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.

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).

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 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.

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.

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.

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.

Mood and appetite: Their relationship with discretionary and total daily energy intake.

BACKGROUND: Negative affect is shown consistently to promote unhealthy food choices and dietary intake in laboratory studies. However, this relationship in naturalistic settings is less clear and previous research is limited by dietary assessment methodology and neglects to account for several important moderating variables. This observational study aimed to examine the association of negative affect and other psychological factors associated with eating behaviour simultaneously with discretionary energy intake and total energy intake, and whether these were moderated by emotional eating predisposition or age, sex and weight status. METHODS: One hundred adults completed a four-day food diary, a concurrent end-of-day questionnaire that assessed daily affect and experience of appetite, and the Three Factor Eating Questionnaire to assess trait eating behaviour. Food diaries provided data on participants' daily intake of total energy and of "discretionary items" (specific energy-dense and nutrient poor foods and beverages as defined by the Australian Guide to Healthy Eating). Stepwise random effects models were used to estimate the association of end-of-day ratings, trait eating behaviour and personal factors, and their interactions, with discretionary and total energy intake. RESULTS: Daily rated negative affect and appetite were significantly and positively associated with discretionary intake, such that a one unit increase in each scale was associated with eating 139 kJ/d [SE 61] and 194 kJ/d [SE 68] more discretionary energy, respectively. Negative affect and its interaction with emotional eating were consistently, positively associated with discretionary energy intake. This relationship was strongest in younger participants (ß = -4.9 [SE 2.2], p < .05). There was no interaction with sex or weight status. Total energy intake was not associated with negative affect nor its interaction with emotional eating but was consistently associated with appetite. CONCLUSION: When personal factors (age, sex, BMI), trait eating behaviours and daily rated negative affect and appetite are considered simultaneously, daily discretionary intake is associated most strongly with negative affect. Individuals, particularly young adults, may be more likely to overeat discretionary energy on days that negative affect is rated more highly. However, this may not necessarily translate into greater total energy intake which was most consistently associated with daily rated appetite.

Modelling the Association between Core and Discretionary Energy Intake in Adults with and without Obesity.

BACKGROUND: Many dietary recommendations for weight control rely on the assumption that greater core food intake will displace intake of energy-dense discretionary foods and beverages. However, there is little evidence to support these assumptions. This study examined the naturalistic relationship between daily core and discretionary energy intake, and with discretionary food and discretionary beverage intake, separately. The impact of weight status on these associations was also examined. METHOD: One hundred participants completed a four-day (non-consecutive) estimated food diary. Discretionary foods and beverages were identified by reference to the Australian Dietary Guidelines. Non-discretionary items were considered core items. Simultaneous-equation random effects models using disaggregated dietary data controlling for sociodemographic variables were used to determine the association between various dietary components. RESULT: Core energy intake correlated negatively with discretionary energy intake (cross-equation correlation, ρ = -0.49 (95% CI: -0.57, -0.39)). Its correlation with discretionary foods (-0.47 (-0.56, -0.37)) was stronger than that with discretionary beverages (-0.19 (-0.30, -0.07)) The correlation between core energy intake and discretionary energy intake was significantly stronger in participants who did not have obesity (-0.67 (-0.71, -0.50)) than those with obesity (-0.32 (-0.46, -0.17)) (p = 0.0002). CONCLUSIONS: Core and discretionary energy intake share an inverse and potentially bidirectional, relationship that appears to be stronger with discretionary foods than discretionary beverages. These relationships were significantly weaker in participants with obesity which may indicate less precise dietary compensation in these individuals. While strategies that promote greater intake of core foods may assist with weight maintenance in individuals of healthy weight, its impact in individuals with obesity may be limited. These strategies should be accompanied by direct messages to reduce commensurately the intake of discretionary items, with special attention paid to discretionary beverage consumption.

Is weight cycling associated with adverse health outcomes? A cohort study.

Evidence about the health effects of weight cycling is not consistent, with some studies suggesting it is harmful for health. Here we investigated whether weight cycling was associated with weight change and mental health outcomes in 10,428 participants in the mid-age cohort of The Australian Longitudinal Study of Women's Health (ALSWH) over 12years. In 1998 the women were asked how many times they had ever intentionally lost at least 5kg and how many times had they regained this amount. Women were categorised into four weight pattern groups: frequent weight cyclers (FWC, three or more weight cycles), low frequency weight cyclers (LFWC, one or two weight cycles), non-weight cyclers (NWC), and weight loss only (WL). We used generalised linear modelling to investigate relationships between weight pattern group, weight change and mental health outcomes. In 1998, 15% of the women were FWC, 24% LFWC, 46% NWC and 15% were WL. Weight change was similar across weight pattern groups in women with obesity, however healthy weight and overweight FWC gained more weight than women who did not weight cycle. We found no difference in overall mental health scores between groups, but both LFWC and FWC had higher odds of depressive symptoms (adjusted OR 1.5, 95%CI: 1.1 to 1.9 and 1.7, 95%CI: 1.1 to 2.4, respectively) than NWC. Our results suggest that, although weight cycling is not associated with greater weight gain in women with obesity, it may increase depressive symptoms.

Are large dinners associated with excess weight, and does eating a smaller dinner achieve greater weight loss? A systematic review and meta-analysis.

There are suggestions that large evening meals are associated with greater BMI. This study reviewed systematically the association between evening energy intake and weight in adults and aimed to determine whether reducing evening intake achieves weight loss. Databases searched were MEDLINE, PubMed, Cinahl, Web of Science, Cochrane Library of Clinical Trials, EMBASE and SCOPUS. Eligible observational studies investigated the relationship between BMI and evening energy intake. Eligible intervention trials compared weight change between groups where the proportion of evening intake was manipulated. Evening intake was defined as energy consumed during a certain time - for example 18.00-21.00 hours - or self-defined meal slots - that is 'dinner'. The search yielded 121 full texts that were reviewed for eligibility by two independent reviewers. In all, ten observational studies and eight clinical trials were included in the systematic review with four and five included in the meta-analyses, respectively. Four observational studies showed a positive association between large evening intake and BMI, five showed no association and one showed an inverse relationship. The meta-analysis of observational studies showed a non-significant trend between BMI and evening intake (P=0·06). The meta-analysis of intervention trials showed no difference in weight change between small and large dinner groups (-0·89 kg; 95 % CI -2·52, 0·75, P=0·29). This analysis was limited by significant heterogeneity, and many trials had an unknown or high risk of bias. Recommendations to reduce evening intake for weight loss cannot be substantiated by clinical evidence, and more well-controlled intervention trials are needed.

The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial.

BACKGROUND: Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type 2 diabetes mellitus. However, further research is needed to understand the effect of probiotics as a therapy for the treatment of metabolic diseases. An evidence-based multi-species probiotic was developed to encourage a shift in the gastrointestinal bacterial cohort from a disease-prone to a balanced state with the aim of improving metabolic markers associated with type 2 diabetes mellitus. METHODS: Sixty adults with a body mass index ≥25 kg/m2 with prediabetes or type 2 diabetes mellitus (diagnosed within the previous 12 months) will be enrolled in a double-blind, placebo-controlled pilot study. Participants will be randomized to a multi-species probiotic or placebo for 12 weeks. Both groups will receive lifestyle and nutritional advice. The primary outcome measure is the change between groups in fasting plasma glucose levels from baseline to 12 weeks. Secondary outcome measures include, but are not limited to, the change in lipid profile, systemic inflammation, gut permeability, and faecal microbial and metabolomic profiles. Blood and stool samples are collected at baseline and 12 weeks after treatment. DISCUSSION: Intentional manipulation of gastrointestinal microbial profiles may be useful for preventing and controlling type 2 diabetes mellitus and its associated metabolic complications. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12613001378718 . Registered on 16 December 2013.

Is self-weighing an effective tool for weight loss: a systematic literature review and meta-analysis.

BACKGROUND: There is a need to identify effective behavioural strategies for weight loss. Self-weighing may be one such strategy. PURPOSE: To examine the effectiveness of self-weighing for weight loss. METHODS: A systematic review and meta-analysis of randomised controlled trials that included self-weighing as an isolated intervention or as a component within an intervention. We used sub groups to analyse differences in frequency of weighing instruction (daily and weekly) and also whether including accountability affected weight loss. RESULTS: Only one study examined self-weighing as a single strategy and there was no evidence it was effective (-0.5 kg 95 % CI -1.3 to 0.3). Four trials added self-weighing/self-regulation techniques to multi-component programmes and resulted in a significant difference of -1.7 kg (95 % CI -2.6 to -0.8). Fifteen trials comparing multi-component interventions including self-weighing compared with no intervention or minimal control resulted in a significant mean difference of -3.4 kg (95 % CI -4.2 to -2.6). There was no significant difference in the interventions with weekly or daily weighing. In trials which included accountability there was significantly greater weight loss (p = 0.03). CONCLUSIONS: There is a lack of evidence of whether advising self-weighing without other intervention components is effective. Adding self-weighing to a behavioural weight loss programme may improve weight loss. Behavioural weight loss programmes that include self-weighing are more effective than minimal interventions. Accountability may improve the effectiveness of interventions that include self-weighing.

Study protocol: the effectiveness and cost effectiveness of a brief behavioural intervention to promote regular self-weighing to prevent weight regain after weight loss: randomised controlled trial (The LIMIT Study).

BACKGROUND: Although obesity causes many adverse health consequences, modest weight loss reduces the incidence. There are effective interventions that help people to lose weight but weight regain is common and long term maintenance remains a critical challenge. As a high proportion of the population of most high and middle income countries are overweight, there are many people who would benefit from weight loss and its maintenance. Therefore, we need to find effective low cost scalable interventions to help people achieve this. One such intervention that has shown promise is regular self-weighing, to check progress against a target, however there is no trial that has tested this using a randomised controlled design (RCT). The aim of this RCT is to evaluate the effectiveness and cost effectiveness of a brief behavioural intervention delivered by non-specialist staff to promote regular self-weighing to prevent weight regain after intentional weight loss. METHODS: A randomised trial of 560 adults who have lost ≥ 5 % of their initial body weight through a 12 week weight loss programme. The comparator group receive a weight maintenance leaflet, a diagram representing healthy diet composition, and a list of websites for weight control. The intervention group receive the same plus minimally trained telephonists will ask participants to set a weight target and encourage them to weigh themselves daily, and provide support materials such as a weight record card. The primary outcome is the difference between groups in weight change from baseline to 12 months. DISCUSSION: If effective, this study will provide public health agencies with a simple, low cost maintenance intervention that could be implemented immediately. TRIAL REGISTRATION: ISRCTN52341938 Date Registered: 31/03/2014.

A randomised controlled trial of the effectiveness of self-weighing as a weight loss intervention.

BACKGROUND: There is a need to find simple cost effective weight loss interventions that can be used in primary care. There is evidence that self-monitoring is an effective intervention for problem drinking and self-weighing might be an effective intervention for weight loss. PURPOSE: To examine the efficacy of daily self-weighing as an intervention for weight loss. METHODS: A randomised controlled trial of 183 obese adults, follow-up three months. The intervention group were given a set of weighing scales and instructed to weigh themselves daily and record their weight. Both groups received two weight loss consultations which were known to be ineffective. RESULTS: 92 participants were randomised to the intervention group and 91 to the control group. The intervention group lost 0.5 kg (95% CI 0.3 to 1.3 kg) more than the control group, but this was not significant. There was no evidence that self-weighing frequency was associated with more weight loss. CONCLUSIONS: As an intervention for weight loss, instruction to weigh daily is ineffective. Unlike other studies, there was no evidence that greater frequency of self-weighing is associated with greater weight loss. TRIAL REGISTRATION: ISRCTN05815264.

Which weight-loss programmes are as effective as Weight Watchers(R)?: non-inferiority analysis.

BACKGROUND: Three randomised controlled trials have provided strong evidence that Weight Watchers(®) is an effective weight-loss programme but there is insufficient evidence to determine whether three other weight-loss programmes are also effective. AIM: To examine whether other group-based weight-loss programmes were not inferior to Weight Watchers. DESIGN AND SETTING: A prospective cohort study using a non-inferiority analysis of 3290 adults referred through primary care. METHOD Participants who met the eligibility criteria for primary care obesity management treatment chose a free programme (Weight Watchers, Rosemary Conley Diet and Fitness Clubs, Slimming World or a NHS group programme) lasting 3 months; they were weighed at 3 months (programme end) and self-reported their weight at 12 months. RESULTS: At 3 months, weight loss achieved through Rosemary Conley and Slimming World was not inferior to Weight Watchers. The NHS group programme was inferior. At 12 months Slimming World and Rosemary Conley were not inferior to Weight Watchers, although participants using Slimming World lost significantly more weight than those using Weight Watchers. Data on the NHS group programme were inconclusive. CONCLUSION: In the short term all commercial weight-loss programmes appear to result in similar weight loss but the NHS alternative appears to produce less weight loss. At 12 months Slimming World led to greater weight loss but the differences between commercial programmes was small and of minor clinical importance.

Regular self-weighing to promote weight maintenance after intentional weight loss: a quasi-randomized controlled trial.

BACKGROUND: Many overweight people take action to lose weight but most regain this weight. PURPOSE: To examine the effectiveness of a weight maintenance intervention focused on regular self-weighing after receiving a 12-week weight loss programme. METHODS: Quasi-randomized controlled trial of 3768 obese or overweight men and women. The intervention group (n = 3290) received two telephone calls, the offer of free weighing scales, encouragement to weigh themselves weekly and record this on a card. The main outcome was change in weight between 3 and 12 months. RESULTS: Using intention to treat analysis both groups regained weight; however, the intervention group on average regained 1.23 kg, whereas the control group regained 1.83 kg. Adjusting for covariates resulted in a mean difference of 0.68 kg (95% CI 0.12, 1.24) at 12-month follow-up. CONCLUSIONS: Encouraging people who have recently lost weight to weigh themselves regularly prevents some weight regain.