A systematic review and qualitative synthesis of weight management interventions for people with spinal cord injury.

People with spinal cord injury (SCI) are at greater risk of developing obesity and related co-morbidities than those without SCI. The objectives of this systematic review were to examine the effectiveness of weight management interventions for people with SCI and to synthesize the experiences of people involved with SCI weight management (e.g., SCI healthcare professionals and caregivers). Five databases were searched (up to July 31, 2023) and 5,491 potentially eligible articles were identified. Following screening, 22 articles were included, comprising 562 adults. There was considerable heterogeneity in study design and weight loss interventions included behavioral nutritional and exercise education sessions, recalling food diaries, exercise interventions, and pharmaceuticals. The mean percentage change of the pooled body mass data equated to -4.0 ± 2.3%, with a range from -0.5 to -7.6%. In addition, 38% of the individuals with SCI who completed a weight loss intervention (N = 262) had a ≥5% reduction in body weight. Collectively, although on average the included interventions led to moderate weight loss, the finding that just over a third of individuals achieved clinically meaningful 5% weight loss suggests that available interventions for this population may need to be improved.

Public and dental teams' views about weight management interventions in dental health settings: Systematic review and meta-analysis.

Collaborative approaches across healthcare to address obesity are needed but intervention in dental settings is not widely implemented. Here we systematically synthesized the views of both the public and dental teams about delivering weight management interventions in dental settings and identified potential barriers to implementation. A systematic review of five databases from inception to April 3, 2023 was completed. Proportional meta-analyses were performed with quantitative data and thematic analysis of qualitative data. A total of 7851 studies were screened and 33 included in the review. The prevalence of height and weight screening in dental settings varied (4%-87%) with an average of 29% undertaking screening (p = <0.01; 95% CI: 14%-46%). A significant proportion of the public were supportive of weight screening in dental settings (83%; p = <0.01; 95% CI:76%-88%). Significant barriers to providing weight screening and/or intervention included fear of offending patients (57%; 95% CI: 45%-68%) and a lack of time (48%; 95% CI: 30%-66%). Qualitative data revealed further barriers including stigmatizing views of dental teams toward people living with overweight/obesity. Enablers of weight discussion included associating weight with oral health. Overall, whilst some barriers were identified, there is potential for weight management interventions to be used more routinely in dental settings.

The Effect of Practitioner Empathy on Patient Satisfaction : A Systematic Review of Randomized Trials.

BACKGROUND: Practitioners who deliver enhanced empathy may improve patient satisfaction with care. Patient satisfaction is associated with positive patient outcomes ranging from medication adherence to survival. PURPOSE: To evaluate the effect of health care practitioner empathy on patient satisfaction, using a systematic review of randomized trials. DATA SOURCES: Ovid MEDLINE, CINAHL, PsycInfo, Cochrane Central Register of Controlled Trials, and Scopus to 23 October 2023. STUDY SELECTION: Randomized trials published in any language that evaluated the effect of empathy on improving patient satisfaction as measured on a validated patient satisfaction scale. DATA EXTRACTION: Data extraction, risk-of-bias assessments, and strength-of-evidence assessments were done by 2 independent reviewers. Disagreements were resolved through consensus. DATA SYNTHESIS: Fourteen eligible randomized trials (80 practitioners; 1986 patients) were included in the analysis. Five studies had high risk of bias, and 9 had some concerns about bias. The trials were heterogeneous in terms of geographic locations (North America, Europe, Asia, and Africa), settings (hospital and primary care), practitioner types (family and hospital physicians, anesthesiologists, nurses, psychologists, and caregivers), and type of randomization (individual patient or clustered by practitioner). Although all trials suggested a positive change in patient satisfaction, inadequate reporting hindered the ability to draw definitive conclusions about the overall effect size. LIMITATIONS: Heterogeneity in the way that empathy was delivered and patient satisfaction was measured and incomplete reporting leading to concerns about the certainty of the underpinning evidence. CONCLUSION: Various empathy interventions have been studied to improve patient satisfaction. Development, testing, and reporting of high-quality studies within well-defined contexts is needed to optimize empathy interventions that increase patient satisfaction. PRIMARY FUNDING SOURCE: Stoneygate Trust. (PROSPERO: CRD42023412981).

A randomised controlled trial to investigate the feasibility and acceptability of a small change approach to prevent weight gain.

A weight gain prevention strategy showing merit is a small change approach (increase energy expenditure and/or decrease energy intake by 100-200 kcal/day). Studies have tested a small change approach in intensive interventions involving multiple contacts, unsuitable for delivery at scale. The aim here was to assess the feasibility and acceptability of a remote small change weight gain prevention intervention. A randomised controlled trial of 122 participants was conducted. The intervention was a remote 12-week small change weight gain prevention programme (targeting dietary and/or physical activity behaviours). The comparator group received a healthy lifestyle leaflet. Data were collected at baseline and 12-weeks. The primary outcome was the feasibility and acceptability, assessed against three stop-go traffic light criteria: retention, number of participants randomised per month and adherence to a small change approach. Participants' opinions of a small change approach and weight change were also measured. The traffic light stop-go criteria results were green for recruitment (122 participants recruited in three months) and retention (91%) and red for intervention adherence. Most participants (62%) found a small change approach helpful for weight management and the mean difference in weight was - 1.1 kg (95% CI - 1.7, - 0.4), favouring the intervention group. Excluding intervention adherence, the trial was feasible and acceptable to participants. Despite adherence being lower than expected, participants found a small change approach useful for weight management and gained less weight than comparators. With refinement to increase intervention adherence, progress to an effectiveness trial is warranted.ISRCTN18309466: 12/04/2022 (retrospectively registered).

Impact of unhealthy food and beverage consumption on children's risk of dental caries: a systematic review.

CONTEXT: The impact of unhealthy foods and beverages, namely those high in sugar, salt, and saturated or trans fats, has been studied extensively in relation to weight, body composition, and noncommunicable diseases, but less so in relation to the risk of dental caries. Few previous reviews have examined the evidence from all countries globally. OBJECTIVE: A systematic review was conducted to assess the impact of unhealthy food and beverage consumption on the risk of dental caries in children aged ≤10 years, commissioned by the World Health Organization to inform updated complementary feeding recommendations. DATA SOURCES: Systematic searches were conducted in the PubMed, Cochrane, and Embase databases for articles meeting the inclusion criteria dating from January 1971 to March 2022; supplementary searches were undertaken for articles from that period to June 2022. DATA EXTRACTION: Unhealthy foods and beverages were identified using nutrient- and food-based approaches. Risk of bias was assessed using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I). DATA ANALYSIS: A total of 30 023 unique citations were screened, yielding 37 studies for inclusion. Studies were conducted in high-income (n = 23 [62.2%]) or middle-income countries (n = 14 [37.8%]). Evidence synthesis was performed narratively, stratified by age (0 years to <2 years, 2 years to <5 years, and 5 years to ≤10 years) and exposure (unhealthy foods and unhealthy beverages). The heterogeneity of the exposures and comparators across studies was high. Almost all studies (n = 34) reported positive associations between the consumption of sugar-sweetened beverages or foods high in free sugars and dental caries. However, 67.6% of studies were assessed as having serious risk of bias. CONCLUSION: The evidence indicates that the consumption of unhealthy food and beverages in children ≤10 years appears to increase the risk of dental caries. Further longitudinal studies with high-quality dietary assessments, including studies in low-income countries and children aged >5 years at baseline, are recommended in order to build a more robust evidence base for use in the development of policy recommendations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42020218109.

The effect of preoperative behaviour change interventions on pre- and post-surgery health behaviours, health outcomes, and health inequalities in adults: A systematic review and meta-analyses.

BACKGROUND: Prehabilitation interventions are being delivered across surgical specialities to improve health risk behaviours leading to better surgical outcomes and potentially reduce length of hospital stay. Most previous research has focused on specific surgery specialities and has not considered the impact of interventions on health inequalities, nor whether prehabilitation improves health behaviour risk profiles beyond surgery. The aim of this review was to examine behavioural Prehabilitation interventions across surgeries to inform policy makers and commissioners of the best available evidence. METHODS AND FINDINGS: A systematic review and meta-analysis of randomised controlled trials (RCTs) was conducted to determine the effect of behavioural prehabilitation interventions targeting at least one of: smoking behaviour, alcohol use, physical activity, dietary intake (including weight loss interventions) on pre- and post-surgery health behaviours, health outcomes, and health inequalities. The comparator was usual care or no treatment. MEDLINE, PubMed, PsychINFO, CINAHL, Web of Science, Google Scholar, Clinical trials and Embase databases were searched from inception to May 2021, and the MEDLINE search was updated twice, most recently in March 2023. Two reviewers independently identified eligible studies, extracted data, and assessed risk of bias using the Cochrane risk of bias tool. Outcomes were length of stay, six-minute walk test, behaviours (smoking, diet, physical activity, weight change, and alcohol), and quality of life. Sixty-seven trials were included; 49 interventions targeted a single behaviour and 18 targeted multiple behaviours. No trials examined effects by equality measures. Length of stay in the intervention group was 1.5 days shorter than the comparator (n = 9 trials, 95% CI -2.6 to -0.4, p = 0.01, I2 83%), although in sensitivity analysis prehabilitation had the most impact in lung cancer patients (-3.5 days). Pre-surgery, there was a mean difference of 31.8 m in the six-minute walk test favouring the prehabilitation group (n = 19 trials, 95% CI 21.2 to 42.4m, I2 55%, P <0.001) and this was sustained to 4-weeks post-surgery (n = 9 trials, mean difference = 34.4m (95%CI 12.8 to 56.0, I2 72%, P = 0.002)). Smoking cessation was greater in the prehabilitation group before surgery (RR 2.9, 95% CI 1.7 to 4.8, I2 84%), and this was sustained at 12 months post-surgery (RR 1.74 (95% CI 1.20 to 2.55, I2 43%, Tau2 0.09, p = 0.004)There was no difference in pre-surgery quality of life (n = 12 trials) or BMI (n = 4 trials). CONCLUSIONS: Behavioural prehabilitation interventions reduced length of stay by 1.5 days, although in sensitivity analysis the difference was only found for Prehabilitation interventions for lung cancer. Prehabilitation can improve functional capacity and smoking outcomes just before surgery. That improvements in smoking outcomes were sustained at 12-months post-surgery suggests that the surgical encounter holds promise as a teachable moment for longer-term behavioural change. Given the paucity of data on the effects on other behavioural risk factors, more research grounded in behavioural science and with longer-term follow-up is needed to further investigate this potential.

A Qualitative Process Evaluation of Participant Experiences in a Feasibility Randomised Controlled Trial to Reduce Indulgent Foods and Beverages.

There is a growing interest in the effects of ultra-processed/energy-dense nutrient-poor foods on health outcomes, and few interventions to reduce their consumption have been tested. We tested a simple intervention to help people reduce the indulgences they consume (energy-dense nutrient-poor (EDNP) foods). Herein, we report the qualitative findings to understand how participants reduced their consumption by exploring intervention fidelity and the factors affecting consumption. We conducted a qualitative descriptive study of 23 adults who had taken part in a feasibility randomised controlled trial that asked participants to say no to seven indulgences/week and record what they said no to. Data were collected using face-to-face semi-structured interviews and analysed thematically. A total of 23 adults with an average BMI of 30.8 kg/m2 took part. Participants liked the term indulgence, as they could apply it to their normal dietary intake and make small changes. They found self-monitoring what they said no to helpful and reported that emotional eating and habits affected consumption. They had difficulty overcoming these. As most people are consuming too many foods that are EDNP, this simple intervention of "Say No" seven times/week has the potential to be developed as a public health campaign.

A Christmas themed physical activity intervention to increase participation in physical activity during Advent: pilot randomised controlled trial.

OBJECTIVES: To examine the recruitment, retention, and preliminary effects of a Christmas themed physical activity intervention designed to increase participation in physical activity and decrease sedentary behaviour in inactive adults. DESIGN: Pilot randomised controlled trial. SETTING: Recruitment from social medial platforms, workplaces, and community groups in the UK. PARTICIPANTS: 107 inactive adults (who did not meet the UK guidelines for physical activity) aged 18-75 years. INTERVENTIONS: The intervention consisted of an email sent to participants each day of Advent (1-24 December 2021), which contained a Christmas themed physical activity idea to be completed that day. Each physical activity idea was presented in three intensity formats, including Easy Elf (light intensity), Moderate Mrs Claus (moderate intensity), and Strenuous Santa (vigorous intensity). The comparator group received a leaflet about healthy living on the 1 December. MAIN OUTCOME MEASURES: Participants were randomly assigned (2:1) to either the intervention or control and were masked to group allocation before randomisation. Primary outcomes were recruitment rate, retention, and weekly minutes of participation in self-reported moderate-to-vigorous intensity physical activity by use of the exercise vital signs questionnaire. Primary analysis compared change in minutes of moderate-to-vigorous intensity physical activity from baseline to weeks one, two, and three during the Active Advent intervention. Secondary outcomes were participation in muscle strengthening based physical activity (days per week), accelerometer measured moderate-to-vigorous intensity physical activity, light intensity physical activity, total physical activity, and sedentary time (minutes per day), and enjoyment of and adherence to the intervention. RESULTS: 323 individuals expressed interest in participating in the trial and 107 were randomly assigned to the intervention (n=71) or the comparator (n=36) group. The recruitment target (n=105) was reached within 19 days of starting recruitment. 23 (21%) of 107 participants were lost to follow-up. On average, the groups reported participation in similar minutes of moderate-to-vigorous intensity physical activity in weeks one and two. At week three, the adjusted mean difference between groups was 20.6 minutes of participation in moderate-to-vigorous intensity physical activity per week (95% confidence interval -29.7 to 70.9) in favour of the intervention group. Accelerometer data showed that the intervention group spent fewer minutes sedentary per day than comparators (mean difference -58.6 (-113.5 to -3.8)). Overall, 42 (70%) of 60 participants in the intervention group reported that they liked the intervention and 41 (69%) of 59 reported that they completed the Active Advent intervention ideas each day. CONCLUSIONS: The public were interested to participate in a Christmas themed physical activity intervention during Advent, which might increase physical activity and reduce time sedentary. Enjoyment of, and adherence to the intervention shows the potential benefit that Christmas themed physical activity campaigns/initiatives might have for improving public health. TRIAL REGISTRATION: ISRCTN12415556.

Effectiveness of weight management interventions for adults delivered in primary care: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To examine the effectiveness of behavioural weight management interventions for adults with obesity delivered in primary care. DESIGN: Systematic review and meta-analysis of randomised controlled trials. ELIGIBILITY CRITERIA FOR SELECTION OF STUDIES: Randomised controlled trials of behavioural weight management interventions for adults with a body mass index ≥25 delivered in primary care compared with no treatment, attention control, or minimal intervention and weight change at ≥12 months follow-up. DATA SOURCES: Trials from a previous systematic review were extracted and the search completed using the Cochrane Central Register of Controlled Trials, Medline, PubMed, and PsychINFO from 1 January 2018 to 19 August 2021. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently identified eligible studies, extracted data, and assessed risk of bias using the Cochrane risk of bias tool. Meta-analyses were conducted with random effects models, and a pooled mean difference for both weight (kg) and waist circumference (cm) were calculated. MAIN OUTCOME MEASURES: Primary outcome was weight change from baseline to 12 months. Secondary outcome was weight change from baseline to ≥24 months. Change in waist circumference was assessed at 12 months. RESULTS: 34 trials were included: 14 were additional, from a previous review. 27 trials (n=8000) were included in the primary outcome of weight change at 12 month follow-up. The mean difference between the intervention and comparator groups at 12 months was -2.3 kg (95% confidence interval -3.0 to -1.6 kg, I2=88%, P<0.001), favouring the intervention group. At ≥24 months (13 trials, n=5011) the mean difference in weight change was -1.8 kg (-2.8 to -0.8 kg, I2=88%, P<0.001) favouring the intervention. The mean difference in waist circumference (18 trials, n=5288) was -2.5 cm (-3.2 to -1.8 cm, I2=69%, P<0.001) in favour of the intervention at 12 months. CONCLUSIONS: Behavioural weight management interventions for adults with obesity delivered in primary care are effective for weight loss and could be offered to members of the public. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021275529.

Most healthcare interventions tested in Cochrane Reviews are not effective according to high quality evidence: a systematic review and meta-analysis.

OBJECTIVE: To estimate the proportion of healthcare interventions tested within Cochrane Reviews that are effective according to high-quality evidence. METHODS: We selected a random sample of 2,428 (35%) of all Cochrane Reviews published between 1 January 2008 and 5 March 2021. We extracted data about interventions within these reviews that were compared with placebo, or no treatment, and whose outcome quality was rated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. We calculated the proportion of interventions whose benefits were based on high-quality evidence (defined as having high quality GRADE rating for at least one primary outcome, statistically significant positive results, and being judged by review authors as effective. We also calculated the proportion of interventions that suggested harm. RESULTS: Of 1,567 eligible interventions, 87 (5.6%) had high-quality evidence supporting their benefits. Harms were measured for 577 (36.8%) interventions. There was statistically significant evidence for harm in 127 (8.1%) of these. Our dependence on the reliability of Cochrane author assessments (including their GRADE assessments) was the main potential limitation of our study. CONCLUSION: More than 9 in 10 healthcare interventions studied within recent Cochrane Reviews are not supported by high-quality evidence, and harms are under-reported.

Effectiveness of physical activity interventions delivered or prompted by health professionals in primary care settings: systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To examine the effectiveness of physical activity interventions delivered or prompted by primary care health professionals for increasing moderate to vigorous intensity physical activity (MVPA) in adult patients. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Databases (Medline and Medline in progress, Embase, PsycINFO, CINAHL, SPORTDiscus, Sports Medicine and Education Index, ASSIA, PEDro, Bibliomap, Science Citation Index, Conference Proceedings Citation Index), trial registries (Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, TRoPHI), and grey literature (OpenGrey) sources were searched (from inception to September 2020). ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials of aerobic based physical activity interventions delivered or prompted by health professionals in primary care with a usual care control group or another control group that did not involve physical activity. STUDY SELECTION AND ANALYSIS: Two independent reviewers screened the search results, extracted data from eligible trials and assessed the risk of bias using the Cochrane risk of bias tool (version 2). Inverse variance meta-analyses using random effects models examined the primary outcome of difference between the groups in MVPA (min/week) from baseline to final follow-up. The odds of meeting the guidelines for MVPA at follow-up were also analysed. RESULTS: 14 566 unique reports were identified and 46 randomised controlled trials with a range of follow-ups (3-60 months) were included in the meta-analysis (n=16 198 participants). Physical activity interventions delivered or prompted by health professionals in primary care increased MVPA by 14 min/week (95% confidence interval 4.2 to 24.6, P=0.006). Heterogeneity was substantial (I2=91%, P<0.001). Limiting analyses to trials that used a device to measure physical activity showed no significant group difference in MVPA (mean difference 4.1 min/week, 95% confidence interval -1.7 to 9.9, P=0.17; I2=56%, P=0.008). Trials that used self-report measures showed that intervention participants achieved 24 min/week more MVPA than controls (95% confidence interval 6.3 to 41.8, P=0.008; I2=72%, P<0.001). Additionally, interventions increased the odds of patients meeting guidelines for MVPA by 33% (95% confidence interval 1.17 to 1.50, P<0.001; I2=25%, P=0.11) versus controls. 14 of 46 studies were at high risk of bias but sensitivity analyses excluding these studies did not alter the results. CONCLUSIONS: Physical activity interventions delivered or prompted by health professionals in primary care appear effective at increasing participation in self-reported MVPA. Such interventions should be considered for routine implementation to increase levels of physical activity and improve health outcomes in the population. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021209484.

Is a small change approach for weight management effective? A systematic review and meta-analysis of randomized controlled trials.

Traditional weight management interventions typically involve people making large changes to their energy intake and/or expenditure and can be effective in the short term, but weight regain is common. An alternative strategy is a small change approach, which asks people to make small(er) changes to their diet and/or physical activity behaviors (e.g., 100-kcal reduction or increases of 1000 steps/day). This approach may lead to sustained weight management because such energy-deficit goals are easier for people to integrate into their lives and then maintain. This systematic review and meta-analysis of randomized and quasi-randomized controlled trials assessed the effectiveness of a small change approach for weight management; 21 trials were included. In weight gain prevention trials with adults, the mean difference in weight change between groups was -0.7 kg (95% CI -1.0 to -0.4, 95% PI -1.1 to -0.3) at program-end and -0.9 kg (95% CI -1.5 to -0.3, 95% PI -3.1 to 1.3) at last follow-up, favoring small change interventions. A small change approach was not effective for weight loss. Only 2/21 trials had a low risk of bias. Initial evidence supports the effectiveness of a small change approach for weight gain prevention but not weight loss. Further high-quality trials with longer follow-up are required.

Testing the short-term effectiveness of primary care referral to online weight loss programmes: A randomised controlled trial.

Guidelines ask health professionals to offer brief advice to encourage weight loss for people living with obesity. We tested whether referral to one of three online programmes could lead to successful weight loss. A total of 528 participants aged ≥18 years with a body mass index of ≥30 kg/m2 were invited via a letter from their GP. Participants were randomised to one of three online weight loss programmes (NHS Weight Loss Plan, Rosemary Online or Slimming World Online) or to a control group receiving no intervention. Participants self-reported weight at baseline and 8 weeks. The primary outcome was weight change in each of the active intervention groups compared with control. We also compared the proportion of participants losing ≥5% or ≥10% of body weight. For Rosemary, Online mean weight loss was modestly greater than control (-1.5 kg [95% confidence interval (CI) -2.3 to -0.6]) and more than three times as many participants in this group lost ≥5% (relative risk [RR] = 3.64, 95% CI: 1.63-8.1). For Slimming World, mean weight loss was not significantly different from control (-0.8 kg [95%CI -1.7 to 0.1]), twice as many participants lost ≥5% (RR = 2.70, 1.17-6.23). There was no significant difference in weight loss for participants using the NHS Weight Loss Plan (-0.4 kg, [95% CI -1.3 to 0.5]), or the proportion losing ≥5% (RR = 2.09, 0.87-5.01). Only one of three online weight loss programmes was superior to no intervention and the effect size modest among participants living with obesity.

Effectiveness of interventions to maintain physical activity behavior (device-measured): Systematic review and meta-analysis of randomized controlled trials.

Physical activity has many physical, mental, and social health benefits. Interventions can be successful at helping people initiate participation, but there is a lack of evidence about the ability of these interventions to help adults maintain their physical activity. This systematic review and meta-analysis aims to address this evidence gap. We investigated the extent to which successful physical activity interventions with demonstrated success within randomized controlled trials result in maintenance of device-measured physical activity (at least 3 months post-intervention end). Five databases were searched, and 8919 titles and abstracts were screened for eligibility, and 29 trials met the inclusion criteria. Of these, 22 were included in the meta-analysis. We found that 60% to 80% of physical activity behavior was maintained, as equivalent to an additional 45 min/week of moderate-to-vigorous physical activity and 945 steps per day compared with comparators. We also examined trials that randomized participants to maintenance interventions after an initial physical activity intervention (n = 7) and we found small effects (standardized mean difference 0.14, 95% confidence interval [CI] 0.1 to 0.27). The evidence suggests that most (60%-80%) of the increases in physical activity in successful programs are maintained for at least 3 months and there are small effects from providing a maintenance intervention to the public. Registration: CRD42019144585.

Measuring the success of blinding in placebo-controlled trials: Should we be so quick to dismiss it?

'Blinding' involves concealing knowledge of which trial participants received the interventions from participants themselves and other trial personnel throughout the trial. Blinding reduces bias arising from the beliefs and expectations of these groups. It is agreed that where possible, blinding should be attempted, for example by ensuring that experimental and control treatments look the same. However, there is a debate about if we should measure whether blinding has been successful, this manuscript will discuss this controversy, including the benefits and risks of measuring blinding within the randomised controlled trial.

Evaluation of an intervention to provide brief support and personalized feedback on food shopping to reduce saturated fat intake (PC-SHOP): A randomized controlled trial.

BACKGROUND: Guidelines recommend reducing saturated fat (SFA) intake to decrease cardiovascular disease (CVD) risk, but there is limited evidence on scalable and effective approaches to change dietary intake, given the large proportion of the population exceeding SFA recommendations. We aimed to develop a system to provide monthly personalized feedback and healthier swaps based on nutritional analysis of loyalty card data from the largest United Kingdom grocery store together with brief advice and support from a healthcare professional (HCP) in the primary care practice. Following a hybrid effectiveness-feasibility design, we tested the effects of the intervention on SFA intake and low-density lipoprotein (LDL) cholesterol as well as the feasibility and acceptability of providing nutritional advice using loyalty card data. METHODS AND FINDINGS: The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study is a parallel randomized controlled trial with a 3 month follow-up conducted between 21 March 2018 to 16 January2019. Adults ≥18 years with LDL cholesterol >3 mmol/L (n = 113) were recruited from general practitioner (GP) practices in Oxfordshire and randomly allocated to "Brief Support" (BS, n = 48), "Brief Support + Shopping Feedback" (SF, n = 48) or "Control" (n = 17). BS consisted of a 10-minute consultation with an HCP to motivate participants to reduce their SFA intake. Shopping feedback comprised a personalized report on the SFA content of grocery purchases and suggestions for lower SFA swaps. The primary outcome was the between-group difference in change in SFA intake (% total energy intake) at 3 months adjusted for baseline SFA and GP practice using intention-to-treat analysis. Secondary outcomes included %SFA in purchases, LDL cholesterol, and feasibility outcomes. The trial was powered to detect an absolute reduction in SFA of 3% (SD3). Neither participants nor the study team were blinded to group allocation. A total of 106 (94%) participants completed the study: 68% women, 95% white ethnicity, average age 62.4 years (SD 10.8), body mass index (BMI) 27.1 kg/m2 (SD 4.7). There were small decreases in SFA intake at 3 months: control = -0.1% (95% CI -1.8 to 1.7), BS = -0.7% (95% CI -1.8 to 0.3), SF = -0.9% (95% CI -2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = -0.33% [95% CI -2.11 to 1.44], p = 0.709; SF versus control = -0.11% [95% CI -1.92 to 1.69], p = 0.901). There were similar trends in %SFA based on supermarket purchases: control = -0.5% (95% CI -2.3 to 1.2), BS = -1.3% (95% CI -2.3 to -0.3), SF = -1.5% (95% CI -2.5 to -0.5) from baseline to follow-up, but these were not significantly different: BS versus control p = 0.379; SF versus control p = 0.411. There were small reductions in LDL from baseline to follow-up (control = -0.14 mmol/L [95% CI -0.48, 0.19), BS: -0.39 mmol/L [95% CI -0.59, -0.19], SF: -0.14 mmol/L [95% CI -0.34, 0.07]), but these were not significantly different: BS versus control p = 0.338; SF versus control p = 0.790. Limitations of this study include the small sample of participants recruited, which limits the power to detect smaller differences, and the low response rate (3%), which may limit the generalisability of these findings. CONCLUSIONS: In this study, we have shown it is feasible to deliver brief advice in primary care to encourage reductions in SFA intake and to provide personalized advice to encourage healthier choices using supermarket loyalty card data. There was no evidence of large reductions in SFA, but we are unable to exclude more modest benefits. The feasibility, acceptability, and scalability of these interventions suggest they have potential to encourage small changes in diet, which could be beneficial at the population level. TRIAL REGISTRATION: ISRCTN14279335.

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

BACKGROUND: Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. METHODS AND FINDINGS: We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. CONCLUSIONS: We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

Targeting the Intestinal Microbiota to Prevent Type 2 Diabetes and Enhance the Effect of Metformin on Glycaemia: A Randomised Controlled Pilot Study.

Early treatment may prevent or delay the onset of type 2 diabetes mellitus (T2DM) in individuals who are at high risk. Lifestyle interventions and the hypoglycemic drug metformin have been shown to reduce T2DM incidence. The effectiveness of such interventions may be enhanced by targeting environmental factors such as the intestinal microbiota, which has been proven to predict the response to lifestyle interventions and play a part in mediating the glucose-lowering effects of metformin. Shifts in the intestinal microbiota "towards a more balanced state" may promote glucose homeostasis by regulating short-chain fatty acids' production. This study aimed to investigate the safety and effect of a multi-strain probiotic on glycemic, inflammatory, and permeability markers in adults with prediabetes and early T2DM and to assess whether the probiotic can enhance metformin's effect on glycaemia. A randomised controlled pilot study was conducted in 60 adults with a BMI ≥ 25 kg/m2 and with prediabetes or T2DM (within the previous 12 months). The participants were randomised to a multi-strain probiotic (L. plantarum, L. bulgaricus, L. gasseri, B. breve, B. animalis sbsp. lactis, B. bifidum, S. thermophilus, and S. boulardii) or placebo for 12 weeks. Analyses of the primary outcome (fasting plasma glucose) and secondary outcomes, including, but not limited to, circulating lipopolysaccharide, zonulin, and short chain fatty acids and a metagenomic analysis of the fecal microbiome were performed at baseline and 12 weeks post-intervention. The results showed no significant differences in the primary and secondary outcome measures between the probiotic and placebo group. An analysis of a subgroup of participants taking metformin showed a decrease in fasting plasma glucose, HbA1c, insulin resistance, and zonulin; an increase in plasma butyrate concentrations; and an enrichment of microbial butyrate-producing pathways in the probiotic group but not in the placebo group. Probiotics may act as an adjunctive to metformin by increasing the production of butyrate, which may consequently enhance glucose management.

Primary care treatment of insomnia: study protocol for a pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy to sleep hygiene (the HABIT trial).

INTRODUCTION: Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice. METHODS AND ANALYSIS: In the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4 weekly sessions; total therapy time is approximately 1 hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6 months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed. ETHICS AND DISSEMINATION: Ethical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder. TRIAL REGISTRATION NUMBER: ISRCTN42499563.

Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial.

BACKGROUND: Despite the clear harm associated with smoking tobacco, many people with smoking-related chronic diseases or serious mental illnesses (SMI) are unwilling or unable to stop smoking. In many cases, these smokers have tried and exhausted all methods to stop smoking and yet clinicians are repeatedly mandated to offer them during routine consultations. Providing nicotine through electronic cigarettes (e-cigarettes) may reduce the adverse health consequences associated with tobacco smoking, but these are not currently offered. The aim of this study is to examine the feasibility, acceptability and effectiveness of general practitioners (GPs) and nurses delivering a brief advice intervention on e-cigarettes and offering an e-cigarette starter pack and patient support resources compared with standard care in smokers with smoking-related chronic diseases or SMI who are unwilling to stop smoking. METHODS/DESIGN: This is an individually randomised, blinded, two-arm trial. Smokers with a smoking-related chronic condition or SMI with no intention of stopping smoking will be recruited through primary care registers. Eligible participants will be randomised to one of two groups if they decline standard care for stopping smoking: a control group who will receive no additional support beyond standard care; or an intervention group who will receive GP or nurse-led brief advice about e-cigarettes, an e-cigarette starter pack with accompanying practical support booklet, and telephone support from experienced vapers and online video tutorials. The primary outcome measures will be smoking reduction, measured through changes in cigarettes per day and 7-day point-prevalence abstinence at 2 months. Secondary outcomes include smoking reduction, 7-day point-prevalence abstinence and prolonged abstinence at 8 months. Other outcomes include patient recruitment and follow-up, patient uptake and use of e-cigarettes, nicotine intake, contamination of randomisation and practitioner adherence to the delivery of the intervention. Qualitative interviews will be conducted in a subsample of practitioners, patients and the vape team to garner their reactions to the programme. DISCUSSION: This is the first randomised controlled trial to investigate whether e-cigarette provision alongside a brief intervention delivered by practitioners leads to reduced smoking and abstinence among smokers with smoking-related chronic diseases or SMI. TRIAL REGISTRATION: ISRCTN registry, ISRCTN59404712. Registered 28/11/17.