In adults with moderate-to-severe OSA and obesity, tirzepatide reduced apnea-hypopnea events vs. placebo.

SOURCE CITATION: Malhotra A, Grunstein RR, Fietze I, et al; SURMOUNT-OSA Investigators. Tirzepatide for the treatment of obstructive sleep apnea and obesity. N Engl J Med. 21 Jun 2024. [Epub ahead of print.] 38912654.

From Policy to Practice: Assessing the State Innovation Models Initiative's Early Success in Incorporating Social Determinants of Health in ASCVD Hospitalizations in the United States.

The study examines effects of the CMS State Innovation Models(SIM) on capturing social risk factors in adults hospitalized with Atherosclerotic Cardiovascular Disease (ASCVD). Using a difference-in-differences(DID) approach with propensity score weights, the study compared documentation of secondary diagnosis of SDOH/social factors using ICD-9 V codes ("SDOH codes") in adults hospitalized with ASCVD as a primary diagnosis (N= 1,485,354). Data were gathered from January 1, 2010, to September 30, 2015, covering the period before and after the SIM implementation in October 2013. From January 2010 to September 2015, SDOH codes were infrequently utilized among adults with ASCVD(0.55%, 95% CI: 0.43%-0.67%). SDOH codes with ASCVD increased from pre- to post-period in SIM states(0.56% to 0.93%) and comparison states (0.46% to 0.56%). SIM implementation was associated with greater improvement in SDOH codes utilization (adjusted OR 1.30, 95%CI: 1.18-1.43) during ASCVD hospitalizations. The odds of SDOH codes utilization were 86% higher in ED admissions(AOR 1.86, 95%CI: 1.76-1.97) than in routine admissions with ASCVD. Findings were similar when limiting population to older adults(>=65 years) enrolled in Medicare(AOR 1.50, 95%CI 1.31-1.71), whereas not significant for Medicaid beneficiaries. The study points to challenges for healthcare providers in documenting SDOH in adults with ASCVD.

Food Environment Quality and Cardiovascular Disease Mortality in the United States: a County-Level Analysis from 2017 to 2019.

BACKGROUND: Upstream socioeconomic circumstances including food insecurity and food desert are important drivers of community-level health disparities in cardiovascular mortality let alone traditional risk factors. The study assessed the association between differences in food environment quality and cardiovascular mortality in US adults. DESIGN: Retrospective analysis of the association between cardiovascular mortality among US adults aged 45 and above and food environment quality, measured as the food environment index (FEI), in 2615 US counties. FEI was measured by equal weights of food insecurity (limited access to a reliable food source) and food desert (limited access to healthy food), ranging from 0 (worst) to 10 (best). Age-adjusted cardiovascular mortality rates per 100,000 adults aged 45 and above in the calendar year 2017-2019. County-level association between CVD mortality rate and FEI was modeled using generalized linear regression. Data were weighted using county population. RESULT: Median CVD deaths per 100,000 population were 645.4 (IQR 561.5, 747.0) among adults aged 45 years and above across US counties in 2017-2019. About 12.8% (IQR 10.7%, 15.1%) of residents were food insecure and 6.3% (IQR 3.6%, 9.9%) were living in food desert areas. Comparing counties by FEI quartiles, the CVD mortality rate was higher in the least healthy FE counties (704.3 vs 598.6 deaths per 100,000 population) compared to the healthiest FE counties. One unit increase in FEI was associated with - 12.95 CVD deaths/100,000 population. In the subgroup analysis of counties with higher income inequality, the healthiest food environment was associated with 46.4 lower CVD deaths/100,000 population than the least healthy food environment. One unit increase in FEI in counties with higher income inequality was associated with a fivefold decrease in CVD mortality difference in African American counties (- 18.4 deaths/100,000 population) when compared to non-African American counties (- 3.63 deaths/100,000 population). CONCLUSION: In this retrospective multi-county study in the USA, a higher food environment index was significantly associated with lower cardiovascular mortality.

Food insecurity and housing instability as determinants of cardiovascular health outcomes: A systematic review.

AIMS: The primary objective of this study is to conduct a systematic review of existing literature on the association between food insecurity and housing instability with CVD and its subtypes-related outcomes. Summarizing the comprehensive evidence for independent/interchangeable relationship of food and housing instability with CVD outcomes may inform specific interventions strategies to reduce CVD-risk. DATA SYNTHESIS: The search focused on English-language articles in PubMed/Medline, from January 1, 2010, to June 1, 2021, with restriction to the US adult population. We included studies estimating the association between food insecurity or/and housing instability(exposure) and CVD-subtypes-related health outcomes (outcome). The study methodological quality was assessed using the Study Quality Assessment Tools (SQAT). Nineteen studies met eligibility criteria, consisted of 15 cross-sectional and 4 cohort studies. Of total studies, 7 examined housing instability, 11 studies focused on food insecurity, and one examined both. Food insecurity/housing instability was associated with increased overall CVD-mortality rate and greater healthcare cost utilization, while evidence were mixed for hospital readmission rate. By subtype, stroke mortality was greater with food insecurity but not with housing instability. The likelihood of myocardial infarction, coronary heart disease, and congestive heart failure was greater with food insecurity. Although mortality with MI was higher with housing instability, readmission and surgical procedure rates were significantly lower than housing stable adults. CONCLUSION: Findings from this review suggest an urgent need to test the impact of screening for food and housing insecurities, referral services, and community engagement for CV health, within clinical and public health settings. PROTOCOL REGISTRATION: Prospero CRD4202123352.

In overweight or obese adults without diabetes, semaglutide increased weight loss and GI disorders.

SOURCE CITATION: Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384:989. 33567185.

COVID-19, Diabetes, and Associated Health Outcomes in China: Results from a Nationwide Survey of 10 545 Adults.

This study examined the associations between diabetes and self-reported/familial COVID-19 infection and investigated health-related outcomes among those with diabetes during China's nationwide quarantine. The 2020 China COVID-19 Survey was administered anonymously via social media (WeChat). It was completed by 10 545 adults in all of mainland China's 31 provinces. The survey consisted of 74 items covering sociodemographic characteristics, preventive measures for COVID-19, lifestyle behaviors, and health-related outcomes during the period of quarantine. Regression models examined associations among study variables. Diabetes was associated with a six-fold increased risk of reporting COVID-19 infection among respondents or their family members. Among people with diabetes, individuals who rarely wore masks had double the risk of suspected COVID-19 infection compared with those who always wore masks, with an inverse J-shaped relationship between face mask wearing and suspected COVID-19 infection. People with diabetes tended to have both poor knowledge of COVID-19 and poor compliance with preventive measures, despite perceiving a high risk of personal infection (40.0% among respondents reporting diabetes and 8.0% without diabetes). Only 54-55% of these respondents claimed to consistently practice preventive measures, including wearing face masks. Almost 60% of those with diabetes experienced food or medication shortages during the quarantine period, which was much higher than those without diabetes. Importantly, respondents who experienced medication shortages reported a 63% higher COVID-19 infection rate. Diabetes was associated with an increased risk of self-reported personal and family member COVID-19 infection, which is mitigated by consistent use of face masks.

Obesity prevalence in large US cities: association with socioeconomic indicators, race/ethnicity and physical activity.

BACKGROUND: Obesity has a complex association with socioeconomic factors. Further clarification of this association could guide population interventions. METHODS: To determine the relationship between obesity prevalence, socioeconomic indicators, race/ethnicity, and physical activity, we performed a cross-sectional, multivariable linear regression, with data from large US cities participating in the Big Cities Health Inventory. RESULTS: Increased household income was significantly associated with decreased obesity prevalence, for White (-1.97% per 10 000USD), and Black (-3.02% per 10 000USD) populations, but not Hispanic. These associations remained significant when controlling for the proportion of the population meeting physical activity guidelines. Educational attainment had a co-linear relationship with income, and only a bachelor's degree or higher was associated with a lower prevalence of obesity in White (-0.30% per percentage) and Black (-0.69% per percentage) populations. No association was found between obesity prevalence and the proportion of the population meeting physical activity guidelines for any race/ethnicity grouping. CONCLUSION: At the population level of large US cities, obesity prevalence is inversely associated with median household income in White and Black populations. Strategies to increase socioeconomic status may also decrease obesity. Targeting attainment of physical activity guidelines as an obesity intervention needs further appraisal.

Protocol for the Mason: Health Starts Here prospective cohort study of young adult college students.

BACKGROUND: Young adulthood is a period of increasing independence for the 40% of young adults enrolled in U.S. colleges. Previous research indicates differences in how students' health behaviors develop and vary by gender, race, ethnicity, and socioeconomic status. George Mason University is a state institution that enrolls a highly diverse student population, making it an ideal setting to launch a longitudinal cohort study using multiple research methods to evaluate the effects of health behaviors on physical and psychological functioning, especially during the COVID-19 pandemic. RESULTS: Mason: Health Starts Here was developed as a longitudinal cohort study of successive waves of first year students that aims to improve understanding of the natural history and determinants of young adults' physical health, mental health, and their role in college completion. The study recruits first year students who are 18 to 24 years old and able to read and understand English. All incoming first year students are recruited through various methods to participate in a longitudinal cohort for 4 years. Data collection occurs in fall and spring semesters, with online surveys conducted in both semesters and in-person clinic visits conducted in the fall. Students receive physical examinations during clinic visits and provide biospecimens (blood and saliva). CONCLUSIONS: The study will produce new knowledge to help understand the development of health-related behaviors during young adulthood. A long-term goal of the cohort study is to support the design of effective, low-cost interventions to encourage young adults' consistent performance of healthful behaviors, improve their mental health, and improve academic performance.

Healthfulness Assessment of Recipes Shared on Pinterest: Natural Language Processing and Content Analysis.

BACKGROUND: Although Pinterest has become a popular platform for distributing influential information that shapes users' behaviors, the role of recipes pinned on Pinterest in these behaviors is not well understood. OBJECTIVE: This study aims to explore the patterns of food ingredients and the nutritional content of recipes posted on Pinterest and to examine the factors associated with recipes that engage more users. METHODS: Data were collected from Pinterest between June 28 and July 12, 2020 (207 recipes and 2818 comments). All samples were collected via 2 new user accounts with no search history. A codebook was developed with a raw agreement rate of 0.97 across all variables. Content analysis and natural language processing sentiment analysis techniques were employed. RESULTS: Recipes using seafood or vegetables as the main ingredient had, on average, fewer calories and less sodium, sugar, and cholesterol than meat- or poultry-based recipes. For recipes using meat as the main ingredient, more than half of the energy was obtained from fat (277/490, 56.6%). Although the most followed pinners tended to post recipes containing more poultry or seafood and less meat, recipes with higher fat content or providing more calories per serving were more popular, having more shared photos or videos and comments. The natural language processing-based sentiment analysis suggested that Pinterest users weighted taste more heavily than complexity (225/2818, 8.0%) and health (84/2828, 2.9%). CONCLUSIONS: Although popular pinners tended to post recipes with more seafood or poultry or vegetables and less meat, recipes with higher fat and sugar content were more user-engaging, with more photo or video shares and comments. Data on Pinterest behaviors can inform the development and implementation of nutrition health interventions to promote healthy recipe sharing on social media platforms.

Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis.

BACKGROUND & AIMS: Bariatric surgery is the most successful treatment for obesity. However, many patients avoid surgery due to its perceived invasive nature and fear of complications. Endoscopic sleeve gastroplasty (ESG) is a seemingly less invasive option for patients with obesity. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ESG in adults. METHODS: We searched MEDLINE, Embase, Web of Science, and Cochrane Library through July 2019. Investigated outcomes included the percent total body weight loss (TBWL), body mass index reduction, percent excess weight loss (EWL), and adverse events. RESULTS: We extracted data from 8 original studies, published from 2016 through 2019, which included a total of 1772 patients. At 6 months, mean TBWL was 15.1% (95% CI, 14.3-16.0), mean decrease in body mass index was 5.65 kg/m2 (95% CI, 5.07-6.22), and mean excess weight loss was 57.7% (95% CI, 52.0-63.4). Weight loss was sustained at 12 months and 18-24 months with a TBWL of 16.5% (95% CI, 15.2-17.8) and 17.2% (95% CI, 14.6-19.7), respectively. The pooled post-ESG rate of severe adverse events was 2.2% (95% CI, 1.6%-3.1%), including pain or nausea requiring hospitalization (n = 18, 1.08%), upper gastrointestinal bleeding (n=9, 0.56%), and peri-gastric leak or fluid collection (n = 8, 0.48%). CONCLUSIONS: In a systematic review and meta-analysis, we found ESG to produce clinically significant weight loss that was reproducible among independent centers and to have a low rate of severe adverse events. ESG appears to be an effective intervention for patients with obesity, although comparative studies and randomized controlled trials are necessary. PROSPERO Identifier: CRD42019121921.

Endoscopic sleeve gastroplasty versus high-intensity diet and lifestyle therapy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is a safe and effective minimally invasive bariatric procedure. This study compared weight loss in patients undergoing ESG with that of matched patients undergoing high-intensity diet and lifestyle therapy (HIDLT). METHODS: In this case-matched study, patients were matched 2/3:1 (HIDLT/ESG) by age, sex, and body mass index (BMI). One hundred five patients (30 men) who underwent ESG + low-intensity diet and lifestyle therapy (LIDLT) between 2016 and 2018 were compared with 281 patients (92 men) who underwent HIDLT at the Johns Hopkins Medical Institutions from 2013 to 2014. Weight was evaluated 1, 3, 6, and 12 months after beginning HIDLT or post-ESG to determine the mean percent total body weight loss (%TBWL). RESULTS: Mean age across both cohorts was 48.0 ± 12.1, and baseline BMI was 40.0 ± 7.7 kg/m2. In multivariable analysis controlling for age, sex, and baseline BMI, the mean %TBWL at 1, 3, 6, and 12 months was significantly higher in patients undergoing ESG than matched patients undergoing HIDLT. Specifically, at 3 months, the mean %TBWL in the ESG cohort was 14.0% compared with 11.3% in the HIDLT cohort (P <.011), and at 12 months the mean %TBWL in the ESG cohort was 20.6% versus 14.3% in the HIDLT cohort (P < .001). ESG patients with baseline BMI ≤40 kg/m2 continued to show significantly greater %TBWL than those of the same BMI group in the HIDLT group at 1, 3, 6, and 12 months after intervention (3 months, coefficient = 3.43 [P < .001]; 12 months, coefficient = 8.14 [P < .001]). CONCLUSIONS: Through 12 months of follow-up, patients who underwent ESG achieved significantly greater weight loss than patients enrolled in HIDLT. ESG appears to be a valuable alternative for patients who experience difficulty complying with HIDLT.

Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) Trial: Results at 1 Year.

Background Bariatric embolization is a new endovascular procedure to treat patients with obesity. However, the safety and efficacy of bariatric embolization are unknown. Purpose To evaluate the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure. Materials and Methods For this prospective study (NCT0216512 on ClinicalTrials.gov ), 20 participants (16 women) aged 27-68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 were enrolled at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300- to 500-µm embolic microspheres. Primary end points were 30-day adverse events and weight loss at up to 12 months. Secondary end points at up to 12 months included technical feasibility, health-related quality of life (Short Form-36 Health Survey ([SF-36]), impact of weight on quality of life (IWQOL-Lite), and hunger or appetite using a visual assessment scale. Analysis of outcomes was performed by using one-sample t tests and other exploratory statistics. Results Bariatric embolization was performed successfully for all participants with no major adverse events. Eight participants had a total of 11 minor adverse events. Mean excess weight loss was 8.2% (95% confidence interval [CI]: 6.3%, 10%; P < .001) at 1 month, 11.5% (95% CI: 8.7%, 14%; P < .001) at 3 months, 12.8% (95% CI: 8.3%, 17%; P < .001) at 6 months, and 11.5% (95% CI: 6.8%, 16%; P < .001) at 12 months. From baseline to 12 months, mean SF-36 scores increased (mental component summary, from 46 ± 11 to 50 ± 10, P = .44; physical component summary, from 46 ± 8.0 to 50 ± 9.3, P = .15) and mean IWQOL-Lite scores increased from 57 ± 18 to 77 ± 18 (P < .001). Hunger or appetite decreased for 4 weeks after embolization and increased thereafter, without reaching pre-embolization levels. Conclusion Bariatric embolization is well tolerated in severely obese adults, inducing appetite suppression and weight loss for up to 12 months. Published under a CC BY-NC-ND 4.0 license. Online supplemental material is available for this article.

Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) reduces the gastric lumen to a size comparable with that of laparoscopic sleeve gastrectomy (LSG). However, there is a paucity of research comparing outcomes between the 2 procedures. Our study compared the 6-month weight loss outcomes and adverse events of ESG with LSG in a case-matched cohort. METHODS: We retrospectively reviewed prospectively collected data for patients undergoing ESG or LSG at a single academic center. Weight was recorded at 1 and 6 months postprocedure, and percent total body weight loss (%TBWL) was calculated. Adverse events and new-onset Gastroesophageal Reflux Disease (GERD) were also recorded. RESULTS: A total of 54 ESG patients were matched with 83 LSG patients by age, sex, and body mass index. The proportion of patients with GERD at baseline was similar in the 2 groups (16.7% in ESG group vs 25.3% in LSG group, P = .27). At the 6-month follow-up, %TBWL (compared with baseline) was significantly lower in the ESG group compared with the LSG group (17.1% ± 6.5% vs 23.6% ± 7.6%, P < .01). ESG patients had significantly lower rates of adverse events compared with LSG patients (5.2% vs 16.9%, P < .05). New-onset GERD was also significantly lower in the ESG group compared with the LSG group (1.9% vs 14.5%, P < .05). CONCLUSIONS: ESG, a minimally invasive same-day procedure, achieved less weight loss at 6 months than LSG, with the caveat that LSG caused more adverse events and new-onset GERD than ESG.

Endoscopic sleeve gastroplasty versus intragastric balloon insertion: efficacy, durability, and safety.

BACKGROUND: Intragastric balloon (IGB) placement and endoscopic sleeve gastroplasty (ESG) are reported to be safe and effective endoscopic bariatric therapies. This study aimed to compare the patient demographics and therapeutic outcomes between the IGB and ESG procedures. METHODS: This was a retrospective review of prospectively collected data from consecutive patients between December 2015 and October 2017 who underwent IGB or ESG at a single academic center. Fluid-filled IGBs implanted for a 6-month duration were used. IGB and ESG patients were subjected to identical post-procedure dietary instructions and follow-up protocols. Body weight was recorded at 1, 3, 6, and 12 months post-procedure. RESULTS: A total of 47 patients underwent IGB insertion and 58 underwent ESG. The IGB cohort had a lower baseline body mass index (BMI) than the ESG (34.5 vs. 41.5 kg/m2; P < 0.001) and a significantly lower proportion of men (2.1 % vs. 41.4 %; P < 0.001). IGB patients showed a mean (standard deviation [SD]) percentage total body weight loss (%TBWL) that was significantly lower than ESG patients at 1 month (6.6 % [2.6 %] vs. 9.9 % [2.4 %]; P < 0.001), 3 months (11.1 % [4.4 %] vs. 14.3 % [4.6 %]; P = 0.004), 6 months (15.0 % [7.6 %] vs. 19.5 % [5.7 %]; P = 0.01), and 12 months (13.9 % [9.0 %] vs. 21.3 % [6.6 %]; P = 0.005). The IGB cohort also experienced significantly more adverse events compared with the ESG (17 % vs. 5.2 %; P = 0.048). CONCLUSIONS: IGB placement and ESG result in clinically meaningful weight loss. However, ESG appears to provide clinically superior and more enduring weight loss with fewer adverse events compared with an IGB.

What is Needed for Evidence-Based Dietary Recommendations for Migraine: A Call to Action for Nutrition and Microbiome Research.

BACKGROUND: The gastrointestinal symptoms of migraine attacks have invited numerous dietary hypotheses for migraine etiology through the centuries. Substantial efforts have been dedicated to identifying dietary interventions for migraine attack prevention, with limited success. Meanwhile, mounting evidence suggests that the reverse relationship may also exist - that the biological mechanisms of migraine may influence dietary intake. More likely, the truth involves some combination of both, where the disease influences food intake, and the foods eaten impact the manifestations of the disease. In addition, the gut's microbiota is increasingly suspected to influence the migraine brain via the gut-brain axis, though these hypotheses remain largely unsubstantiated. OBJECTIVE: This paper presents an overview of the strength of existing evidence for food-based dietary interventions for migraine, noting that there is frequently evidence to suggest that a dietary risk factor for migraine exists but no evidence for how to best intervene; in fact, our intuitive assumptions on interventions are being challenged with new evidence. We then look to the future for promising avenues of research, notably the gut microbiome. CONCLUSION: The evidence supports a call to action for high-quality dietary and microbiome research in migraine, both to substantiate hypothesized relationships and build the evidence base regarding nutrition's potential impact on migraine attack prevention and treatment.

Methods for Evaluating Natural Experiments in Obesity: A Systematic Review.

Background: Given the obesity pandemic, rigorous methodological approaches, including natural experiments, are needed. Purpose: To identify studies that report effects of programs, policies, or built environment changes on obesity prevention and control and to describe their methods. Data Sources: PubMed, CINAHL, PsycINFO, and EconLit (January 2000 to August 2017). Study Selection: Natural experiments and experimental studies evaluating a program, policy, or built environment change in U.S. or non-U.S. populations by using measures of obesity or obesity-related health behaviors. Data Extraction: 2 reviewers serially extracted data on study design, population characteristics, data sources and linkages, measures, and analytic methods and independently evaluated risk of bias. Data Synthesis: 294 studies (188 U.S., 106 non-U.S.) were identified, including 156 natural experiments (53%), 118 experimental studies (40%), and 20 (7%) with unclear study design. Studies used 106 (71 U.S., 35 non-U.S.) data systems; 37% of the U.S. data systems were linked to another data source. For outcomes, 112 studies reported childhood weight and 32 adult weight; 152 had physical activity and 148 had dietary measures. For analysis, natural experiments most commonly used cross-sectional comparisons of exposed and unexposed groups (n = 55 [35%]). Most natural experiments had a high risk of bias, and 63% had weak handling of withdrawals and dropouts. Limitation: Outcomes restricted to obesity measures and health behaviors; inconsistent or unclear descriptions of natural experiment designs; and imperfect methods for assessing risk of bias in natural experiments. Conclusion: Many methodologically diverse natural experiments and experimental studies were identified that reported effects of U.S. and non-U.S. programs, policies, or built environment changes on obesity prevention and control. The findings reinforce the need for methodological and analytic advances that would strengthen evaluations of obesity prevention and control initiatives. Primary Funding Source: National Institutes of Health, Office of Disease Prevention, and Agency for Healthcare Research and Quality. (PROSPERO: CRD42017055750).

Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss.

BACKGROUND & AIMS: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. METHODS: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. RESULTS: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. CONCLUSION: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population.

BACKGROUND & AIMS: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. METHODS: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. RESULTS: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (ß = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). CONCLUSIONS: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

Effectiveness of Policies and Programs to Combat Adult Obesity: a Systematic Review.

BACKGROUND: This systematic review identifies programs, policies, and built-environment changes targeting prevention and control of adult obesity and evaluates their effectiveness. METHODS: We searched PubMed, CINAHL, PsycINFO, and EconLit from January 2000 to March 2018. We included natural experiment studies evaluating a program, policy, or built-environment change targeting adult obesity and reporting weight/body mass index (BMI). Studies were categorized by primary intervention target: physical activity/built environment, food/beverage, messaging, or multiple. Two reviewers independently assessed the risk of bias for each study using the Effective Public Health Practice Project tool. RESULTS: Of 158 natural experiments targeting obesity, 17 reported adult weight/BMI outcomes. Four of 9 studies reporting on physical activity/built environment demonstrated reduced weight/BMI, although effect sizes were small with low strength of evidence and high risk of bias. None of the 5 studies targeting the food/beverage environment decreased weight/BMI; strength of evidence was low, and 2 studies were rated high risk of bias. DISCUSSION: We identified few natural experiments reporting on the effectiveness of programs, policies, and built-environment changes on adult obesity. Overall, we found no evidence that policies intending to promote physical activity and healthy eating had beneficial effects on weight/BMI and most studies had a high risk of bias. Limitations include few studies met our inclusion criteria; excluded studies in children and those not reporting on weight/BMI outcomes; weight/BMI reporting was very heterogeneous. More high-quality research, including natural experiments studies, is critical for informing the population-level effectiveness of obesity prevention and control initiatives in adults.

A multilevel, multicomponent childhood obesity prevention group-randomized controlled trial improves healthier food purchasing and reduces sweet-snack consumption among low-income African-American youth.

BACKGROUND: Consumption of foods and beverages rich in sugar remains high across all races and ages in the United States. Interventions to address childhood obesity and decrease sugar intake are needed, particularly in low-income settings. METHODS: B'more Healthy Communities for Kids (BHCK) was a group-randomized, controlled trial implemented among 9-15-year olds in 30 low-income areas of Baltimore. We increased access to low-sugar foods and beverages at wholesalers and small food stores. Concurrently, we encouraged their purchase and consumption by children through youth-led nutrition education in recreation centers, in-store promotions, text messaging and a social media program directed at caregivers. Sugar consumption (sugar sweetened beverage (SSB), sweets) in youth was assessed pre- (n = 534) and post-intervention (n = 401) using the Block Kids Food Frequency Questionnaire. Purchasing of 38 healthier and 28 less healthier food/beverage varieties in the previous 7 days was assessed via self-report. Multilevel models at the community and individual levels were used. Analyses were stratified by age (younger: 9-12-year olds (n = 339) vs older: 13-15 (n = 170)). Models were controlled for child's sex, race, total daily caloric intake, and caregiver's age and sex. RESULTS: Overall baseline mean healthier food purchasing was 2.5 (+ 3.6; min. 0, max. 34 items per week), and unhealthier food purchasing 4.6 (+ 3.7; 0-19 items per week). Mean intake at baseline for kcal from SSB was 176 (+ 189.1) and 153 (+ 142.5), and % of calories from sweets (i.e. cookies, cakes, pies, donuts, candy, ice cream, sweetened cereals, and chocolate beverages) was 15.9 (+ 9.7) and 15.9 (+ 7.7) in comparison and intervention youth, respectively. Intervention youth increased healthier foods and beverages purchases by 1.4 more items per week than comparison youth (ß = 1.4; 95% CI: 0.1; 2.8). After the intervention, there was a 3.5% decrease in kcal from sweets for older intervention youth, compared to the control group (ß = - 3.5; 95% CI: -7.76; - 0.05). No impact was seen on SSB consumption. CONCLUSION: BHCK successfully increased healthier food purchasing variety in youth, and decreased % calories from sweet snacks in older youth. Multilevel, multicomponent environmental childhood obesity programs are a promising strategy to improve eating behaviors among low-income urban youth. TRIAL REGISTRATION: NCT02181010 (July 2, 2014, retrospectively registered).