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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.

Clinical control is difficult to achieve in obese patients with asthma. Bariatric surgery has been recommended for weight loss and to improve asthma control; however, the benefits of nonsurgical interventions have been poorly investigated. To examine the effect of exercise training in a weight-loss program on asthma control, quality of life, inflammatory biomarkers, and lung function. Fifty-five obese patients with asthma were randomly assigned to either a weight-loss program plus exercise (WL + E group, n = 28) or a weight-loss program plus sham (WL + S group, n = 27), where the weight-loss program included nutrition (caloric restriction) and psychological therapies. The WL + E group incorporated aerobic and resistance muscle training, whereas the WL + S group incorporated breathing and stretching exercises. The primary outcome was clinical improvement in asthma control over 3 months. Secondary outcomes included quality of life, lung function, body composition, aerobic capacity, muscle strength, and inflammatory/antiinflammatory biomarkers. After 3 months, 51 patients were analyzed. Compared with the WL + S group, the WL + E group demonstrated improved clinical control scores (median [25th to 75th percentile], -0.7 [-1.3 to -0.3] vs. -0.3 [-0.9 to 0.4]; P = 0.01) and greater weight loss (mean ± SD, -6.8% ± 3.5 vs. -3.1% ± 2.6; P < 0.001) and aerobic capacity (median [25th to 75th percentile], 3.0 [2.4 to 4.0] vs. 0.9 [-0.3 to 1.3] ml O  × kg  × min ; P < 0.001). These improvements in the WL + E group were also accompanied by improvements in lung function, antiinflammatory biomarkers, and vitamin D levels, as well as reductions in airway and systemic inflammation. Adding exercise to a short-term weight-loss program should be considered as a useful strategy for achieving clinical control of asthma in obese patients. Clinical trial registered with www.clinicaltrials.gov (NCT 02188940).

There is growing interest in the use of information communication technologies to treat obesity. An intervention delivered by smartphone could be a convenient, potentially cost-effective, and wide-reaching weight management strategy. Although there have been studies of texting-based interventions and smartphone applications (apps) used as adjuncts to other treatments, there are currently no randomized controlled trials (RCT) of a stand-alone smartphone application for weight loss that focuses primarily on self-monitoring of diet and physical activity. The aim of this pilot study was to collect acceptability and feasibility outcomes of a self-monitoring weight management intervention delivered by a smartphone app, compared to a website and paper diary. A sample of 128 overweight volunteers were randomized to receive a weight management intervention delivered by smartphone app, website, or paper diary. The smartphone app intervention, My Meal Mate (MMM), was developed by the research team using an evidence-based behavioral approach. The app incorporates goal setting, self-monitoring of diet and activity, and feedback via weekly text message. The website group used an existing commercially available slimming website from a company called Weight Loss Resources who also provided the paper diaries. The comparator groups delivered a similar self-monitoring intervention to the app, but by different modes of delivery. Participants were recruited by email, intranet, newsletters, and posters from large local employers. Trial duration was 6 months. The intervention and comparator groups were self-directed with no ongoing human input from the research team. The only face-to-face components were at baseline enrollment and brief follow-up sessions at 6 weeks and 6 months to take anthropometric measures and administer questionnaires. Trial retention was 40/43 (93%) in the smartphone group, 19/42 (55%) in the website group, and 20/43 (53%) in the diary group at 6 months. Adherence was statistically significantly higher in the smartphone group with a mean of 92 days (SD 67) of dietary recording compared with 35 days (SD 44) in the website group and 29 days (SD 39) in the diary group (P<.001). Self-monitoring declined over time in all groups. In an intention-to-treat analysis using baseline observation carried forward for missing data, mean weight change at 6 months was -4.6 kg (95% CI -6.2 to -3.0) in the smartphone app group, -2.9 kg (95% CI -4.7 to -1.1) in the diary group, and -1.3 kg (95% CI -2.7 to 0.1) in the website group. BMI change at 6 months was -1.6 kg/m(2) (95% CI -2.2 to -1.1) in the smartphone group, -1.0 kg/m(2) (95% CI -1.6 to -0.4) in the diary group, and -0.5 kg/m(2) (95% CI -0.9 to 0.0) in the website group. Change in body fat was -1.3% (95% CI -1.7 to -0.8) in the smartphone group, -0.9% (95% CI -1.5 to -0.4) in the diary group, and -0.5% (95% CI -0.9 to 0.0) in the website group. The MMM app is an acceptable and feasible weight loss intervention and a full RCT of this approach is warranted. ClinicalTrials.gov NCT01744535; http://clinicaltrials.gov/ct2/show/NCT01744535 (Archived by WebCite at http://www.webcitation.org/6FEtc3PVB).

Background Given the current worldwide epidemic of obesity , there is a demand for interventions with higher impact, such as those carried out in the primary health care (PHC) setting. Here we evaluate the effect of intervention performed according to the stages of change of the transtheoretical model (TTM) for weight management. Methods This randomized controlled trial in Brazilian PHC offered free physical exercise and nutrition education. The participants were women, aged 20 years or older who were obese or overweight, users in PHC service. The intervention group (IG, n  = 51) received the same orientation as the comparison group (CG, n  = 35) plus individual health counseling based on the TTM aimed at weight loss, which lasted 6 months. The outcome measures were anthropometric, food, and nutrient profiles. Inflammatory parameters were evaluated in a random subsample. The inter-group and intra-group differences were evaluated using interntion-to-treat analysis, and analysis of covariance (ANCOVA) used to assess intervention effectiveness. Results There was a difference between groups of − 1.4 kg (CI95%: − 2.5; − 0.3) in body weight after the intervention. About 97% of women in the IG reported benefits of the intervention and presented positive changes in diet, biochemical markers, and anthropometry. The IG showed better body mass index, resistine, and blood glucose results compared to the CG during follow-up. Conclusion The individualized TTM-based intervention, combined with usual care, was an effective strategy in PHC. These results should encourage the use of interdisciplinary practices; nevertheless, research to identify additional strategies is needed to address barriers to weight maintenance among obese low-income women. Trial registration The trial is registered with Brazilian clinical trials under the code: RBR-8t7ssv , Registration date: 12/12/2017 (retrospectively registered).

Recent evidence shows that sport settings can act as a powerful draw to engage men in weight loss. The primary objective of this pilot study was to test the feasibility of delivering and to evaluate preliminary efficacy of Aussie-FIT, a weight-loss program for men with overweight/obesity delivered in Australian Football League (AFL) settings, in preparation for a future definitive trial. This 6-month pilot trial took place in Perth, Australia. Participants were overweight/obese (Body Mass Index [BMI] ≥ 28 kg/m2), middle-aged (35-65 years old) men. Participants were recruited in May 2018, and the intervention took place between June and December 2018. The intervention involved 12 weekly 90-min face-to-face sessions, incorporating physical activity, nutrition, and behaviour change information and practical activities delivered by coaches at 2 clubs. Data were collected at baseline and immediately postintervention. For trial feasibility purposes, 6-month follow-ups were completed. Outcomes were differences in weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure at 3 months. Within 3 days of advertising at each club, 426 men registered interest; 306 (72%) were eligible. Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87) and randomised by a blinded researcher. Trial retention was 86% and 63% at 3- and 6-month follow-ups (respectively). No adverse events were reported. At 3 months, mean difference in weight between groups, adjusted for baseline weight and group, was 3.3 kg (95% CI 1.9, 4.8) in favour of the intervention group (p < 0.001). The intervention group's moderate-to-vigorous physical activity (MVPA) was higher than the control group by 8.54 min/day (95% CI 1.37, 15.71, p = 0.02). MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement. Aussie-FIT was feasible to deliver; participants increased physical activity, decreased weight, and reported improvements in other outcomes. Issues with retention were a limitation of this trial. In a future, fully powered randomised controlled trial (RCT), retention could be improved by conducting assessments outside of holiday seasons. Australian New Zealand Clinical Trials Registry: ACTRN12617000515392.

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.

The effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear. We aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity. This pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m , and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes. Among the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (-1.08 kg, 95% CI -1.41 to -0.75 vs -1.57 kg, 95% CI -1.92 to -1.22 vs -0.66 kg, 95% CI -0.98 to -0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs -3%, 95% CI -5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (-18%, 95% CI -23% to -13% vs -25%, 95% CI -30% to -20% vs -12%, 95% CI -16% to -8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04). The web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss. ClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445. RR2-10.2196/10.1186/s12889-018-5882-y.

While there has been an explosion of mobile device applications (apps) promoting healthful behaviors, including physical activity and sedentary patterns, surprisingly few have been based explicitly on strategies drawn from behavioral theory and evidence. This study provided an initial 8-week evaluation of three different customized physical activity-sedentary behavior apps drawn from conceptually distinct motivational frames in comparison with a commercially available control app. Ninety-five underactive adults ages 45 years and older with no prior smartphone experience were randomized to use an analytically framed app, a socially framed app, an affectively framed app, or a diet-tracker control app. Daily physical activity and sedentary behavior were measured using the smartphone's built-in accelerometer and daily self-report measures. Mixed-effects models indicated that, over the 8-week period, the social app users showed significantly greater overall increases in weekly accelerometry-derived moderate to vigorous physical activity relative to the other three arms (P values for between-arm differences = .04-.005; Social vs. Control app: d = 1.05, CI = 0.44,1.67; Social vs. Affect app: d = 0.89, CI = 0.27,1.51; Social vs. Analytic app: d = 0.89, CI = 0.27,1.51), while more variable responses were observed among users of the other two motivationally framed apps. Social app users also had significantly lower overall amounts of accelerometry-derived sedentary behavior relative to the other three arms (P values for between-arm differences = .02-.001; Social vs. Control app: d = 1.10,CI = 0.48,1.72; Social vs. Affect app: d = 0.94, CI = 0.32,1.56; Social vs. Analytic app: d = 1.24, CI = 0.59,1.89). Additionally, Social and Affect app users reported lower overall sitting time compared to the other two arms (P values for between-arm differences < .001; Social vs. Control app: d = 1.59,CI = 0.92, 2.25; Social vs. Analytic app: d = 1.89,CI = 1.17, 2.61; Affect vs. Control app: d = 1.19,CI = 0.56, 1.81; Affect vs. Analytic app: d = 1.41,CI = 0.74, 2.07). The results provide initial support for the use of a smartphone-delivered social frame in the early induction of both physical activity and sedentary behavior changes. The information obtained also sets the stage for further investigation of subgroups that might particularly benefit from different motivationally framed apps in these two key health promotion areas. ClinicalTrials.gov NCT01516411.

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.

In the few weight loss studies assessing diet quality, improvements have been minimal and recommended calculation methods have not been used. This secondary analysis of a parallel group randomised trial (regsitered: https://clinicaltrials.gov/ct2/show/NCT03367936) assessed whether self-monitoring with feedback (SM + FB) v. self-monitoring alone (SM) improved diet quality. Adults with overweight/obesity (randomised: SM n 251, SM + FB n 251; analysed SM n 170, SM + FB n 186) self-monitored diet, physical activity and weight. Real-time, personalised feedback, delivered via a study-specific app up to three times daily, was based on reported energy, fat and added sugar intake. Healthy Eating Index 2015 (HEI-2015) scores were calculated from 24-hour recalls. Higher scores represent better diet quality. Data were collected August 2018 to March 2021 and analysed spring 2022. The sample was mostly female (78·9 %) and white (85·4 %). At baseline, HEI-2015 total scores and bootstrapped 95 % CI were similar by treatment group (SM + FB: 63·11 (60·41, 65·24); SM: 61·02 (58·72, 62·81)) with similar minimal improvement observed at 6 months (SM + FB: 65·42 (63·30, 67·20); SM: 63·19 (61·22, 64·97)) and 12 months (SM + FB: 63·94 (61·40, 66·29); SM: 63·56 (60·81, 65·42)). Among those who lost ≥ 5 % of baseline weight, HEI-2015 scores improved (baseline: 62·00 (58·94, 64·12); 6 months: 68·02 (65·41, 71·23); 12 months: 65·93 (63·40, 68·61)). There was no effect of the intervention on diet quality change. Clinically meaningful weight loss was related to diet quality improvement. Feedback may need to incorporate more targeted nutritional content.