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Background When compared with conventional weight loss strategies, bariatric surgery results in substantially greater durable weight loss and rates of disease remission. Objective The ENGAGE CVD (Effectiveness of Gastric Bypass versus Gastric Sleeve for Cardiovascular Disease) cohort study aimed to provide population-based, comprehensive, rigorous evidence for clinical and policy decision making regarding the choice between gastric bypass and gastric sleeve for overall cardiovascular disease (CVD) risk reduction, risk factor remission, and safety. Methods The cohort had 22,095 weight loss surgery patients from a large integrated health care system in Southern California assembled from 2009 to 2016 who were followed up through 2018. Bariatric surgery patients were followed up for the length of their membership in the health care system. Of the patients who had at least five years of follow-up (surgery between 2009 and 2013), 85.86% (13,774/16,043) could contribute to the outcome analyses for the ENGAGE CVD cohort. Results Patients in the ENGAGE CVD cohort were 44.6 (SD 11.4) years old, mostly women (17,718/22,095; 80.19%), with 18.94% (4185/22,095) non-Hispanic black and 41.80% (9235/22,095) Hispanic, and had an average BMI of 44.3 (SD 6.9) kg/m2 at the time of surgery. When compared with patients who did not contribute data to the 5-year outcome analysis for the ENGAGE CVD cohort (2269/16,043; 14.14%), patients who contributed data (13,774/16,043; 85.86%) were older (P=.002), more likely to be women (P=.02), more likely to be non-Hispanic white (P Conclusions This study had one of the largest populations of gastric sleeve patients (n=13,459). The 5-year follow-up for those patients who had surgery between 2009 and 2013 was excellent for a retrospective cohort study at 85.86% (13,774/16,043). Unlike almost any study in the literature, the majority of the ENGAGE CVD cohort was racial and ethnic minority, providing a rare opportunity to study the effects of bariatric surgery for different racial and ethnic groups, some of whom have the highest rates of severe obesity in the United States. Finally, it also used state-of-the-art statistical and econometric comparative effectiveness methods to mimic the effect of random assignment and control for sources of confounding inherent in large observational studies. International Registered Report Identifier (IRRID) RR1-10.2196/14936

Background Studies assessing the impact of built environments on body weight are often limited by modest power to detect residential effects that are small for individuals but may nonetheless comprise large attributable risks. Objective We used data extracted from electronic health records to construct a large retrospective cohort of patients. This cohort will be used to explore both the impact of moving between environments and the long-term impact of changing neighborhood environments. Methods We identified members with at least 12 months of Kaiser Permanente Washington (KPWA) membership and at least one weight measurement in their records during a period between January 2005 and April 2017 in which they lived in King County, Washington. Information on member demographics, address history, diagnoses, and clinical visits data (including weight) was extracted. This paper describes the characteristics of the adult (aged 18-89 years) cohort constructed from these data. Results We identified 229,755 adults representing nearly 1.2 million person-years of follow-up. The mean age at baseline was 45 years, and 58.0% (133,326/229,755) were female. Nearly one-fourth of people (55,150/229,755) moved within King County at least once during the follow-up, representing 84,698 total moves. Members tended to move to new neighborhoods matching their origin neighborhoods on residential density and property values. Conclusions Data were available in the KPWA database to construct a very large cohort based in King County, Washington. Future analyses will directly examine associations between neighborhood conditions and longitudinal changes in body weight and diabetes as well as other health conditions. International Registered Report Identifier (IRRID) DERR1-10.2196/16787

Background: Older adults have high rates of obesity and are prone to chronic health conditions. These conditions are in part due to high rates of sedentary time (ST). As such, reducing ST could be an innovative strategy for improving health outcomes among obese older adults. To test this theory, we developed a novel, technology-enhanced intervention to reduce sitting time (I-STAND) and pilot tested it to assess the feasibility, acceptability, and preliminary effects of the intervention on ST and biometric outcomes. Objective: The current paper aims to describe the rationale, design, and methods of the I-STAND sitting reduction pilot trial. Methods: Older adults with obesity (n=60) were recruited from a large health care system and randomized to receive I-STAND or a healthy living intervention. I-STAND combined personal coaching with a technology-enhanced intervention (Jawbone UP band) to cue breaks from sitting. Participants completed self-report and biometric assessments at baseline and 3 months. Additional qualitative results were collected from a subset of I-STAND participants (n=22) to further inform the feasibility and acceptability of the interventions. The primary outcome was total hours of daily sitting time measured by the activPAL device. Secondary outcomes included sit-to-stand transitions, bouts of sitting longer than 30 minutes, physical function, blood pressure, fasting glucose, cholesterol, and depressive symptoms. Results: Study enrollment has ended and data processing is underway. Conclusions: Data from randomized trials on sitting reduction are needed to inform novel approaches to health promotion among older adults with obesity. Our trial will help fill this gap. The methods used in our study can guide future research on using technology-based devices to assess or prompt sedentary behavior reduction, or those interested in behavioral interventions targeting obese older adults with novel approaches Trial Registration: ClinicalTrials.gov: NCT02692560; https://clinicaltrials.gov/ct2/show/NCT02692560 (Archived by WebCite at http://www.webcitation.org/6wppLTWAl)

Background: The Patient-Centered Outcomes Research Institute (PCORI) created a new national network infrastructure to enable large-scale observational comparative effectiveness research across diverse clinical care settings. As part of testing the feasibility of this effort, each clinical data research network (CDRN) was required to construct cohorts of patients, including one of patients with overweight and obesity. Objective: The aim of this paper is to report on the development of the Patient Outcomes Research to Advance Learning (PORTAL) overweight and obese cohort, which includes patients from 10 health plans located across the United States. Methods: Information was gathered from each plan’s electronic health records (EHR). Eligibility included 18 years of age or older, a valid height and weight in 2012 or 2013, and body mass index (BMI) greater than 22.9 kg/m2. Pre-diabetes and diabetes status was defined using the American Diabetes Association (ADA) criteria, using lab values of glycated hemoglobin (HbA1c) or fasting glucose available in the EHR. Hypertension was identified from the International Classification of Diseases (ICD) diagnosis codes. Individuals were classified into BMI categories: healthy weight (23.0-24.9 kg/m2), overweight (25.0-29.9 kg/m2), obese class 1 (30.0-34.9 kg/m2), obese class 2 (35.0-39.9 kg/m2), obese class 3 (40.0-49.0 kg/m2), and obese class 4 (>50.0 kg/m2). Results: A cohort of 5,293,458 non-pregnant adults was created. Weight status was 20.39% (1,079,289/5,293,458) healthy weight, 40.40% (2,138,520/5,293,458) overweight, 22.78% (1,205,866/5,293,458) obese class 1, 9.86% (521,872/5,293,458) obese class 2, 5.59% (295,786/5,293,458) obese class 3, and 0.98% (52,125/5,293,458) obese class 4. Race/ethnicity was 49.02% (2,594,776/5,293,458) non-Hispanic white, 22.89% (1,211,677/5,293,458) Hispanic, 10.40% (550,608/5,293,458) Asian, 10.83% (573,506/5,293,458) black, and 6.59% (348,830/5,293,458) other. About 34.33% (1,817,438/5,293,458) met the definition of hypertension, 20.49% (1,660,940/5,293,458) of individuals met the criteria for pre-diabetes, and 14.98% (793,069/5,293,458) met criteria for diabetes. Prevalence of pre-diabetes and diabetes varied across health plans to a greater extent than expected based on hypertension prevalence and BMI status variability. Conclusions: This large, race, ethnic, and geographically diverse cohort will be useful for future studies of rare exposures or outcomes and differences in health care practices. [JMIR Res Protoc 2016;5(2):e87]

Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort. Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice.