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Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were −3·26 kg (brief intervention), −4·75 kg (12-week programme), and −6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference −2·71 kg, 95% CI −3·86 to −1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (−2·14 kg, −3·05 to −1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY). For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term. National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

ObjectivesTo test the long-term effectiveness of a total diet replacement programme (TDR) for routine treatment of obesity in a primary care setting.MethodsThis study was a pragmatic, two-arm, parallel-group, open-label, individually randomised controlled trial in adults with obesity. The outcomes were change in weight and biomarkers of diabetes and cardiovascular disease risk from baseline to 3 years, analysed as intention-to-treat with mixed effects models.InterventionsThe intervention was TDR for 8 weeks, followed by food-reintroduction over 4 weeks. Behavioural support was provided weekly for 8 weeks, bi-weekly for the next 4 weeks, then monthly for 3 months after which no further support was provided. The usual care (UC) group received dietary advice and behavioural support from a practice nurse for up to 3 months.ResultsOutcome measures were collected from 179 (66%) participants. Compared with baseline, at 3 years the TDR group lost −6.2 kg (SD 9.1) and usual care −2.7 kg (SD 7.7); adjusted mean difference −3.3 kg (95% CI: −5.2, −1.5), p < 0.0001. Regain from programme end (6 months) to 3 years was greater in TDR group +8.9 kg (SD 9.4) than UC + 1.2, (SD 9.1); adjusted mean difference +6.9 kg (95% CI 4.2, 9.5) P < 0.001. At 3 years TDR led to greater reductions than UC in diastolic blood pressure (mean difference −3.3 mmHg (95% CI:−6.2; −0.4) P = 0.024), and systolic blood pressure (mean differences −3.7 mmHg (95% CI: −7.4; 0.1) P = 0.057). There was no evidence of differences between groups in the change from baseline to 3 years HbA1c (−1.9 mmol/mol (95% CI: −0.7; 4.5; P = 0.15), LDL cholesterol concentrations (0.2 mmol/L (95% CI −0.3, 0.7) P = 0.39), cardiovascular risk score (QRISK2) (−0.37 (95% CI −0.96; 0.22); P = 0.22).ConclusionsTreatment of people with obesity with a TDR programme compared with support from a practice nurse leads to greater weight loss which persists to at least 3 years, but there was only evidence of sustained improvements in BP and not in other aspects of cardiometabolic risk.

Long-term effects of COVID-19 infection, termed Long COVID (LC), are associated with reduced quality of life. Symptoms associated with overweight/obesity overlap with and may aggravate those of LC. This paper reports the economic evaluation alongside the ReDIRECT Trial, which evaluated the impact of an evidence-based, remotely-delivered weight management programme on self-reported symptoms of LC in those living with overweight/obesity in the United Kingdom. Recruited participants ( n  = 234) were randomly allocated to the intervention group (weight management) or control group (usual care). Incremental costs and Quality-Adjusted Life Years (QALYs) were calculated using intervention cost, healthcare resource use and EQ-5D-5L data collected at baseline, three and 6 months. In this work, we show that the ReDIRECT intervention is likely cost-effective in improving LC symptoms from an NHS/PSS perspective, compared to usual care (Incremental Cost-Effectiveness Ratio of £14,754/QALY). Adopting a broader societal perspective, the intervention becomes potentially cost saving compared to usual care. A recent randomised controlled trial demonstrated effectiveness of a remote diet intervention to reduce long covid symptoms in people living with overweight/obesity in the UK. Here, the authors assess the cost-effectiveness of this intervention from the health system and societal perspectives.

AbstractObjectiveTo test the effectiveness and safety of a total diet replacement (TDR) programme for routine treatment of obesity in a primary care setting.DesignPragmatic, two arm, parallel group, open label, individually randomised controlled trial.Setting10 primary care practices in Oxfordshire, UK.Participants278 adults who were obese and seeking support to lose weight: 138 were assigned to the TDR programme and 140 to usual care. 73% of participants were re-measured at 12 months.InterventionsThe TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months, with formula food products providing 810 kcal/day (3389 kJ/day) as the sole food during the first eight weeks followed by reintroduction of food. Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction.Main outcome measuresThe primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models. Secondary outcomes included biomarkers of cardiovascular and metabolic risk. Adverse events were recorded.ResultsParticipants in the TDR group lost more weight (−10.7 kg) than those in the usual care group (−3.1 kg): adjusted mean difference −7.2 kg (95% confidence interval −9.4 to −4.9 kg). 45% of participants in the TDR group and 15% in the usual care group experienced weight losses of 10% or more. The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group. 11% of participants in the TDR group and 12% in the usual care group experienced adverse events of moderate or greater severity.ConclusionsCompared with regular weight loss support from a practice nurse, a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable, and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease.Trial registrationInternational Standard Randomised Controlled Trials No ISRCTN75092026.

Background/objectiveMaintenance interventions inherently require BMI improvement to maintain. This overlooks individuals initially unresponsive to obesity interventions. Staged pediatric clinical treatment guidelines were adapted to the school setting to develop an escalated treatment option for individuals initially unresponsive. This staged randomized controlled trial examined differences between escalated treatment (Take CHARGE!) and a maintenance program (PE Planners). Take CHARGE was hypothesized to have greater improvements in BMI as a percentage of the 95th BMI Percentile (%BMIp95) than PE Planners.Subjects/methodsFrom 2018 to 2020, 171 middle and high schoolers (BMI Percentile ≥ 85) were recruited from a Houston school district to participate in a staged obesity intervention in their physical education (PE) class. After receiving a semester-long intensive lifestyle intervention (ILI) with established efficacy, all participants were randomized to Take CHARGE (n = 85) or PE Planners (n = 86). Take CHARGE escalated the behavioral treatment of obesity received in ILI with more frequent individual sessions, additional opportunities for parental and school staff involvement, and increased mentorship from trained college students. PE Planners allowed participants to decide how they wanted to be active in PE class. Mixed linear modeling examined %BMIp95 overtime between groups. This trial was registered at ClinicalTrials.gov (#NCT04362280).ResultsParticipants were 13.63 ± 1.32 years old; 59% were female, and 85% were Hispanic. Among those initially unresponsive to ILI, Take CHARGE had significantly greater decreases in %BMIp95 than PE Planners (β = −0.01, p < 0.01). Conversely, among those initially responsive, Take CHARGE had significantly smaller decreases in %BMIp95 than PE Planners (β = 0.02, p < 0.05). Intention-to-treat analysis had similar results.ConclusionsParticipant outcomes in semester two differed based on initial response. Individuals responsive to initial intervention were most likely to benefit from a maintenance intervention and those initially unresponsive benefited more from escalated treatment. This indicates the need for staged intervention protocols to better address obesity in the school setting.

Employers commonly use adjustments to health insurance premiums as incentives to encourage healthy behavior, but the effectiveness of those adjustments is controversial. We gave 197 obese participants in a workplace wellness program a weight loss goal equivalent to 5 percent of their baseline weight. They were randomly assigned to a control arm, with no financial incentive for achieving the goal, or to one of three intervention arms offering an incentive valued at $550. Two intervention arms used health insurance premium adjustments, beginning the following year (delayed) or in the first pay period after achieving the goal (immediate). A third arm used a daily lottery incentive separate from premiums. At twelve months there were no statistically significant differences in mean weight change either between the control group (whose members had a mean gain of 0.1 pound) and any of the incentive groups (delayed premium adjustment, -1.2 pound; immediate premium adjustment, -1.4 pound; daily lottery incentive, -1.0 pound) or among the intervention groups. The apparent failure of the incentives to promote weight loss suggests that employers that encourage weight reduction through workplace wellness programs should test alternatives to the conventional premium adjustment approach by using alternative incentive designs, larger incentives, or both.

The Ten Top Tips (10TT) is an intervention based on the habit formation theory that promotes a set of weight management behaviors alongside advice about repetition in a consistent context. Overall, 3 studies have demonstrated that the 10TT can support individuals to lose weight when delivered in a leaflet format. Delivery of 10TT via new technology such as a mobile app could potentially improve its effectiveness and make it more convenient, appealing, and wide reaching. This study aimed to provide preliminary indications of the usage, effectiveness, and acceptability of an Android app of the 10TT intervention (Top Tips only app) and a second version including self-regulatory strategies for dealing with tempting foods (Top Tips plus app). The 3-month pilot randomized adults with overweight or obesity to (1) Top Tips only app, (2) Top Tips plus app, or (3) waiting list condition. Automated data from app users were collected. Validated questionnaires assessed self-regulatory skills, weight loss (kg), and behaviors at baseline and 3 months. Users' feedback on their experience using the app was assessed using open questions. A total of 81 participants took part in the pilot; 28 participants were randomized to the Top Tips only app, 27 to the Top Tips plus app, and 26 to the waiting list condition. On average, participants viewed a mean of 43.4 (SD 66.9) screens during a mean of 24.5 (SD 44.07) log-ins and used the app for 124.2 (SD 240.2) min over the 3-month period. Participants randomized to the Top Tips only app reported the greatest improvement in self-regulatory skills (mean 0.59, SD 1.0), weight loss (mean 4.5 kg, SD 5.2), and adherence to the target behaviors (mean 0.59, SD 0.49) compared with the Top Tips plus (mean 0.15, SD 0.42; mean -1.9, SD 3.9; and mean 0.29, SD 0.29) and waiting list condition (mean -0.02, SD 0.29; mean -0.01, SD 0.51; and mean 0.08, SD 0.38). Participants who reported the largest improvements, on average, viewed pages 2 to 3 times more, had 2 to 3 times more log-ins, logged their weight 2 to 3 times more, and achieved the tips more than those who reported smaller changes in these outcomes. According to users' feedback, engagement with the app could be increased by making the app more interactive and allowing more tailoring. This study suggests that the Top Tips app could potentially be a useful intervention for promoting eating self-regulatory skills, weight loss, and weight management behaviors among adults with overweight or obesity. Future research should develop the app further based on user feedback and test it in larger sample sizes. ISRCTN Registry ISRCTN10470937; http://www.isrctn.com/ISRCTN10470937 (Archived by Webcite at http://www.webcitation.org/76j6rQibI).

Providing financial incentives has gained popularity as a strategy to promote weight loss, but questions remain about how best to utilize them. A promising mobile health strategy provides users with near-real-time financial incentives based on both the process of weight loss (behavioral modification) and actual weight loss. To maximize the impact of this strategy, a methodology is needed to close the gap between the desired behavior and the financial incentive. Leveraging mobile health tools-such as mobile phone apps, cellular body weight scales that transmit data to physicians and researchers, and text messaging for instructions and encouragement-has the potential to close this gap. This study aimed to describe the development of an innovative technology-based solution and lessons learned from a feasibility trial-Log2Lose-that encouraged individuals to lose weight by providing near-real-time financial incentives for weight loss and/or dietary self-monitoring. We recruited participants (N=96) with a body mass index greater than or equal to 30 kg/m for a 24-week weight loss trial. Participants received a behavioral intervention of biweekly, in-person group sessions and were instructed to log a minimum number of daily calories in MyFitnessPal and to step on the BodyTrace cellular scale at least twice per week. In a 2×2 design, participants were randomized into 4 groups to receive financial incentives for the following: (group 1) weekly weight loss and dietary self-monitoring, (group 2) dietary self-monitoring only, (group 3) weekly weight loss only, or (group 4) no financial incentives. Diet and weight data from the devices were obtained through application programming interfaces. Each week, we applied algorithms to participants' data to determine whether they qualified for a monetary incentive (groups 1-3). A text message notified these participants of whether they met weight loss and/or self-monitoring requirements to earn an incentive and the amount they earned or would have earned. The money was uploaded to a debit card. Our custom-engineered software platform analyzed data from multiple sources, collated and processed the data to send appropriate text messages automatically, and informed study staff of the appropriate incentives. We present lessons learned from the development of the software system and challenges encountered with technology, data transmission, and participants (eg, lost connections or delayed communication). With consistent and constant validation checks and a robust beta test run, the process of analyzing data and determining eligibility for weekly incentives can be mostly automated. We were able to accomplish this project within an academic health system, which required significant security and privacy safeguards. Our success demonstrates how this methodology of automated feedback loops can provide health interventions via mobile technology. ClinicalTrials.gov NCT02691260; https://clinicaltrials.gov/ct2/show/NCT02691260.

Gestational diabetes mellitus (GDM) is associated with a sevenfold increased lifetime risk of type 2 diabetes. Excessive gestational weight gain and postpartum weight retention are established predictors of long-term obesity. To determine the impact of a postnatal lifestyle intervention program for overweight women with previous gestational diabetes mellitus (PAIGE). Postnatal overweight women with previous GDM participated in a multicenter randomized controlled trial between June 2013 and December 2014. The intervention comprised a 1-hour educational program, a free 3-month referral to a commercial weight management organization (Slimming World), a pedometer, and structured telephone and text support, in addition to usual care. The control group received usual care only. The primary outcome was weight loss at 6 months. Sixty women were randomized (29 intervention; 31 control) in two centers based on their week of attendance. The intervention group demonstrated significant weight loss at 6 months after randomization compared with the control group: mean ±SD, 3.9 ± 7.0 kg vs 0.7 ±3.8 kg (P = 0.02). Blood glucose levels did not significantly differ. With respect to well-being measures, a bodily pain was significantly reduced in the intervention group (P = 0.007). PAIGE resulted in significantly greater weight loss at 6 months compared with usual care. Such weight loss could prove beneficial in terms of better long-term health and subsequent prevention of type 2 diabetes in overweight women with previous GDM. Future interventions must consider recruitment strategies, timing of the intervention, and inclusion of partners and/or other family members.

Metformin and weight loss relationships with epigenetic age measures—biological aging biomarkers—remain understudied. We performed a post-hoc analysis of a randomized controlled trial among overweight/obese breast cancer survivors ( N  = 192) assigned to metformin, placebo, weight loss with metformin, or weight loss with placebo interventions for 6 months. Epigenetic age was correlated with chronological age ( r  = 0.20–0.86; P  < 0.005). However, no significant epigenetic aging associations were observed by intervention arms. Consistent with published reports in non-cancer patients, 6 months of metformin therapy may be inadequate to observe expected epigenetic age deceleration. Longer duration studies are needed to better characterize these relationships. Trial Registration : Registry Name: ClincialTrials.Gov. Registration Number: NCT01302379. Date of Registration: February 2011. URL: https://clinicaltrials.gov/ct2/show/NCT01302379