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TOS to FDA: Disclosure of interim results could undermine integrity of CV outcomes trials
TOS
On Monday, Aug. 11, TOS Clinical Committee Chair, Lee Kaplan, MD, PhD, testified to FDA during a public meeting held to discuss the confidentiality of interim results in cardiovascular outcome safety trials (CVOTs). These interim analyses are often used as part of the FDA approval decision for drugs to treat type 2 diabetes and obesity, with the CVOT anticipated to be completed after marketing of the drug. Speaking on behalf of TOS, Dr. Kaplan recommended against publicly disclosing interim results for CVOTs because the early release of this information could be "highly misleading" and would compromise the integrity and reliability of the continued trial.

"Public disclosure of the detailed, but necessarily incomplete, results of the interim analysis could establish an incorrect impression of the safety of the drug to patients, providers and other stakeholders — thus inappropriately influencing its clinical use," said Dr. Kaplan. "In certain situations, limited disclosure of interim results may be required to guide providers and protect the public, but those situations are likely to be unusual and should be handled on a case-by-case basis."

He also noted that because obesity is a complex, chronic disease with multiple potential complications — drugs for the treatment of obesity often offer improvements in other comorbidities or decreased overall mortality that may offset some adverse CV outcomes. Dr. Kaplan's full presentation focused on clinical, statistical and operational considerations, summarized from a five-page document prepared by the Clinical Committee and approved by TOS's Executive Committee. Read the full comments submitted to FDA by Nikhil Dhurandhar, PhD, TOS President-Elect online here and see the FDA slide presentation here.
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ASSOCIATION NEWS


ObesityWeek: A case study on joining forces to address a common challenge
TOS
When the inaugural ObesityWeek conference launched last year, the meeting was five years in the making. Since, the success of the collaboration between TOS and ASMBS has sparked the interest of many, and recently resulted in a feature article by Convene Magazine, published by the Professional Convention Management Association (PCMA). In her article, "Two Associations, One Issue: Joining Forces to Fight Obesity," contributing editor, Molly Brennen, explores the process of co-locating two separate meetings, while also maintaining individual identities. Executive Directors, Francesca Dea of TOS, and Georgeann Mallory of ASMBS, talk about the importance ensuring the program is at the "cutting edge of obesity" to effectively respond to the epidemic. According to Mallory, the biggest change in creating ObesityWeek is also the biggest advantage: "networking, collaboration and the exchange of information." Take a few minutes to explore ObesityWeek in the making here.
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Decision-making, sensitivity to reward, and attrition in weight-management
Contributed by Amanda Staiano, PhD
Attrition, in which participants drop out or do not complete, is a common challenge for weight management programs, with an average of 32% attrition for a typical 10-to-16 week program. In a new study published in the August issue of Obesity, Koritsky and colleagues tested a number of psychological risk factors that may explain why some individuals stick with their weight management program when others drop out.

Using neurophysiological theory, the research team surveyed 52 adults, the majority of whom were women, who were enrolled in the 16-week Lifestyle Redesign Weight Management program at the University of Southern California. Those with higher sensitivity to reward were more likely to drop out of the program, whereas indicators like initial BMI, age, employment status, prior weight loss history or other psychological traits including impulsivity, risk taking, or delay of gratification had no effect on the outcome.

The authors concluded that adults who were more sensitive to reward had the greatest risk for dropping out because they were drawn to gratifying behaviors that conflicted with the program. Targeting this reward sensitivity mechanism may help professionals to better individualize weight management programs for those at greatest risk of attrition.

Read the full study here.

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TOS supports Children's National with Race for Every Child
TOS
On September 13, TOS staff will participate in the second annual Race for Every Child 5K and 100-yard kids' dash in Washington, DC, to benefit the Children's National Health System. Children's National sees about half a million patients annually, regardless of their families' ability to pay. The event will help support specialized medical care, research into diseases like childhood obesity and important wellness and prevention services to keep children healthy.

If you’d like to offer your support, take the first step and find out more at RaceForEveryChild.org. From there you can support The Obesity Society team, donate, and, if you’re in the area, run or volunteer on race day! Please be sure to sign up for The Obesity Society team and note that you heard about the event from TOS. TOS is proud to support Children’s National Health System for this important cause.

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Clues to curbing obesity found in brain's 'sweet spot'
Contributed by Health Central
Weight gain and obesity may be prevented by deactivating a nuclear receptor in the brain, according to a new study. Scientists at Yale School of Medicine examined the effects of blocking a nuclear receptor known as PPARgamma in the brain cells of mice. Over time, the researchers observed that the mice began to eat less and became resistant to a high-fat diet. Both the experimental group of mice and a control group continued to eat fat and sugar, but the former group did not gain weight, while the control group did. Read the full article here.
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eHealth/mHealth Reading Corner
TOS
To keep the community up to date on the developments in this important area, TOS eHealth/mHealth section offers the eHealth/mHealth Reading Corner. This week's articles include:
    Verwey R, van der Weegen S, Spreeuwenberg M, Tange H, van der Weijden T, de Witte L. Technology combined with a counseling protocol to stimulate physical activity of chronically ill patients in primary care. Studies in Health Technology and Informatics. 2014;201:264-270. http://www.ncbi.nlm.nih.gov/pubmed/24943553

    Eakin EG, Winkler EA, Dunstan DW, Healy GN, Owen N, Marshall AM, Graves N, Reeves MM. Living well with diabetes: 24-month outcomes from a randomized trial of telephone-delivered weight loss and physical activity intervention to improve glycemic control. Diabetes Care. 2014 Aug;37(8):2177-2185. http://www.ncbi.nlm.nih.gov/pubmed/24658390

    McMahon S, Vankipuram M, Hekler EB, Fleury J. Design and evaluation of theory-informed technology to augment a wellness motivation intervention. Translational Behavioral Medicine. 2014 Mar;4(1):95-107. http://www.ncbi.nlm.nih.gov/pubmed/24653780
If you have an article you would like to share, we would love to hear from you! Please send article information to Anne Gilmore (anne.gilmore@pbrc.edu), and we'll add it to the EMS Reading Corner Library.

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ObesityWeek 2014 Early Bird Registration Closes August 15
TOS
The second annual conference will take place at the Boston Convention and Exhibition Center, in Boston, MA, Nov. 2 – 7, 2014. In addition to joint sessions and keynotes, a single registration fee covers both TOS and ASMBS meeting sessions and events. Register for ObesityWeek 2014 before Friday, August 15 to take advantage of early bird rates. ASMBS and TOS Members get discounted rates by entering ASMBS or TOS username when registering.
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OBESITY IN THE NEWS


Latest in weight loss strategies to be unveiled at premier international meeting for obesity science and treatment
PR Newswire via MultiVu
Americans spend billions of dollars every year on unproven weight loss products, according to the Federal Trade Commission, leaving many desperate for effective solutions. While consumers pick up these fraudulent supplements, foods and devices, well-trained but often overlooked obesity professionals — scientists, clinicians, surgeons and others — are developing evidence-based solutions to obesity, America's most prominent health crisis.
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Shocking anti-obesity PSA sparks debate
Yahoo Health
An anti-obesity campaign video featuring a 300-pound man having a heart attack in the ER as his life of overeating flashes before his eyes is going viral, stirring viewers with its powerful life-or-death message. The PSA, "Rewind the Future," is from Children's Healthcare of Atlanta's Strong4Life wellness movement, which has made waves in the past with its shock-value campaigns. The latest video has been viewed more than 3 million times since Sunday, and is sparking intense discussion about obesity on Reddit and YouTube.
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Childhood obesity remains top health concern for children
Yahoo News
Childhood obesity remains the top health concern for children in 2014, but when asked about national concerns, adults put school violence and gun-related injuries in the top 10, according to a new University of Michigan C.S. Mott Children's Hospital National Poll on Children's Health.
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Exercise of any kind benefits patients with diabetes, people at risk
Healio
With exercise a critical piece of diabetes lifestyle modification, and mounting research on what types of exercise most improve the disease's state, the best option is one a patient will continue and enjoy, according to a presenter at the American Association of Diabetes Educators Annual Meeting.
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The United States of Obesity
Health Central
It's no secret America is fighting an obesity epidemic. But do you know how it is affecting you? Here's a visual breakdown of our unhealthy habits and their consequences.
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Mexican-American adolescents expressed fears, regret about their diabetes
Healio
Mexican-American adolescents with a family history of diabetes reported distinct emotional beliefs at the time of their own type 2 diagnoses, according to a presentation at the American Association of Diabetes Educators Annual Meeting.
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What's becoming of the word 'fat?'
ConscienHealth
The word fat seems to be in a state of transition. On one hand, fat activists are reclaiming the word with pride. Media is feeling some license to use the word to grab our attention with headlines like "What makes us Fat?" And then there's the Weather Channel serving up Fat Guys in the Woods, more in a vein of exploitation than pride.
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The Obesity Society eNews
Mollie Turner, News Editor, The Obesity Society  
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Colby Horton, Vice President of Publishing, 469.420.2601
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Caitlin McNeely, Senior Editor, 469.420.2692   
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Disclaimer: eNews is a digest of the most important news selected for The Obesity Society from thousands of sources by the editors of MultiBriefs, an independent organization that also manages and sells advertising. The Obesity Society does not endorse any of the advertised products and services. Opinions expressed in the articles are those of the author and not of The Obesity Society.

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