Two-year outcomes of Whanau Pakari, a multi-disciplinary assessment and intervention for children and adolescents with weight issues: A randomized clinical trial.

OBJECTIVE: To determine whether 12-month BMI SDS reductions persisted at 24 months in a multi-disciplinary assessment and intervention program for children and adolescents with obesity, and whether secondary outcomes improved. METHODS: This was a community-based 12-month RCT in Aotearoa/New Zealand. Eligible participants were aged 5 to 16 years with BMI ≥98th centile or BMI >91st centile with weight-related comorbidities. The low-intensity control received comprehensive home-based baseline assessments and advice, and 6-monthly follow-up. The high-intensity intervention received the same assessments and advice, but also weekly multidisciplinary sessions. Primary outcome was BMI SDS at 12 months. Secondary outcomes included cardiovascular and metabolic markers. RESULTS: 121 participants (60% of participants at baseline) were assessed at 24 months. BMI SDS reduction at 12 months was lost at 24 months in the modified intention-to-treat analysis [Control -0.03 (95%CI -0.14, 0.09) and Intervention -0.02 (-0.12, 0.08); P = .93]. However, sweet drink intake was reduced, water intake increased, and there were improvements in cardiovascular fitness in the high-intensity intervention. ≥70% attendance in the high-intensity intervention resulted in a persistent BMI SDS reduction of -0.22 after 24 months (95%CI -0.38, -0.06). CONCLUSIONS: This trial was negative in terms of primary outcome at 24 months. However, high engagement led to sustained treatment effect, and there were multiple improvements in health measures.

The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state.

Diabetes prevalence has risen rapidly and has become a global health challenge. The Diabetes Prevention Program (DPP) has been shown to prevent or delay the development of diabetes among individuals with prediabetes. Yet, diabetes prevention studies within the Medicaid population are limited and results are mixed. This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State. A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. Study participants were offered a 16-week DPP with various incentive strategies based on class attendance and weight loss as follows: Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss. A control group was offered DPP with no incentives for attendance or weight loss. We evaluated the impact of incentives on achievement of the program completion and weight-loss milestone. Participants who received incentives for the Attendance-Only class were least likely to be lost to follow-up, more likely to complete the program, and had two times higher percentage of meeting the weight-loss milestone compared to the control group. Results for the other incentive cohorts were mixed. A strong positive association was observed for participants who attended 9 or more classes and weight-loss regardless of incentive strategies. Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone. However, the results from this study indicate that participant enrollment and retention remained challenges despite the incentives.

The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.

BACKGROUND: Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors. PURPOSE: Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older. METHODS: Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months. CONCLUSIONS: If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.

DIAL now protocol: A randomized trial examining the provision of phone coaching to those with sub-optimal early weight loss during an Internet weight management program.

BACKGROUND: While low-intensity Internet-delivered weight loss (IDWL) programs are efficacious, many patients fail to achieve clinically significant weight loss (WL). Given the positive association between 4-week and post-treatment WL, providing a more intensive intervention for those with sub-optimal 4-week WL may improve outcomes for a greater proportion of individuals. This stepped-care approach would minimize cost by reserving more aggressive treatment for those with sub-optimal early WL. OBJECTIVE: This randomized trial examines whether the provision of brief or extended phone coaching for those with sub-optimal early WL improves 4- and 12-month WL when compared to no coaching. Secondary aims include examination of cost/kg WL and intervention engagement. METHODS: 450 individuals (age 18-70 years, BMI: 25-45 kg/m2) will be randomized to: 1) IDWL+3 weeks of coaching ('Brief'), 2) IDWL+12 weeks of coaching ('Extended'), or 3) IDWL only ('Control'). All individuals will receive a 4-month IDWL program followed by an 8-month IDWL maintenance program. At week 4, individuals will be classified as early sub-optimal responders (<4% WL) or initial responders (≥4% WL). Individuals with sub-optimal early WL randomized to 'Brief' or 'Extended' will receive 3 and 12 weeks of phone coaching respectively, starting at week 5. Those with sub-optimal early WL randomized to 'Control', and initial responders will not receive any coaching. Assessments will occur at 4 and 12 months. DISCUSSION: Study findings can inform the development of more effective IDWL programs. This model which provides additional support to those with sub-optimal early WL can easily be translated into healthcare and community settings.

Insurance Coverage Criteria for Bariatric Surgery: A Survey of Policies.

BACKGROUND: Bariatric surgery remains underutilized at a national scale, and insurance company reimbursement is an important determinant of access to these procedures. We examined the current state of coverage criteria for bariatric surgery set by private insurance companies. METHODS: We surveyed medical policies of the 64 highest market share health insurance providers in the USA. ASMBS guidelines and the CMS criteria for pre-bariatric evaluation were used to collect private insurer coverage criteria, which included procedures covered, age, BMI, co-morbidities, medical weight management program (MWM), psychosocial evaluation, and a center of excellence designation. We derive a comprehensive checklist for pre-bariatric patient evaluation. RESULTS: Sixty-one companies (95%) had defined pre-authorization policies. All policies covered the RYGB, and 57 (93%) covered the LAGB or the SG. Procedures had coverage limited to center of excellence in 43% of policies (n = 26). A total of 92% required a BMI of 40 or above or of 35 or above with a co-morbidity; however, 43% (n = 23) of policies covering adolescents (n = 36) had a higher BMI requirement of 40 or above with a co-morbidity. Additional evaluation was required in the majority of policies (MWM 87%, psychosocial evaluation 75%). Revision procedures were covered in 79% (n = 48) of policies. Reimbursement of a second bariatric procedure for failure of weight loss was less frequently found (n = 41, 67%). CONCLUSIONS: A majority of private insurers still require a supervised medical weight management program prior to approval, and most will not cover adolescent bariatric surgery unless certain criteria, which are not supported by current evidence, are met.

Self-efficacy and Physical Activity in Overweight and Obese Adults Participating in a Worksite Weight Loss Intervention: Multistate Modeling of Wearable Device Data.

BACKGROUND: Physical activity is associated with a reduced risk of numerous types of cancer and plays an important role in maintaining a healthy weight. Wearable physical activity trackers may supplement behavioral intervention and enable researchers to study how determinants like self-efficacy predict physical activity patterns over time. METHODS: We used multistate models to evaluate how self-efficacy predicted physical activity states among overweight and obese individuals participating in a 26-week weight loss program (N = 96). We specified five states to capture physical activity patterns: (i) active (i.e., meeting recommendations for 2 weeks), (ii) insufficiently active, (iii) nonvalid wear, (iv) favorable transition (i.e., improvement in physical activity over 2 weeks), and (v) unfavorable transition. We calculated HRs of transition probabilities by self-efficacy, body mass index, age, and time. RESULTS: The average prevalence of individuals in the active, insufficiently active, and nonvalid wear states was 13%, 44%, and 16%, respectively. Low self-efficacy negatively predicted entering an active state [HR, 0.51; 95% confidence interval (CI), 0.29-0.88]. Obesity negatively predicted making a favorable transition out of an insufficiently active state (HR, 0.61; 95% CI, 0.40-0.91). Older participants were less likely to transition to the nonvalid wear state (HR, 0.53; 95% CI, 0.30-0.93). Device nonwear increased in the second half of the intervention (HR, 1.73; 95% CI, 1.07-2.81). CONCLUSIONS: Self-efficacy is an important predictor for clinically relevant physical activity change in overweight and obese individuals. Multistate modeling is useful for analyzing longitudinal physical activity data. IMPACT: Multistate modeling can be used for statistical inference of covariates and allow for explicit modeling of nonvalid wear.See all articles in this CEBP Focus section, "Modernizing Population Science."

Linking two randomised controlled trials for Healthy Beginnings©: optimising early obesity prevention programs for children under 3 years.

BACKGROUND: Beginning in 2017 we have conducted a 3-arm randomised controlled trial (RCT) to determine the effectiveness of an early obesity intervention in the first two years of life using either telephone or Short Message Service (SMS) support for mothers. The trial recruited 1155 mothers from their third trimester of pregnancy. This protocol is for a new trial to build on the existing trial using the mother-child dyads retained at 24 months for recruitment to the new RCT. The aim of this new trial is to test whether use of a combination of telephone and SMS interventions is effective in promoting healthy eating and physical activity, as well as reducing child body mass index (BMI) at 3 years of age. METHODS: We will conduct a parallel RCT with an estimated sample of 750 mother-child dyads retained from the existing trial at 24 months. Mothers who completed the 24 months survey, including a telephone survey and measurement of child's height and weight will be invited to participate in the new trial. Informed consent will be obtained at the 24 months survey. The participating mother-child dyads will then be randomly allocated to the intervention (combined telephone and text messaging intervention) or the control group. The intervention will comprise three staged telephone consultations and text messages after each of the three intervention booklets is mailed to mothers at specific time-points between two and three years of child age. The main trial outcome measures include a) BMI and BMI z-score measured at 36 months, b) diet, physical activity and screen time c) cost-effectiveness, and d) feasibility and acceptability of the intervention. DISCUSSION: This unique opportunity to link two studies will expedite project start up time, utilise existing research infrastructure and systems to run the study, and optimise the use of an already engaged population of study participants. It can address a significant knowledge gap regarding early obesity prevention for children aged 2 to 3 years. The feasibility and effectiveness of the combined telephone and SMS intervention will indicate whether this is a scaleable, broad-reach and low-cost early obesity intervention. TRIAL REGISTRATION: The trial was registered with the Australian Clinical Trial Registry ( ACTRN12618001571268 ) on 20/09/2018.

Factors affecting access and use of preventive and weight management care: A public health lens.

Obesity is an important risk factor for various chronic diseases. While people with obesity use the health system more and incur higher costs, they may forego using preventive care services (e.g., gynecological cancer screenings) due to issues of service use and service access. The aim of this paper was to use a public health lens to elucidate system level factors that affect healthcare access and utilization for preventive and weight management care by patients with obesity. Some elucidated factors include lack of access to a Primary Care Provider (PCP) and multidisciplinary healthcare settings, gender of the PCP, duration of medical visits and health professionals' attitudes about obesity. We highlight potential strategies for leaders to use when improving access and use of health services by patients with obesity in Canada and the need for future empirical studies in this research area.

Incentivizing healthy lifestyle behaviors to reduce cardiovascular risk in people with serious mental illness: An equipoise randomized controlled trial of the wellness incentives program.

BACKGROUND: Medicaid recipients with serious mental illness die 25-30 years earlier than people in the general population due to health conditions that are modifiable through lifestyle changes. Cardiovascular diseases from excess weight, smoking, and sedentary lifestyle contribute substantially to this life expectancy disparity. The current study evaluated the impact of incentives on participation in weight management programming (for overweight and obese adults) and smoking cessation treatment (for regular smokers). METHODS: Participants were Medicaid recipients with disabling mental illness receiving services at any one of 10 community mental health centers across New Hampshire. Using an equipoise stratified randomized design, n = 1348 were enrolled and assigned to one of four weight management programs (Healthy Choices Healthy Changes: HCHC) and n = 661 were enrolled and assigned to one of three smoking cessation interventions (Breathe Well Live Well: BWLW). Following assignment to an intervention, participants were randomized to receive financial incentives (to attend weight management programs, or to achieve abstinence from smoking) or not. Data were collected at baseline and every 3 months for 12 months. DISCUSSION: New Hampshire's HCHC and BWLW programs were designed to address serious and preventable health disparities by providing incentivized health promotion programs to overweight/obese and/or tobacco-smoking Medicaid beneficiaries with mental illness. This study was an unprecedented opportunity to evaluate an innovative statewide implementation of incentivized health promotion targeting the most at-risk and costly beneficiaries. If proven effective, this program has the potential to serve as a national model for widespread implementation.

Influence of subsidies and promotional strategies on outcomes in a beneficiary-based commercial weight-loss programme.

To determine whether initial engagement, continued participation, and weight loss vary by subsidy and promotional strategies in a beneficiary-based, commercial weight-loss programme. We conducted a retrospective analysis of data from 2013 to 2016. Our dependent variables included initial engagement (≥1 calls; ≥2 weights), coach calls and weight change. Our independent variables were subsidy strategy (total subsidy (n = 9) vs cost sharing (n = 3)) and combination of promotional-subsidy strategies (mixed campaign + total subsidy (n = 6) vs mass media + total subsidy (n = 3)). We used logistic and linear regression analyses adjusted for beneficiary factors and clustering by organization. From 12 participating organizations, 26 068 beneficiaries registered of which 6215 initially engaged. Cost sharing was associated with significantly greater initial engagement as compared to total subsidy (OR 3.73, P < 0.001); however, no significant between-group differences existed in calls or weight change. Mass media + total subsidy group had significantly greater calls and weight loss at 12 months compared to mixed campaign + total subsidy (-2.6% vs -1.8%, P = 0.04). Cost sharing may promote greater initial engagement, although does not contribute to better participation or weight loss relative to total subsidy. If organizations elect total subsidy, then pairing this strategy with a mass media campaign may promote greater participation and weight loss among beneficiaries.

Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers.

Weight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus, the workplace offers a useful setting to target low-SES workers. The current paper presents the design of a study testing a workplace intervention aimed at low-SES employees. Partnering with a large healthcare system and affiliated university, this project will test an innovative multi-level intervention ("Working for You") adapted from existing group- and individual-level intervention models to promote healthy weight among low-wage workers. The individual-level component is an interactive obesity treatment approach (iOTA) program that involves assessment of behavior risks, collaborative goal-setting with a health coach, and interactive SMS text-messages for ongoing support and self-monitoring. This mHealth intervention is embedded in the group-level component, a workplace participatory program that involves worker teams engaged in the design and implementation of interventions to change their workplace environments. These nested interventions are being tested in a group-randomized trial among 22 work groups (~1000 total workers, ~300 workers with obesity). The primary outcome will be program effects on weight at 2-year follow-up, compared to control, and the secondary outcomes will be effects on diet and physical activity; iOTA adherence, process measures, and work environment/support will also be examined. This pragmatic clinical trial will test scalable interventions that can be translated to other work settings to reduce obesity and related health risks among low-SES workers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02934113.

How does whole of government action address inequities in obesity? A case study from Australia.

BACKGROUND: There are many factors across different sectors that contribute to inequities in obesity levels. This implies the need for action across different government departments and policy domains (hereafter referred to as whole of government multisectoral action). In this study we explored the public policy attention given to inequities in obesity using an Australian case study. METHODS: Interviews were conducted with 33 stakeholders involved in the development and implementation of the whole of government Healthy Weight Initiative (HWI). A thematic analysis was undertaken to identify ways in which government policy makers and implementers explicitly or implicitly described how actions delivered through the HWI addressed inequities in obesity within the population. RESULTS: The analysis revealed that the focus of the HWI was predominantly aimed at the general population, with minimal attention given to addressing the social distribution of obesity. The reasons for this were explained in terms of five themes: (1) rationale for a population wide approach; (2) when to apply an equity lens, (3) issues of government responsibility, (4) philosophically opposing concepts of equity, and (5) tensions across departments as a result of competing concepts of equity. CONCLUSIONS: It is important to create a shared understanding plus a concern for addressing inequities in public policy, regardless of whether or not a universal population-wide or a targeted approach is being applied. It is also important that policies and programs address the social distribution of obesity while understanding local contexts and needs. In striving to develop policy that brings an explicit focus on health equity, policymakers must consider the sociological, political, economic, and philosophical tensions at play between different policy actors and government departments, and identify how to navigate these without reverting to siloed working.

Effect of Process- and Outcome-Based Financial Incentives on Weight Loss Among Prediabetic New York Medicaid Patients: A Randomized Clinical Trial.

PURPOSE: To determine whether different financial incentives are effective in promoting weight loss among prediabetic Medicaid recipients. DESIGN: Four-group, multicenter, randomized clinical trial. SETTING AND PARTICIPANTS: Medicaid managed care enrollees residing in New York, aged 18 to 64 years, and diagnosed as prediabetic or high risk for diabetes (N = 703). INTERVENTION: In a 16-week program, participants were randomly assigned to one of 4 arms: (1) control (no incentives), (2) process incentives for attending weekly Diabetes Prevention Program sessions, (3) outcome incentives for achieving weekly weight loss goals, and (4) combined process and outcome incentives. MEASURES: Weight loss over a 16-week period; proportion who completed educational sessions; proportion who met weight loss goals. ANALYSIS AND RESULTS: No intervention arm achieved greater reduction in weight than control (outcome incentive -6.6 lb [-9.1 to -4.1 lb], process incentive -7.3 lb [-9.5 to -5.1 lb], combined incentive -5.8 lb [-8.8 to -2.8 lb], control -7.9 lb [-11.1 to -4.7 lb]; all P > .29). Session attendance in the process incentive arm (50%) was significantly higher than control (31%; P < .0001) and combined incentive arms (28%; P < .0001), but not significantly higher than the outcome incentive arm (38%). CONCLUSION: Process incentives increased session attendance, but when combined at half strength with outcome incentives did not achieve that effect. There were no significant effects of either process or outcomes incentives on weight loss.

A description of health care system factors in the implementation of universal weight management services for children with overweight or obesity: case studies from Queensland and New South Wales, Australia.

BACKGROUND: The prevalence of childhood obesity poses an urgent global challenge. The World Health Organization (WHO) Commission on Ending Childhood Obesity recommends the provision of appropriate family-based, lifestyle weight management services through universal health care to support families of children with overweight or obesity; however, there are few examples of their implementation 'at scale'. The purpose of this research was to compare and contrast the impact of system and organisational factors on the implementation of childhood obesity management services within two Australian States (New South Wales and Queensland) to comprehensively describe their influence on the achievement of the WHO recommendation. METHODS: Purposeful stratified sampling was used to select health service study sites (n = 16) representative of program implementation (none, discontinued, repeated) and geographic location within each State. Within each health service site, staff involved in program delivery, co-ordination and management roles participated (n = 39). An additional 11 staff involved in implementation at State level also participated. The Consolidated Framework for Implementation Research (CFIR) was used to develop interview scripts. Telephone interviews were recorded and transcribed. Transcripts were thematically coded and scored according to CFIR constructs and rating rules to identify enablers and barriers to implementation according to sample characteristics. RESULTS: New South Wales achieved ongoing implementation; Queensland did not. Enablers included a quality evidence-based program, State government recognition of the urgency of the health issue and a commitment to address it, formally appointed and funded internal implementation leaders, strong communication and reporting at all levels. Barriers included the complexity of the health issue, in particular a lack of clear roles and responsibilities for local health service delivery, inadequate ongoing funding and challenges in meeting the diverse needs of families. CONCLUSIONS: This research is an important progression of the evidence base in relation to the translation of childhood obesity management trials into routine health service delivery. Understanding enablers and barriers to program implementation 'at scale' is imperative to inform future planning and investment by Australia and WHO member states to meet their commitment to deliver childhood weight management services as part of universal health coverage.

A narrative account of implementation lessons learnt from the dissemination of an up-scaled state-wide child obesity management program in Australia: PEACH™ (Parenting, Eating and Activity for Child Health) Queensland.

BACKGROUND: PEACH™QLD translated the PEACH™ Program, designed to manage overweight/obesity in primary school-aged children, from efficacious RCT and small scale community trial to a larger state-wide program. This paper describes the lessons learnt when upscaling to universal health coverage. METHODS: The 6-month, family-focussed program was delivered in Queensland, Australia from 2013 to 2016. Its implementation was planned by researchers who developed the program and conducted the RCT, and experienced project managers and practitioners across the health continuum. The intervention targeted parents as the agents of change and was delivered via parent-only group sessions. Concurrently, children attended fun, non-competitive activity sessions. Sessions were delivered by facilitators who received standardised training and were employed by a range of service providers. Participants were referred by health professionals or self-referred in response to extensive promotion and marketing. A pilot phase and a quality improvement framework were planned to respond to emerging challenges. RESULTS: Implementation challenges included engagement of the health system; participant recruitment; and engagement. A total of 1513 children (1216 families) enrolled, with 1122 children (919 families) in the face-to-face program (105 groups in 50 unique venues) and 391 children (297 families) in PEACH™ Online. Self-referral generated 68% of enrolments. Unexpected, concurrent and, far-reaching public health system changes contributed to poor program uptake by the sector (only 56 [53%] groups delivered by publicly-funded health organisations) requiring substantial modification of the original implementation plan. Process evaluation during the pilot phase and an ongoing quality improvement framework informed program adaptations that included changing from fortnightly to weekly sessions aligned with school terms, revision of parent materials, modification of eligibility criteria to include healthy weight children and provision of services privately. Comparisons between pilot versus state-wide waves showed comparable prevalence of families not attending any sessions (25% vs 28%) but improved number of sessions attended (median = 5 vs 7) and completion rates (43% vs 56%). CONCLUSIONS: Translating programs developed in the research context to enable implementation at scale is complex and presents substantial challenges. Planning must ensure there is flexibility to accommodate and proactively manage the system changes that are inevitable over time. TRIAL REGISTRATION: ACTRN12617000315314 . This trial was registered retrospectively on 28 February, 2017.

It's not just 'What' you do, it's also the 'Way' that you do it: Patient and Public Involvement in the Development of Health Research.

PURPOSE: This article presents a reflective account of Patient and Public Involvement (PPI) in the development of obesity and binge eating research. METHOD: We established Patient Advisory Groups (PAGs) at two English regional National Health Service (NHS) weight management services. PPI was evaluated as follows: (i) PAG members completed a Post Participation Evaluation Questionnaire, (ii) PAG meetings captured group discussion on PPI involvement, (iii) practitioner and researchers produced written reflections on PPI and (iv) sources one to three were consolidated during reflections that took place via e-mail and telephone correspondence between researchers and practitioners, culminating in a summary SKYPE meeting between one practitioner and one researcher involved in the PAGs. RESULTS: Results in the form of reflections suggest guidelines on undertaking PPI were helpful with regard 'what to do', but less helpful on 'how'. For example, suggestions for the management of interpersonal factors such as eliciting self-disclosure and managing power differentials are insufficiently addressed in existing guidelines. CONCLUSIONS: The present case study illustrated how interpersonal considerations can help or hinder the optimal use of PPI. Recommendations for practitioners and researchers planning PPI are offered.

Parent Recommendations to Enhance Enrollment in Multidisciplinary Clinical Care for Pediatric Weight Management.

OBJECTIVE: To explore parents' recommendations to enhance enrollment in multidisciplinary clinical care for managing pediatric obesity. STUDY DESIGN: Data for this interpretative description study were collected through individual, semistructured interviews that were audiorecorded, transcribed verbatim, and analyzed thematically. Parents (n = 79) were recruited from 4 multidisciplinary weight management clinics in Canada located in Edmonton, Hamilton, Montreal, and Vancouver. RESULTS: Most interviewed parents had children with obesity (body mass index ≥95th percentile; 84.2%), were female (87.3%), had postsecondary education (69.6%), and were white (75.9%). Parents' recommendations referred to enrollment opportunities, information about obesity services, motivation for treatment, and accessibility to obesity services. Specifically, parents recommended to increase referral options and follow-up contacts with families during the enrollment process, inform referring physicians and families about the availability and characteristics of obesity services, enhance families' motivation for treatment, prevent families from getting discouraged, make services more appealing to families, and address accessibility issues (eg, offering multiple options for appointment times, providing support for transportation). CONCLUSIONS: Parents' recommendations support the need for family-centered approaches to enhance enrollment; however, their feasibility, acceptability, and effectiveness remain to be tested empirically.

Weight and Veterans' Environments Study (WAVES) I and II: Rationale, Methods, and Cohort Characteristics.

PURPOSE: To present the rationale, methods, and cohort characteristics for 2 complementary "big data" studies of residential environment contributions to body weight, metabolic risk, and weight management program participation and effectiveness. DESIGN: Retrospective cohort. SETTING: Continental United States. PARTICIPANTS: A total of 3 261 115 veterans who received Department of Veterans Affairs (VA) health care in 2009 to 2014, including 169 910 weight management program participants and a propensity score-derived comparison group. INTERVENTION: The VA MOVE! weight management program, an evidence-based lifestyle intervention. MEASURES: Body mass index, metabolic risk measures, and MOVE! participation; residential environmental attributes (eg, food outlet availability and walkability); and MOVE! program characteristics. ANALYSIS: Descriptive statistics presented on cohort characteristics and environments where they live. RESULTS: Forty-four percent of men and 42.8% of women were obese, whereas 4.9% of men and 9.9% of women engaged in MOVE!. About half of the cohort had at least 1 supermarket within 1 mile of their home, whereas they averaged close to 4 convenience stores (3.6 for men, 3.9 for women) and 8 fast-food restaurants (7.9 for men, 8.2 for women). Forty-one percent of men and 38.6% of women did not have a park, and 35.5% of men and 31.3% of women did not have a commercial fitness facility within 1 mile. CONCLUSION: Drawing on a large nationwide cohort residing in diverse environments, these studies are poised to significantly inform policy and weight management program design.

Impact of a Weight Management Intervention on Eating Competence: Importance of Measurement Interval in Protocol Design.

PURPOSE: To examine changes in eating competence (EC) in 12-month weight loss intervention. DESIGN: Randomized, parallel-arm with weight loss phase (baseline to month 4) and weight-maintenance phase (months 4-12). SETTING: Face-to-face in University classrooms, supervised and self-directed fitness sessions at University fitness center, and home. PARTICIPANTS: Premenopausal, mostly college-educated Pennsylvania women, body mass index >25 (n = 101). INTERVENTION: Twenty-eight, 1-hour classes tailored for extremes of the Dietary Guidelines' fat recommendations, based on social cognitive theory, problem-based learning delivery over 12 months. Exercise component included supervised and self-directed stretching, aerobics, and strength training. MEASURES: Anthropometrics, lipid profile, blood pressure, 24-hour dietary recalls, cognitive behavioral measures, Satter Eating Competence Inventory (ecSI). ANALYSIS: General linear model repeated measures analysis of variance for outcome variables. RESULTS: A total of 40% (n = 40) completed the ecSI. Overall, education and supervised exercise session attendance were 77% and 88%, respectively. Similar weight loss for lower and moderate fat groups (6.7 kg and 5.4 kg). The EC was unchanged baseline to month 4 but increased significantly from months 4 to 12, baseline to month 12 for both groups. The EC change baseline to month 12 was inversely associated with weight change from baseline to months 4 and 12. CONCLUSION: Weight management interventions, likely to introduce concerns with eating attitudes, behaviors, and foods, can reduce EC. Short-term measurement of EC change captures these consequent adjustments without opportunity to regain self-efficacy. Extending the measurement interval better reflects intervention impact on EC.

Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).