Reach and Weight Loss Among Comparison Group Participants Who Enrolled in the Active Intervention After a Diabetes Prevention Trial.

We examined participation rates, engagement, and weight-loss outcomes of comparison group participants in a diabetes prevention trial who enrolled in a digitally delivered diabetes prevention program (ie, an active intervention) after the original trial ended. We evaluated these outcomes by using the Wilcoxon signed-rank test and 1-sample z test. We found a high participation rate (73%) among comparison group participants and comparable weight-loss outcomes at 12 months (6.8 lb) after initiating participation in the active intervention relative to intervention group participants during the original trial. Findings support providing evidence-based interventions for comparison or control group participants post-trial. Findings also support examining the cost-effectiveness of post-trial interventions, regardless of the limitations of acquiring post-trial data on weight in an uncontrolled setting.

Cost and cost-effectiveness analysis of a digital diabetes prevention program: results from the PREDICTS trial.

Although technology-assisted diabetes prevention programs (DPPs) have been shown to improve glycemic control and weight loss, information are limited regarding relevant costs and their cost-effectiveness. To describe a retrospective within-trial cost and cost-effectiveness analysis (CEA) to compare a digital-based DPP (d-DPP) with small group education (SGE), over a 1-year study period. The costs were summarized into direct medical costs, direct nonmedical costs (i.e., times that participants spent engaging with the interventions), and indirect costs (i.e., lost work productivity costs). The CEA was measured by the incremental cost-effectiveness ratio (ICER). Sensitivity analysis was performed using nonparametric bootstrap analysis. Over 1 year, the direct medical costs, direct nonmedical costs, and indirect costs per participant were $4,556, $1,595, and $6,942 in the d-DPP group versus $4,177, $1,350, and $9,204 in the SGE group. The CEA results showed cost savings from d-DPP relative to SGE based on a societal perspective. Using a private payer perspective for d-DPP, ICERs were $4,739 and $114 to obtain an additional unit reduction in HbA1c (%) and weight (kg), and were $19,955 for an additional unit gain of quality-adjusted life years (QALYs) compared to SGE, respectively. From a societal perspective, bootstrapping results indicated that d-DPP has a 39% and a 69% probability, at a willingness-to-pay of $50,000/QALY and $100,000/QALY, respectively, of being cost-effective. The d-DPP was cost-effective and offers the prospect of high scalability and sustainability due to its program features and delivery modes, which can be easily translated to other settings.

Although technology-assisted DPPs have been shown to improve glycemic control and/or weight loss, information is limited on examining relevant costs and the cost-effectiveness of DPPs with the use of remote technologies within a randomized controlled trial design. We evaluated the costs associated with a d-DPP and further examined the cost-effectiveness of the d-DPP with an enhanced usual care condition. The d-DPP was cost-effective in achieving HbA1c reduction and weight loss and offers the prospect of high scalability and sustainability due to its program features and delivery modes, which can be easily translated to other settings.

Effects of a digital diabetes prevention program on cardiovascular risk among individuals with prediabetes.

OBJECTIVE: To examine changes in cardiovascular disease (CVD) risk outcomes of overweight/obese adults with prediabetes. METHODS: Using data from a randomized control trial of digital diabetes prevention program (d-DPP) with 599 participants. We applied the atherosclerotic CVD (ASCVD) risk calculator to predict 10-year CVD risk for d-DPP and small education (comparison) groups. Between-group risk changes at 4 and 12 months were compared using a repeated measures linear mixed-effect model. We examined within-group differences in proportion of participants over time for specific CVD risk factors using generalized estimating equations. RESULTS: We found no differences between baseline 10-year ASCVD risk. Relative to the comparison group, the d-DPP group experienced greater reductions in predicted 10-year ASCVD risk at each follow-up visit and a significant group difference at 4 months (-0.96%; 95% confidence interval: -1.58%, -0.34%) (but not at 12 months). Additionally, we observed that the d-DPP group experienced a decreased proportion of individuals with hyperlipidemia (18% and 16% from baseline to 4 and 12 months), high-risk total cholesterol (8% from baseline to 12 months), and being insufficiently active (26% and 22% from baseline to 4 and 12 months at follow-up time points. CONCLUSIONS: Our findings suggest that a digitally adapted DPP may promote the prevention of cardiometabolic disease among overweight/obese individuals with prediabetes. However, given the lack of maintenance of effect on ASCVD risk at 12 months, there may also be a need for additional interventions to sustain the effect detected at 4 months.

Cost analysis of a remote patient monitoring programme for post-discharge patients with type 2 diabetes.

INTRODUCTION: Assessing costs of an evidence-based health promotion programme is crucial to understand the economic feasibility of adopting or sustaining the programme. This study conducted a cost analysis of a remote patient monitoring (RPM) programme to enhance the post-discharge management of type 2 diabetes. METHODS: Using retrospective data collected during RPM implementation from September 2014 to February 2018, we estimated the costs of implementing an RPM in the primary care setting. Measures included total and average annual costs, costs per participant who was enrolled or completed the programme, and costs per person-day. We further conducted sensitivity and scenario analyses to examine variations in estimated programme costs associated with varying programme efficiencies and alternative personnel compositions of the RPM team. RESULTS: The total RPM implementation costs were estimated at US$4,374,544 with an average annual programme costs of US$1,249,870, which translated to US$3207 per participant (n = 1364) completing the three-month programme. The per person-day cost was averaged at US$24 (182,932 person-days). Sensitivity and scenario analyses results indicate that the sustainment costs were approximately US$1.6 million annually and the per-person-day costs were between US$21 and US$29 with each nurse coach on average serving a panel of 62-93 patients. CONCLUSION: The implementation and sustainment costs of an RPM programme, estimated under various assumptions of programme efficiency and care team compositions, as exemplified in this study, will help healthcare organizations make informed decisions in budgeting for and sustaining telehealth programmes to enhance diabetes management.

Reasons for E-cigarette Use, Vaping Patterns, and Cessation Behaviors Among US Adolescents.

INTRODUCTION: This study sought to examine reasons for youth e-cigarette use in association with vaping patterns and cessation behaviors. AIMS AND METHODS: A national representative sample of current (past 30-day) e-cigarette users in grades 6-12 was analyzed using the National Youth Tobacco Survey (NYTS), conducted from January to March 2020. An exploratory oblique factor analysis using a rotated pattern matrix to select salient variable-factor relationships yielded four subscales related to reasons for youth e-cigarette use. Multivariate logistic regressions were performed to assess the associations of each subscale with vaping patterns (frequent e-cigarette use, dual use of e-cigarettes and other tobacco products) and vaping cessation behaviors (intention to quit vaping and past-year quit attempts). RESULTS: The 2020 NYTS sampled 180 schools with 1769 current e-cigarette users. Four main reasons for vaping were identified through factor analysis, including (1) replacing cigarettes, (2) product characteristics [eg, flavors, concealability, and vape tricks], (3) family/friend use, and (4) curiosity. Curiosity was associated with lower odds of frequent e-cigarette use (adjusted odds ratio [AOR] = 0.5, p < .0001) and dual use of e-cigarettes and other tobacco products (AOR = 0.6, p = .01) but higher odds of intention to quit (AOR = 1.2, p = .26) and past year quit attempts (AOR =1.5, p = .01). Vaping due to product characteristics was associated with higher odds of frequent e-cigarette use (AOR = 1.7, p < .0001) and lower odds of intention to quit (AOR = 0.3, p < .0001) and past year quit attempts (AOR = 0.9, p = .01). CONCLUSIONS: Adolescents vape for various reasons that follow distinct patterns and user characteristics. Overall, interventions tailored to address heterogeneous reasons for vaping may help optimize the reduction in youth e-cigarette use. IMPLICATIONS: E-cigarettes have surpassed cigarettes and become the most commonly used tobacco product by US youths. Adolescents choose to vape for different reasons. This study examined reasons for youth e-cigarette use and their associations with vaping patterns and cessation behaviors. The product characteristics factor (eg, flavors, concealability, and vape tricks) was associated with more frequent e-cigarette use and lower odds of cessation behaviors, suggesting a need for flavor bans and product design regulation.

Vaping Media Literacy, Harm Perception, and Susceptibility of E-Cigarette Use Among Youth.

INTRODUCTION: Exposure to E-cigarette marketing and media advertisements is prevalent among adolescents. A validated vaping media literacy scale is needed to inform effective vaping prevention programs. METHODS: A 6-item vaping media literacy scale was adapted from validated smoking and general media literacy scales with an emphasis on marketing influences. A school-based survey (N=856) was conducted to assess the reliability of vaping media literacy and 3 subscales (i.e., authors and audiences [vaping Authors and Audiences], messages and meanings [vaping Messages and Meanings], and representation and reality [vaping Representation and Reality]). Multivariable logistic regression models were performed to examine the associations of vaping media literacy with perceived harmfulness of E-cigarette use and susceptibility to use E-cigarettes. Analyses were conducted in 2021. RESULTS: The mean vaping media literacy among students was 2.6 (range=0-6). There were significant disparities with lower vaping media literacy among middle-school (versus high-school, p=0.03) students, males (versus females, p=0.003), and racial/ethnic minority students (Blacks, Hispanics, others versus Whites, p=0.0009). A higher vaping media literacy was significantly associated with increased perceived harmfulness of E-cigarette use (AOR=1.2; 95% CI=1.1, 1.2; p<0.0001). All subscales were also associated with E-cigarette harm perception. Among never E-cigarette users, students with a higher (versus those with a lower) vaping media literacy had lower susceptibility to initiating E-cigarettes (AOR=0.90; 95% CI=0.83, 0.97; p=0.005). Both vaping Messages and Meanings and vaping Representation and Reality subscales were adversely associated with susceptibility to vaping. CONCLUSIONS: The vaping media literacy scale may gauge the influence of E-cigarette marketing on adolescents with high reliability and validity. Racial minorities, younger adolescents, and males appear relatively vulnerable to vaping marketing influence. Efforts to increase vaping media literacy are needed to curb youth E-cigarette use.

Effectiveness of incentives to improve the reach of health promotion programs- a systematic review and meta-analysis.

The reach (i.e., enrollment, engagement, and retention) of health promotion evidence-based programs (EBPs) at the participant level has been challenging. Incentives based on behavioral economics may be used to improve EBP reach. We aimed to systematically review and synthesize the evidence of the effectiveness of incentives as a dissemination strategy to increase EBP reach. We conducted a literature search in PubMed, SCOPUS, EMBASE, Cochrane Review and Cochrane CENTRAL for articles published between January 2000 and March 2020 to identify incentive strategies used to increase program reach among health promotion EBPs. Inclusion criteria included studies published in English, experimental or quasi-experimental designs, comparison of incentive to non-incentive or control strategies, and reported on reach (n = 35 health promotion studies). Monetary incentives using cash and a fixed schedule of reinforcement were the most used incentive schemes (71%). Incentives alone or combined with other strategies as a multicomponent approach were effective in improving program enrollment, engagement, and retention. Specifically, incentive strategies were associated with higher odds of program enrollment (odds ratio [OR], 2.78; 95% confidence interval [CI], 1.82-4.24; n = 10) and retention (OR, 2.54, 95% CI, 1.34-4.85; n = 9) with considerable heterogeneity (I2 = 94% and 91%, respectively). Incentives are a promising individual-level dissemination strategy to improve the reach of health promotion EBPs. However, understanding the optimal amount, type, frequency, and target of incentives, and how incentives fit in a multicomponent approach in different contexts requires further research.

Scoping review of costs of implementation strategies in community, public health and healthcare settings.

OBJECTIVES: To identify existing evidence concerning the cost of dissemination and implementation (D&I) strategies in community, public health and health service research, mapped with the 'Expert Recommendations for Implementing Change' (ERIC) taxonomy. DESIGN: Scoping review. DATA SOURCES: MEDLINE, EMBASE, CINAHL, PsycINFO, Scopus and the Cochrane Library were searched to identify any English language reports that had been published between January 2008 and December 2019 concerning the cost of D&I strategies. DATA EXTRACTION: We matched the strategies identified in each article using ERIC taxonomies; further classified them into five areas (eg, dissemination, implementation, integration, capacity building and scale-up); and extracted the corresponding costs (total costs and cots per action target and per evidence-based programme (EBP) participant). We also recorded the reported level of costing methodology used for cost assessment of D&I strategies. RESULTS: Of the 6445 articles identified, 52 studies were eligible for data extraction. Lack of D&I strategy cost data was the predominant reason (55% of the excluded studies) for study exclusion. Predominant topic, setting, country and research design in the included studies were mental health (19%), primary care settings (44%), the US (35%) and observational (42%). Thirty-five (67%) studies used multicomponent D&I strategies (ranging from two to five discrete strategies). The most frequently applied strategies were Conduct ongoing training (50%) and Conduct educational meetings (23%). Adoption (42%) and reach (27%) were the two most frequently assessed outcomes. The overall costs of Conduct ongoing training ranged from $199 to $105 772 ($1-$13 973 per action target and $0.02-$412 per EBP participant); whereas the cost of Conduct educational meetings ranged from $987 to $1.1-$2.9 million/year ($33-$54 869 per action target and $0.2-$146 per EBP participant). The wide range of costs was due to the varying scales of the studies, intended audiences/diseases and the complexities of the strategy components. Most studies presented limited information on costing methodology, making interpretation difficult. CONCLUSIONS: The quantity of published D&I strategy cost analyses is increasing, yet guidance on conducting and reporting of D&I strategy cost analysis is necessary to facilitate and promote the application of comparative economic evaluation in the field of D&I research.

Stress Correlates Related to Depressive Symptoms Among Young Black Men in Southern California.

Black men experience higher levels of chronic stress, life stressors, and discrimination due to oppressive social and economic conditions. Black men are at greater risk of depression, but most published research on stress and depression has focused on Black people in general, Black women, or older Black men. We sought to determine whether discrimination, perceived stress, major life stress, daily hassles, and social capital were associated with depressive symptoms in young Black men. Survey data were collected from April 2010 to March 2012 in Southern California from a convenience sample of Black men (N = 201). We used two-sample t tests and one-way analysis of variance (ANOVA) to examine the association of stress correlates with depressive symptoms. Logistic regression was conducted to estimate the likelihood of reporting depressive symptoms for each significant correlate. Over half of the sample reported depressive symptoms. Health status, perceived discrimination, urban hassles, perceived stress, and neighborhood trust and safety were significantly related to depressive symptoms. Those who reported higher perceived stress had higher odds of reporting depressive symptoms, whereas lower everyday discrimination experiences were associated with lower odds of depressive symptoms. Future studies should consider examining the effectiveness of embedding coping mechanisms for stress, including perceived discrimination, in health interventions for young Black men to prevent or reduce depression.

Understanding implementation costs of a pediatric weight management intervention: an economic evaluation protocol.

BACKGROUND: Understanding the cost and/or cost-effectiveness of implementation strategies is crucial for organizations to make informed decisions about the resources needed to implement and sustain evidence-based interventions (EBIs). This economic evaluation protocol describes the methods and processes that will be used to assess costs and cost-effectiveness across implementation strategies used to improve the reach, adoption, implementation, and organizational maintenance of an evidence-based pediatric weight management intervention- Building Health Families (BHF). METHODS: A within-trial cost and cost-effectiveness analysis (CEA) will be completed as part of a hybrid type III effectiveness-implementation trial (HEI) designed to examine the impact of an action Learning Collaborative (LC) strategy consisting of network weaving, consultee-centered training, goal-setting and feedback, and sustainability action planning to improve the adoption, implementation, organizational maintenance, and program reach of BHF in micropolitan and surrounding rural communities in the USA, over a 12-month period. We discuss key features of implementation strategy components and the associated cost collection and outcome measures and present brief examples on what will be included in the CEA for each discrete implementation strategy and how the results will be interpreted. The cost data will be collected by identifying implementation activities associated with each strategy and using a digital-based time tracking tool to capture the time associated with each activity. Costs will be assessed relative to the BHF program implementation and the multicomponent implementation strategy, included within and external to a LC designed to improve reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of BHF. The CEA results will be reported by RE-AIM outcomes, using the average cost-effectiveness ratio or incremental cost-effectiveness ratio. All the CEAs will be performed from the community perspective. DISCUSSION: The proposed costing approach and economic evaluation framework for dissemination and implementation strategies and EBI implementation will contribute to the evolving but still scant literature on economic evaluation of implementation and strategies used and facilitate the comparative economic analysis. TRIAL REGISTRATION: ClinicalTrials.gov NCT04719442 . Registered on January 22, 2021.

Cost and cost-effectiveness of the 'Stand and Move at Work' multicomponent intervention to reduce workplace sedentary time and cardiometabolic risk.

OBJECTIVE: Few studies have reported the cost and cost-effectiveness of workplace interventions to reduce sedentary time. The purpose of this study was to complete an economic evaluation of a multilevel intervention to reduce sitting time and increase light-intensity physical activity (LPA) among employees. METHODS: We conducted a retrospective within-trial cost and cost-effectiveness analysis (CEA) to compare a 12-month multilevel intervention with (STAND+) and without (MOVE+) a sit-stand workstation, across 24 worksites (N=630 employee participants) enrolled in a cluster randomized clinical trial. We estimated the intervention costs using activity-based costing strategy. The intervention costs were further expressed as per person and per worksite. CEA was conducted using an incremental cost-effectiveness ratio (ICER) metric, expressed as costs for additional unit of sitting time (minute/day), LPA (minutes/day), cardiometabolic risk score, and quality-adjusted life years (QALY) increased/decreased at 12 months. We assessed the cost analysis and CEA from the organizational (ie, employer) perspective with a one-year time horizon. RESULTS: Total intervention costs were $134 and $72 per person, and $3939 and $1650 per worksite for the STAND+ (N worksites = 12; N employees = 354) and MOVE+ (N worksites = 12; N employees = 276) interventions, respectively. The ICER was $1 (95% CI $0.8-1.4) for each additional minute reduction of workplace sitting time (standardized to 8-hour workday); and $4656 per QALY gained at 12 months. There was a modest and non-significant change of loss of work productivity improvement (-0.03 hours, 95% CI -4.16-4.09 hours), which was associated with a $0.34 return for every $1 invested. CONCLUSIONS: The multi-level intervention with sit-stand workstations has the potential to be widely implemented to reduce workplace sitting time. Future research into work productivity outcomes in terms of cost-benefits for employers is warranted.

Effects of a Digital Diabetes Prevention Program: An RCT.

INTRODUCTION: In light of the need to expand the reach and access of clinically proven digital Diabetes Prevention Programs (d-DPPs) and the need for rigorous evidence of effectiveness, the purpose of this study was to determine the effectiveness of a digital Diabetes Prevention Program for improving weight, HbA1c, and cardiovascular risk factors among people with prediabetes compared to enhanced standard care plus waitlist control. STUDY DESIGN: This was a single-blind RCT among participants at risk of developing type 2 diabetes and included 12 months of follow-up. SETTING/PARTICIPANTS: A total of 599 volunteer patients with prediabetes were recruited primarily through electronic medical records and primary care practices. INTERVENTION: Participants were randomized to either a d-DPP (n=299) or a single-session small-group diabetes-prevention education class (n=300) focused on action planning for weight loss. The d-DPPs consisted of 52 weekly sessions, lifestyle coaching, virtual peer support, and behavior tracking tools. MAIN OUTCOME MEASURES: The primary outcome was a change in HbA1c from baseline to 12 months using intent-to-treat analyses. On the basis of multiple comparisons of endpoints, 95% CIs are presented and 2-sided p<0.025 was required for statistical significance. Secondary outcomes included body weight and cardiovascular disease risk factors. RESULTS: Among 599 randomized participants (mean age=55.4 years, 61.4% women), 483 (80%) completed the study. The d-DPPs produced significantly greater reductions in HbA1c (0.08%, 95% CI= -0.12, -0.03) and percentage change in body weight (-5.5% vs -2.1%, p<0.001) at 12 months. A greater proportion of the d-DPPs group achieved a clinically significant weight loss ≥5% (43% vs 21%, p<0.001), and more participants shifted from prediabetes to normal HbA1c range (58% vs 48%, p=0.04). Engagement in d-DPPs was significantly related to improved HbA1c and weight loss. CONCLUSIONS: This d-DPPs demonstrated clinical effectiveness and has significant potential for widespread dissemination and impact, particularly considering the growing demand for telemedicine in preventive healthcare services. TRIAL REGISTRATION: This study is registered at www. CLINICALTRIALS: gov (ClinicalTrials.gov Identifier: NCT03312764).

Examining Ways to Improve Weight Control Programs' Population Reach and Representativeness: A Discrete Choice Experiment of Financial Incentives.

BACKGROUND: Both theoretical and empirical evidence supports the potential of modest financial incentives to increase the reach of evidence-based weight control programs. However, few studies exist that examine the best incentive design for achieving the highest reach and representativeness at the lowest cost and whether or not incentive designs may be valued differentially by subgroups that experience obesity-related health disparities. METHODS: A discrete choice experiment was conducted (n = 1232 participants; over 90% of them were overweight/obese) to collect stated preference towards different financial incentive attributes, including reward amount, program location, reward contingency, and payment form and frequency. Mixed logit and conditional logit models were used to determine overall and subgroup preference ranking of attributes. Using the National Health and Nutrition Examination Survey data sample weights and the estimated models, we predicted US nationally representative participation rates by subgroups and examined the effect of offering more than one incentive design. External validity was checked by using a completed cluster randomized control trial. RESULTS: There were significant subgroup differences in preference toward incentive attributes. There was also a sizable negative response to larger incentive amounts among African Americans, suggesting that higher amounts would reduce participation from this population. We also find that offering participants a menu of incentive designs to choose from would increase reach more than offering higher reward amounts. CONCLUSIONS: We confirmed the existence of preference heterogeneity and the importance of subgroup-targeted incentive designs in any evidence-based weight control program to maximize population reach and reduce health disparities.

Reach Outcomes and Costs of Different Physician Referral Strategies for a Weight Management Program Among Rural Primary Care Patients: Type 3 Hybrid Effectiveness-Implementation Trial.

BACKGROUND: Rural residents are at high risk for obesity; however, little resources exist to address this disproportional burden of disease. Primary care may provide an opportunity to connect primary care patients with overweight and obesity to effective weight management programming. OBJECTIVE: The purpose of this study is to examine the utility of different physician referral and engagement processes for improving the reach of an evidence-based and technology-delivered weight management program with counseling support for rural primary care patients. METHODS: A total of 5 rural primary care physicians were randomly assigned a sequence of four referral strategies: point-of-care (POC) referral with active telephone follow-up (ATF); POC referral, no ATF; a population health registry-derived letter referral with ATF; and letter referral, no ATF. For registry-derived referrals, physicians screened a list of patients with BMI ≥25 and approved patients for participation to receive a personalized referral letter via mail. RESULTS: Out of a potential 991 referrals, 573 (57.8%) referrals were made over 16 weeks, and 98 (9.9%) patients were enrolled in the program (58/98, 59.2% female). Differences based on letter (485/991, 48.9%) versus POC (506/991, 51.1%) referrals were identified for completion (100% vs 7%; P<.001) and for proportion screened (36% vs 12%; P<.001) but not for proportion enrolled (12% vs 8%; P=.10). Patients receiving ATF were more likely to be screened (47% vs 7%; P<.001) and enrolled (15% vs 7%; P<.001) than those not receiving ATF. On the basis of the number of referrals made in each condition, we found variations in the proportion and number of enrollees (POC with ATF: 27/190, 50%; POC no ATF: 14/316, 41%; letter ATF: 30/199; 15.1%; letter no ATF: 27/286, 9.4%). Across all conditions, participants were representative of the racial and ethnic characteristics of the region (60% female, P=.15; 94% White individuals, P=.60; 94% non-Hispanic, P=.19). Recruitment costs totaled US $6192, and the overall recruitment cost per enrolled participant was US $63. Cost per enrolled participant ranged from POC with ATF (US $47), registry-derived letter without ATF (US $52), and POC without ATF (US $56) to registry-derived letter with ATF (US $91). CONCLUSIONS: Letter referral with ATF appears to be the best option for enrolling a large number of patients in a digitally delivered weight management program; however, POC with ATF and letters without ATF yielded similar numbers at a lower cost. The best referral option is likely dependent on the best fit with clinical resources. TRIAL REGISTRATION: ClinicalTrials.gov NCT03690557; http://clinicaltrials.gov/ct2/show/NCT03690557.

Psychometric assessment of the Brief Weight-Loss-Related Behavior Self-Efficacy Survey in adults with prediabetes.

Self-efficacy is a commonly examined cognitive determinant of behavior change in weight-loss trials, but there has been little uniformity in its measurement. To address this, a recently developed survey captures self-efficacy as it relates to three behavioral domains of interest to weight-loss interventionists: physical activity (PA), healthful eating, and weight loss. The purpose of this study was to test the psychometric properties of the Brief Weight-Loss-Related Behavior Self-Efficacy Scales in a large sample (n = 599) of adults with prediabetes. Participants completed the self-efficacy survey, as well as measures of PA, dietary intake, weight, and height. The factor structure was scrutinized using exploratory and confirmatory factor analysis, which supported a factor structure with three correlated first-order latent self-efficacy factors, specific to PA, healthful eating, and weight loss. This model is statistically equivalent to a hierarchical model including a second-order factor for overall behavioral weight-management self-efficacy. Measurement equivalence/invariance between relevant demographic groups was also supported by tests for equivalence of covariance matrices. Bivariate correlations between self-efficacy factors and measures of PA, dietary intake, and weight support the concurrent validity of score interpretations. Overall, these psychometric analyses support the validity of these scales' scores as independently reflective of self-efficacy for PA, healthful eating, and weight loss. This instrument is useful in clinical research to identify the cognitive drivers of weight loss and weight loss-inducing behavior. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Examining the feasibility and characteristics of realistic weight management support for patients: Focus groups with rural, micropolitan, and metropolitan primary care providers.

The purpose of this investigation was to understand perspectives of physicians, nurses, and staff regarding the feasibility of implementing an evidence-based weight management program to support primary care practice. An exploratory aim was to examine differences in responses based on the clinic location. Ten focus groups were conducted with primary care staff from rural, micropolitan, and metropolitan clinics. The Promoting Action on Research in Health Services (PARIHS) framework was used to inform the interview guide. Transcripts were reviewed to identify common themes among PARIHS constructs (evidence, context, and facilitation). Presence of comorbidities (e.g., diabetes, hypertension) were typical prompts for provider-led discussions about patient weight. Metropolitan clinics reported the availability of health coaching, diabetes education, or dietician consultation, but no clinic reported offering a comprehensive weight management program. Participants agreed it is possible to implement a weight management program through primary care, but cited potential facilitation challenges such as costs, clinic resources, and individual patient barriers. More enthusiasm arose for a referral program with patient tracking. Program characteristics such as proven efficacy, individual tailoring, program accessibility, and patient feedback to the providers were desired. Rural focus group participants reported unique barriers (lack of local resources) and facilitators (more flexibility in practice changes) to weight management when compared to metropolitan and micropolitan focus groups. Primary care staff are interested in weight management solutions for their patients and would prefer an evidence-based program to which they could refer patients, receive feedback on patient progress, and sustainably include as part of their regular services.

Costing a population health management approach for participant recruitment to a diabetes prevention study.

Limited research has reported the economic feasibility-from both a research and practice perspective-of efforts to recruit and enroll an intended audience in evidence-based approaches for disease prevention. We aimed to retrospectively assess and estimate the costs of a population health management (PHM) approach to identify, engage, and enroll patients in a Type 1 Hybrid Effectiveness-Implementation (HEI), diabetes-prevention trial. We used activity-based costing to estimate the recruitment costs of a PHM approach integrated within an HEI trial. We took the perspective of a healthcare system that may adopt, and possibly sustain, the strategy in the typical practice. We also estimated replication costs based on how the strategy could be applied in healthcare systems interested in referring patients to a local diabetes prevention program from a payer perspective. The total recruitment and enrollment costs were $360,424 to accrue 599 participants over approximately 15 months. The average cost per screened and enrolled participant was $263 and $620, respectively. Translating to the typical settings, total recruitment costs for replication were estimated as $193,971 (range: $43,827-$210,721). Sensitivity and scenario analysis results indicated replication costs would be approximately $283-$444 per patient enrolled if glucose testing was necessary, based on the Medicare-covered services. From a private payer perspective, and without glucose testing, per-participant assessed costs were estimated at $31. A PHM approach can be used to accrue a large number of participants in a short period of time for an HEI trial, at a comparable cost per participant.

Using a population health management approach to enroll participants in a diabetes prevention trial: reach outcomes from the PREDICTS randomized clinical trial.

Population health management (PHM) strategies to address diabetes prevention have the potential to engage large numbers of at-risk individuals in a short duration. We examined a PHM approach to recruit participants to a diabetes prevention clinical trial in a metropolitan health system. We examined reach and representativeness and assessed differences from active and passive respondents to recruitment outreach, and participants enrolled through two clinical screening protocols. The PHM approach included an electronic health record (EHR) query, physician review of identified patients, letter invitation, and telephone follow-up. Data describe the reach and representativeness of potential participants at multiple stages during the recruitment process. Subgroup analyses examined proportional reach, participant differences based on passive versus active recruitment response, and clinical screening method used to determine diabetes risk status. The PHM approach identified 10,177 potential participants to receive a physician letter invitation, 60% were contacted by telephone, 2,796 (46%) completed telephone screening, 1,961 were eligible from telephone screen, and 599 were enrolled in 15 months. Accrual was unaffected by shifting clinical screening protocols despite the increase in participant burden. Relative to census data, study participants were more likely to be obese, female, older, and Caucasian. Relative to the patient population, enrolled participants were less likely to be Black and were older. Active respondents were more likely to have a higher income than passive responders. PHM strategies have the potential to reach a large number of participants in a relatively short period, though concerted efforts are needed to increase participant diversity.

Assessing the Impact of Telemonitoring-Facilitated Lifestyle Modifications on Diabetes Outcomes: A Systematic Review and Meta-Analysis.

Introduction: Lifestyle modification to promote regular physical activity and healthy eating is a key element of diabetes management. We aimed at evaluating randomized controlled trials that assess the impact of telemonitoring on diabetes outcomes with the inclusion of lifestyle change components. Methods: A systematic review search in relevant databases was conducted for studies published from January 2000 to October 2018. The search was restricted to studies published in English and included adult patients with type 2 diabetes. Study selection criteria included telehealth programs with remote monitoring of physiological data and feedback features. We further performed meta-analyses to summarize the pooled effect size (presented by the mean difference [MD]) of hemoglobin A1c (HbA1c) and weight loss outcomes. Results: Seventeen studies were included in the data synthesis (15 of them were included in the meta-analysis), with the sample size ranging from 18 to 484 and the study period ranging from 3 to 12 months. Telemonitoring achieved a significant but modest reduction in HbA1c (MD = -0.30%; 95% confidence interval [CI]: -0.31% to -0.29%) and weight loss (kg) outcomes (MD = -0.62; 95% CI: -0.78 to -0.45) compared with usual care. In the subgroup analyses, it was suggested that telemonitoring with automatic mobile transmission or with real-time feedback modality led to a greater improvement in HbA1c outcomes (MD = -0.61% and -0.77%, respectively) when compared with telemonitoring without these features. Conclusions: Telemonitoring has a great potential to further enhance diabetes management with the inclusion of a system approach for supporting patients' lifestyle changes. Features such as automatic mobile transmission and real-time feedback show promise to boost effectiveness of telemonitoring in diabetes management in the future.

Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic, feasibility, online randomized trial protocol.

BACKGROUND: High attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap. PURPOSE: To describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business. METHODS: This study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m2, and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program. DISCUSSION: This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.