"We're one small piece of the puzzle": evaluating the impact of short-term funding for tier two weight management services.

Introduction: Overweight and obesity are a global health epidemic and many attempts have been made to address the rising prevalence. In March 2021 the UK government announced £100 million of additional funding for weight management provisions. Of this, £30.5 million was split across local authorities in England to support the expansion of tier two behavioural weight management services for adults. The present work aimed to explore how this funding was used within the Yorkshire and Humber region to consolidate learning, collate best practice, and provide recommendations for future funding use. Method: One-hour semi-structured interviews were conducted with 11 weight management service commissioners representing 9 of the 15 local authorities in the region. Interviews were recorded, transcribed and analysed using an established health inequality framework. From this, recommendations were co-developed with the commissioner group to establish best practice for future funding use. Results: Commissioners recognised that targeted weight management services were only one small piece of the puzzle for effectively managing obesity. Therefore, recommendations include targeting underserved communities, focussing on early prevention, addressing weight management in a whole systems context, and embracing innovative and holistic approaches to weight management. Discussion: Current short-term funding and restrictive commissioning processes of tier two services prevents sustainable and innovative weight management practice which is detrimental to patients, falls short of addressing health inequalities and negatively impacts staff health and wellbeing.

Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial.

INTRODUCTION: The reproductive years can increase women's weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development. METHODS AND ANALYSIS: Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost-utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants' experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences. TRIAL REGISTRATION NUMBER: ISRCTN16299220.

"I Want a Program That Looks at My Whole Life." A Focus Group Study on the Ideal Components for an mHealth Weight Management Program for African American Women.

BACKGROUND: The high rate of obesity, ownership of smartphones, and online search for nutrition and dieting information among African American women (AAW) provide a unique opportunity to develop cost-effective, accessible, and acceptable mHealth weight management programs for them. Furthermore, they should participate in the development and evaluation of these programs. OBJECTIVE: To explore ideal components of a culturally relevant mHealth weight management program for AAW and to examine how these components may vary by age group. DESIGN: Twelve focus group triads were conducted with AAW in north central Florida. The framework method was used to manage, organize, synthesize, and analyze data themes by age groups: 18 to 29 (young), 30 to 50 (middle age), and 51+ (older). PARTICIPANTS/SETTING: Thirty-six smartphone owners who expressed a desire to lose weight were recruited through several community partnerships. RESULTS: Based on body mass index (BMI), young women were classified as overweight (BMI 26.23 ± 6.7), middle-aged women as obese (BMI30.72 ± 8.31), and older women as obese (BMI 31.03 ± 5.67). Most searched online for dieting information within the past 12 months. Five overarching themes for designing mHealth weight management programs were identified: (1) holistic program that goes beyond dieting; (2) social media integration for support and sense of community; (3) self-monitoring app; (4) two-way text messaging; and (5) programs of varying lengths and meaningful incentives. CONCLUSION: AAW were receptive to mHealth weight management programs, which may be appealing during and after the COVID-19 pandemic. Holistic programs of 4 to 6 weeks that addressed stress eating, had a social media component, and included a few educational texts per week may be appealing to AAW.

Financial implications of New York City's weight management initiative.

PURPOSE: To estimate potential annual savings in medical expenditures from a subsidized weight management program from the NYC Government perspective. DESIGN: Longitudinal observational study. SETTING: Employees of New York City (NYC) government and enrolled dependents. SAMPLE: 14,946 participants with overweight and obesity. INTERVENTION: WW (formerly Weight Watchers®) 'Workshop' and 'Digital' programs. MEASURES: Participation rate, enrollment duration, weight change, and predicted gross and net total and per capita medical expenditure savings and return on investment (ROI). ANALYSIS: Participation rate, enrollment duration, weight change, and program costs are based on direct observation. Predicted savings are simulated based on published data relating weight loss to medical expenditure reductions. RESULTS: In total, 47% of participating employees and 50% of participating dependents lost weight during the enrollment period. Mean (median) enrollment duration for employees was 7.1 months (7.0) and for dependents was 6.9 months (6.0). Mean (median) weight losses for the employees in 'Workshops' and 'Digital' was 6.6 lbs (2.80) and 6.3 lbs (0.0). For dependents, weight losses were 7.4 lbs (3.59) and 11.6 lbs (2.0). Per capita and total predicted net savings to NYC Government from employees was estimated to be $120 and $1,486,102 for an ROI of 143%. Including dependents, predicted net savings increases to $1,963,431 for an ROI of 189%. Over 80% of savings came from participants in the Obese III category. CONCLUSION: An evidence-based weight management program has the potential to generate a positive ROI for employers. Future studies should validate these estimates using actual data and more rigorous designs.

Pharmacoeconomics of obesity in China: a scoping review.

Background: With the growing rate of obesity and associated chronic conditions in China, there is a need to assess the health and economic burdens of obesity and examine the effectiveness of pharmaceutical, medical, and comprehensive weight-loss interventions.Areas covered: This article reviewed publications retrieved from PubMed and Google Scholar during 2010-2020 on pharmacoeconomic studies related to overweight and obesity in China. We identified five cost-of-illness studies and four cost-effectiveness analyses of weight-loss interventions, including bariatric surgeries and a comprehensive intervention program.Expert opinion: There is a lack of pharmacoeconomic analyses of obesity in China. Existing studies have often taken the health system perspective without accounting for productivity loss. Cohort studies and studies based on electronic health records or claims data are needed to provide the epidemiologic parameters required for homegrown economic evaluations of the health and economic burdens of obesity in China, as well as the cost-effectiveness of interventions to reduce obesity and its sequela.

Are education, exercise and diet interventions a cost-effective treatment to manage hip and knee osteoarthritis? A systematic review.

OBJECTIVE: To identify research gaps and inform implementation we systematically reviewed the literature evaluating cost-effectiveness of recommended treatments (education, exercise and diet) for the management of hip and/or knee OA. METHODS: We searched Medline, Embase, Cochrane Central Register of Controlled Trials, National Health Services Economic Evaluation Database, and EconLit from inception to November 2019 for trial-based economic evaluations investigating hip and/or knee OA core treatments. Two investigators screened relevant publications, extracted data and synthesized results. Risk of bias was assessed using the Consensus on Health Economic Criteria list. RESULTS: Two cost-minimization, five cost-effectiveness and 16 cost-utility analyses evaluated core treatments in six health systems. Exercise therapy with and without education or diet was cost-effective or cost-saving compared to education or physician-delivered usual care at conventional willingness to pay (WTP) thresholds in 15 out of 16 publications. Exercise interventions were cost-effective compared to physiotherapist-delivered usual care in three studies at conventional WTP thresholds. Education interventions were not cost-effective compared to usual care or placebo at conventional WTP thresholds in three out of four publications. CONCLUSIONS: Structured core treatment programs were clinically effective and cost-effective, compared to physician-delivered usual care, in five health care systems. Providing education about core treatments was not consistently cost-effective. Implementing structured core treatment programs into funded clinical pathways would likely be an efficient use of health system resources and enhance physician-delivered usual primary care.

[Closing the gap in conservative obesity therapy: a fully health insurance-financed obesity program - Prospective analysis of clinical real world data]. / Ausweg aus der Versorgungslücke: Voll Krankenkassen-finanzierte konservative Adipositas-Therapie.

BACKGROUND: The obesity treatment program "Leipziger Adipositasmanagement" is a long-term (i. e., four years long) conservative treatment program which is completely covered by a public health insurance company for patients with obesity grades 2 and 3 (i. e., body mass index > 35 kg/m2). Here we evaluate the effectiveness of the first part of the program which was on average 72 weeks long. METHODS: Body weight, body circumferences, metabolic and psychological parameters were collected prior to the start (t0) and after completion of the first part (t1). The whole first treatment part was completed by 243 persons. The analysis design was a prospective evaluation of clinical real world data. RESULTS: Treatment costs per patient were 2,022 € on average. There were significant clinically meaningful improvements from t0 to t1. On average, patients lost 5 kg (95 % confidence interval, KI 3.8 to 6.2 kg) or 4 % (KI 3.1 to 4.9 %) of their initial body weight. The hemoglobin A1c value decreased from 5.9 % to 5.6 % in all patients and from 6.7 % to 6.2 % in diabetic patients. Further metabolic (e. g., low density lipoprotein and total cholesterol) and psychological (e. g., quality of life) parameters improved significantly as well. CONCLUSIONS: The available real world data show, that an obesity treatment program, which is completely covered by a public health insurance company, can reach a clinically significant weight loss with metabolic improvements. The treatment program "Leipziger Adipositasmanagement" contributes to improving long-term treatment of obesity in Germany.

A Secondary Data Analysis Examining Young Adults' Performance in an Internet Weight Loss Program with Financial Incentives.

OBJECTIVE: In traditional behavioral weight loss (BWL) programs, young adults fare worse than older adults with respect to engagement, retention, and weight loss, but money and use of technology have been cited as program factors that might improve outcomes for this population. This study evaluated young adult performance in internet-based BWL (IBWL) offering financial incentives for self-monitoring and weight loss. METHODS: Participants (N = 180; BMI = 33.2 ± 6.0 kg/m2 ) were randomly assigned to a 12-week IBWL or IBWL + incentives (IBWL + $) group. This secondary data analysis compared young adults (ages 18-35) in IBWL (n = 16) with young adults in IBWL + $ (n = 12) on percent weight loss, engagement, and retention. Young adults (n = 28) were also compared with older adults (ages 36-70; n = 152) on these outcomes. RESULTS: Young adult weight loss was -2.8% ± 5.2% in IBWL and -5.4% ± 5.7% in IBWL + $ (P = 0.23, partial η2 = 0.06). A greater proportion of young adults in IBWL + $ achieved a 10% weight loss compared with IBWL (42% vs. 6%, P = 0.02). Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05). CONCLUSIONS: Findings suggest that technology-based BWL has the potential to eliminate weight loss disparities observed between young adults and older adults in in-person BWL trials. Moreover, adding financial incentives holds promise for promoting clinically meaningful weight loss for young adults.

Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand.

BACKGROUND: A healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Maori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training (FFIT), a weight management and healthy lifestyle program for overweight and obese men aged 35-65 years , delivered by community coaching staff at professional football clubs, has been shown to be beneficial and cost-effective. A pilot program inspired by FFIT but delivered by professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, improved physiological outcomes, and adherence to healthy lifestyle behaviors in overweight and obese men. The objective of this trial is to determine the effectiveness and cost-effectiveness of the Rugby Fans in Training New Zealand (RUFIT-NZ) program. METHODS: A pragmatic, two-arm, multi-center, randomized controlled trial involving 308 overweight and obese men aged 30-65 years, randomized to either an intervention group (n = 154) or a wait-list control group (n = 154). The intervention-group participated in the 12-week RUFIT-NZ program, a gender-sensitized, healthy lifestyle intervention adapted to the environment and cultural diversity of NZ and delivered through professional rugby clubs. Participants in the intervention group undergo physical training sessions, in addition to workshop-based sessions to learn about nutrition, physical activity, sleep, sedentary behavior, and a range of behavior-change strategies for sustaining a healthier lifestyle. The control group receives the program after 52 weeks. The primary outcome is change in body weight from baseline to 52 weeks. Secondary outcomes include change in body weight at 12 weeks; waist circumference, blood pressure, fitness, and lifestyle behaviors at 12 and 52 weeks; and cost-effectiveness. A process evaluation informed by the RE-AIM framework will evaluate potential implementation of RUFIT-NZ as an ongoing program in NZ after the trial. DISCUSSION: This trial will investigate the effectiveness and cost-effectiveness of the RUFIT-NZ program in overweight and obese NZ men. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered on 18 January 2019, according to the World Health Organization Trial Registration Data Set. Universal Trial Number, U1111-1245-0645.

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.

Health benefits and costs of weight-loss dietary counselling by nurses in primary care: a cost-effectiveness analysis.

OBJECTIVE: We aimed to estimate the cost-effectiveness of brief weight-loss counselling by dietitian-trained practice nurses, in a high-income-country case study. DESIGN: A literature search of the impact of dietary counselling on BMI was performed to source the 'best' effect size for use in modelling. This was combined with multiple other input parameters (e.g. epidemiological and cost parameters for obesity-related diseases, likely uptake of counselling) in an established multistate life-table model with fourteen parallel BMI-related disease life tables using a 3 % discount rate. SETTING: New Zealand (NZ). PARTICIPANTS: We calculated quality-adjusted life-years (QALY) gained and health-system costs over the remainder of the lifespan of the NZ population alive in 2011 (n 4·4 million). RESULTS: Counselling was estimated to result in an increase of 250 QALY (95 % uncertainty interval -70, 560 QALY) over the population's lifetime. The incremental cost-effectiveness ratio was 2011 $NZ 138 200 per QALY gained (2018 $US 102 700). Per capita QALY gains were higher for Maori (Indigenous population) than for non-Maori, but were still not cost-effective. If willingness-to-pay was set to the level of gross domestic product per capita per QALY gained (i.e. 2011 $NZ 45 000 or 2018 $US 33 400), the probability that the intervention would be cost-effective was 2 %. CONCLUSIONS: The study provides modelling-level evidence that brief dietary counselling for weight loss in primary care generates relatively small health gains at the population level and is unlikely to be cost-effective.

Cost-Effectiveness of a Weight Loss Intervention: An Adaptation of the Look AHEAD Lifestyle Intervention in the US Military.

OBJECTIVE: This study aimed to assess whether a counselor-initiated (CI) adaptation of the Look AHEAD (Action for Health in Diabetes) intensive lifestyle intervention in a military setting was cost-effective relative to a self-paced (SP) adaptation. METHODS: A cost-effectiveness analysis from a payer perspective was performed alongside a 2014-2017 randomized behavioral weight loss trial among 248 active-duty military personnel stationed at a US Air Force base in Texas. Incremental cost-effectiveness ratios were calculated for weight loss, reductions in waist circumference, and quality-adjusted life-years (QALYs). RESULTS: After 12 months, the CI adaptation cost more per participant compared with the SP adaptation ($1,081 vs. $120) but achieved greater weight loss (1.86 kg vs. 0.06 kg), greater reductions in waist circumference (1.85 cm vs. 0.48 cm), and more QALYs (0.871 vs. 0.856). The incremental cost-effectiveness ratio for the CI adaptation relative to the SP adaptation was $61,268 per additional QALY. At willingness-to-pay thresholds of $50,000 and $100,000 per QALY, the CI adaptation was 45% and 49% likely to be cost-effective, respectively. CONCLUSIONS: The CI delivery of the Look AHEAD Intensive Lifestyle Intervention may offer a cost-effective approach to tackle excess weight in the US military.

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.

The Relevant Perspective of Economic Evaluations Informing Local Decision Makers: An Exploration in Weight Loss Services.

Since 2013, obesity services in the UK National Health Service (NHS) have focused on a tiered structure, with tiers 3 (specialist weight management services) and 4 (primarily bariatric surgery) commissioned by Clinical Commissioning Groups (CCGs) and widely reported as cost effective and recommended by national guidelines. However, CCGs have been reluctant to fully conform to the guidance. We explore how the different evaluative perspective of those generating evidence from local decision makers has contributed to this failure of the CCGs to provide services considered cost effective. We explore four elements where the conventional economic evaluation framework, as applied by the National Institute for Health and Care Excellence (NICE), differ from the reality faced by local decision makers: the cost-effectiveness threshold, the implications of decision uncertainty and budgetary excess, the valuation of future costs and outcomes, and the scope of included costs. We argue that the failure of the conventional framework to reflect the reality faced by local decision makers is rendering much of the existing literature and guidance inappropriate to the key commissioners. Our analysis demonstrates that it is not reasonable to assume that the framework of economic evaluation used to inform national guidance applies to local decision makers, such as in the commissioning of weight loss services. This failure is likely to apply to the majority of cases where evidence is generated to inform national decision makers but commissioning is at a local level.

Evaluating differences in the clinical impact of a free online weight loss programme, a resource-intensive commercial weight loss programme and an active control condition: a parallel randomised controlled trial.

BACKGROUND: Finding effective intervention strategies to combat rising obesity levels could significantly reduce the burden that obesity and associated non-communicable diseases places on both individuals and the National Health Service. METHODS: In this parallel randomised-controlled trial, 76 participants who are overweight or obese (50 female) were given free access to a fitness centre for the duration of the 12-week intervention and randomised to one of three interventions. The commercial intervention, the Healthy Weight Programme, (HWP, n = 25, 10/15 men/women) consisted of twelve 1-h nutrition coaching sessions with a nutritionist delivered as a mixture of group and 1 to 1 sessions. In addition, twice-weekly exercise sessions (24 in total) were delivered by personal trainers for 12 weeks. The NHS intervention (n = 25, 8/17 men/women) consisted of following an entirely self-managed 12-week online NHS resource. The GYM intervention (n = 26, 8/18 men/women) received no guidance or formal intervention. All participants were provided with a gym induction for safety and both the NHS and GYM participants were familiarised with ACSM physical activity guidelines by way of a hand-out. RESULTS: The overall follow-up rate was 83%. Body mass was significantly reduced at post-intervention in all groups (HWP: N = 18, - 5.17 ± 4.22 kg, NHS: N = 21-4.19 ± 5.49 kg; GYM: N = 24-1.17 ± 3.00 kg; p < 0.001) with greater reductions observed in HWP and NHS groups compared to GYM (p < 0.05). Out with body mass and BMI, there were no additional statistically significant time x intervention interaction effects. CONCLUSIONS: This is the first study to evaluate the efficacy of both a free online NHS self-help weight-loss tool and a commercial weight loss programme that provides face-to-face nutritional support and supervised exercise. The findings suggest that both interventions are superior to an active control condition with regard to eliciting short-term weight-loss. TRIAL REGISTRATION: ISRCTN Registry - ISRCTN31489026. Prospectively registered: 27/07/16.

A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial.

BACKGROUND: There is a need for new strategies to improve the success of obesity treatment within the primary care setting. OBJECTIVE: To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care. DESIGN: Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital. PARTICIPANTS: From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention. INTERVENTIONS: Medical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months. MAIN MEASURES: The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss. KEY RESULTS: Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes. CONCLUSIONS: Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01922934.

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.

Parents' Willingness to Pay for Pediatric Weight Management Programs.

OBJECTIVE: To examine parents' interest in continuing and willingness to pay (WTP) for 2 pediatric weight management programs following their participation. METHODS: Participants were parents of 2- to 12-year-old children with body mass index ≥ 85th percentile who participated in the Connect for Health trial. One group received enhanced primary care (EPC) and the other received EPC plus individualized coaching (EPC+C). At 1 year, we assessed parents' self-reported WTP for a similar program and the maximum amount ($/month) they would pay. We used multivariable regression to examine differences in WTP and WTP amount by intervention arm and by individual and family-level factors. RESULTS: Of 638 parents who completed the survey, 85% were interested in continuing and 38% of those parents were willing to pay (31% in the EPC group and 45% in the EPC+C group). The median amount parents were willing to pay was $25/month (interquartile range, $15-$50). In multivariable models, the EPC+C parents were more likely to endorse WTP than the EPC parents (odds ratio, 1.53; 95% confidence interval, 1.05-2.22). Parents of children with Hispanic/Latino versus white ethnicity and those reporting higher satisfaction with the program were also more likely to endorse WTP. CONCLUSIONS: Most parents of children in a weight management program were interested in continuing it after it ended, but fewer were willing to pay out of pocket for it. A greater proportion of parents were willing to pay if the program included individualized health coaching.

Goal-directed versus outcome-based financial incentives for weight loss among low-income patients with obesity: rationale and design of the Financial Incentives foR Weight Reduction (FIReWoRk) randomised controlled trial.

INTRODUCTION: Obesity is a major public health challenge and exacerbates economic disparities through employment discrimination and increased personal health expenditures. Financial incentives for weight management may intensify individuals' utilisation of evidence-based behavioural strategies while addressing obesity-related economic disparities in low-income populations. Trials have focused on testing incentives contingent on achieving weight loss outcomes. However, based on social cognitive and self-determination theories, providing incentives for achieving intermediate behavioural goals may be more sustainable than incentivising outcomes if they enhance an individual's skills and self-efficacy for maintaining long-term weight loss. The objective of this paper is to describe the rationale and design of the Financial Incentives foR Weight Reduction study, a randomised controlled trial to test the comparative effectiveness and cost-effectiveness of two financial incentive strategies for weight loss (goal directed vs outcome based) among low-income adults with obesity, as well as compared with the provision of health behaviour change resources alone. METHODS AND ANALYSIS: We are recruiting 795 adults, aged 18-70 years with a body mass index ≥30 kg/m2, from three primary care clinics serving residents of socioeconomically disadvantaged neighbourhoods in New York City and Los Angeles. All participants receive a 1-year commercial weight loss programme membership, self-monitoring tools (bathroom scale, food journal and Fitbit Alta HR), health education and monthly check-in visits. In addition to these resources, those in the two intervention groups can earn up to $750 over 6 months for: (1) participating in an intensive weight management programme, self-monitoring weight and diet and meeting physical activity guidelines (goal-directed arm); or (2) a ≥1.5% to ≥5% reduction in baseline weight (outcome-based arm). To maximise incentive efficacy, we incorporate concepts from behavioural economics, including immediacy of payments and framing feedback to elicit regret aversion. We will use generalised mixed effect models for repeated measures to examine intervention effects on weight at 6, 9 and 12 months. ETHICS AND DISSEMINATION: Human research protection committees at New York University School of Medicine, University of California Los Angeles (UCLA) David Geffen School of Medicine and Olive-View-UCLA Medical Center granted ethics approval. We will disseminate the results of this research via peer-reviewed publications, conference presentations and meetings with stakeholders. TRIAL REGISTRATION NUMBER: NCT03157713.

Estimating the potential impact of the UK government's sugar reduction programme on child and adult health: modelling study.

OBJECTIVE: To estimate the impact of the UK government's sugar reduction programme on child and adult obesity, adult disease burden, and healthcare costs. DESIGN: Modelling study. SETTING: Simulated scenario based on National Diet and Nutrition Survey waves 5 and 6, England. PARTICIPANTS: 1508 survey respondents were used to model weight change among the population of England aged 4-80 years. MAIN OUTCOME MEASURES: Calorie change, weight change, and body mass index change were estimated for children and adults. Impact on non-communicable disease incidence, quality adjusted life years, and healthcare costs were estimated for adults. Changes to disease burden were modelled with the PRIMEtime-CE Model, based on the 2014 population in England aged 18-80. RESULTS: If the sugar reduction programme was achieved in its entirety and resulted in the planned sugar reduction, then the calorie reduction was estimated to be 25 kcal/day (1 kcal=4.18 kJ=0.00418 MJ) for 4-10 year olds (95% confidence interval 23 to 26), 25 kcal/day (24 to 28) for 11-18 year olds, and 19 kcal/day (17 to 20) for adults. The reduction in obesity could represent 5.5% of the baseline obese population of 4-10 year olds, 2.2% of obese 11-18 year olds, and 5.5% of obese 19-80 year olds. A modelled 51 729 quality adjusted life years (95% uncertainty interval 45 768 to 57 242) were saved over 10 years, including 154 550 (132 623 to 174 604) cases of diabetes and relating to a net healthcare saving of £285.8m (€332.5m, $373.5m; £249.7m to £319.8m). CONCLUSIONS: The UK government's sugar reduction programme could reduce the burden of obesity and obesity related disease, provided that reductions in sugar levels and portion sizes do not prompt unanticipated changes in eating patterns or product formulation.