A community pharmacy weight management programme: an evaluation of effectiveness

<p>Background: Community pharmacies may offer an accessible way of delivering weight-management programmes but there have been few trials that use clinically significant weight loss outcomes, objective measures of weight and follow-up to 12 months. We aimed to evaluate weight change among patients who used the Counterweight weight management programme delivered by community pharmacies.</p> <p>Methods: The Counterweight Programme was introduced into community pharmacies in Fife, Scotland in 2009 for patients with a BMI ≥ 30 kg/m2 or a BMI ≥ 28 kg/m2 with a co-morbidity in localities in which Counterweight was not available at GP practices. The aim was to achieve an energy deficit of 500-600 kcal per day. Counterweight specialist dietitians delivered training, support and patient information materials to community pharmacies. Patient weight was measured by pharmacy staff at each weight management session. Weight data recorded at each weight management session were used to estimate weight change and attendance at 3, 6 and 12 months.</p> <p>Results: Between March 2009 and July 2012, 458 patients were enrolled by the community pharmacies. Three-quarters of patients were women, mean age was 54 (SD 7.4) years and mean BMI 36.1 (SD 5.9) kg/m2. Of 314 patients enrolled for at least 12 months, 32 (10.2% on an intention to treat basis) had achieved the target weight loss of ≥5%; this was 41.6% of those who attended at 12 months representing a mean weight loss of 4.1 kg. Using Last Observation Carried Forward, 15.9% achieved the target weight loss within 12 months of enrolling. There was no significant effect of sex, baseline BMI or age on weight loss.</p> <p>Conclusions: The Counterweight pharmacy programme has a similar effectiveness to other primary care based weight management programmes and should be considered as part of a range of services available to a community to manage overweight and obesity.</p&gt

Filling the intervention gap: service evaluation of an intensive nonsurgical weight management programme for severe and complex obesity

Background: Weight management including formula total diet replacement (TDR) is emerging as an effective intervention for severe and complex obesity, particularly with respect to type 2 diabetes (T2DM). However, no prospective audit and service evaluation of such programmes have been reported. Methods: Following initial feasibility piloting, the Counterweight‐Plus programme was commissioned across a variety of healthcare providers. The programme includes: Screening, TDR (formula low energy diet), food reintroduction and weight loss maintenance, all delivered by staff with 8 h of training, in‐service mentoring, ongoing specialist support and access to medical consultant expertise. Anonymised data are returned centrally for clinical evaluation. Results: Up to December 2016, 288 patients commenced the programme. Mean (SD) baseline characteristics were: age 47.5 (12.7) years, weight 128.0 (32.0) kg, body mass index 45.7 (10.1) kg m−2, n = 76 (26.5%) were male and n = 99 (34.5%) had T2DM. On an intention‐to‐treat (ITT) basis, a loss of ≥15 kg at 12 months was achieved by 48 patients, representing 22.1% of all who started and 40% of those who maintained engagement. For complete cases, mean (95% confidence interval) weight loss was 13.3 (12.1–14.4) kg at 3 months, 16.0 (14.4–17.6) kg at 6 months and 14.2 (12.1–16.3) kg at 12 months (all P < 0.001), with losses to follow‐up of 10.8%, 29.3% and 44.2%, respectively. Mean loss at 12 months by ITT analyses was: single imputation –10.5 (9.5) kg, last observation carried forward –10.9 (11.6) kg and baseline observation carried forward –7.9 (11.1) kg. The presence of diabetes had no significant impact on weight change outcomes. Conclusions: This nonsurgical approach is effective for many individuals with severe and complex obesity, representing an option before considering surgery. The results are equally effective in terms of weight loss for people with T2DM

Predictors of type 2 diabetes in the Diabetes Remission Clinical Trial (DiRECT)

AIM:To identify predictors of type 2 diabetes remission in the intervention arm of DiRECT (Diabetes Remission Clinical Trial). METHODS:Participants were aged 20-65 years, with type 2 diabetes duration of <6 years and BMI 27-45 kg/m2 , and were not receiving insulin. Weight loss was initiated by total diet replacement (825-853 kcal/day, 3-5 months, shakes/soups), and weight loss maintenance support was provided for 2 years. Remissions [HbA1c <48 mmol/mol (<6.5%), without antidiabetes medications] in the intervention group (n = 149, mean age 53 years, BMI 35 kg/m2 ) were achieved by 68/149 participants (46%) at 12 months and by 53/149 participants (36%) at 24 months. Potential predictors were examined by logistic regression analyses, with adjustments for weight loss and effects independent of weight loss. RESULTS:Baseline predictors of remission at 12 and 24 months included being prescribed fewer antidiabetes medications, having lower triglyceride and gamma-glutamyl transferase levels, and reporting better quality of life with less anxiety/depression. Lower baseline HbA1c was a predictor at 12 months, and older age and male sex were predictors at 24 months. Being prescribed antidepressants predicted non-remission. Some, but not all effects were explained by weight loss. Weight loss was the strongest predictor of remission at 12 months (adjusted odds ratio per kg weight loss 1.24, 95% CI 1.14, 1.34; P < 0.0001) and 24 months (adjusted odds ratio 1.23, 95% CI 1.13, 1.35; P <0.0001). Weight loss in kilograms and percentage weight loss were equally good predictors. Early weight loss and higher programme attendance predicted more remissions. Baseline BMI, fasting insulin, fasting C-peptide and diabetes duration did not predict remission. CONCLUSIONS:Other than weight loss, most predictors were modest, and not sufficient to identify subgroups for which remission was not a worthwhile target

The remote diet intervention to reduce Long COVID symptoms trial (ReDIRECT): protocol for a randomised controlled trial to determine the effectiveness and cost-effectiveness of a remotely delivered supported weight management programme for people with Long COVID and excess weight, with personalised improvement goals

Objectives: The Remote Diet Intervention to Reduce Long COVID Symptoms Trial (ReDIRECT) evaluates whether the digitally delivered, evidence-based, cost-effective Counterweight-Plus weight management programme improves symptoms of Long COVID in people with overweight/obesity. Methods: Baseline randomised, non-blinded design with 240 participants allocated in a 1:1 ratio either to continue usual care or to add the remotely delivered Counterweight-Plus weight management programme, which includes a Counterweight dietitian supported delivery of 12 weeks total diet replacement, food reintroduction, and long-term weight loss maintenance. Randomisation is achieved by accessing a web-based randomisation system incorporated into the study web portal developed by a registered Clinical Trials Unit. We are using an innovative approach to outcome personalisation, with each participant selecting their most dominant Long COVID symptom as their primary outcome assessed at six months. Participants in the control arm enter the weight management programme after six months. We are recruiting participants from social media and existing networks (e.g., Long COVID Scotland groups), through newspaper advertisements and from primary care. Main inclusion criteria: people with Long COVID symptoms persisting > three months, aged 18 years or above, body mass index (BMI) above 27kg/m2 (>25kg/m2 for South Asians). The trial includes a process evaluation (involving qualitative interviews with participants and analysis of data on dose, fidelity and reach of the intervention) and economic evaluation (within-trial and long-term cost-utility analyses). Anticipated results: The recruitment for this study started in December 2021 and ended in July 2022. Project results are not yet available and will be shared via peer-reviewed publication once the six-months outcomes have been analysed. Trial registration: Current Controlled Trials ISRCTN1259552

Standardised Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD): study protocol for establishing a core outcome set in polycystic kidney disease

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is the most common potentially life threatening inherited kidney disease and is responsible for 5-10% of cases of end-stage kidney disease (ESKD). Cystic kidneys may enlarge up to 20 times the weight of a normal kidney due to the growth of renal cysts, and patients with ADPKD have an increased risk of morbidity, premature mortality, and other life-time complications including renal and hepatic cyst and urinary tract infection, intracranial aneurysm, diverticulosis, and kidney pain which impair quality of life. Despite some therapeutic advances and the growing number of clinical trials in ADPKD, the outcomes that are relevant to patients and clinicians, such as symptoms and quality of life, are infrequently and inconsistently reported. This potentially limits the contribution of trials to inform evidence-based decision-making. The Standardised Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) project aims to establish a consensus-based set of core outcomes for trials in PKD (with an initial focus on ADPKD but inclusive of all stages) that patients and health professionals identify as critically important. METHODS: The five phases of SONG-PKD are: a systematic review to identify outcomes that have been reported in existing PKD trials; focus groups with nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with health professionals to elicit individual values and perspectives on outcomes for trials involving patients with PKD; an international three-round Delphi survey with all stakeholder groups (including patients, caregivers, healthcare providers, policy makers, researchers, and industry) to gain consensus on critically important core outcome domains; and a consensus workshop to review and establish a set of core outcome domains and measures for trials in PKD. DISCUSSION: The SONG-PKD core outcome set is aimed at improving the consistency and completeness of outcome reporting across ADPKD trials, leading to improvements in the reliability and relevance of trial-based evidence to inform decisions about treatment and ultimately improve the care and outcomes for people with ADPKD

Micromechanical Properties of Injection-Molded Starch–Wood Particle Composites

The micromechanical properties of injection molded starch–wood particle composites were investigated as a function of particle content and humidity conditions. The composite materials were characterized by scanning electron microscopy and X-ray diffraction methods. The microhardness of the composites was shown to increase notably with the concentration of the wood particles. In addition,creep behavior under the indenter and temperature dependence were evaluated in terms of the independent contribution of the starch matrix and the wood microparticles to the hardness value. The influence of drying time on the density and weight uptake of the injection-molded composites was highlighted. The results revealed the role of the mechanism of water evaporation, showing that the dependence of water uptake and temperature was greater for the starch–wood composites than for the pure starch sample. Experiments performed during the drying process at 70°C indicated that the wood in the starch composites did not prevent water loss from the samples.Peer reviewe

Levels of alpha-toxin correlate with distinct phenotypic response profiles of blood mononuclear cells and with agr background of community-associated Staphylococcus aureus isolates

Epidemiological studies of Staphylococcus aureus have shown a relation between certain clones and the presence of specific virulence genes, but how this translates into virulence-associated functional responses is not fully elucidated. Here we addressed this issue by analyses of community-acquired S. aureus strains characterized with respect to antibiotic resistance, ST types, agr types, and virulence gene profiles. Supernatants containing exotoxins were prepared from overnight bacterial cultures, and tested in proliferation assays using human peripheral blood mononuclear cells (PBMC). The strains displayed stable phenotypic response profiles, defined by either a proliferative or cytotoxic response. Although, virtually all strains elicited superantigen-mediated proliferative responses, the strains with a cytotoxic profile induced proliferation only in cultures with the most diluted supernatants. This indicated that the superantigen-response was masked by a cytotoxic effect which was also confirmed by flow cytometry analysis. The cytotoxic supernatants contained significantly higher levels of α-toxin than did the proliferative supernatants. Addition of α-toxin to supernatants characterized as proliferative switched the response into cytotoxic profiles. In contrast, no effect of Panton Valentine Leukocidin, δ-toxin or phenol soluble modulin α-3 was noted in the proliferative assay. Furthermore, a significant association between agr type and phenotypic profile was found, where agrII and agrIII strains had predominantly a proliferative profile whereas agrI and IV strains had a predominantly cytotoxic profile. The differential response profiles associated with specific S. aureus strains with varying toxin production could possibly have an impact on disease manifestations, and as such may reflect specific pathotypes

Patterns of post-glacial genetic differentiation in marginal populations of a marine microalga

Peer reviewe