Impact of large scale, multicomponent intervention to reduce proton pump inhibitor overuse in integrated healthcare system: difference-in-difference study.

OBJECTIVE: To determine how a large scale, multicomponent, pharmacy based intervention to reduce proton pump inhibitor (PPI) overuse affected prescribing patterns, healthcare utilization, and clinical outcomes. DESIGN: Difference-in-difference study. SETTING: US Veterans Affairs Healthcare System, in which one regional network implemented the overuse intervention and all 17 others served as controls. PARTICIPANTS: All individuals receiving primary care from 2009 to 2019. INTERVENTION: Limits on PPI refills for patients without a documented indication for long term use, voiding of PPI prescriptions not recently filled, facilitated electronic prescribing of H2 receptor antagonists, and education for patients and clinicians. MAIN OUTCOME MEASURES: The primary outcome was the percentage of patients who filled a PPI prescription per 6 months. Secondary outcomes included percentage of days PPI gastroprotection was prescribed in patients at high risk for upper gastrointestinal bleeding, percentage of patients who filled either a PPI or H2 receptor antagonist prescription, hospital admission for acid peptic disease in older adults appropriate for PPI gastroprotection, primary care visits for an upper gastrointestinal diagnosis, upper endoscopies, and PPI associated clinical conditions. RESULTS: The number of patients analyzed per interval ranged from 192 607 to 250 349 in intervention sites and from 3 775 953 to 4 360 868 in control sites, with 26% of patients receiving PPIs before the intervention. The intervention was associated with an absolute reduction of 7.3% (95% confidence interval -7.6% to -7.0%) in patients who filled PPI prescriptions, an absolute reduction of 11.3% (-12.0% to -10.5%) in PPI use among patients appropriate for gastroprotection, and an absolute reduction of 5.72% (-6.08% to -5.36%) in patients who filled a PPI or H2 receptor antagonist prescription. No increases were seen in primary care visits for upper gastrointestinal diagnoses, upper endoscopies, or hospital admissions for acid peptic disease in older patients appropriate for gastroprotection. No clinically significant changes were seen in any PPI associated clinical conditions. CONCLUSIONS: The multicomponent intervention was associated with reduced PPI use overall but also in patients appropriate for gastroprotection, with minimal evidence of either clinical benefits or harms.

Adoption of Extended-Interval Dosing of Single-Agent Pembrolizumab and Comparative Effectiveness vs Standard Dosing in Time-to-Treatment Discontinuation.

Importance: Extended-interval dosing of pembrolizumab (400 mg every 6 weeks) was approved by US Food and Drug Administration (FDA) in April 2020 as an alternative to standard-interval dosing (200 mg every 3 weeks). Extended-interval dosing may enhance access, alleviate patient and health system financial toxicity, and improve patient quality of life, particularly during the COVID-19 pandemic. Neither adoption nor effectiveness of extended interval in the US has been adequately described. Objective: To describe adoption of extended-interval dosing of pembrolizumab since its FDA approval and to measure its preliminary real-world effectiveness compared with standard-interval dosing. Design, Setting, and Participants: This was a retrospective cohort study that used data from the Veterans Health Administration (VHA), a US-based, nationwide single-payer health system. Participants were veterans who were prescribed single-agent pembrolizumab within the VHA between April 1, 2020, and July 1, 2021. Patients receiving combinations of pembrolizumab and cytotoxic chemotherapy or tyrosine kinase inhibitors were excluded. A subcohort of veterans with non-small cell lung cancer (NSCLC) was also identified using claims-based codes. Exposures: Single-agent pembrolizumab at extended or standard intervals. Main Outcomes and Measures: The number and proportion of single-agent pembrolizumab prescriptions that were extended compared with standard interval. Effectiveness was described in terms of time-to-treatment discontinuation (TTD) and extended- to standard-interval pembrolizumab prescriptions were compared using Cox proportional hazards regression. Results: A total of 835 veterans (mean age [SD], 70.9 [8.7] years; 809 [96.9%] men) began single-agent pembrolizumab during the study period (all-diseases cohort), and of these, 234 (mean [SD] age, 71.6 [7.3] years; 225 [96.2%] men) had NSCLC (NSCLC cohort). Extended-interval adoption reached its steady state plateau of approximately 35% by January 2021; 65% of participants who began standard-interval single-agent pembrolizumab received only standard-interval dosing during the treatment course. In analysis consistent with the intention-to-treat principle, no differences in TTD were observed between standard- and extended-interval dosing in either the all-diseases cohort (HR, 1.00; 95% CI, 1.00-1.00) or the NSCLC cohort (HR, 1.00; 95% CI, 1.00-1.00). Conclusions and Relevance: This retrospective cohort study found that extended-interval dosing comprised a minority of single-agent pembrolizumab prescriptions despite the FDA approval and its potential health system and public health benefits. The findings support the TTD equivalence of standard- and extended-interval pembrolizumab across indications, complementing clinical pharmacology and single-arm clinical trial data in melanoma. This study provides further support for extended-interval pembrolizumab dosing.

Agreement among measures examining low-value imaging for low back pain.

OBJECTIVES: To quantify the extent of patient-level agreement among 3 published measures of low-value imaging for acute low back pain (LBP). STUDY DESIGN: In this retrospective cohort study using commercial insurance claims from MarketScan, we assessed 3 published measures of low-value imaging for agreement in identifying LBP diagnoses (denominator), red-flag diagnoses (denominator exclusions), and imaging procedures (numerator). METHODS: Using a cohort of patients, aged 18 to 64 years, with a diagnosis of LBP in 2014, we assessed agreement surrounding both the overuse event (imaging procedures) and inclusion in the reference population (LBP definition and exclusion diagnoses) using percent agreement and Fleiss κ among 3 overuse measures. RESULTS: In our cohort of 1,835,620 patients with acute LBP, the 3 measures agreed 100% on the presence of acute LBP and also had excellent agreement (99%; κ = 0.98) in identifying imaging for LBP. However, there was substantial disagreement on whom to exclude for red-flag diagnoses, leading to lower agreement (75%; κ = 0.61) on whom to include in the reference population of acute LBP without red flags, among whom imaging for LBP is considered of low value. CONCLUSIONS: Our findings demonstrate the need for further consensus surrounding how to translate guideline recommendations to administrative measures that assess overuse of imaging for acute LBP, particularly with respect to defining which patients should be excluded from the measures. This finding is also important for other overuse measures that rely on exclusions.

Trends in Wait Time for Outpatient Colonoscopy in the Veterans Health Administration, 2008-2015.

BACKGROUND: The Veterans Health Administration (VA) recently has been scrutinized for prolonged wait times for routine medical care, including elective outpatient procedures such as colonoscopy. Wait times for colonoscopy following positive fecal occult blood test (FOBT) are associated with worse clinical outcomes only if greater than 6 months. OBJECTIVE: We aimed to investigate time trends in wait time for outpatient colonoscopy in VA and factors influencing wait time. DESIGN: Retrospective cohort study using mixed-effects regression of VA administrative data from the Corporate Data Warehouse. PARTICIPANTS: Veterans who underwent outpatient colonoscopy for positive FOBT in 2008-2015 at 124 VA endoscopy facilities. MAIN MEASURES: The main outcome measure was wait time (in days) between positive FOBT and colonoscopy completion, stratified by year and adjusted for sedation type, year, and potentially influential patient- and facility-level factors. KEY RESULTS: In total, 125,866 outpatient colonoscopy encounters for positive FOBT occurred during the study period. The number of colonoscopies for this indication declined slightly over time (17,586 in 2008 vs. 13,245 in 2015; range 13,425-19,814). In 2008, median wait time across sites was 50 days (interquartile range [IQR] = 33, 75). There was no secular trend in wait times (2015 median = 52 days, IQR = 34, 77). Examining the adjusted effect of patient- and facility-level factors on wait time, no clinically meaningful difference was found. CONCLUSIONS: Wait times for colonoscopy for positive FOBT have been stable over time. Despite the perception of prolonged VA wait times, wait times for outpatient colonoscopy for positive FOBT are well below the threshold at which clinically meaningful differences in patient outcomes have been observed.

Older Adults and Diabetes Prevention Programs in the Veterans Health Administration.

OBJECTIVE: To investigate whether older veterans enrolled in two diabetes prevention programs (DPPs) in the Veterans Health Administration will have similar weight loss as younger veterans. RESEARCH DESIGN AND METHODS: Post hoc analysis of data from two prospective, pragmatic, nonrandomized studies of behavioral weight management interventions that were delivered in-person (Department of Veterans Affairs [VA]-DPP) or online (Online-DPP), comparing participation and weight loss between participants aged ≥65 years (N = 120) vs. <65 years (N = 258). RESULTS: Over 70% of participants in both age groups completed eight or more sessions within 6 months; a higher proportion completed eight or more sessions in the Online-DPP intervention than in the VA-DPP intervention (P < 0.05). The overall weight changes at 6 and 12 months were similar across the two age groups: ∼5 kg or 5% weight loss compared with baseline (P > 0.05). CONCLUSIONS: DPPs delivered in person or online can be similarly effective in older and younger veterans. Online programs may be an important means to improve the reach of DPPs for older adults.

Quality Improvement and Personalization for Statins: the QUIPS Quality Improvement Randomized Trial of Veterans' Primary Care Statin Use.

BACKGROUND: Implementation of new practice guidelines for statin use was very poor. OBJECTIVE: To test a multi-component quality improvement intervention to encourage use of new guidelines for statin use. DESIGN: Cluster-randomized, usual-care controlled trial. PARTICIPANTS: The study population was primary care visits for patients who were recommended statins by the 2013 guidelines, but were not receiving them. We excluded patients who were over 75 years old, or had an ICD9 or ICD10 code for end-stage renal disease, muscle pain, pregnancy, or in vitro fertilization in the 2 years prior to the study visit. INTERVENTIONS: A novel quality improvement intervention consisting of a personalized decision support tool, an educational program, a performance measure, and an audit and feedback system. Randomization was at the level of the primary care team. MAIN MEASURES: Our primary outcome was prescription of a medium- or high-strength statin. We studied how receiving the intervention changed care during the quality improvement intervention compared to before it and if that change continued after the intervention. KEY RESULTS: Among 3787 visits to 43 primary care providers, being in the intervention arm tripled the odds of patients being prescribed an appropriate statin (OR 3.0, 95% CI 1.8-4.9), though the effect resolved after the personalized decision support ended (OR 1.7, 95% CI 0.99-2.77). CONCLUSIONS: A simple, personalized quality improvement intervention is promising for enabling the adoption of new guidelines. CLINICALTRIALS. GOV IDENTIFIER: NCT02820870.

Results From a Trial of an Online Diabetes Prevention Program Intervention.

INTRODUCTION: Online Diabetes Prevention Programs (DPPs) can be scaled up and delivered broadly. However, little is known about real-world effectiveness and how outcomes compare with in-person DPP. This study examined online DPP weight loss and participation outcomes and secondarily compared outcomes among participating individuals with parallel in-person interventions. STUDY DESIGN: A large non-randomized trial supplemented by a comparative analysis of participating individuals from a concurrent trial of two parallel in-person programs: in-person DPP and the Veterans Administration's standard of care weight loss program (MOVE!). SETTING/PARTICIPANTS: Obese/overweight Veterans with prediabetes enrolled in online DPP (n = 268) between 2013 and 2014. Similar eligibility criteria were used to enroll in-person participants between 2012 and 2014 (n = 273 in-person DPP, n = 114 MOVE!) within a separate trial. INTERVENTION: Online DPP included a virtual group format, live e-coach, weekly modules delivered asynchronously, and wireless home scales. In-person programs included eight to 22 group-based, face-to-face sessions. MAIN OUTCOMES MEASURES: Weight change at 6 and 12 months using wirelessly uploaded home scale data or electronic medical record weights from clinical in-person visits. Outcomes were analyzed between 2015 and 2017. RESULTS: From 1,182 invitations, 268 (23%) participants enrolled in online DPP. Among these, 158 (56%) completed eight or more modules; mean weight change was -4.7kg at 6 months and -4.0kg at 12 months. In a supplemental analysis of participants completing one or more sessions/modules, online DPP participants were most likely to complete eight or more sessions/modules (87% online DPP vs 59% in-person DPP vs 55% MOVE!, p < 0.001). Online and in-person DPP participants lost significantly more weight than MOVE! participants at 6 and 12 months; there was no significant difference in weight change between online and in-person DPP. CONCLUSIONS: An intensive, multifaceted online DPP intervention had higher participation but similar weight loss compared to in-person DPP. An intensive, multifaceted online DPP intervention may be as effective as in-person DPP and help expand reach to those at risk.

Does mental health influence weight loss in adults with prediabetes? Findings from the VA Diabetes Prevention Program.

OBJECTIVES: Mental illness may impact outcomes from structured behavioral weight loss interventions. This secondary analysis investigated the influence of mental health on weight loss among Veterans with prediabetes enrolled in either an in-person diabetes prevention program (DPP) or the usual care weight management program (MOVE!) designed to help patients achieve weight loss through changes in physical activity and diet. METHODS: Prediabetes was defined by Hemoglobin A1c between 5.7 and 6.4% or Fasting Plasma Glucose 100-125 mg/dL and no use of antiglycemic medications during the past six months. Veterans Health Administrative data were used to assign Veterans into one of three mental health diagnoses: severe mental illness (SMI), affective disorder (AD) without SMI, or No SMI/No AD. The influence of mental health on weight changes at 6 and 12 months was modeled using linear mixed-effects regression. RESULTS: On average, Veterans with prediabetes (n = 386) were 59 years old (SD = 10.0 years), with a BMI of 34.8 kg/m2 (SD = 5.3 kg/m2) and A1c of 6.0% (SD = 0.2%). The sample consisted of 12% (n = 47), 39% (n = 150), and 49% (n = 189) diagnosed with SMI, AD and No SMI/No AD, respectively. Across interventions, Veterans with SMI lost less weight than those with AD or No SMI/No AD. From baseline to 6 months, weight loss was significantly less for Veterans with SMI (1.53 kg) compared to Veterans with AD (3.85 kg) or No SMI/No AD (3.73 kg). This weight loss trend by mental health diagnosis continued from baseline to 12 months but was no longer statistically significant at 12 months. CONCLUSION: Weight loss was not clinically or statistically different among Veterans with prediabetes diagnosed with AD or No SMI/No AD. However, Veterans diagnosed with SMI exhibited less weight loss over 6 months than Veterans with AD or No SMI/No AD and though not statistically significant, the trend continued to 12 months, suggesting that SMI may influence weight loss outcomes.

Predictors of Use of Monitored Anesthesia Care for Outpatient Gastrointestinal Endoscopy in a Capitated Payment System.

BACKGROUND & AIMS: Use of monitored anesthesia care (MAC) for gastrointestinal endoscopy has increased in the Veterans Health Administration (VHA) as in fee-for-service environments, despite the absence of financial incentives. We investigated factors associated with use of MAC in an integrated health care delivery system with a capitated payment model. METHODS: We performed a retrospective cohort study using multilevel logistic regression, with MAC use modeled as a function of procedure year, patient- and provider-level factors, and facility effects. We collected data from 2,091,590 veterans who underwent outpatient esophagogastroduodenoscopy and/or colonoscopy during fiscal years 2000-2013 at 133 facilities. RESULTS: The adjusted rate of MAC use in the VHA increased 17% per year (odds ratio for increase, 1.17; 95% confidence interval, 1.09-1.27) from fiscal year 2000 through 2013. The most rapid increase occurred starting in 2011. VHA use of MAC was associated with patient-level factors that included obesity, obstructive sleep apnea, higher comorbidity, and use of prescription opioids and/or benzodiazepines, although the magnitude of these effects was small. Provider-level and facility factors were also associated with use of MAC, although again the magnitude of these associations was small. Unmeasured facility-level effects had the greatest effect on the trend of MAC use. CONCLUSIONS: In a retrospective study of veterans who underwent outpatient esophagogastroduodenoscopy and/or colonoscopy from fiscal year 2000 through 2013, we found that even in a capitated system, patient factors are only weakly associated with use of MAC. Facility-level effects are the most prominent factor influencing increasing use of MAC. Future studies should focus on better defining the role of MAC and facility and organizational factors that affect choice of endoscopic sedation. It will also be important to align resources and incentives to promote appropriate allocation of MAC based on clinically meaningful patient factors.

Overuse of Repeat Upper Endoscopy in the Veterans Health Administration: A Retrospective Analysis.

OBJECTIVES: Americans undergo ∼7 million esophagogastroduodenoscopies (EGDs) annually, and one-third of Medicare beneficiaries undergo a repeat EGD within 3 years. As many as 43% of these repeat EGDs are inappropriate. We aimed to determine the rate of repeat inappropriate EGD within the Veterans Health Administration (VHA), and identify factors associated with repeat EGD. METHODS: We conducted retrospective analyses of Veterans undergoing an index EGD at 159 VHA facilities between 1 January 2003 and 30 June 2007. We excluded Veterans without regular use of VHA for health care or 5 years of follow-up. Appropriateness of repeat EGDs was classified based on diagnostic and procedure codes into three categories: Likely Appropriate, Possible Overuse, and Probable Overuse. The proportion of repeat EGDs in each category was tabulated. Multilevel logistic regression was performed to estimate the impact of patient-level and site-level factors on the odds of repeat EGD. RESULTS: Of the 235,855 included Veterans, 85,690 (36.3%) underwent a repeat EGD within 5 years. Of the repeat EGDs, 42,412 (49.5%) were Likely Appropriate, 35,503 (41.4%) represented Possible Overuse, and 7,756 (9.1%) represented Probable Overuse. Patients with more frequent encounters with primary care providers and access to facilities performing EGD and with greater complexity of services were more likely to receive repeat EGD, regardless of whether the repeat EGD was appropriate or overuse. Women were slightly more likely to undergo repeat EGD in Probable Overuse situations. CONCLUSIONS: Overuse of repeat EGD is common in VHA despite the absence of financial incentives that promote overuse. Efforts are needed to better understand the motivations for overuse and barriers to appropriate use, and to promote appropriate use of repeat EGD.

Behavioral Treatment for Veterans with Obesity: 24-Month Weight Outcomes from the ASPIRE-VA Small Changes Randomized Trial.

BACKGROUND: Small Changes (SC) is a weight management approach that demonstrated superior 12-month outcomes compared to the existing MOVE!® Weight Management Program at two Veterans Affairs (VA) sites. However, approaches are needed to help graduates of treatment continue to lose or maintain their weight over the longer term. OBJECTIVE: The purpose of the present study was to examine the effectiveness of a second year of low-intensity SC support compared to support offered by the usual care MOVE! programs. DESIGN: Following participation in the year-long Aspiring to Lifelong Health in VA (ASPIRE-VA) randomized controlled trial, participants were invited to extend their participation in their assigned program for another year. Three programs were extended to include six SC sessions delivered via telephone (ASPIRE-Phone) or an in-person group (ASPIRE-Group), or 12 sessions offered by the MOVE! programs. PARTICIPANTS: Three hundred thirty-two overweight/obese veterans who consented to extend their participation in the ASPIRE-VA trial by an additional year. MAIN MEASURES: Twenty-four-month weight change (kg). KEY RESULTS: Twenty-four months after baseline, participants in all three groups had modest weight loss (-1.40 kg [-2.61 to -0.18] in the ASPIRE-Group, -2.13 kg [-3.43 to -0.83] in ASPIRE-Phone, and -1.78 kg [-3.07 to -0.49] in MOVE!), with no significant differences among the three groups. Exploratory post hoc analyses revealed that participants diagnosed with diabetes initially benefited from the ASPIRE-Group program (-2.6 kg [-4.37 to 0.83]), but experienced significant weight regain during the second year (+2.8 kg [0.92-4.69]) compared to those without diabetes. CONCLUSIONS: Participants in all three programs lost weight and maintained a statistically significant, though clinically modest, amount of weight loss over a 24-month period. Although participants in the ASPIRE-Group initially had greater weight loss, treatment was not sufficient to sustain weight loss through the second year, particularly in veterans with diabetes. Consistent, continuous-care treatment is needed to address obesity in the VA.

Mental health and behavioral weight loss: 24-month outcomes in Veterans.

BACKGROUND: Individuals with mental health (MH) disorders have an increased risk of being overweight/obese; however research on behavioral weight loss interventions has been limited. A priori hypothesis was that Veterans with serious mental illness (SMI) and/or affective disorders (AD) would lose significantly less weight and have a different pattern of weight loss than Veterans without these diagnoses. METHODS: Secondary data analysis of ASPIRE-VA study, three-arm randomized, effectiveness weight loss trial among Veterans (n=409) categorized by MH diagnoses: 1) SMI, 2) AD without SMI, or 3) No SMI/No AD. Linear mixed-effects model analyzed weight changes from baseline thru 24 months. RESULTS: SMI and AD were diagnosed in 10% (n=41) and 31% (n=125). Participants attended approximately 15 sessions from baseline to 24 months. On average, participants lost a modest amount of weight over 24 months regardless of MH diagnosis. Longitudinally, no statistically significant differences were found in weight loss patterns by MH diagnosis. Unadjusted average weight loss (kg) was 1.6±4.0 at 3 months (n=373), 1.9±6.5 at 12 months (n=361), 1.5±7.8 at 18 months (n=289), and 1.4±8.0 at 24 months (n=279). LIMITATIONS: ASPIRE-VA study was not designed or powered to detect weight loss differences among MH diagnostic groups. CONCLUSIONS: Veterans achieved and maintained modest weight loss, through 24 months, with the three behavioral weight loss interventions. Contrary to our hypotheses, the amount and pattern of weight loss did not differ by MH diagnosis. Greater inclusion of individuals with MH diagnoses may be warranted in behavioral weight loss interventions not specifically tailored for them.

Diabetes Prevention Program Translation in the Veterans Health Administration.

INTRODUCTION: This clinical demonstration trial compared the effectiveness of the Veterans Affairs Diabetes Prevention Program (VA-DPP) with an evidence-based usual care weight management program (MOVE!®) in the Veterans Health Administration health system. DESIGN: Prospective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions. SETTING/PARTICIPANTS: Obese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014. INTERVENTION: VA-DPP included 22 group-based intensive lifestyle change sessions. MAIN OUTCOME MEASURES: Weight change at 6 and 12 months, hemoglobin A1c (HbA1c) at 12 months, and VA health expenditure changes at 15 months were assessed using VA electronic health record and claims data. Between- and within-group comparisons for weight and HbA1c were done using linear mixed-effects models controlling for age, gender, race/ethnicity, baseline outcome values, and site. Analyses were conducted in 2015-2016. RESULTS: A total of 387 participants enrolled (273 VA-DPP, 114 MOVE!). More VA-DPP participants completed at least one (73.3% VA-DPP vs 57.5% MOVE! p=0.002); four (57.5% VA-DPP vs 42.5% MOVE!, p=0.007); and eight or more sessions (42.5% VA-DPP vs 31% MOVE!, p=0.035). Weight loss from baseline was significant at both 6 (p<0.001) and 12 months (p<0.001) for VA-DPP participants, but only significant at 6 months for MOVE! participants (p=0.004). Between groups, there were significant differences in 6-month weight loss (-4.1 kg VA-DPP vs -1.9 kg MOVE!, p<0.001), but not 12-month weight loss (-3.4 kg VA-DPP vs -2.0 kg MOVE!, p=0.16). There were no significant differences in HbA1c change or outpatient, inpatient, and total VA expenditures. CONCLUSIONS: VA-DPP participants had higher participation rates and weight loss at 6 months, but similar weight, HbA1c, and health expenditures at 12 months compared to MOVE! PARTICIPANTS: Features of VA-DPP may help enhance the capability of MOVE! to reach a larger proportion of the served population and promote individual-level weight maintenance.

Weight loss among women and men in the ASPIRE-VA behavioral weight loss intervention trial.

OBJECTIVE: Weight loss was examined among women and men veterans in a clinical trial comparing Aspiring for Lifelong Health (ASPIRE), a "small changes" weight loss program using either mixed-sex group-visit or telephone-based coaching, to MOVE!(®) , the usual mixed-sex group-based program. METHODS: Linear mixed-effects models were used to calculate adjusted percent weight change at 12 months by sex and compare outcomes across arms within sex. RESULTS: Analyses included 72 women (ASPIRE-Phone = 26; ASPIRE-Group = 26; MOVE! = 20) and 409 men (ASPIRE-Phone = 136; ASPIRE-Group = 134; MOVE! = 139). At 12 months, women displayed significant weight loss from baseline in ASPIRE-Group (-2.6%) and MOVE! (-2.7%), but not ASPIRE-Phone (+0.2%). Between-arm differences in weight change among women were: ASPIRE-Group versus ASPIRE-Phone, -2.8% (P = 0.15); MOVE! versus ASPIRE-Phone, -2.8% (P = 0.20); and ASPIRE-Group versus MOVE!, 0.0% (P = 1.0). At 12 months, men lost significant weight from baseline across arms (ASPIRE-Phone, -1.5%; ASPIRE-Group, -2.5%; MOVE!, -1.0%). Between-arm differences in weight change among men were: ASPIRE-Group versus ASPIRE-Phone, -0.9% (P = 0.23); MOVE! versus ASPIRE-Phone, +0.5% (P = 0.76); ASPIRE-Group versus MOVE!, -1.5% (P = 0.03). CONCLUSIONS: Mixed-sex, group-based programs can result in weight loss for both women and men veterans.

Long-Term Effects of an Internet-Mediated Pedometer-Based Walking Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial.

BACKGROUND: Regular physical activity (PA) is recommended for persons with chronic obstructive pulmonary disease (COPD). Interventions that promote PA and sustain long-term adherence to PA are needed. OBJECTIVE: We examined the effects of an Internet-mediated, pedometer-based walking intervention, called Taking Healthy Steps, at 12 months. METHODS: Veterans with COPD (N=239) were randomized in a 2:1 ratio to the intervention or wait-list control. During the first 4 months, participants in the intervention group were instructed to wear the pedometer every day, upload daily step counts at least once a week, and were provided access to a website with four key components: individualized goal setting, iterative feedback, educational and motivational content, and an online community forum. The subsequent 8-month maintenance phase was the same except that participants no longer received new educational content. Participants randomized to the wait-list control group were instructed to wear the pedometer, but they did not receive step-count goals or instructions to increase PA. The primary outcome was health-related quality of life (HRQL) assessed by the St George's Respiratory Questionnaire Total Score (SGRQ-TS); the secondary outcome was daily step count. Linear mixed-effect models assessed the effect of intervention over time. One participant was excluded from the analysis because he was an outlier. Within the intervention group, we assessed pedometer adherence and website engagement by examining percent of days with valid step-count data, number of log-ins to the website each month, use of the online community forum, and responses to a structured survey. RESULTS: Participants were 93.7% male (223/238) with a mean age of 67 (SD 9) years. At 12 months, there were no significant between-group differences in SGRQ-TS or daily step count. Between-group difference in daily step count was maximal and statistically significant at month 4 (P<.001), but approached zero in months 8-12. Within the intervention group, mean 76.7% (SD 29.5) of 366 days had valid step-count data, which decreased over the months of study (P<.001). Mean number of log-ins to the website each month also significantly decreased over the months of study (P<.001). The online community forum was used at least once during the study by 83.8% (129/154) of participants. Responses to questions assessing participants' goal commitment and intervention engagement were not significantly different at 12 months compared to 4 months. CONCLUSIONS: An Internet-mediated, pedometer-based PA intervention, although efficacious at 4 months, does not maintain improvements in HRQL and daily step counts at 12 months. Waning pedometer adherence and website engagement by the intervention group were observed. Future efforts should focus on improving features of PA interventions to promote long-term behavior change and sustain engagement in PA. CLINICALTRIAL: Clinicaltrials.gov NCT01102777; https://clinicaltrials.gov/ct2/show/NCT01102777 (Archived by WebCite at http://www.webcitation.org/6iyNP9KUC).

Development and validation of the ASPIRE-VA coaching fidelity checklist (ACFC): a tool to help ensure delivery of high-quality weight management interventions.

Practical and valid instruments are needed to assess fidelity of coaching for weight loss. The purpose of this study was to develop and validate the ASPIRE Coaching Fidelity Checklist (ACFC). Classical test theory guided ACFC development. Principal component analyses were used to determine item groupings. Psychometric properties, internal consistency, and inter-rater reliability were evaluated for each subscale. Criterion validity was tested by predicting weight loss as a function of coaching fidelity. The final 19-item ACFC consists of two domains (session process and session structure) and five subscales (sets goals and monitor progress, assess and personalize self-regulatory content, manages the session, creates a supportive and empathetic climate, and stays on track). Four of five subscales showed high internal consistency (Cronbach alphas > 0.70) for group-based coaching; only two of five subscales had high internal reliability for phone-based coaching. All five sub-scales were positively and significantly associated with weight loss for group- but not for phone-based coaching. The ACFC is a reliable and valid instrument that can be used to assess fidelity and guide skill-building for weight management interventionists.

Sex Differences in Weight Loss among Veterans with Serious Mental Illness: Observational Study of a National Weight Management Program.

PURPOSE: Obesity disproportionately burdens individuals with serious mental illness (SMI), especially women. This observational study investigated whether there were sex differences in weight loss and program participation among veterans with SMI enrolled in the Veterans Health Administration's (VHA) MOVE! weight management program. PROCEDURES: Participants were identified from a national cohort of 148,254 veterans enrolled in MOVE! during fiscal years 2008 through 2012 who attended two or more sessions within 12 months of enrollment. The cohort included those with International Classification of Disease, 9th Edition, Clinical Modification (ICD-9-CM) diagnoses for SMI, age less than 70 years, and weight data at baseline and one or more follow-up timepoints within approximately 1 year of enrollment (n = 8,943 men; n = 2,245 women). Linear mixed models assessed associations of sex with 6- and 12-month weight change from baseline, adjusting for demographic- and site-level variables. FINDINGS: Both sexes averaged 6.4 (standard deviation, 4.6) sessions within 12 months; however, women with and without SMI participated at rates double their respective proportion rates among all VHA users. Participants averaged statistically significant weight loss at 6 months (men, -2.5 lb [95% CI, -2.8 to -2.1]; women, -2.4 lb [95% CI, -3.1 to -1.7]) and 12 months (men, -2.5 lb [95% CI, -2.8 to -2.2]; women, -2.9 lb [95% CI, -3.6 to -2.2]), but no sex-based difference in absolute weight loss at either timepoint. Slightly more women achieved 5% or greater (clinically significant) weight loss at the 12-month follow-up than did men (25.7% vs. 23.0%; p < .05). CONCLUSIONS: Women with SMI participated in MOVE! at rates equivalent to or greater than men with SMI, with comparable weight loss. More women were Black, single, had bipolar and posttraumatic stress disorder, and higher service-connected disability, suggesting areas for program customization.

A Comparative Effectiveness Trial of Three Walking Self-monitoring Strategies.

PURPOSE: Walking programs improve health outcomes in adults at risk for cardiovascular disease and self-monitoring strategies can improve adherence to such programs. The objective of this study was to determine if a six-month internet-based walking program using web-enhanced pedometers results in more weight loss than walking programs based on time or simple pedometer-step count goals in adults with or at risk for cardiovascular disease (CVD). METHODS: This was a multi-site, randomized controlled trial of 255 male Veterans who were ambulatory, insufficiently active, BMI ≥ 28, and who reported 1 ≥ CVD risk factors. Participants were randomized to one of three self-monitoring strategies to increase walking: (1) time-based walking goals; (2) simple pedometer-based walking goals; and (3) web-enhanced pedometer feedback goals with Internet-mediated feedback. All participants also attended five individual weight loss sessions with a dietitian. The main outcome measure was change in weight at six months (kg) and secondary outcomes were change in accelerometer-measured physical activity (min) and change in health-related quality of life at six months. RESULTS: The 255 participants had a mean age of 56.3 years (SD = 10.0), BMI=36.3 (SD = 5.3) with a mean of 5.2 (SD = 2.3) medical comorbidities. Dropouts were distributed evenly across the three groups and 72% of participants completed the program. At six months, participants in the web-enhanced pedometer arm lost significantly more weight (-1.9 kg, 95% CI=-2.7, -1.1) than those in the time-based group (-0.7 kg, 95% CI=-1.5, 0.0; p = 0.04) and simple pedometer group (-0.6 kg, 95% CI=-1.4, 0.2; p = 0.02). CONCLUSION: Internet-enhanced pedometers result in greater weight loss in Veterans than walking programs using time-based walking goals or simple pedometers.

Physical activity and sedentary behavior measured objectively and subjectively in overweight and obese adults with schizophrenia or schizoaffective disorders.

OBJECTIVE: Describe objective and subjective physical activity levels and time spent being sedentary in adults with schizophrenia or schizoaffective disorders (SZO/SA). METHOD: Baseline physical activity and sedentary behaviors were assessed among 46 overweight and obese community-dwelling adults (aged 18-70 years; BMI > 27 kg/m(2)) diagnosed with SZO/SA by DSM-IV-TR, with mild symptom severity (Positive and Negative Syndrome Scale score < 90) who were interested in losing weight and participated in the Weight Assessment and Intervention in Schizophrenia Treatment (WAIST) study from 2004 to 2008. Objective physical activity levels, measured using actigraphs, in WAIST were compared to a nationally representative sample of users (n = 46) and nonusers (n = 46) of mental health service (MHS) from the National Health and Nutrition Examination Survey (NHANES 2003-2004) matched by sex, BMI, and age. RESULTS: On average, adults with SZO/SA wore actigraphs more than 15 h/d for 7 days averaging 151,000 counts/d. The majority of monitoring time (81%) was classified as sedentary (approximately 13 h/d). Moderate/vigorous and light physical activity accounted for only 2% (19 min/d) and 17% (157 min/d) of monitoring time/d, respectively. Primary source of activity was household activities (409 ± 438 min/wk). Fifty-three percent reported walking for transportation or leisure. Adults with SZO/SA were significantly less active (176 min/d) and more sedentary (756 min/d) than NHANES users of MHS (293 and 640 min/d, respectively) and nonusers of MHS (338 and 552 min/d, respectively) (P < .01). CONCLUSIONS: Overweight and obese adults with SZO/SA were extremely sedentary; engaged in unstructured, intermittent, low-intensity physical activity; and significantly less active than NHANES users and nonusers of MHS. This sedentary lifestyle is significantly lower than those of other inactive US populations, is costly for the individual and community, and highlights the need for physical activity promotion and interventions in this high risk population.