Comparison of Sales From Vending Machines With 4 Different Food and Beverage Messages: A Randomized Trial.

Importance: Point-of-sale food messaging can encourage healthier purchases, but no studies have directly compared multiple interventions in the field. Objective: To examine which of 4 food and beverage messages would increase healthier vending machine purchases. Design, Setting, and Participants: This randomized trial assessed 13 months (February 1, 2019, to February 29, 2020) of vending sales data from 267 machines and 1065 customer purchase assessments from vending machines on government property in Philadelphia, Pennsylvania. Data analysis was performed from March 5, 2020, to November 8, 2022. Interventions: Study interventions were 4 food and beverage messaging systems: (1) beverage tax posters encouraging healthy choices because of the Philadelphia tax on sweetened drinks; (2) green labels for healthy products; (3) traffic light labels: green (healthy), yellow (moderately healthy), or red (unhealthy); or (4) physical activity equivalent labels (minutes of activity to metabolize product calories). Main Outcomes and Measures: Sales data were analyzed separately for beverages and snacks. The main outcomes analyzed at the transaction level were calories sold and the health status (using traffic light criteria) of each item sold. Additional outcomes were analyzed at the monthly machine level: total units sold, calories sold, and units of each health status sold. The customer purchase assessment outcome was calories purchased per vending trip. Results: Monthly sales data came from 150 beverage and 117 snack vending machines, whereas 1065 customers (558 [52%] male) contributed purchase assessment data. Traffic light labels led to a 30% decrease in the mean monthly number of unhealthy beverages sold (mean ratio [MR], 0.70; 95% CI, 0.55-0.88) compared with beverage tax posters. Physical activity labels led to a 34% (MR, 0.66; 95% CI, 0.51-0.87) reduction in the number of unhealthy beverages sold at the machine level and 35% (MR, 0.65; 95% CI, 0.50-0.86) reduction in mean calories sold. Traffic light labels also led to a 30-calorie reduction (b = -30.46; 95% CI, -49.36 to -11.56) per customer trip in the customer purchase analyses compared to physical activity labels. There were very few significant differences for snack machines. Conclusions and Relevance: In this 13-month randomized trial of 267 vending machines, the traffic light and physical activity labels encouraged healthier beverage purchases, but no change in snack sales, compared with a beverage tax poster. Corporations and governments should consider such labeling approaches to promote healthier beverage choices. Trial Registration: ClinicalTrials.gov Identifier: NCT06260176.

Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial.

BACKGROUND: Physical activity is associated with a lower risk of major adverse cardiovascular events, but few individuals achieve guideline-recommended levels of physical activity. Strategies informed by behavioral economics increase physical activity, but their longer-term effectiveness is uncertain. We sought to determine the effect of behaviorally designed gamification, loss-framed financial incentives, or their combination on physical activity compared with attention control over 12-month intervention and 6-month postintervention follow-up periods. METHODS: Between May 2019 and January 2024, participants with clinical atherosclerotic cardiovascular disease or a 10-year risk of myocardial infarction, stroke, or cardiovascular death of ≥7.5% by the Pooled Cohort equation were enrolled in a pragmatic randomized clinical trial. Participants received a wearable device to track daily steps, established a baseline, selected a step goal increase, and were randomly assigned to control (n=151), behaviorally designed gamification (n=304), loss-framed financial incentives (n=302), or gamification+financial incentives (n=305). The primary outcome of the trial was the change in mean daily steps from baseline through the 12-month intervention period. RESULTS: A total of 1062 patients (mean±SD age, 67±8; 61% female; 31% non-White) were enrolled. Compared with control subjects, participants had significantly greater increases in mean daily steps from baseline during the 12-month intervention in the gamification arm (adjusted difference, 538.0 [95% CI, 186.2-889.9]; P=0.0027), financial incentives arm (adjusted difference, 491.8 [95% CI, 139.6-844.1]; P=0.0062), and gamification+financial incentives arm (adjusted difference, 868.0 [95% CI, 516.3-1219.7]; P<0.0001). During the 6-month follow-up, physical activity remained significantly greater in the gamification+financial incentives arm than in the control arm (adjusted difference, 576.2 [95% CI, 198.5-954]; P=0.0028), but it was not significantly greater in the gamification (adjusted difference, 459.8 [95% CI, 82.0-837.6]; P=0.0171) or financial incentives (adjusted difference, 327.9 [95% CI, -50.2 to 706]; P=0.09) arms after adjustment for multiple comparisons. CONCLUSIONS: Behaviorally designed gamification, loss-framed financial incentives, and the combination of both increased physical activity compared with control over a 12-month intervention period, with the largest effect in gamification+financial incentives. These interventions could be a useful component of strategies to reduce cardiovascular risk in high-risk patients. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT03911141.

Qualitative study of perceptions of factors contributing to success or failure among participants in a US weight loss trial of financial incentives and environmental change strategies.

BACKGROUND: The use of financial incentives and environmental change strategies to encourage health behaviour change is increasingly prevalent. However, the experiences of participants in incentive interventions are not well characterised. Examination of participant perceptions of financial incentives and environmental strategies can offer insights about how these interventions are facilitating or failing to encourage behaviour change. OBJECTIVE: This study aimed to learn how participants in a randomised trial that tested financial incentives and environmental interventions to support weight loss perceived factors contributing to their success or failure in the trial. DESIGN: Qualitative study with one-time interviews of trial participants with high and low success in losing weight, supplemented by study records of incentive payments and weight loss. PARTICIPANTS: 24 trial participants (12 with substantial weight loss and 12 with no weight loss) stratified equally across the 4 trial arms (incentives, environmental strategies, combined and usual care) were interviewed. ANALYTICAL APPROACH: Transcribed interviews were coded and interpreted using an iterative process. Explanation development was completed using an abductive approach. RESULTS: Responses of trial participants who were very successful in losing weight differed in several ways from those who were not. Successful participants described more robust prior attempts at dietary and exercise modification, more active engagement with self-limitations, more substantial social support and a greater ability to routinise dietary and exercise changes than did participants who did not lose weight. Successful participants often stated that weight loss was its own reward, even without receiving incentives. Neither group could articulate the details of the incentive intervention or consistently differentiate incentives from study payments. CONCLUSIONS: A number of factors distinguished successful from unsuccessful participants in this intervention. Participants who were successful tended to attribute their success to intrinsic motivation and prior experience. Making incentives more salient may make them more effective for participants with greater extrinsic motivation. TRIAL REGISTRATION NUMBER: NCT02878343.

Public Views on Medicaid Work Requirements and Mandatory Premiums in Kentucky.

Importance: Federal and state policymakers continue to pursue work requirements and premiums as conditions of Medicaid participation. Opinion polling should distinguish between general policy preferences and specific views on quotas, penalties, and other elements. Objective: To identify views of adults in Kentucky regarding the design of Medicaid work requirements and premiums. Design, Setting, and Participant: A cross-sectional survey was conducted via telephone and the internet from June 27 through July 11, 2019, of 1203 Kentucky residents 9 months before the state intended to implement Medicaid work requirements and mandatory premiums. Statistical analysis was performed from October 2019 to August 2023. Main Outcomes and Measures: Agreement, disagreement, or neutral views on policy components were the main outcomes. Recruitment for the survey used statewide random-digit dialing and an internet panel to recruit residents aged 18 years or older. Findings were weighted to reflect state demographics. Of 39 110 landlines called, 209 reached an eligible person (of whom 150 participated), 8654 were of unknown eligibility, and 30 247 were ineligible. Of 55 305 cell phone lines called, 617 reached an eligible person (of whom 451 participated), 29 951 were of unknown eligibility, and 24 737 were ineligible. Internet recruitment (602 participants) used a panel of adult Kentucky residents maintained by an external data collector. Results: Percentages were weighted to resemble the adult population of Kentucky residents. Of the participants in the study, 52% (95% CI, 48%-55%) were women, 80% (95% CI, 77%-82%) were younger than 65 years, 41% (95% CI, 38%-45%) were enrolled in Medicaid, 36% (95% CI, 32%-39%) were Republican voters, 32% (95% CI, 29%-36%) were Democratic voters, 14% (95% CI, 11%-16%) were members of racial and ethnic minority groups (including but not limited to American Indian or Alaska Native, Asian, Black, Hispanic or Latinx, and Native Hawaiian or Pacific Islander), and 48% (95% CI, 44%-52%) were employed. Most participants supported work requirements generally (69% [95% CI, 66%-72%]) but did not support terminating benefits due to noncompliance (43% [95% CI, 39%-46%]) or requiring quotas of 20 or more hours per week (34% [95% CI, 31%-38%]). Support for monthly premiums (34% [95% CI, 31%-38%]) and exclusion penalties for premium nonpayment (22% [95% CI, 19%-25%]) was limited. Medicaid enrollees were significantly less supportive of these policies than nonenrollees. For instance, regarding work requirements, agreement was lower (64% [95% CI, 59%-69%] vs 72% [95% CI, 68%-77%]) and disagreement higher (26% [95% CI, 21%-31%] vs 20% [95% CI, 16%-24%]) among current Medicaid enrollees compared with nonenrollees (P = .04). Among Medicaid enrollees, some beliefs about work requirements varied significantly by employment status but not by political affiliation. Among nonenrollees, beliefs about work requirements, premiums, and Medicaid varied significantly by political affiliation but not by employment. Conclusions and Relevance: This study suggests that even when public constituencies express general support for Medicaid work requirements or premiums, they may oppose central design features, such as quotas and termination of benefits. Program participants may also hold significantly different beliefs than nonparticipants, which should be understood before policies are changed.

Food Is Medicine: A Presidential Advisory From the American Heart Association.

Unhealthy diets are a major impediment to achieving a healthier population in the United States. Although there is a relatively clear sense of what constitutes a healthy diet, most of the US population does not eat healthy food at rates consistent with the recommended clinical guidelines. An abundance of barriers, including food and nutrition insecurity, how food is marketed and advertised, access to and affordability of healthy foods, and behavioral challenges such as a focus on immediate versus delayed gratification, stand in the way of healthier dietary patterns for many Americans. Food Is Medicine may be defined as the provision of healthy food resources to prevent, manage, or treat specific clinical conditions in coordination with the health care sector. Although the field has promise, relatively few studies have been conducted with designs that provide strong evidence of associations between Food Is Medicine interventions and health outcomes or health costs. Much work needs to be done to create a stronger body of evidence that convincingly demonstrates the effectiveness and cost-effectiveness of different types of Food Is Medicine interventions. An estimated 90% of the $4.3 trillion annual cost of health care in the United States is spent on medical care for chronic disease. For many of these diseases, diet is a major risk factor, so even modest improvements in diet could have a significant impact. This presidential advisory offers an overview of the state of the field of Food Is Medicine and a road map for a new research initiative that strategically approaches the outstanding questions in the field while prioritizing a human-centered design approach to achieve high rates of patient engagement and sustained behavior change. This will ideally happen in the context of broader efforts to use a health equity-centered approach to enhance the ways in which our food system and related policies support improvements in health.

Philadelphia Beverage Tax and Association With Prices, Purchasing, and Individual-Level Substitution in a National Pharmacy Chain.

Importance: Taxes on sweetened beverages are being implemented around the globe; an understanding of these taxes on individual-level behavior is necessary. Objective: To evaluate the degree to which the sweetened beverage tax in Philadelphia, Pennsylvania, was associated with changes in beverage prices and individual-level purchasing over time at a national pharmacy chain in Philadelphia compared with Baltimore, Maryland. Design, Setting, and Participants: Using a difference-in-differences approach and generalized linear mixed models, this cohort study examined beverage purchases made by loyalty cardholders at a national chain pharmacy retailer with stores in Philadelphia and Baltimore (control city) from before tax to after tax. Beverage sales (in US dollars) were linked by unique loyalty card numbers to enable longitudinal analyses. Data were collected from January 1, 2015, through December 31, 2017 (2 years before tax and 1 year after tax); data analyses were conducted from January through October 2022. Exposure: Implementation of Philadelphia's 1.5 cents/oz tax on sweetened beverages. Main Outcomes and Measures: The outcomes were the change in mean beverage price per-ounce and mean beverage volume purchased per cardholder transaction. Individual-level point-of-sale scanner data from all beverage purchases were analyzed. Results: A total of 1188 unique beverages were purchased from the same stores before tax and after tax. There were 231 065 unique cardholders in Philadelphia and 82 517 in Baltimore. Mean prices of taxed beverages (n = 2 094 220) increased by 1.6 (95% CI, 1.3-2.0) cents/oz (106.7% pass-through) in Philadelphia compared with Baltimore from before tax to after tax. Philadelphia cardholders purchased 7.8% (95% CI -8.1% to -7.5%) fewer ounces of taxed beverages and 1.1% (95% CI, 0.6%-1.7%) more ounces of nontaxed beverages per transaction. Taxed beverages made up a smaller percentage of cardholders' overall beverage purchases after tax (-13.4% [95% CI, -14.2% to -12.6%]), while nontaxed beverages made up a larger share (9.3% [95% CI, 7.7%-10.7%]). Conclusions and Relevance: In this longitudinal cohort study of the Philadelphia beverage tax, the tax was completely passed through to prices and was associated with a 7.8% decline in ounces of taxed beverages purchased at a national pharmacy chain.

A randomized controlled trial of gamification, financial incentives, or both to increase physical activity among patients with elevated risk for cardiovascular disease: rationale and design of the be active study.

BACKGROUND: Higher levels of physical activity are associated with improvements in cardiovascular health, and consensus guidelines recommend that individuals with or at risk for atherosclerotic cardiovascular disease (ASCVD) participate in regular physical activity. However, most adults do not achieve recommended levels of physical activity. Concepts from behavioral economics have been used to design scalable interventions that increase physical activity over short time periods, but the longer-term efficacy of these strategies is uncertain. STUDY DESIGN AND OBJECTIVES: BE ACTIVE (NCT03911141) is a pragmatic, virtual, randomized controlled trial designed to evaluate the effectiveness of 3 strategies informed by behavioral economic concepts to increase daily physical activity in patients with established ASCVD or 10-year ASCVD risk > 7.5% who are seen in primary care and cardiology clinics affiliated with the University of Pennsylvania Health System. Patients are contacted by email or text message, and complete enrollment and informed consent on the Penn Way to Health online platform. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 33% to 50%, and are randomized 1:2:2:2 to control, gamification, financial incentives, or both gamification and financial incentives. Interventions continue for 12 months, with follow-up for an additional 6 months to evaluate the durability of behavior change. The trial has met its enrollment goal of 1050 participants, with a primary endpoint of change from baseline in daily steps over the 12-month intervention period. Key secondary endpoints include change from baseline in daily steps over the 6-month post-intervention follow-up period and change in moderate to vigorous physical activity over the intervention and follow-up periods. If the interventions prove effective, their effects on life expectancy will be compared with their costs in cost-effectiveness analysis. CONCLUSIONS: BE ACTIVE is a virtual, pragmatic randomized clinical trial powered to demonstrate whether gamification, financial incentives, or both are superior to attention control in increasing physical activity. Its results will have important implications for strategies to promote physical activity in patients with or at risk for ASCVD, as well as for the design and implementation of pragmatic virtual clinical trials within health systems.

Behavioural economic interventions to embed palliative care in community oncology (BE-EPIC): study protocol for the BE-EPIC randomised controlled trial.

INTRODUCTION: Palliative care (PC) is a medical specialty focusing on providing relief from the symptoms and stress of serious illnesses such as cancer. Early outpatient specialty PC concurrent with cancer-directed treatment improves quality of life and symptom burden, decreases aggressive end-of-life care and is an evidence-based practice endorsed by national guidelines. However, nearly half of patients with advanced cancer do not receive specialty PC prior to dying. The objective of this study is to test the impact of an oncologist-directed default PC referral orders on rates of PC utilisation and patient quality of life. METHODS AND ANALYSIS: This single-centre two-arm pragmatic randomised trial randomises four clinician-led pods, caring for approximately 250 patients who meet guideline-based criteria for PC referral, in a 1:1 fashion into a control or intervention arm. Intervention oncologists receive a nudge consisting of an electronic health record message indicating a patient has a default pended order for PC. Intervention oncologists are given an opportunity to opt out of referral to PC. Oncologists in pods randomised to the control arm will receive no intervention beyond usual practice. The primary outcome is completed PC visits within 12 weeks. Secondary outcomes are change in quality of life and absolute quality of life scores between the two arms. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board at the University of Pennsylvania. Study results will be disseminated in peer-reviewed journals and scientific conferences using methods that describe the results in ways that key stakeholders can best understand and implement. TRIAL REGISTRATION NUMBER: NCT05365997.

Study protocol: Behavioral economics and self-determination theory to change diabetes risk (BEST Change).

BACKGROUND: The Diabetes Prevention Program (DPP) and metformin can prevent or delay the onset of type 2 diabetes mellitus (T2DM) among patients with prediabetes. Yet, even when these evidence-based strategies are accessible and affordable, uptake is low. Thus, there is a critical need for effective, scalable, and sustainable approaches to increase uptake and engagement in these interventions. METHODS: In this randomized controlled trial, we will test whether financial incentives and automated messaging to promote autonomous motivation for preventing T2DM can increase DPP participation, metformin use, or both among adults with prediabetes. Participants (n = 380) will be randomized to one of four study arms. Control Arm participants will receive usual care and educational text messages about preventing T2DM. Incentives Arm participants will receive the Control Arm intervention plus financial incentives for DPP participation or metformin use. Tailored Messages Arm participants will receive the Control Arm intervention plus tailored messages promoting autonomous motivation for preventing T2DM. Combined Arm participants will receive the Incentives Arm and Tailored Messages Arm interventions plus messages to increase the personal salience of financial incentives. The primary outcome is change in hemoglobin A1c from baseline to 12 months. Secondary outcomes are change in body weight, DPP participation, and metformin use. DISCUSSION: If effective, these scalable and sustainable approaches to increase patient motivation to prevent T2DM can be deployed by health systems, health plans, and employers to help individuals with prediabetes lower their risk for developing T2DM.

Remote Monitoring and Behavioral Economics in Managing Heart Failure in Patients Discharged From the Hospital: A Randomized Clinical Trial.

Importance: Close remote monitoring of patients following discharge for heart failure (HF) may reduce readmissions or death. Objective: To determine whether remote monitoring of diuretic adherence and weight changes with financial incentives reduces hospital readmissions or death following discharge with HF. Design, Setting, and Participants: The Electronic Monitoring of Patients Offers Ways to Enhance Recovery (EMPOWER) study, a 3-hospital pragmatic trial, randomized 552 adults recently discharged with HF to usual care (n = 280) or a compound intervention (n = 272) designed to inform clinicians of diuretic adherence and changes in patient weight. Patients were recruited from May 25, 2016, to April 8, 2019, and followed up for 12 months. Investigators were blinded to assignment but patients were not. Analysis was by intent to treat. Interventions: Participants randomized to the intervention arm received digital scales, electronic pill bottles for diuretic medication, and regret lottery incentives conditional on the previous day's adherence to both medication and weight measurement, with $1.40 expected daily value. Participants' physicians were alerted if participants' weights increased 1.4 kg in 24 hours or 2.3 kg in 72 hours or if diuretic medications were missed for 5 days. Alerts and weights were integrated into the electronic health record. Participants randomized to the control arm received usual care and no further study contact. Main Outcomes and Measures: Time to death or readmission for any cause within 12 months. Results: Of the 552 participants, 290 were men (52.5%); 291 patients (52.7%) were Black, 231 were White (41.8%), and 16 were Hispanic (2.9%); mean (SD) age was 64.5 (11.8) years. The mean (SD) ejection fraction was 43% (18.1%). Each month, approximately 75% of participants were 80% adherent to both medication and weight measurement. There were 423 readmissions and 26 deaths in the control group and 377 readmissions and 23 deaths in the intervention group. There was no significant difference between the 2 groups for the combined outcome of all-cause inpatient readmission or death (unadjusted hazard ratio, 0.91; 95% CI, 0.74-1.13; P = .40) and no significant differences in all-cause inpatient readmission or observation stay or death, all-cause cardiovascular readmission or death, time to first event, and total all-cause deaths. Participants in the intervention group were slightly more likely to spend fewer days in the hospital. Conclusions and Relevance: In this randomized clinical trial, there was no reduction in the combined outcome of readmission or mortality in a year-long intensive remote monitoring program with incentives for patients previously hospitalized for HF. Trial Registration: ClinicalTrials.gov Identifier: NCT02708654.

Association between statewide financial incentive programs and COVID-19 vaccination rates.

To promote COVID-19 vaccination, many states in the US introduced financial incentives ranging from small, guaranteed rewards to lotteries that give vaccinated individuals a chance to win large prizes. There is limited evidence on the effectiveness of these programs and conflicting evidence from survey experiments and studies of individual states' lotteries. To assess the effectiveness of COVID-19 vaccination incentive programs, we combined information on statewide incentive programs in the US with data on daily vaccine doses administered in each state. Leveraging variation across states in the daily availability of incentives, our difference-in-differences analyses showed that statewide programs were not associated with a significant change in vaccination rates. Furthermore, there was no significant difference in vaccination trends between states with and without incentives in any of the 14 days before or after incentives were introduced. Heterogeneity analyses indicated that neither lotteries nor guaranteed rewards were associated with significant change in vaccination rates.

Design of a randomized controlled trial of digital health and community health worker support for diabetes management among low-income patients.

BACKGROUND: Insulin-dependent diabetes is a challenging disease to manage and involves complex behaviors, such as self-monitoring of blood glucose. This can be especially challenging in the face of socioeconomic barriers and in the wake of the COVID-19 pandemic. Digital health self-monitoring interventions and community health worker support are promising and complementary best practices for improving diabetes-related health behaviors and outcomes. Yet, these strategies have not been tested in combination. This protocol paper describes the rationale and design of a trial that measures the combined effect of digital health and community health worker support on glucose self-monitoring and glycosylated hemoglobin. METHODS: The study population was uninsured or publicly insured; lived in high-poverty, urban neighborhoods; and had poorly controlled diabetes mellitus with insulin dependence. The study consisted of three arms: usual diabetes care; digital health self-monitoring; or combined digital health and community health worker support. The primary outcome was adherence to blood glucose self-monitoring. The exploratory outcome was change in glycosylated hemoglobin. CONCLUSION: The design of this trial was grounded in social justice and community engagement. The study protocols were designed in collaboration with frontline community health workers, the study aim was explicit about furthering knowledge useful for advancing health equity, and the population was focused on low-income people. This trial will advance knowledge of whether combining digital health and community health worker interventions can improve glucose self-monitoring and diabetes-related outcomes in a high-risk population.

Effect of Financial Incentives for Process, Outcomes, or Both on Cholesterol Level Change: A Randomized Clinical Trial.

Importance: Financial incentives may improve health behaviors. It is unknown whether incentives are more effective if they target a key process (eg, medication adherence), an outcome (eg, low-density lipoprotein cholesterol [LDL-C] levels), or both. Objective: To determine whether financial incentives awarded daily for process (adherence to statins), awarded quarterly for outcomes (personalized LDL-C level targets), or awarded for process plus outcomes induce reductions in LDL-C levels compared with control. Design, Setting, and Participants: A randomized clinical trial was conducted from February 12, 2015, to October 3, 2018; data analysis was performed from October 4, 2018, to May 27, 2021, at the University of Pennsylvania Health System, Philadelphia. Participants included 764 adults with an active statin prescription, elevated risk of atherosclerotic cardiovascular disease, suboptimal LDL-C level, and evidence of imperfect adherence to statin medication. Interventions: Interventions lasted 12 months. All participants received a smart pill bottle to measure adherence and underwent LDL-C measurement every 3 months. In the process group, daily financial incentives were awarded for statin adherence. In the outcomes group, participants received incentives for achieving or sustaining at least a quarterly 10-mg/dL LDL-C level reduction. The process plus outcomes group participants were eligible for incentives split between statin adherence and quarterly LDL-C level targets. Main Outcomes and Measures: Change in LDL-C level from baseline to 12 months, determined using intention-to-treat analysis. Results: Of the 764 participants, 390 were women (51.2%); mean (SD) age was 62.4 (10.0) years, 310 (40.6%) had diabetes, 298 (39.0%) had hypertension, and mean (SD) baseline LDL-C level was 138.8 (37.6) mg/dL. Mean LDL-C level reductions from baseline to 12 months were -36.9 mg/dL (95% CI, -42.0 to -31.9 mg/dL) among control participants, -40.0 mg/dL (95% CI, -44.7 to -35.4 mg/dL) among process participants, -41.6 mg/dL (95% CI, -46.3 to -37.0 mg/dL) among outcomes participants, and -42.8 mg/dL (95% CI, -47.4 to -38.1 mg/dL) among process plus outcomes participants. In exploratory analysis among participants with diabetes and hypertension, no spillover effects of incentives were detected compared with the control group on hemoglobin A1c level and blood pressure over 12 months. Conclusions and Relevance: In this randomized clinical trial, process-, outcomes-, or process plus outcomes-based financial incentives did not improve LDL-C levels vs control. Trial Registration: ClinicalTrials.gov Identifier: NCT02246959.

Effect of Goal-Setting Approaches Within a Gamification Intervention to Increase Physical Activity Among Economically Disadvantaged Adults at Elevated Risk for Major Adverse Cardiovascular Events: The ENGAGE Randomized Clinical Trial.

Importance: Health promotion efforts commonly communicate goals for healthy behavior, but the best way to design goal setting among high-risk patients has not been well examined. Objective: To test the effectiveness of different ways to set and implement goals within a behaviorally designed gamification intervention to increase physical activity. Design, Setting, and Participants: Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences was conducted from January 15, 2019, to June 1, 2020. The 24-week randomized clinical trial included a remotely monitored 8-week introductory intervention period, 8-week maintenance intervention period, and 8-week follow-up period. A total of 500 adults from lower-income neighborhoods in and around Philadelphia, Pennsylvania, who had either an atherosclerotic cardiovascular disease (ASCVD) condition or a 10-year ASCVD risk score greater than or equal to 7.5% were enrolled. Participants were paid for enrolling in and completing the trial. Interventions: All participants used a wearable device to track daily steps, established a baseline level, and were then randomly assigned to an attention control or 1 of 4 gamification interventions that varied only on how daily step goals were set (self-chosen or assigned) and implemented (immediately or gradually). Main Outcome Measures: The primary outcome was change in mean daily steps from baseline to the 8-week maintenance intervention period. Other outcomes included changes in minutes of moderate to vigorous physical activity. All randomly assigned participants were included in the intention-to-treat analysis. Results: Of the 500 participants, 331 individuals (66.2%) were Black, 114 were White (22.8%), and 348 were women (69.6%). Mean (SD) age was 58.5 (10.8) years and body mass index was 33.2 (7.8). A total of 215 participants (43.0%) had an ASCVD condition. Compared with the control arm, participants with self-chosen and immediate goals had significant increases in the number of daily steps during the maintenance intervention period (1384; 95% CI, 805-1963; P < .001) that were sustained during the 8-week follow-up (1391; 95% CI, 785-1998; P < .001). This group also had significant increases in daily minutes of moderate to vigorous physical activity during the maintenance intervention (4.1; 95% CI, 1.8-6.4; P < .001) that were sustained during follow-up (3.5; 95% CI, 1.1-5.8; P = .004). No other gamification arms had consistent increases in physical activity compared with the control arm. No major adverse events were reported. Conclusions and Relevance: In this trial among economically disadvantaged adults at elevated risk for major adverse cardiovascular events, a gamification intervention led to increases in physical activity that were sustained during 8 weeks of follow-up when goals were self-chosen and implemented immediately. Trial Registration: ClinicalTrials.gov Identifier: NCT03749473.

Effect of Financial Incentives and Environmental Strategies on Weight Loss in the Healthy Weigh Study: A Randomized Clinical Trial.

Importance: Modest weight loss can lead to meaningful risk reduction in adults with obesity. Although both behavioral economic incentives and environmental change strategies have shown promise for initial weight loss, to date they have not been combined, or compared, in a randomized clinical trial. Objective: To test the relative effectiveness of financial incentives and environmental strategies, alone and in combination, on initial weight loss and maintenance of weight loss in adults with obesity. Design, Setting, and Participants: This randomized clinical trial was conducted from 2015 to 2019 at 3 large employers in Philadelphia, Pennsylvania. A 2-by-2 factorial design was used to compare the effects of lottery-based financial incentives, environmental strategies, and their combination vs usual care on weight loss and maintenance. Interventions were delivered via website, text messages, and social media. Participants included adult employees with a body mass index (BMI; weight in kilograms divided by height in meters squared) of 30 to 55 and at least 1 other cardiovascular risk factor. Data analysis was performed from June to July 2021. Interventions: Interventions included lottery-based financial incentives based on meeting weight loss goals, environmental change strategies tailored for individuals and delivered by text messages and social media, and combined incentives and environmental strategies. Main Outcome and Measures: The primary outcome was weight change from baseline to 18 months, measured in person. Results: A total of 344 participants were enrolled, with 86 participants each randomized to the financial incentives group, environmental strategies group, combined financial incentives and environmental strategies group, and usual care (control) group. Participants had a mean (SD) age of 45.6 (10.5) years and a mean (SD) BMI of 36.5 (7.1); 247 participants (71.8%) were women, 172 (50.0%) were Black, and 138 (40.1%) were White. At the primary end point of 18 months, participants in the incentives group lost a mean of 5.4 lb (95% CI, -11.3 to 0.5 lb [mean, 2.45 kg; 95% CI, -5.09 to 0.23 kg]), those in the environmental strategies group lost a mean of a 2.2 lb (95% CI, -7.7 to 3.3 lb [mean, 1.00 kg; 95% CI, -3.47 to 1.49 kg]), and the combination group lost a mean of 2.4 lb (95% CI, -8.2 to 3.3 lb [mean, 1.09 kg; 95% CI, -3.69 to 1.49 kg]) more than participants in the usual care group. Financial incentives, environmental change strategies, and their combination were not significantly more effective than usual care. At 24 months, after 6 months without an intervention, the difference in the change from baseline was similar to the 18-month results, with no significant differences among groups. Conclusions and Relevance: In this randomized clinical trial, across all study groups, participants lost a modest amount of weight but those who received financial incentives, environmental change, or the combined intervention did not lose significantly more weight than those in the usual care group. Employees with obesity may benefit from more intensive individualized weight loss strategies. Trial Registration: ClinicalTrials.gov Identifier: NCT02878343.

Oral health and oral health care use among able-bodied adults enrolled in Medicaid in Kentucky after Medicaid expansion: A mixed methods study.

BACKGROUND: Oral health care use remains low among adult Medicaid recipients, despite the Patient Protection and Affordable Care Act's expansion increasing access to care in many states. It remains unclear the extent to which low use reflects either low demand for care or barriers to accessing care. The authors aimed to examine factors associated with low oral health care use among adults enrolled in Medicaid. METHODS: The authors conducted a survey from May through September 2018 among able-bodied (n = 9,363) Medicaid recipients who were aged 19 through 65 years and nondisabled childless adults in Kentucky. The survey included questions on perceived oral health care use. Semistructured interviews were also conducted from May through November 2018 among a subset of participants (n = 127). RESULTS: More than one-third (37.8%) of respondents reported fair or poor oral health, compared with 26.2% who reported fair or poor physical health. Although 47.6% of respondents indicated needing oral health care in the past 6 months, only one-half of this group reported receiving all of the care they needed. Self-reported barriers included lack of coverage for needed services and lack of access to care (for example, low provider availability and transportation difficulties). CONCLUSIONS: Low rates of oral health care use can be attributed to a subset of the study population having low demand and another subset facing barriers to accessing care. Although Medicaid-covered services might be adequate for beneficiaries with good oral health, those with advanced dental diseases and a history of irregular care might benefit from coverage for more extensive restorative services. PRACTICAL IMPLICATIONS: These results can inform dentists and policy makers about how to design effective interventions and policies to improve oral health care use and oral health outcomes.

Cost-Effectiveness of Four Financial Incentive Programs for Smoking Cessation.

Rationale: A trial of four financial incentive programs, conducted at CVS Caremark, a large employer, documented their effectiveness in promoting sustained abstinence from smoking, but their cost-effectiveness is unknown, and the significant up-front cost of the incentives is a deterrent to their adoption. Objectives: To determine the cost-effectiveness of these incentives from the healthcare sector and employer perspectives. Methods: This study examines a decision model built with trial data, supplemented by data from the literature. Life-expectancy gains for quitters were projected on the basis of U.S. life tables. The two individual-oriented programs paid $800 for smoking cessation at 6 months; one required participants to deposit $150 at baseline. Payments in the two group-oriented programs varied with the group's success; again, one required participants to deposit $150. Results: Life-years, quality-adjusted life-years (QALYs), costs (2012 dollars), and cost-effectiveness ratios are described. From the healthcare sector perspective, costs ranged from $3,200 per life-year ($2,500 per QALY) for the competitive deposit program, compared with usual care, to $6,500 per life-year ($5,100 per QALY) for the individual reward program. From the employer perspective, costs ranged from $256,600 per life-year gained for the individual deposit program to $1,711,100 per life-year gained for the individual reward program; the cost per QALY ranged from $65,300 for the competitive deposit program to $128,800 for the individual reward program. Cost-effectiveness from the employer perspective improved with longer decision horizons. Including future medical costs reduced cost-effectiveness from both perspectives. Conclusions: Four financial incentive programs that paid smokers to quit are very cost-effective from the healthcare sector perspective. They are more expensive from the employer perspective but may be cost-effective for employers with longer decision horizons.

Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists.

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.