The success of behavioral economics in improving patient retention within an intensive primary care practice.

BACKGROUND: A minority of the U.S. population comprises a majority of health care expenses. Health system interventions for high-cost populations aim to improve patient outcomes while reducing costly over-utilization. Missed and inconsistent appointments are associated with poor patient outcomes and increased health care utilization. PEAK Health- Mount Sinai's intensive primary care clinic for high-cost patients- employed a novel behavioral economics-based intervention to reduce the rate of missed appointments at the practice. Behavioral economics has accomplished numerous successes across the health care field; the effect of a clinic-based behavioral economics intervention on reducing missed appointments has yet to be assessed. METHODS: This was a single-arm, pre-post trial conducted over 1 year involving all active patients at PEAK Health. The intervention consisted of: a) clinic signage, and b) appointment reminder cards containing behavioral economics messaging designed to increase the likelihood patients would complete their subsequent visit; appointment cards (t1) were transitioned to an identical EMR template (t2) at 6 months to boost provider utilization. The primary objective, the success of scheduled appointments, was assessed with visit adherence: the proportion of successful over all scheduled appointments, excluding those cancelled or rescheduled. The secondary objective, the consistency of appointments, was assessed with a 2-month visit constancy rate: the percentage of patients with at least one successful visit every 2 months for 1 year. Both metrics were assessed via a χ2 analysis and together define patient retention. RESULTS: The visit adherence rate increased from 74.7% at baseline to 76.5% (p = .22) during t1 and 78.0% (p = .03) during t2. The 2-month visit constancy rate increased from 59.5% at baseline to 74.3% (p = .01) post-intervention. CONCLUSIONS: A low-resource, clinic-based behavioral economics intervention was capable of improving patient retention within a traditionally high-cost population. A renewed focus on patient retention- employing the metrics described here- could bolster chronic care efforts and significantly improve the outcomes of high-cost programs by reducing the deleterious effects of missed and inconsistent appointments.

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP).

PURPOSE: Cancer survivors are often sedentary. Self-monitoring may promote physical activity through self-activation. We conducted a pilot trial to evaluate whether wearable activity tracker with personalized text message feedback would increase physical activity. METHODS: We enrolled 30 patients with solid tumor cancers into a non-randomized prospective intervention trial (NCT02627079): 15 had completed treatment in the past year and 15 under active treatment. Each participant received an activity tracker and daily text messages personalized to their activity level. We assessed patient-reported outcomes and 6-min walk (6 MW) at baseline and 3 months. RESULTS: Twenty-six participants completed the study. There was substantial variation in baseline activity. Overall, 39% of participants increased their steps taken by at least 20%, and 23% increased their 6 MW distance by 20% or more. More participants who had completed treatment strongly agreed (73%) that the intervention increased their exercise levels than those receiving active treatment (47%). At 3 months, there was a significant improvement in median Beck Depression Inventory-II and Godin Leisure Index composite scores. At 6 months, 72% still wore their activity tracker at least 4 days per week. CONCLUSION: We found that the intervention was well-accepted with a high completion rate at 3 months and continued self-use at 6 months. In this pilot study of combined activity tracker and motivational messaging, we found a signal for increased physical activity over a 3-month period. Future research is needed to study this technique for its impact on activity and other physical and psychological measures of well-being. IMPLICATION FOR CANCER SURVIVORS: Activity tracker with personalized motivational messaging may be useful in promoting physical activity in cancer survivors.

A web-based intervention to increase weight loss treatment initiation: results of a cluster randomized feasibility and acceptability trial.

Evidence-based behavioral weight loss treatment is under-utilized. To increase initiation of treatment, we developed a single-session, online, primary care-based intervention ("mobilization tool"). We evaluated the mobilization tool's acceptability for primary care patients with obesity, trial design feasibility, and signal of an effect of the tool on treatment initiation. In this cluster randomized feasibility trial, primary care providers (PCPs) were randomized to a mobilization tool or comparator tool arm. Patients with obesity and a scheduled appointment with a randomized PCP were assigned to complete the mobilization or comparator tool prior to their appointment. The online mobilization tool asks patients to answer questions about a variety of weight-related topics and then provides automated, tailored feedback that addresses psychosocial determinants of weight loss treatment initiation. The comparator tool provided a nontailored description of treatments. All participants were offered free enrollment in behavioral weight loss treatments. Six PCPs were randomized. Sixty patients (57% female; 66% white; aged 55 ± 13 years) participated in this study of 296 contacted for eligibility evaluation (20.2%). Six-month follow-up assessments were completed by 65% (22/34) of the mobilization and 73% (19/26) of comparator tool participants. Participants completing the acceptability survey reported that the mobilization tool was usable, enjoyable, informative, and useful. Weight loss treatment was initiated by 59% (n = 19) of mobilization and 33% (n = 8) of comparator tool participants. The mobilization tool shows promise for increasing treatment initiation among primary care patients, which may increase population weight loss. Trial Registration: Clinicaltrials.gov identifier: NCT02708121.

A randomized feasibility pilot trial of a financial incentives intervention for dietary self-monitoring and weight loss in adults with obesity.

Financial incentives could be used to improve adherence to behavioral weight loss interventions, increasing their effectiveness. This Phase IIb randomized pilot study evaluated the feasibility and acceptability of a study protocol for providing financial incentives for dietary self-monitoring and/or weight loss. Community-dwelling adults with obesity were enrolled in a 24 week, group-based weight loss program. Participants were randomized in a 2 × 2 factorial design to receive financial incentives for both dietary self-monitoring and weekly weight loss, just one, or neither. Participants could earn up to $300, evolving from fixed weekly payments to intermittent, variable payments. The notice of reward was provided by text message. The study was conducted in three successive cohorts to evaluate study procedure changes, including dietary approach, recruitment and retention strategies, text messaging, and incentives. Descriptive statistics calculated separately for each cohort described study performance relative to predefined targets for recruitment, including minority representation; retention; adherence; and weight loss. Acceptability was assessed via postintervention qualitative interviews. In Cohort 1 (n = 34), a low-carbohydrate diet was used. Recruitment, retention, adherence, and weight loss were adequate, but minority representation was not. For Cohort 2 (n = 31), employing an additional recruitment method and switching to a reduced-calorie diet yielded adequate recruitment, minority representation, retention, and adherence but less weight loss. Returning to a low-carbohydrate diet in Cohort 3 (n = 28) yielded recruitment, minority representation, retention, adherence, and weight loss similar to Cohort 2. Participant feedback informed changes to text message timing and content and incentive amount. Through successive cohorts, we optimized recruitment and retention strategies and text messaging. An adequately powered trial is warranted to evaluate the efficacy of these incentive structures for reducing weight. The trial registration number is NCT02691260.

Correction: Prevalence of multiple chronic conditions by U.S. state and territory, 2017.

[This corrects the article DOI: 10.1371/journal.pone.0232346.].

Prevalence of multiple chronic conditions by U.S. state and territory, 2017.

Having multiple (two or more) chronic conditions (MCC) is associated with an increased risk of mortality and functional decline, health resource utilization, and healthcare expenditures. As a result, understanding the prevalence of MCC is increasingly being recognized as a public health imperative. This research describes the prevalence and distribution of adults with MCC across the United States using 2017 data from the Behavioral Risk Factors Surveillance System (BRFSS). Prevalence of MCC was calculated for each U.S. state and territory overall, by sex and by age. Additionally, the most common condition dyads (two condition combinations) and triads (three condition combinations) were assessed for each state. Prevalence of MCC ranged from 37.9% in the District of Columbia to 64.4% in West Virginia. Females had a higher prevalence than males in 47 of 53 states and territories, and MCC prevalence increased with age in every state and territory. Overall prevalence estimates were higher than estimates using data from the National Health Interview Survey (NHIS), especially in the younger population (aged 18-44), due partly to the inclusion of high cholesterol, obesity, and depression as chronic conditions. Analysis of the most prevalent dyads and triads revealed the greatest state-by-state variability in the 18-44-year-old population. Multiple states' most prevalent dyads and triads for this population included obesity and depression. These findings build an accurate picture of the prevalence of multiple chronic conditions across the United States and will aid public health officials in creating programs targeted to their region.

An integrated intervention for chronic care management in rural Nepal: protocol of a type 2 hybrid effectiveness-implementation study.

BACKGROUND: In Nepal, the burden of noncommunicable, chronic diseases is rapidly rising, and disproportionately affecting low and middle-income countries. Integrated interventions are essential in strengthening primary care systems and addressing the burden of multiple comorbidities. A growing body of literature supports the involvement of frontline providers, namely mid-level practitioners and community health workers, in chronic care management. Important operational questions remain, however, around the digital, training, and supervisory structures to support the implementation of effective, affordable, and equitable chronic care management programs. METHODS: A 12-month, population-level, type 2 hybrid effectiveness-implementation study will be conducted in rural Nepal to evaluate an integrated noncommunicable disease care management intervention within Nepal's new municipal governance structure. The intervention will leverage the government's planned roll-out of the World Health Organization's Package of Essential Noncommunicable Disease Interventions (WHO-PEN) program in four municipalities in Nepal, with a study population of 80,000. The intervention will leverage both the WHO-PEN and its cardiovascular disease-specific technical guidelines (HEARTS), and will include three evidence-based components: noncommunicable disease care provision using mid-level practitioners and community health workers; digital clinical decision support tools to ensure delivery of evidence-based care; and training and digitally supported supervision of mid-level practitioners to provide motivational interviewing for modifiable risk factor optimization, with a focus on medication adherence, and tobacco and alcohol use. The study will evaluate effectiveness using a pre-post design with stepped implementation. The primary outcomes will be disease-specific, "at-goal" metrics of chronic care management; secondary outcomes will include alcohol and tobacco consumption levels. DISCUSSION: This is the first population-level, hybrid effectiveness-implementation study of an integrated chronic care management intervention in Nepal. As low and middle-income countries plan for the Sustainable Development Goals and universal health coverage, the results of this pragmatic study will offer insights into policy and programmatic design for noncommunicable disease care management in the future. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04087369. Registered on 12 September 2019.

Multiple chronic conditions at a major urban health system: a retrospective cross-sectional analysis of frequencies, costs and comorbidity patterns.

OBJECTIVE: To (1) examine the burden of multiple chronic conditions (MCC) in an urban health system, and (2) propose a methodology to identify subpopulations of interest based on diagnosis groups and costs. DESIGN: Retrospective cross-sectional study. SETTING: Mount Sinai Health System, set in all five boroughs of New York City, USA. PARTICIPANTS: 192 085 adult (18+) plan members of capitated Medicaid contracts between the Healthfirst managed care organisation and the Mount Sinai Health System in the years 2012 to 2014. METHODS: We classified adults as having 0, 1, 2, 3, 4 or 5+ chronic conditions from a list of 69 chronic conditions. After summarising the demographics, geography and prevalence of MCC within this population, we then described groups of patients (segments) using a novel methodology: we combinatorially defined 18 768 potential segments of patients by a pair of chronic conditions, a sex and an age group, and then ranked segments by (1) frequency, (2) cost and (3) ratios of observed to expected frequencies of co-occurring chronic conditions. We then compiled pairs of conditions that occur more frequently together than otherwise expected. RESULTS: 61.5% of the study population suffers from two or more chronic conditions. The most frequent dyad was hypertension and hyperlipidaemia (19%) and the most frequent triad was diabetes, hypertension and hyperlipidaemia (10%). Women aged 50 to 65 with hypertension and hyperlipidaemia were the leading cost segment in the study population. Costs and prevalence of MCC increase with number of conditions and age. The disease dyads associated with the largest observed/expected ratios were pulmonary disease and myocardial infarction. Inter-borough range MCC prevalence was 16%. CONCLUSIONS: In this low-income, urban population, MCC is more prevalent (61%) than nationally (42%), motivating further research and intervention in this population. By identifying potential target populations in an interpretable manner, this segmenting methodology has utility for health services analysts.

Enhancing Diabetes Self-Management Through Collection and Visualization of Data From Multiple Mobile Health Technologies: Protocol for a Development and Feasibility Trial.

BACKGROUND: Self-management is integral for control of type 2 diabetes mellitus (T2DM). Patient self-management is improved when they receive real-time information on their health status and behaviors and ongoing facilitation from health professionals. However, timely information for these behaviors is notably absent in the health care system. Providing real-time data could help improve patient understanding of the dynamics of their illness and assist clinicians in developing targeted approaches to improve health outcomes and in delivering personalized care when and where it is most needed. Mobile technologies (eg, wearables, apps, and connected scales) have the potential to make these patient-provider interactions a reality. What strategies might best help patients overcome self-management challenges using self-generated diabetes-related data? How might clinicians effectively guide patient self-management with the advantage of real-time data? OBJECTIVE: This study aims to describe the protocol for an ongoing study (June 2016-May 2019) that examines trajectories of symptoms, health behaviors, and associated challenges among individuals with T2DM utilizing multiple mobile technologies, including a wireless body scale, wireless glucometer, and a wrist-worn accelerometer over a 6-month period. METHODS: We are conducting an explanatory sequential mixed methods study of 60 patients with T2DM recruited from a primary care clinic. Patients were asked to track relevant clinical data for 6 months using a wireless body scale, wireless glucometer, a wrist-worn accelerometer, and a medication adherence text message (short message service, SMS) survey. Data generated from the devices were then analyzed and visualized. A subset of patients is currently being interviewed to discuss their challenges and successes in diabetes self-management, and they are being shown visualizations of their own data. Following the data collection period, we will conduct interviews with study clinicians to explore ways in which they might collaborate with patients. RESULTS: This study has received regulatory approval. Patient enrollment ongoing with a sample size of 60 patients is complete, and up to 20 clinicians will be enrolled. At the patient level, data collection is complete, but data analysis is pending. At the clinician level, data collection is currently ongoing. CONCLUSIONS: This study seeks to expand the use of mobile technologies to generate real-time data to enhance self-management strategies. It also seeks to obtain both patient and provider perspectives on using real-time data to develop algorithms for software that will facilitate real-time self-management strategies. We expect that the findings of this study will offer important insight into how to support patients and providers using real-time data to manage a complex chronic illness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13517.

A Digital Behavioral Weight Gain Prevention Intervention in Primary Care Practice: Cost and Cost-Effectiveness Analysis.

BACKGROUND: Obesity is one of the largest drivers of health care spending but nearly half of the population with obesity demonstrate suboptimal readiness for weight loss treatment. Black women are disproportionately likely to have both obesity and limited weight loss readiness. However, they have been shown to be receptive to strategies that prevent weight gain. OBJECTIVE: The aim of this study was to evaluate the costs and cost-effectiveness of a digital weight gain prevention intervention (Shape) for black women. Shape consisted of adaptive telephone-based coaching by health system personnel, a tailored skills training curriculum, and patient self-monitoring delivered via a fully automated interactive voice response system. METHODS: A cost and cost-effectiveness analysis based on a randomized clinical trial of the Shape intervention was conducted from the payer perspective. Costs included those of delivering the program to 91 intervention participants in the trial and were summarized by program elements: self-monitoring, skills training, coaching, and administration. Effectiveness was measured in quality-adjusted life years (QALYs). The primary outcome was the incremental cost per QALY of Shape relative to usual care. RESULTS: Shape cost an average of US $758 per participant. The base-case model in which quality of life benefits decay linearly to zero 5 years post intervention cessation, generated an incremental cost-effectiveness ratio (ICER) of US $55,264 per QALY. Probabilistic sensitivity analyses suggest an ICER below US $50,000 per QALY and US $100,000 per QALY in 39% and 98% of simulations, respectively. Results are highly sensitive to durability of benefits, rising to US $165,730 if benefits end 6 months post intervention. CONCLUSIONS: Results suggest that the Shape intervention is cost-effective based on established benchmarks, indicating that it can be a part of a successful strategy to address the nation's growing obesity epidemic in low-income at-risk communities.

An Automated Text-Messaging Platform for Enhanced Retention and Data Collection in a Longitudinal Birth Cohort: Cohort Management Platform Analysis.

BACKGROUND: Traditional methods for recruiting and maintaining contact with participants in cohort studies include print-based correspondence, which can be unidirectional, labor intensive, and slow. Leveraging technology can substantially enhance communication, maintain engagement of study participants in cohort studies, and facilitate data collection on a range of outcomes. OBJECTIVE: This paper provides an overview of the development process and design of a cohort management platform (CMP) used in the Newborn Epigenetic STudy (NEST), a large longitudinal birth cohort study. METHODS: The platform uses short message service (SMS) text messaging to facilitate interactive communication with participants; it also semiautomatically performs many recruitment and retention procedures typically completed by research assistants over the course of multiple study follow-up visits. RESULTS: Since February 2016, 302 participants have consented to enrollment in the platform and 162 have enrolled with active engagement in the system. Daily reminders are being used to help improve adherence to the study's accelerometer wear protocol. At the time of this report, 213 participants in our follow-up study who were also registered to use the CMP were eligible for the accelerometer protocol. Preliminary data show that texters (138/213, 64.8%), when compared to nontexters (75/213, 35.2%), had significantly longer average accelerometer-wearing hours (165.6 hours, SD 56.5, vs 145.3 hours, SD 58.5, P=.01) when instructed to wear the devices for 1 full week. CONCLUSIONS: This platform can serve as a model for enhancing communication and engagement with longitudinal study cohorts, especially those involved in studies assessing environmental exposures.

Log2Lose: Development and Lessons Learned From a Mobile Technology Weight Loss Intervention.

BACKGROUND: Providing financial incentives has gained popularity as a strategy to promote weight loss, but questions remain about how best to utilize them. A promising mobile health strategy provides users with near-real-time financial incentives based on both the process of weight loss (behavioral modification) and actual weight loss. To maximize the impact of this strategy, a methodology is needed to close the gap between the desired behavior and the financial incentive. Leveraging mobile health tools-such as mobile phone apps, cellular body weight scales that transmit data to physicians and researchers, and text messaging for instructions and encouragement-has the potential to close this gap. OBJECTIVE: This study aimed to describe the development of an innovative technology-based solution and lessons learned from a feasibility trial-Log2Lose-that encouraged individuals to lose weight by providing near-real-time financial incentives for weight loss and/or dietary self-monitoring. METHODS: We recruited participants (N=96) with a body mass index greater than or equal to 30 kg/m2 for a 24-week weight loss trial. Participants received a behavioral intervention of biweekly, in-person group sessions and were instructed to log a minimum number of daily calories in MyFitnessPal and to step on the BodyTrace cellular scale at least twice per week. In a 2×2 design, participants were randomized into 4 groups to receive financial incentives for the following: (group 1) weekly weight loss and dietary self-monitoring, (group 2) dietary self-monitoring only, (group 3) weekly weight loss only, or (group 4) no financial incentives. Diet and weight data from the devices were obtained through application programming interfaces. Each week, we applied algorithms to participants' data to determine whether they qualified for a monetary incentive (groups 1-3). A text message notified these participants of whether they met weight loss and/or self-monitoring requirements to earn an incentive and the amount they earned or would have earned. The money was uploaded to a debit card. RESULTS: Our custom-engineered software platform analyzed data from multiple sources, collated and processed the data to send appropriate text messages automatically, and informed study staff of the appropriate incentives. We present lessons learned from the development of the software system and challenges encountered with technology, data transmission, and participants (eg, lost connections or delayed communication). CONCLUSIONS: With consistent and constant validation checks and a robust beta test run, the process of analyzing data and determining eligibility for weekly incentives can be mostly automated. We were able to accomplish this project within an academic health system, which required significant security and privacy safeguards. Our success demonstrates how this methodology of automated feedback loops can provide health interventions via mobile technology. TRIAL REGISTRATION: ClinicalTrials.gov NCT02691260; https://clinicaltrials.gov/ct2/show/NCT02691260.

Prevalence of multiple chronic conditions in New York State, 2011-2016.

INTRODUCTION: To design effective policy and interventions, public health officials must have an accurate and granular picture of the state of multiple chronic conditions (MCC) in their region. The objective of this research is to describe the prevalence and distribution of MCC in New York State. METHODS: We performed a secondary data analysis of the Behavioral Risk Factor Surveillance System (BRFSS) from 2011 through 2016 for New York adults (n = 76,186). We analyzed the self-reported prevalence of individuals having 0, 1, 2, or ≥ 3 chronic conditions by sex, race/ethnicity, age, health insurance type, annual household income, and whether respondents lived in New York City. We also examined the most common condition dyads and triads. Finally, we assessed the prevalence of MCC (2 or more chronic conditions) by county across New York State, and neighborhood within New York City. RESULTS: During 2011-2016, 25.2% of adults in New York State had zero chronic conditions, 24.1% had 1 condition, 18.4% had 2 conditions, and 32.4% had 3 or more. The most prevalent dyad was hypertension and high cholesterol in 17.0% of individuals. The most prevalent triad was hypertension, high cholesterol, and arthritis in 4.5% of individuals. County prevalence of MCC ranged from 42.6% in Westchester County to 66.1% in Oneida County. The prevalence of MCC in New York City neighborhoods ranged from 33.5% in Gramercy Park-Murray Hill to 60.6% in High Bridge-Morrisania. CONCLUSION: This research contributes to the field's understanding of multiple chronic conditions and allows policy and public health leaders in New York to better understand the prevalence and distribution of MCC.

Effectiveness of an App and Provider Counseling for Obesity Treatment in Primary Care.

INTRODUCTION: Obesity treatment is less successful for socioeconomically disadvantaged populations, particularly when delivered in primary care. Digital health strategies can extend the reach of clinical obesity treatments to care settings serving patients at highest risk. METHODS: Track was an effectiveness RCT of a 12-month digital weight-loss intervention, embedded within a community health center system. Participants were 351 adult patients (aged 21-65 years) with obesity and hypertension, diabetes, and hyperlipidemia. Patients were randomized to usual care (n=175) or an intervention (n=176) comprising app-based self-monitoring of behavior change goals with tailored feedback, a smart scale, dietitian-delivered counseling calls, and clinician counseling informed by app-generated recommendations, delivered via electronic health record. The primary outcome was 12-month weight change. Randomization began on June 18, 2013, final assessments were completed on September 10, 2015. Data analysis was conducted in 2016 and 2017. The trial retained 92% of usual care and 96% of intervention participants at 12 months. RESULTS: The Track intervention produced larger weight losses relative to usual care at 6 months (net effect: -4.4 kg, 95% CI= -5.5, -3.3, p<0.001) and 12 months (net effect: -3.8 kg, 95% CI= -5.0, -2.5, p<0.001). Intervention participants were more likely to lose ≥5% of their baseline weight at 6 months (43% vs 6%, p<0.001) and 12 months (40% vs 17%, p<0.001). Intervention participants completing ≥80% of expected self-monitoring episodes (-3.5 kg); counseling calls (-3.0 kg); or self-weighing days (-4.4 kg) lost significantly more weight than less engaged intervention participants (all p<0.01). CONCLUSIONS: A digital obesity treatment, integrated with health system resources, can produce clinically meaningful weight-loss outcomes among socioeconomically disadvantaged primary care patients with elevated cardiovascular disease risk. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01827800.

Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity.

The obesity epidemic has negative physical, psychological, and financial consequences. Despite the existence of effective behavioral weight loss interventions, many individuals do not achieve adequate weight loss, and most regain lost weight in the year following intervention. We report the rationale and design for a 2×2 factorial study that involves financial incentives for dietary self-monitoring (yes vs. no) and/or interim weight loss (yes vs. no). Outpatients with obesity participate in a 24-week, group-based weight loss intervention. All participants are asked to record their daily dietary and liquid intake on a smartphone application (app) and to weigh themselves daily at home on a study-provided cellular scale. An innovative information technology (IT) solution collates dietary data from the app and weight from the scale. Using these data, an algorithm classifies participants weekly according to whether they met their group's criteria to receive a cash reward ranging from $0 to $30 for dietary self-monitoring and/or interim weight loss. Notice of the reward is provided via text message, and credit is uploaded to a gift card. This pilot study will provide information on the feasibility of using this novel IT solution to provide variable-ratio financial incentives in real time via its effects on recruitment, intervention adherence, retention, and cost. This study will provide the foundation for a comprehensive, adequately-powered, randomized controlled trial to promote short-term weight loss and long-term weight maintenance. If efficacious, this approach could reduce the prevalence, adverse outcomes, and costs of obesity for millions of Americans. Clinicaltrials.gov registration: NCT02691260.

Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.

INTRODUCTION: Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings. METHODS: Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months. RESULTS: Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression. CONCLUSIONS: Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment.

Quantitative method for the determination of iso-fludelone (KOS-1803) in human plasma by LC-MS/MS.

Epothilones are relatively new tubulin-poison anticancer drugs. Iso-fludelone (KOS-1803) is a synthetic third generation epothilone drug discovered at Memorial Sloan Kettering Cancer Center, and currently in phase I clinical trials. We report an LC-MS/MS assay for the sensitive, accurate and precise quantitation of iso-fludelone in 0.2mL of human plasma. Validation was performed according to FDA guidance. The assay comprised of KOS-1724 as the internal standard and an MTBE liquid-liquid extraction with a water wash step. Separation was achieved with an YMC-Pack ODS-AQ column and an isocratic mobile phase of 0.1% formic acid in acetonitrile and water (70:30, v/v) at 0.3mL/min for 4min. Chromatographic separation was followed by electrospray, positive-mode ionization tandem mass spectrometric detection in the multiple reaction monitoring (MRM) mode. The assay was linear from 0.1 to 300ng/mL and was accurate (-9.41 to -7.07%) and precise (1.03-13.7%) which fulfilled FDA criteria for validation. Recovery from plasma was 73.9-79.7% and ion suppression was negligible (-22.8 to -31.3%). Plasma freeze-thaw stability (99.97-105.7%), stability for 11 months at -80°C (94.93-107.9%), and stability for 6h at room temperature (94.75-105.5%) were all acceptable. This assay is currently being applied to quantitate iso-fludelone in clinical samples.

The effect of a "maintain, don't gain" approach to weight management on depression among black women: results from a randomized controlled trial.

OBJECTIVES: We evaluated the effect of a weight gain prevention intervention (Shape Program) on depression among socioeconomically disadvantaged overweight and obese Black women. METHODS: Between 2009 and 2012, we conducted a randomized trial comparing a 12-month electronic health-based weight gain prevention intervention to usual primary care at 5 central North Carolina community health centers. We assessed depression with the Patient Health Questionnaire (PHQ-8). We analyzed change in depression score from baseline to 12- and 18-month follow-up across groups with mixed models. We used generalized estimating equation models to analyze group differences in the proportion above the clinical threshold for depression (PHQ-8 score ≥ 10). RESULTS: At baseline, 20% of participants reported depression. Twelve-month change in depression scores was larger for intervention participants (mean difference = -1.85; 95% confidence interval = -3.08, -0.61; P = .004). There was a significant reduction in the proportion of intervention participants with depression at 12 months with no change in the usual-care group (11% vs 19%; P = .035). All effects persisted after we controlled for weight change and medication use. We saw similar findings at 18 months. CONCLUSIONS: The Shape Program, which includes no mention of mood, improved depression among socioeconomically disadvantaged Black women.

Adherence to self-monitoring via interactive voice response technology in an eHealth intervention targeting weight gain prevention among Black women: randomized controlled trial.

BACKGROUND: eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. OBJECTIVE: This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. METHODS: The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. RESULTS: Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (-1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference -0.94 kg, 95% CI -1.64 to -0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring. CONCLUSIONS: Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability. TRIAL REGISTRATION: Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535.

A text messaging-assisted randomized lifestyle weight loss clinical trial among overweight adults in Beijing.

OBJECTIVE: The impact of a text messaging-assisted lifestyle weight loss intervention on weight change among overweight adults in Beijing was examined. METHODS: It was a 6-month randomized two arm clinical trial. The control group received a brief advice session after randomization. The intervention group received three group sessions, five coaching calls, and a daily text message prompting participants to follow predetermined lifestyle goals. RESULTS: A total of 123 participants were randomized. At 6 months, controls gained 0.24 ± 0.28 kg (0.21% ± 0.38%) (NS) while intervention participants lost 1.6 ± 0.28 kg (2.31% ± 0.38%) (p < 0.0001). Intervention participants decreased waist circumference (WC) (-2.69 ± 0.43 cm, p < 0.0001), percent body fat (%BF) (-0.66% ± 0.19%, p = 0.0007), and systolic/diastolic blood pressure (SBP/DBP) significantly (-1.71 ± 1.12/-3.24 ± 0.87 mmHg), while the controls had no change in WC and %BF and increased SBP/DBP by 2.43 ± 1.14/1.20 ± 0.88 mmHg (between groups: p = 0.01/p = 0.0004). CONCLUSIONS: This text message-assisted lifestyle intervention was effective in reducing weight, WC, %BF, and improving BP. Coupled with the scalable feature of the intervention, this finding is intriguing in light of the potential reach of the intervention for countries like China where mobile phone penetration is high and the obesity rate continues to rise.