Posts Tagged ‘diabetes prevention program’

Look AHEAD Crashes

October 22nd, 2012

 

Behind Look Ahead

The National Institutes of Health (NIH) has announced that the Look AHEAD trial has been stopped in its 11th year, two years short of completion. The extensive trial, involving over 5,000 patients at 16 centers, was intended to find out if there was increased mortality from intentional weight loss and to see if intentional weight loss among obese patients with type 2 diabetes would result in fewer cardiovascular (CV) events. At the end of the trial, there was no difference between the study group, which received intensive behavioral counseling and the control group which received standard diabetes education and occasional support group meetings.  The NIH press release indicates that both arms had lower CV rates that reported for patients with diabetes in previous studies. NIHNEWS: Weight Loss Not Reduce CV events in Type 2 diabetes

While this is news is something of a shock, many folks saw it coming. Two years into the trial, which began in 2001, the monitoring board noticed that the event rate in the control arm was much lower than expected. The expected CVD event rate in the control arm was 3.125% per year; in fact it was 0.7%. A committee was formed and made changes to the original study protocol designed to capture more events. These changes went into effect in 2008. There appeared to be three reasons for the lower event rate. First, while cardiovascular disease (CVD) is still the major cause of death in the United States, mortality has gone down, resulting from better control of dyslipidemia and high blood pressure and improved care of chronic and acute coronary syndromes. (See NCHS Data Brief, NCHS DataBrief: Prevalence of Uncontrolled Risk Factors for CVD)  Second, study participants who choose to involve themselves in a long clinical trial may well be healthier than a community sample and more motivated to follow the diet and exercise and participation requirements. Finally, the Look AHEAD trial employed the Graded Exercise Test which excluded participants most likely to develop CVD. Because of the low event rate, an additional primary endpoint was added (hospitalized angina) and the trial was extended for 2 years. (See PubMed: Brancati_Midcourse Correction to clinical trial whe the event rate is underestimated: the Look Ahead Study) Readers may recall that the SCOUT trial of sibutramine also had to revise its protocol midway through the study for the same reason, resulting in a population which was older and sicker than typical clinical population. In both cases, revising the protocol did not favor the intervention.

The stopping of Look AHEAD raises a host of questions. Was the study protocol correct? Did it end up studying healthy obese diabetics? Do long-term studies produce more noise than insight? Are we really studying the aging process when we cannot control for changes in health status, drug utilization (including drugs which can increase weight) and changes in energy intake, fitness levels, etc.? What is the picture for sub-groups, such as the 60-74 age group which had good weight loss in the DPP and 4 year results of Look AHEAD? Were there specific improvements, such as reductions in medications usage, fewer hospitalizations or shorter length of stays, improvements in quality of life? Did the presence of any the alleles associated with success in bariatric surgery affect outcomes? PubMed: High allelic burden of four obesity SNPs associated with poorer wt loss.  Should future efforts be devoted to cases where the disease process is already well-established or where high-risk populations can be identified and appropriate interventions evaluated? In future trials, should comorbid management be left to the local standards of care or defined in the study protocol?

Looking Ahead of Look Ahead

Whither behavioral lifestyle interventions?

The lifestyle interventions in the DPP and Look AHEAD were regarded as the ‘gold standard.’ They involved recruiting and training health professionals who provided not only the intervention but provided a supportive environment and a community spirit. Extensive communication with the patient was maintained. PUBMED: Look AHEAD: Description of the Lifestyle Intervention. Look AHEAD  participants even received an honoraria of $100 at each annual visit to improve adherence. (FDA EMDAC Hearing, March 28, 2012, Dr. Rena Wing, transcript, p. 169).

Recently the CDC and the NIH were looking at ways to take the DPP/Look AHEAD model to a more replicable model. The CDC’s National DPP program awarded $6.75 million in grants to develop lifestyle interventions program among people at high risk. One involves using the YMCA to provide lifestyle counseling. http://www.ymca.net/diabetes-prevention/ Questions will certainly be asked if highly trained professionals with incentives for participants did not produce better results will a down-scale program do better?

Whither diabetes prevention?

Look AHEAD was designed following the Diabetes Prevention Program (DPP). The DPP established that both lifestyle changes and metformin could reduce the incidence of type 2 diabetes, through weight loss, although lifestyle was superior to metformin alone. Look AHEAD was taking this important finding one step further asking whether weight loss among type 2 diabetics would reduce the incidence of cardiovascular events.

Even though the DPP has been promoted as a model for preventing the development of type 2 diabetes through weight loss, there were problems.

Dr. William Knowler of the National Institute on Diabetes, Digestive, and Kidney Disease (NIDDK) told the FDA Advisory Committee earlier this year,that, after three years of the DPP,

“the rates (of development of type 2 diabetes) have tended to flatten out and become parallel among all three groups. The rate of new development of diabetes has actually slowed down in the placebo and metformin groups, compared to what it was in the first three years. And the lifestyle group has flattened out a little bit at the end, but the difference that was attained has been largely maintained over time.  Notice, though, that over 10 years, although there still are remarkable treatment effects, if you look at things in an absolute sense, we can’t say that we still know how to prevent diabetes because, still, close to half of the people who enrolled in the trial developed diabetes over a 10-year period. But at least it’s been substantially delayed in those who have had the interventions.” ( FDA Endocrinologic and Metabolic Drug Advisory Committee Hearing on assessing cardiovascular safety of obesity drugs, March 28, 2012, Transcript, p 131-2).


(Figure: Diabetes Prevention Program Outcomes Study, Lancet (2009) 374; 1677-1686)

Is ‘delaying’ diabetes onset as powerful as ‘preventing’ diabetes from occurring in the competitive race for health care dollars and public attention?

Furthermore, a study earlier this year indicate poor outcomes in drug treatment of adolescents with type 2 diabetes with barely half showing glycemic control with metformin. PubMed: Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes

Will the Look AHEAD experience affect FDA approval of drugs and devices to treat obesity?

The FDA has viewed obesity as a cosmetic issue and only recently acknowledged it as a disease, worthy of attention as other cardiovascular risk factors. They (meaning the FDA Endocrinologic and Metabolic Drug Advisory Committee and FDA staff) have started, just barely, to view obesity as a cardiovascular disease risk factor, like hypertension. They have also opined, from time to time, that if folks only ate less and exercised more, they would not need drugs. So how does this decision play into these views? On one hand, they may be convinced that obesity is not so easy to treat as they thought by diet and exercise. On the other hand, they may think that there is less need for anti-obesity medications because other treatments, e.g. statins, lipid-lowering drugs, anti-hypertensives, are doing their job in reducing CV risk factors. So, this view may raise the bar for approval of new anti-obesity medications. On the other (the third?) hand, we may need a re-definition of obesity which tones down its “diabetes-metabolic syndrome-mortality” axis and raises its “disability-mobility-quality of life” axis. (Running out of hands here, I would not underestimate the potential for greater evidence of obesity’s role in the development of various cancers).

The recent trend in thinking at the FDA Endocrinologic and Metabolic Drug Advisory Committee (EMDAC) has been to view anti-obesity medications narrowly as cardiovascular disease treatments. The EMDAC met on March 28th and 29th,2012  and discussed how to assess the cardiovascular benefits and safety of anti-obesity medications. At the end of March 28, Dr. Rasmussen, who is the Industry Representative on the committee had the following exchange with Dr. Eric Coleman of the FDA.

Dr. Rasmussen: In your (Dr. Colman’s) presentation, you showed that there are different            populations pre-approval and in post-approval studies. ..Are we compromising the risk-            benefit evaluation if we impose more risk-based patients pre-approval?

Dr. Colman: I’m not sure I understood your question. Could you rephrase it?

Dr. Rasmussen: Maybe I’m preempting some of the discussion that we’ll be having                        tomorrow, whether we should require more high-risk CV patients pre-approval to rule out        a upper bound of the 95 percent confidence interval. But by doing so, we will likely be                including older patients with established cardiovascular risk disease. And I’m wondering          whether including more of those types of patients will compromise the benefits side of                doing the benefit-risk evaluation.

Dr. Coleman: Yes. And it might be that if the program had the resources to do this, that              that would just be one component of the program, and that there would be other be other,        smaller, shorter-term studies where they could study lower-risk individuals, younger                   individuals for shorter periods of time.

Dr. Rasmussen: But my concern was based on the fact that the SCOUT study didn’t really – I      mean, it looks like it wouldn’t be actually be able to be approved if it was submitted pre-            approval. ..(FDA EMDAC, March 28, 2012, transcript at p. 334-5)

On the second day of the hearing, Dr. Rasmussen returned to the topic.

Dr. Rasmussen: So I would just like to add a little bit of perspective on what “enrichment”          (Editor: “enrichment” is the term used here by the FDA referring to adding persons at high        risk of CVD to the pool of subjects in obesity drug trials) in this context will mean. I mean, I      did a little bit of “back-of-the-envelope” calculation, and maybe we’ll have that confirmed        after lunch. But, I mean, current programs, approximately 3,000 patient-years of                        exposure generate 15 MACE events or so. Even if we were to double that patient-year                  exposure with a population of a 3-percent annual event rate coming to additional 60                    events, we would still only be able to exclude a doubling of the hazard ratio. So, I mean,              what we’re talking about here is actually completely shifting the population that we’re                going to study in obesity programs to establish cardiovascular disease and not necessarily        the population that we know actually seek treatment in the real world. So, I think that’s              worth keeping in mind, that enrichment may sound appealing because it sounds like we will       add a fraction of sick patients, but in reality, this will be a complete shift of the population.        (FDA, EMDAC, March 29, 2012, at p. 169)

(Dr. Rasmussen’s calculations appear correction. The cardiovascular safety trial the FDA asked Orexigen Therapeutics to undertake surpassed its original goal of 7,000 patients in process of enrolling 9,000 patients to find 87 major CV events earlier than expected. Orexigen: Press Release Contrave CV study.)

A bit later, Dr. Rena Wing was asked about the influence of statins on the Look AHEAD trial. She responded:

Number one, that more and more people are being treated with statins. There’s better                blood sugar control. There’s better hypertension control. So you’re going to have to look          at what’s going to happen to the event rates in these studies. I was very surprised that your      event rates that you’re showing me in many of these trials looked so high compared to the        event rates we’re seeing in Look AHEAD. Now, some of that is because we did do GXTs.                (Editor: Graded Exercise Tests.) We did select healthier patients. But I also think that if you      are doing trials, in the United States especially, and with diabetics where there’s more and        more emphasis on increasing the use of lipids, increasing their blood pressure control, that      you’re going to be driving down your risk factors, and you’re going to have more and more      confounds with medication. (FDA, EMDAC, March 29, 2012 transcript, at p. 346)

At the Cleveland Clinic’s Obesity Summit earlier this month, I asked cardiologist Steve Nissen about the FDA’s pushing companies to undertake clinical trials to rule out a CVD risk. He responded that one of the challenges of cardiovascular outcome studies of obesity drugs is that in order to get enough cv events you have to study patients with existing heart disease or at very high risk of a cv event . This pushes the trial into populations which are considerably sicker than the population likely to take the obesity drug. He suggested that FDA should look at absolute risk rather than the relative risk of the drug. If one looks at the absolute risk, you can study any reasonable population likely to take the drug. This change in the statistical approach allows one to study more typical populations.

 

In any event, it will be sometime before we know how the newer anti-obesity medications, like Contrave if approved), Belviq™ and Qysemia™ will impact cardiovascular disease risk factors.

Bariatric Surgery: Last Man Standing?

A study out of the Cleveland Clinic published in the New England Journal of Medicine in April, 2012 followed over 90% of 150 patients for 12 months. The study, a face to face comparison of medical therapy versus surgery in patients with uncontrolled type 2 diabetes, showed a clear superiority for bariatric surgery.  The proportion of patients achieving a hemoglobin A1c level of 6% after 12 months by medical therapy alone was 12%; for those in the medical plus gastric bypass surgical group it was 42% and for the medical plus sleeve-gastrectomy group it was 37%. Weight loss was greater in the gastric bypass group (-24kg) and sleeve gastretcomy group (-25.1kg) than in the medical therapy group (-5.4kg). Use of drugs for glucose control, lipids and blood pressure control decreased in the surgical group but increased in the medical group. PubMed: Bariatric surgery versus intensive medical therapy in obese patients with diabetes

In regard to cardiovascular risk factors, a systematic review of the literature on bariatric surgery analyzed over 60 studies involving 19,543 patients. At baseline, the mean patient was 41.7 years old, female and had a BMI of 47.1. Baseline prevalence of comorbid conditions which increase risk of CVD was hypertension (44.4%), diabetes (24%) and hyperlipidemia (43.6%). After correcting for publication bias, 36% of subjects had improvements in hypertension, 26% for diabetes and 34% for hyperlipidemia. Calculating the changes for mean participants, the authors found that a woman, without baseline CVD, diabetes or smoking, who is taking anti-hypertensive drugs, will move from an 8.6% 10 year global risk for CVD to a 3.9% risk. A man, with no CVD or smoking but whose diabetes and need for anti-hypertensive drugs resolves after surgery, will move from a 10 year global risk of 18.4% to 4.7%. PubMed: Bariatric Surgery and Cardiovascular outcomes: a systematic review

So, where are we? The gold standard of lifestyle change is tarnished. The drug story is muddy at best. Bariatric surgery is clearly producing the superior results. However, access to surgery is, and will remain, a problem. The challenge for the leaders in the field is to find ways to have surgery reach more people and not be a procedure for the 1 percent. Even with greater access to surgery, the obesity-diabetes epidemic will continue to be a major health crisis. It’s time to be humble in the face of this disease and realize a lot more research is going to be needed…and soon.

 

Genetic Variations Affect Weight Loss, Regain, Eating Behavior

May 1st, 2012

The Diabetes Prevention Program (DPP) is a highly publicized study comparing lifestyle intervention against metformin in preventing type 2 diabetes. It has been widely used by public health authorities to promote lifestyle changes over drugs in addressing obesity and type 2 diabetes. Delahanty LM and colleagues looked at genetic polymorphisms for an effect on short term and long term weight loss and weight regain. They found that the Ala allele at PPARG (think of this as the longitude and latitude for a gene variation) was associated with short term and long term – weight loss regardless of treatment. This study adds to the literature that genetic information can help identify those who can are more likely or less likely to benefit from intervention. PubMed:Genetic Predictors of weight loss, regain DPP

In a another trial, Look AHEAD, another obesity related risk allele at FTO rs1421085 significantly predicted more eating episodes per day. Variants within BDNF were significantly associated with more servings of dairy, meat, eggs, nut and beans. Another allele was associated with a significantly lower percentage of energy from protein. PubMed:Genetic alleles and dietary intake in Look AHEAD trial

 

Genetics and Treatments

December 20th, 2011

The Diabetes Prevention Program (DPP) is regarded as a hallmark of behavioral intervention in the treatment of adult obesity. Now comes a paper from the DPP Study Group, as well as drug therapy via metformin. It recognizes that genetic factors affect the success of participants in achieving and maintain weight loss. Genetic Predictors of Weight Loss and Weight R… [Diabetes Care. 2011] – PubMed – NCBI

Cancer and Obesity Explored

November 3rd, 2011

The Institute of Medicine’s National Cancer Policy Forum this week convened a two-day workshop, “The Role of Obesity in Cancer Survival and Recurrance.” So this is a good opportunity to re-visit the relationship between these two deadly diseases. Susan Gapstur of the American Cancer Society noted the growing list of cancers associated with obesity. For men, these include cancers of the colon, esophagus, kidney, colorectum, pancreas, gallbladder and liver. Women are affected by the same cancers as well as of the endometrium and postmenopausal breast cancer. Evidence is accumulating for an association with non-Hodgkin’s lymphoma, ovarian cancer in women and aggressive prostate in men. Obesity, she pointed out, is not the second (to tobacco) leading risk factor of cancer. Ominously, she pointed out we do not know what the health effects will be for the children now obesity who will obese for a lifetime.

Pamela J. Goodwin of the University of Toronto explored potential mechanisms in the progression to cancer including inflammation, adipokines, hyperinsulinemia, diabetes/diabetes drugs and sex steroids. She pointed to studies showing reductions in cancer risk with intentional weight loss of 20 pounds or more. Intentional weight loss and in… [Int J Obes Relat Metab Disord. 2003] – PubMed – NCBI and reduction in the relative risks of death and of cancer following bariatric surgery. Metabolic surgery and cancer: protective effects of b… [Cancer. 2011] – PubMed – NCBI.  Specifically, she showed the positive effect of intentional weight loss on breast cancer risk   Does intentional weight loss reduce canc… [Diabetes Obes Metab. 2011] – PubMed – NCBI and the impact of physical activity on improvements in insulin in breast cancer survivors Impact of a mixed strength and endurance exerci… [J Clin Oncol. 2008] – PubMed – NCBI.

Bruce Wolfe of the Oregon and Science University and a bariatric surgeon reminded the participants that the Swedish Obesity Study found the reduction in mortality after bariatric surgery was greater for cancer than for cardiovascular events Effects of bariatric surgery on mortality in Sw… [N Engl J Med. 2007] – PubMed – NCBI. In a Utah study, bariatric surgery reduced deaths from cancer by 60% compared to a 48% reduction in cardiovascular events. Long-term mortality after gastric bypass surgery. [N Engl J Med. 2007] – PubMed – NCBI

Rachel Ballard-Barbash of the National Cancer Institute, who has been a leader in exploring the obesity-cancer connection for many years, moved the discussion to look at the co-morbid conditions of obesity and their relationship to cancer mortality, including renal disease, congestive heart failure, cerebrovascular disease, citing A refined comorbidity measurement algorithm fo… [Ann Epidemiol. 2007] – PubMed – NCBI

Patricia Ganz of the UCLA Schools of Medicine picked up the point and explained that about half of all deaths of breast cancer survivors are due to causes other than breast cancer. She recommended prevention of weight gain and/or weight loss in those breast cancer survivors who are obese. 

Thomas Wadden described the non-surgical approaches to weight loss used in the Diabetes Prevention Program and the LOOK Ahead study and the contribution of intensive behavioral counseling to reduction in comorbid conditions associated with obesity

Some of the workshop’s presentations are on-line at Workshop on the Role of Obesity in Cancer Survival and Recurrence – Institute of Medicine. Watch that site for future information on a publication from the workshop.

Employer Incentives

September 27th, 2009

Employer Wellness Programs

In recent years, employers, mainly large ones, have developed wellness programs designed to promote healthier lifestyles among their employees while at the same time reducing their health care expenses. Recently, questions have arisen addressing how much of an incentive can an employer provide before it becomes a punitive measure. The National Business Group on Health has proposed as part of health care reform that the tax code be amended so that the expense of the employer-sponsored program is not taxed as income to the employee when provided off-site. Likewise, employees would be able to use their own health spending accounts for fitness and weight management.

Others have sought to change current laws to allow employers to provide significant financial rewards to persons with certain conditions under control or, from the other viewpoint, penalize workers who cannot bring such conditions, under control.

New research from the National Bureau for Economic Research indicates that financial rewards for weight loss simply do not work. Outcomes in a Program that Offers Financial Rewards for Weight Loss

Safeway, for example, has been promoting their plan called Health Measures. This plan gives employees reduction in their insurance premiums if they are, and stay, within certain limits on four medical risk factors: smoking, obesity, blood pressure and cholesterol. Rebates for achieving the goals total nearly $800 for an employee or $1,600 for a family. People who test within the limits get lower health premiums at the outset of the year. An employee who fails the obesity test can get a retroactive payment if he or she loses 10% of his or her body weight by the end of the year. But if the person’s BMI is still over 30 at the beginning of the following year, the payment is withheld until the employee reaches the permanent goal of under a BMI of 30. (See, Bensinger Gail, Corporate Wellness, Safeway style, http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/01/02/CM1714IPV8.DTL&type=health, accessed May 24, 2009)

Legally, the Safeway program may be pushing the envelope. Under the Health Insurance Portability and Accountability Act of 1996 (HIPPA), no person can be denied or charged more for coverage than other similarly situated person (e.g. full time, part time) because of health status, genetic history, evidence of insurability, disability or claims experience. HIPPA “makes it easy for health plans to reward members for participating in health-promotion programs but difficult to reward them for achieving a particular health standard, “ according to Mello and Rosenthal. In one allowable category for wellness programs, employee rewards are based solely on participation. The second category allows rewards based on attainment of a specific standard, such as losing a specific amount of weight, but the financial incentive is limited to less that 20% of the cost of the employee’s coverage. If the person cannot meet the standard if it is unreasonably difficult or medically inadvisable, that person must be offered a reasonable alternative standard. Other federal and state laws also apply to this situation. (Mello MM, Rosenthal MB, Wellness Programs and Lifestyle Discrimination – The Legal Limits, NEJM July 10, 2008; 359: 192-199) Wellness programs and lifestyle discrimination–th…[N Engl J Med. 2008] – PubMed Result

Safeway President Steven Burd has called for overturning the HIPPA 20% rule and the provisions of the Americans with Disabilities Act which prevent companies from being more aggressive about pushing employees reaching specific personal targets.

This is a highly sensitive issue for several reasons:

  1. Obesity is caused by a multitude of factors a few of which are under an individual’s control. By the time a person enters the workforce, the number of fat cells (adipose tissue) has been established and will not change no matter what the intervention, including bariatric surgery. Genetic predisposition and an environment overwhelming favoring the easy availability of food are two extremely strong factors for an individual to try to overcome. Eating and exercise habits are ingrained. It is therefore of some concern that the person who designed the Safeway program, Ken Shaclmut, Senior VP for Strategic Initiatives, indicated, “I want to be clear – we were adamant about designing this program to cover only those things for which our employees had control and which were clearly behavioral in nature. We do not differentiate for genetics and we did everything prospectively and transparently so that everyone had equal opportunity to improve their behaviors.” ( Emphasis added. http://www.thehealthcareblog.com/the_health_care_blog/2008/10/safeway-uses-in.html Accessed May 24, 2009).

A few things about this statement. First, obesity has a strong genetic basis. See, Understanding Obesity.

Second, Mr. Shaclmut may overstate the level of individual control over the three other factors – smoking, blood pressure and cholesterol. What makes these risks controllable has little to do with behavior and more to do with a variety of prescription and over-the-counter drugs for their control. Obesity is, unfortunately, lacking the number and variety of such products.

Three, employers already discriminate against persons with obesity in firing, promotion and hiring decisions. A recent paper addressed 32 experimental studies in weight discrimination in employment. The findings demonstrated that overweight and obese individuals are disadvantaged in workplace interactions, evaluations, and employment outcomes as a result of negative weight stereotypes. (Roehling MV, Pilcher S, Oswald F, Bruce T, The effects of weight bias on job-related outcomes: a meta-analysis of experimental studies. Academy of Management Annual Meeting, Anahiem, CA, 2008 )

Fourth, another recent study for the negative association between BMI and wages is larger in occupations requiring interpersonal skills with presumably more social interactions. This wage penalty increases as employees get older. This study demonstrates that being overweight and obese penalizes the probability of employment across all race and gender groups except for black men and women. (Han E, Norton ED, Stearns SC, Weight and Wages: Fat Versus Lean Paychecks, Health Econ 2009; 18:535-548 Weight and wages: fat versus lean paychecks. [Health Econ. 2009] – PubMed Result)

Fifth, obese employees in firms which provide employer paid health care are paid less than their peers for the same work. This indicates that employers are offsetting the higher health care costs of obese employees with lower wages. Bundorf MK, Bhattacharya J. The Incidence of the Health Care Costs of Obesity, Abstr AcademyHealth Meeting 2004;21: No. 1329. Available at www.nber.org/papers/w11303 – 17k – 2005-05-02)

Sixth, the difficulties of weight loss and maintenance of weight loss need to be understood. About 1/3 of American adults are engaged in weight loss efforts at any given time. Yet, obesity increases. Why is that? Some dieters do succeed in weight loss but few, 5-10%, manage to keep the weight off over the long term. (See, Freedman MR, King J, Kennedy E, Popular Diets: A Scientific Review. 2001, Obesity Res. 9 Suppl.1: 1S-40S. Popular diets: a scientific review. [Obes Res. 2001] – PubMed Result Maintaining weight loss is extremely difficult. As soon as weight starts to decrease, energy expenditure also drops in obese individuals. Not only is resting metabolic rate decreased; non-resting energy expenditure is also less because less mass is being moved. Take the situation with persons with type 2 diabetes, a common chronic disease highly correlated with obesity. Weight loss in this population is very difficult. Typically, patients lose weight over 4-6 months then plateau. Patients generally lose about 4-10% of their baseline weight. Hypothalamic signals in defense of body weight increase and intervene to prevent further weight loss. This initiates a regain of the lost weight. Neurotransmitters are activated to such an extent that the signal levels of increased hunger and decreased satiety become extremely difficult to ignore. Also, most diabetic patients are on anti-diabetes medications, many of which, like insulin, actually cause weight gain. (See, Pi-Sunyer, FX, Weight Loss in Type 2 Diabetic Patients, Diabetes Care, June 2005, 28;6:1526-7 Weight loss in type 2 diabetic patients. [Diabetes Care. 2005] – PubMed Result )

Seventh, employer wellness programs, as they apply to obesity, are not precisely defined. At present they encompass a variety of approaches and do not have a standardized format. It does appear that they provide advice on nutrition and physical activity and perhaps the ill effects of obesity. As such, they would be similar to the behavioral format used as standard therapy for control groups in randomized clinical trials, usually of pharmacological compounds. Such interventions have not been particularly effective. (See, Poston WS, Haddock CK, Lifestyle Treatments in Randomized Clinical Trials of Pharmacotherapies for Obesity. Obesity Research 2001 9;9:552-563. Lifestyle treatments in randomized clinical trials…[Obes Res. 2001] – PubMed Result) However structured, it is impossible to think that an employer wellness program would be as intense and well-funded as the Diabetes Prevention Program (DPP). In this study over 3,000 non-diabetic persons with elevated fasting and plasma glucose concentrations ( but not diabetes) were assigned to placebo, metformin (a drug to treat diabetes) or an intensive life-style modification program with the goal of at least a 7% weight loss and at least 150 minutes of physical activity per week. “The lifestyle modification intervention reduced the incidence of diabetes by 58% compared to 31% in the metformin group. The advantage of lifestyle intervention over metformin was greater in older persons and those with a lower body-mass index than in younger persons and those with higher body-mass index.” The weight loss difference between the lifestyle group and the metformin group was barely 4 pounds after 4 years. Only 10 million persons in the United States resemble the participants in the DPP. (Diabetes Prevention Program Research Group, Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin, New England Journal of Medicine, 2/7/2002 346:393-403. Reduction in the incidence of type 2 diabetes with…[N Engl J Med. 2002] – PubMed Result)

Eight, employer wellness programs do have adequate evidence of their effectiveness at long term weight loss and maintenance. A CDC Report evaluating such programs reported, “The Task Force determined that insufficient evidence existed to determine the effectiveness of single-component worksite interventions focused on nutrition, physical activity, or other behavioral interventions among adults.” (Katz DL, et al, Public Health Strategies for Preventing and Controlling Overweight and Obesity in School and Worksite Settings, A Report on Recommendations of the Task Force on Community Preventive Services, MMWR, Oct. 7, 2005 Public health strategies for preventing and contro…[MMWR Recomm Rep. 2005] – PubMed Result) More recently, Goetzel and Ozminkowski looked at the health and cost benefits of work site health-promotion programs. Commenting on a 2007 systematic literature review they observed, “Health and productivity outcomes from these interventions were reported from 50 studies qualifying for inclusion in the review. The outcomes included a range of health behaviors, physiologic measurements, and productivity indicators linked to changes in health status. Although many of the changes in these outcomes were small when measured at an individual level, such changes when measured at an individual level were considered substantial.” 38 38 (Goetzel RZ, Ozminkowski RJ, The Health and Cost Benefits of Work Site Health-Promotion Programs. Annu. Rev. Public Health 2008;29:303-23 The health and cost benefits of work site health-p…[Annu Rev Public Health. 2008] – PubMed Result)

Ninth, wellnessand prevention programs also may actually be working at cross purposes. It is not uncommon to see programs stress smoking cessation and weight loss. Rarely, however, do they seem to address the perception that smoking cessation will lead to weight gain. A 1991 study by the Centers for Disease Control published in the New England Journal of Medicine found mean weight gain after smoking cessation was 2.8 kg for men and 3.8 for women. Major weight gain of over 13kg occurred in 9.8% of the men and 13.4% of the women. (Williamson DF, Madans J, Anda RF, Smoking Cessation and severity of weight gain in a national cohort. NEJM, 1991 Mar.14;324 (11):739-45. Smoking cessation and severity of weight gain in a…[N Engl J Med. 1991] – PubMed Result) Smoking creates insulin resistance and is associated with central fat accumulation. As a result, smoking increases the risk of the metabolic syndrome and type 2 diabetes. ( Chiolero A, Consequences of smoking for body weight, body fat …[Am J Clin Nutr. 2008] – PubMed Result ) Weight control advice was not associated with reduction in weight gain after cessation. (See, Parsons AC, Shraim M, Inglis J, Interventions for prevention weight gain after smoking cessation. Cochrane Database Syst. Rev. 2009 Jan. 21;(1):CD006219 Interventions for preventing weight gain after smo…[Cochrane Database Syst Rev. 2009] – PubMed Result

Tenth, to the extent that wellness programs which shift costs to employees create stress, they may actually lead to weight gain. We know that chronic stress is a contributor to obesity and the metabolic syndrome. (See, Kyroou I, Tsigos C Chronic stress, visceral obesity and gonadal dysfunction, Hormones 2008 7(4):287-293. Chronic stress, visceral obesity and gonadal dysfu…[Hormones (Athens). 2008 Oct-Dec] – PubMed Result) Overweight women experience more stressful lives events than normal women. Obese and extremely obese men and women are more likely to report several specific stressful life events and more stressful life events overall compared to normal weight individuals. ( See, Gender differences in associations between stressf…[Prev Med. 2008] – PubMed Result

Twelfth, more punitive employer wellness programs are likely to operate like a tax on overweight employees. Compliance with any weight loss regimen involves both time and money. While employers may bear some of this in their programs, the economic burden is likely to fall mainly on overweight/ obese employees, who have already paid a penalty in their wages for their largely inherited status.

Successful maintainers who have lost at least 30 lbs. for an average of five years expended and average of 1.5 hours a day on exercise and consume less that 1,400-1, 500 calories. (See, Klem, ML, Wing RR, McGuire MT, Seagle HM, Hill JO, A descriptive study of individuals successful at long-term maintenance of substantial weight loss. 1997 Am J Clin Nutr 66;239-246 A descriptive study of individuals successful at l…[Am J Clin Nutr. 1997] – PubMed Result))

A recent collaborative position paper explains the issues of money, place and time stated:

The Role of Money

One hypothesis linking SES variables and childhood obesity is the low cost of widely available energy-dense but nutrient-poor foods. Fast foods, snacks, and soft drinks have all been linked to rising obesity prevalence among children and youth. Fast food consumption, in particular, has been associated with energy-dense diets and to higher energy intake overall. Calorie for calorie, refined grains, added sugars and fats provide inexpensive dietary energy, while more nutrient-dense foods cost more, and the price disparity between the low-nutrient, high-calorie foods and healthier food options continues to grow. Whereas fats and sweets cost only 30% more than 20 years ago, the cost of fresh produce has increased more than 100%. More recent studies in Seattle supermarkets showed that the lowest energy density foods (mostly fresh vegetables and fruit) increased in price by almost 20% over 2 years, whereas the price of energy-dense foods high in sugar and fat remained constant.

Lower cost foods make up a greater proportion of the diet of lower income persons. In U.S. Department of Agriculture (USDA) studies, female recipients of food assistance had more energy-dense diets, consumed fewer vegetables and fruit, and were more likely to be obese. Healthy Eating Index scores are inversely associated with body weight and positively associated with education and income .

The Importance of Place

Knowing the child’s place of residence can provide additional insight into the complex relationships between social and economic resources and obesity prevalence. Area-based SES measures, including poverty levels, property taxes and house values, provide a more objective way to assess the wealth or the relative deprivation of a neighborhood. All these factors affect access to healthy foods and opportunities for physical activity.

Living in high-poverty areas has been associated with higher prevalence of obesity and diabetes in adults, even after controlling for individual education, occupation, and income. In the Harvard Geocoding Study, census tract poverty was a more powerful predictor of health outcomes than was race/ethnicity. Childhood obesity prevalence also varies by geographic location. The California Fitnessgram data showed that higher prevalence of childhood obesity was observed in lower income legislative districts. In Los Angeles, obesity in youth was associated with economic hardship level and park area per capita. Thus, the built environment and disadvantaged areas may contribute in significant ways to childhood obesity.

The Poverty of Time

The loss of manufacturing jobs, the growth of a service economy and the increasing number of women in the labor force have been associated with a dramatic shift in family eating habits, from the decline of the family dinner to the emerging importance of snacks and fast foods. The allocation of time resources by individuals and households depends on socioeconomic status.

The concept of “time poverty” addresses the difficult choices faced by lower income households. When it comes to diet selection, the common tradeoff is between money and time. One illustration of the dilemma is provided by the Thrifty Food Plan (TFP), a recommended diet meeting federal nutrition recommendations at the estimated cost of $27 per person per week. While this price is attractive, it has been estimated that TFP menus would require the commitment of 16 hours of food preparation per week. By contrast, a typical working American woman spends only 6 hours per week, whereas a non-working woman spends 11 hours per week preparing meals . Thus, TFP may provide adequate calories at low cost, but requires an unrealistic investment in time. ( See, Caprio S, Daniels SR, Drewnowski A, Kaufman FR, Palinkas LA, Rosenbloom AL, Schwimmer JB Influence of race, ethinicity, and culture on childhood obesity: implications for prevention and treatment: a consensus statement of Shaping America’s Health and the Obesity Society. Diabetes Care 2008 Nov;31(11):2211-21. Influence of race, ethnicity, and culture on child…[Obesity (Silver Spring). 2008] – PubMed Result)

It is useful to consider that weight management is not the only thing people have to do. Time taken for physical activity and nutritional improvement is going to be time taken away from other activities, such as care for self and others, self-improvement, community activities and volunteering, time with children and family members, and recreation (including television viewing and using a computer/Internet)

Intrusive wellness programs have the potential to interfere with the employees’ right to privacy and complicate the doctor-patient relationship. Under the Safeway plan, for example, an employee can request an exception on recommendation of a physician. To whom the employee can request this is not clear. Nor is it clear under what circumstances the exception would be granted. Look at two common scenarios:

1. The employee has a disease like HIV/AIDs or cancer in which weigh loss is common and his or her physician does not want the employee to lose any weight if they can help it. Would the employee have to reveal this condition?

2. The employee has common diseases like type 2 diabetes or depression. The physician has recommended drugs which actually cause weight gain. Does the employee have to disclose this? What if the employer decides that another medication could be used? Does now the doctor, patient and often managed care plan have to discuss medical alternatives with Human Resources? In other words, will the employees health be endangered by the effort to live a healthy lifestyle?

Who is disadvantaged by employer wellness program? Programs such as Safeway’s may have unintended discriminatory effects. The biometrics used in such programs, to the extent they include obesity, elevated triglycerides and blood pressure, are part of what is known as the metabolic syndrome. Approximately 34% of adults meet the National Cholesterol Education Program’s criteria. Older males and females from 40-59 years of age are about 3 times as likely as those 20-39 to meet the criteria for the metabolic syndrome. Males and females over 60 were more than 4 and 6 times respectively to meet the criteria. Overweight and obese males were 6 and 32 times as likely as normal weight males to the meet the criteria and overweight and obese females were 5 and 17 times as likely to meet the criteria. (See, Ervin RB, Prevalence of metabolic syndrome among adults 20 years of age and over, by sex, age, race and ethnicity, and body mass index: United States, 2003-2006. National Health Statistics Reports; No. 13.National Health Statistics metabolic syndrome – PubMed Results )

Therefore, we can expect that such programs deliver little in the way of improvements in individual’s body weight, while having a disproportionate impact on minorities, the elderly and those with serious health conditions. To the extent that these employees see a reduction in their health insurance (possibly to the point of zero if the 20% limitation is totally removed), they will only increase the ranks of the uninsured, thereby frustrating the whole purpose of health care reform.

For further information, see;

Insurance coverage and incentives for weight loss …[Obesity (Silver Spring). 2008] – PubMed Result

Effects of a reimbursement incentive on enrollment…[Obesity (Silver Spring). 2007] – PubMed Result

Worksite Opportunities for Wellness (WOW): Effects…[Prev Med. 2009] – PubMed Result

The Working Healthy Project: a worksite health-pro…[J Occup Environ Med. 1999] – PubMed Result

LEAN Works: About CDC’s LEAN Works | DNPAO | CDC

Public Health Strategies for Preventing and Controlling Overweight and Obesity in School and Worksite Settings </P><P>A Report on Recommendations of the Task Force on Community Preventive Services

Financial incentive-based approaches for weight lo…[JAMA. 2008] – PubMed Result