anxiety and improve explanatory style in students aged 8-17 years. Studies were meta-analysed and effect sizes with confidence intervals were calculated. The Quality Assessment Tool for Quantitative Studies of the Effective Public Health Practice Project was used to determine the confidence in the effect estimates. Nine trials from Australia, the Netherlands and USA met the inclusion criteria. No evidence of PRP in reducing depression or anxiety and improving explanatory style was found. The large scale roll-out of PRP cannot be recommended. The content and structure of universal PRP should be re-considered.

Illness perceptions, illness-related problems, subjective health and the role of perceived primal threat: preliminary findings.

Many theories suggest that a threatening situation impacts health because it affects core needs. Our assumption was that a set of interdependent ;perceived primal threats' to basic human needs (self-preservation, social integration, personal identity and growth, and positive worldview), which result from the presence of a disease, are related to illness perceptions and subjective health. Participants were 121 chronic medical patients. According to the results, perceived primal threat was strongly associated with illness-related perceptions and problems, as well as perceived psychological and overall self-rated health. Also, perceived primal threat mediated the relationship between illness-related factors and subjective health measures.