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BackgroundPeople with serious mental illness have high rates of obesity and related medical problems, and die years prematurely, most commonly from cardiovascular disease. Specialized, in-person weight management interventions result in weight loss in efficacy trials with highly motivated patients. In usual care, patient enrollment and retention are low with these interventions, and effectiveness has been inconsistent.ObjectiveTo determine whether computerized provision of weight management with peer coaching is feasible to deliver, is acceptable to patients, and is more effective than in-person delivery or usual care.DesignMixed-methods randomized controlled trial.ParticipantsTwo hundred seventy-six overweight patients with serious mental illness receiving care at a Veterans Administration medical center.InterventionsPatients were randomized to 1) computerized weight management with peer coaching (WebMOVE), 2) in-person clinician-led weight services, or 3) usual care. Both active interventions offered the same educational content.Main MeasuresBody mass index; and feasibility and acceptability of the intervention.Key ResultsAt 6 months, in obese patients (n = 200), there was a significant condition by visit effect (F = 4.02, p = 0.02). The WebMOVE group had an average estimated BMI change from baseline to 6 months of 34.9 ± 0.4 to 34.1 ± 0.4. This corresponds to 2.8 kg (6.2 lbs) weight loss (t = 3.2, p = 0.001). No significant change in BMI was seen with either in-person services (t = 0.10, p = 0.92), or usual care (t = −0.25, p = 0.80). The average percentage of modules completed in the WebMOVE group was 49% and in the in-person group was 41% (t = 1.4, p = 0.17). When non-obese patients were included in the analyses, there was a trend towards a condition by visit effect (F = 2.8, p = 0.06). WebMOVE was well received, while the acceptability of in-person services was mixed.ConclusionsComputerized weight management with peer support results in lower weight, and can have greater effectiveness than clinician-led in-person services. This intervention is well received, and could be feasible to disseminate.

Aims/hypothesisApproximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT).MethodsWithin-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs.ResultsMean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI –£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years.Conclusions/interpretationIncorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention.Trial registrationISRCTN03267836

Abstract Context Higher levels of insulin-like growth factor-1 (IGF-1) are associated with increased risk of cancers and higher mortality. Therapies that reduce IGF-1 have considerable appeal as means to prevent recurrence. Design Randomized, 3-parallel-arm controlled clinical trial. Interventions and Outcomes Cancer survivors with overweight or obesity were randomized to (1) self-directed weight loss (comparison), (2) coach-directed weight loss, or (3) metformin treatment. Main outcomes were changes in IGF-1 and IGF-1:IGFBP3 molar ratio at 6 months. The trial duration was 12 months. Results Of the 121 randomized participants, 79% were women, 46% were African Americans, and the mean age was 60 years. At baseline, the average body mass index was 35 kg/m2; mean IGF-1 was 72.9 (SD, 21.7) ng/mL; and mean IGF1:IGFBP3 molar ratio was 0.17 (SD, 0.05). At 6 months, weight changes were -1.0% (P = 0.07), -4.2% (P < 0.0001), and -2.8% (P < 0.0001) in self-directed, coach-directed, and metformin groups, respectively. Compared with the self-directed group, participants in metformin had significant decreases on IGF-1 (mean difference in change: -5.50 ng/mL, P = 0.02) and IGF1:IGFBP3 molar ratio (mean difference in change: -0.0119, P = 0.011) at 3 months. The significant decrease of IGF-1 remained in participants with obesity at 6 months (mean difference in change: -7.2 ng/mL; 95% CI: -13.3 to -1.1), but not in participants with overweight (P for interaction = 0.045). There were no significant differences in changes between the coach-directed and self-directed groups. There were no differences in outcomes at 12 months. Conclusions In cancer survivors with obesity, metformin may have a short-term effect on IGF-1 reduction that wanes over time.

This study presents the guideline and preliminary results of a randomized controlled community trial of group-based nutrition interventions for obesity management in Brazilian Primary Health Care (PHC), occurring between 2022 and 2023. Belo Horizonte PHC units were randomly sampled and allocated to the control (CG) or intervention group (IG). Participants were those in preparation with high self-efficacy, action, or maintenance stages of change for weight reduction who were willing to participate in groups. CG participants received usual care, while IG participants were allocated into two therapeutic groups (TGs): non-severe (TG1) or severe obesity (TG2). We analyzed demographics data, stages of change and self-efficacy for weight reduction, and intervention adherence. The six-month theory-based interventions included face-to-face groups (TG1:7; TG2:9) and phone messages and postcards delivered (TG1:4; TG2:5). There were 1120 participants. Most were women, with a median age of 61.4 years; 45.4% were in the maintenance stage of change for weight reduction, and 76.1% had high self-efficacy. A total of 350 groups were held, 13,473 phone calls made, and 1973 postcards delivered. The median adherence was 52.4%. The reach and adherence to groups demonstrate their viability and scalable potential for the treatment of obesity in Brazilian PHC, contributing to the strengthening of chronic disease management actions.

Background Obesity is a chronic disease characterized by excess body fat and is a risk factor for other chronic non-communicable diseases. Its multifactorial and complex nature makes its management a challenge for health services. This manuscript presents an investigation protocol that aims to analyze the effectiveness of collective nutritional interventions for obesity management applicable to primary health care. Methods Randomized Controlled Community Trial (RCCT) in a representative sample of users of the Programa Academia de Saúde (PAS), in Belo Horizonte, Minas Gerais, Brazil, with obesity. The research consists of four phases: (1) Screening to identify the participants eligible for the nutritional interventions (individuals with obesity, readiness for change to lose body weight, and willingness and interest to participate in a group activity for six months or more); (2) Baseline to characterize the participants; (3) Implementation of collective nutritional interventions; (4) Reassessment of the participants. Participants in the control group (CG) will receive the usual health service care, and participants in the intervention group (IG) will participate in collective nutritional interventions based on Therapeutic Group 1 (TG1) or Therapeutic Group 2 (TG2) of the “Instructive of Collective Approach for the obesity management in SUS”. Discussion The strengths of the study include its robust RCCT design, which allows for longitudinal analyses and is suitable for investigating causal hypotheses and applying strategies to improve adherence to interventions. Furthermore, the study included a representative sample of a public health service and aims to evaluate therapeutic proposals from the Brazilian Ministry of Health, which can contribute to implementation and extension in the national territory. Trial registration RBR-3vzsyqq and RBR-6pg682m.

ObjectivesTo examine the acceptability and feasibility of narrative text messages with or without financial incentives to support weight loss for men.DesignIndividually randomised three-arm feasibility trial with 12 months’ follow-up.SettingTwo sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD).ParticipantsMen with obesity (n=105) recruited through community outreach and general practitioner registers.InterventionsParticipants randomised to: (A) narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control.OutcomesAcceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data at 3, 6 and 12 months.Results105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2). Retention at 12 months was 74%. Fewer SMS+I participants (64%) completed 12-month assessments compared with SMS only (79%) and control (83%). Narrative texts were acceptable to many men, but some reported negative reactions. No evidence emerged that level of disadvantage was related to acceptability of narrative texts. Eleven SMS+I participants (31%) successfully met or partially met weight loss targets. The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30). Incentives were acceptable, but improving health was reported as the key motivator for weight loss. All groups lost weight (SMS+I: −2.51 kg (SD=4.94); SMS only: −1.29 kg (SD=5.03); control: −0.86 kg (SD=5.64) at 12 months).ConclusionsThis three-arm weight management feasibility trial recruited and retained men from across the socioeconomic spectrum, with the majority from areas of disadvantage, was broadly acceptable to most participants and feasible to deliver.Trial registration numberNCT03040518.

BackgroundSmall Changes (SC) is a weight management approach that demonstrated superior 12-month outcomes compared to the existing MOVE!® Weight Management Program at two Veterans Affairs (VA) sites. However, approaches are needed to help graduates of treatment continue to lose or maintain their weight over the longer term.ObjectiveThe purpose of the present study was to examine the effectiveness of a second year of low-intensity SC support compared to support offered by the usual care MOVE! programs.DesignFollowing participation in the year-long Aspiring to Lifelong Health in VA (ASPIRE-VA) randomized controlled trial, participants were invited to extend their participation in their assigned program for another year. Three programs were extended to include six SC sessions delivered via telephone (ASPIRE-Phone) or an in-person group (ASPIRE-Group), or 12 sessions offered by the MOVE! programs.ParticipantsThree hundred thirty-two overweight/obese veterans who consented to extend their participation in the ASPIRE-VA trial by an additional year.Main MeasuresTwenty-four-month weight change (kg).Key ResultsTwenty-four months after baseline, participants in all three groups had modest weight loss (−1.40 kg [−2.61 to −0.18] in the ASPIRE-Group, −2.13 kg [−3.43 to −0.83] in ASPIRE-Phone, and −1.78 kg [−3.07 to −0.49] in MOVE!), with no significant differences among the three groups. Exploratory post hoc analyses revealed that participants diagnosed with diabetes initially benefited from the ASPIRE-Group program (−2.6 kg [−4.37 to 0.83]), but experienced significant weight regain during the second year (+2.8 kg [0.92–4.69]) compared to those without diabetes.ConclusionsParticipants in all three programs lost weight and maintained a statistically significant, though clinically modest, amount of weight loss over a 24-month period. Although participants in the ASPIRE-Group initially had greater weight loss, treatment was not sufficient to sustain weight loss through the second year, particularly in veterans with diabetes. Consistent, continuous-care treatment is needed to address obesity in the VA.

BackgroundBehavioral treatment strategies improve adherence to lifestyle intervention for adults with obesity, but can be time and resource intensive when delivered via traditional face-to-face care. This study aimed to investigate the efficacy and optimal timing of using telephone calls and text message as adjunctive tools to support a community-based obesity management program.MethodThis 8-month randomized controlled crossover trial recruited 61 adults with class III obesity (BMI > 40 kg/m2) enrolled in a publicly funded obesity management service (OMS). Participants were randomly assigned to receive telephone and text message support in addition to standard OMS care, or standard OMS care alone. After 4 months, participants crossed over to the alternative sequence. The technological support was based on self-determination theory. Outcome measures included diet, physical activity, anthropometry, self-efficacy, and treatment self-regulation.ResultsTelephone and text message support improved lifestyle intervention adherence and clinical outcomes when compared with standard care. Participants who received the intervention in the first 4-month period lost 4.87 kg, compared with no weight loss (+ 0.38 kg) in the standard care only group. There was no evidence to indicate an optimal timing of the intervention, with both groups achieving significant results by the end of the intervention.ConclusionThese results suggest a high degree of promise for the incorporation of telephone and text message support into community-based obesity management services. The findings have the potential to improve existing practices and reduce the burden on the health care system by demonstrating a resource-effective improvement to obesity management service delivery.

IntroductionFamily-based behavioural weight management interventions are efficacious and widely used to address childhood obesity. Curriculum and strategies vary extensively and scale-up often depends on ensuring that the intervention fits the adoption context.Aims and objectivesTo evaluate the impact and implementation of a ‘made in British Columbia’ (BC) family-based early intervention programme (EIP) for 8–12 years old with overweight and obesity and their families.Methods and analysisA randomised waitlist-control trial will assess a 10-week interactive, family-based lifestyle intervention followed by four maintenance sessions, in BC, Canada. We aim to enrol 186 families. The blended intervention includes at least 26 contact hours between participants and programme providers, including interactive activities and educational materials through weekly 90-min group sessions, an online family portal, and self-directed family activities. Curricular content includes information and activities related to healthy eating, physical activity (PA), positive mental health, parenting practices and sleep hygiene. The waitlist control group will receive a modified programme with the same 10-week sessions in the family portal, and four group sessions. Families participate in data collection at baseline, postintervention (week 10) and follow-up (week 18). The primary outcome is to assess changes in child body mass index z-score at 10 weeks between the groups. Secondary outcomes include changes at 10 weeks between the groups in child and parent PA behaviour and skills, healthy eating behaviour, and mental health. Process evaluation will address reach, implementation and maintenance (baseline, 10-week and 18-week) using recruitment tracking forms, parent questionnaire, programme attendance tracking forms, leader feedback surveys, parents and children satisfaction surveys and postprogramme interviews with facilitators, stakeholders and parents. Intention-to-treat analyses will be conducted. Process evaluation will be analysed thematically.Ethics and disseminationStudy procedures were designed to address research and community needs and will follow ethical standards.Trial registration numberNCT03643341.

BackgroundWeight gain and other metabolic sequelae of antipsychotic medications can lead to medication non-adherence, reduced quality of life, increased costs, and premature mortality. Of the approaches to address this, behavioral interventions are less invasive, cost less, and can result in sustained long-term benefits.ObjectiveWe investigated behavioral weight management interventions for veterans with mental illness across four medical centers within the Veterans Affairs (VA) Healthcare System.DesignWe conducted a 12-month, multi-site extension of our previous randomized, controlled study, comparing treatment and control groups.ParticipantsVeterans (and some non-veteran women) diagnosed with mental illness, overweight (defined as having a BMI over 25), and required ongoing antipsychotic therapy.InterventionsOne group received “Lifestyle Balance” (LB; modified from the Diabetes Prevention Program) consisting of classes and individual nutritional counseling with a dietitian. A second group received less intensive “Usual Care” (UC) consisting of weight monitoring and provision of self-help.Main MeasuresParticipants completed anthropometric and nutrition assessments weekly for 8 weeks, then monthly. Psychiatric, behavioral, and physical assessments were conducted at baseline and months 2, 6, and 12. Metabolic and lipid laboratory tests were performed quarterly.Key ResultsParticipants in both groups lost weight. LB participants had a greater decrease in average waist circumference [F(1,1244) = 11.9, p < 0.001] and percent body fat [F(1,1121) = 4.3, p = 0.038]. Controlling for gender yielded statistically significant changes between groups in BMI [F(1,1246) = 13.9, p < 0.001]. Waist circumference and percent body fat decreased for LB women [F(1,1243) = 22.5, p < 0.001 and F(1,1221) = 4.8, p = 0.029, respectively]. The majority of LB participants kept food and activity journals (92%), and average daily calorie intake decreased from 2055 to 1650 during the study (p < 0.001).ConclusionsBehavioral interventions specifically designed for individuals with mental illness can be effective for weight loss and improve dietary behaviors. “Lifestyle Balance” integrates well with VA healthcare’s patient-centered “Whole Health” approach.ClinicalTrials.gov identifier NCT01052714.