Does Diet and Exercise Prevent Diabetes or Help Persons with Diabetes Live Longer?

It's such a no-brainer, right?  If persons at risk for diabetes would only eat right and exercise more, they'd avoid the disease.  And for those who develop diabetes, diet and exercise will reduce death rates and complications.

Yes and no, say Elizabeth Sumamo Schellenberg and colleagues at the University of Alberta.  Their review of the mixed published scientific evidence on the topic appears in the October 15 issue of the Annals of Internal Medicine.  The purpose of their study was to ascertain the impact of diet and exercise on the prevention of "Type 2 diabetes," as well as lowering complications among persons with who had established Type 2 diabetes. 

To be included, studies had to be prospective and compare the outcomes from an intervention versus a randomly selected control group. The study could only be included if it examined the impact of exercise plus diet and "one other component," such as "counseling, smoking cessation and behavior modification."  The outcomes had to include the development of Type 2 diabetes (in the prevention trials) or complications (in the treatment trials).

1289 candidate studies were found but only 20 made the grade. Nine were prevention trials and 11 were treatment trials.

For the prevention trials:

The interventions lasted from 6 to 72 months, with follow-up going for 3 to 20 years for between 39 to 3234 participants.  The counseling varied and included group and/or individual with or without tobacco cessation, telephony, goal setting, cooking classes or pills involving a range of physician and non-physician professionals.

Results?

Seven of the nine studies showed that diabetes can be delayed. When the results were pooled, compared to the control patients, the risk of developing diabetes over 10 years was only a third and the difference was statistically significant.

But, there was no detectable impact on cardiovascular disease events or on eye, kidney or nerve damage. That may have been due to not all the studies including these outcomes as well as the time it takes for these complications to occur once diabetes develops.  With more patients or more time, a difference could have become apparent.
 
For the treatment trials:

The interventions lasted from 6 to 48 months with follow-up for 6 to 93 months. The counseling was as varied as the prevention trials but included glucose and blood pressure monitoring as well as stress management and, in one instance, a three day residential retreat. There was likewise the range of professionals who provided the interventions.

Results? 

Compared to the control patients, there was no statistically significant difference in all-cause mortality.  Some individual studies had beneficial outcomes involving cardiovascular events or diabetes complications, but they included the aggressive use of medications.  There were no sustained impacts on weight or dietary intake.  And if pills were not included, there was also no real improvement in measures of blood glucose control.

The Disease Management Care Blog's take?

The good news is that there is good evidence that exercise and diet can prevent diabetes.  The bad news is that it takes years for that "return on investment" to declare itself and typically involves interventions that fall outside the traditional health care delivery system.  It's unlikely, thinks the DMCB, that current iterations of payment reform (value based purchasing, bundled payments or upside risk) can be marshaled to make this a reality.  That being said, population health management (PHM) companies like Omada Health are making their evidence-based services available to, for example, employers who have a longer term commitment to the well being of their "human capital" outside of the traditional insurance market.

The bad news is that once diabetes declares itself, diet and exercise don't result in life extension, and control of complications as well as overall blood sugar levels is more a function of pills than lifestyle. Accordingly, expectations need to be realisitically shared with patients and PHM should emphasize taking the pills as prescribed.

Image from Wikipedia

The Important Look AHEAD (Action for Health in Diabetes) Study: No Benefit from Exercise and Weight Loss in Diabetes?

Diabetes? Exercise and then die just as soon.

It makes sense, doesn't it? If persons are overweight and have diabetes, diet and exercise-based "prevention" should translate into fewer heart attacks, strokes and deaths, right?

Wrong.

It turns out that a just-published and high quality research study shows it's not so simple.  What's more, the Disease Management Care Blog brazenly suggests that the disease management/population health vendors discovered this years ago.

The just-published study is here in the prestigious New England Journal of Medicine. The DMCB suspects that, thanks to the mainstream media's fixation on Snowden, SCOTUS, and Shakira possibly hawking Obamacare, this important research may not get the front-page attention it deserves.  Considering that it was ten-year, prospective, randomized multi-center academic study involving over 5000 patients, that'd be a shame.

Here's the DMCB's summary:

Eligibility: Participants had to be between 45 and 75 years of age with adequately controlled (A1c less than 11) "type 2" diabetes, an "overweight" body mass index (BMI) of 25 or more, blood pressure less than 160/100, an ability to exercise and access to a primary care provider. 

Recruitment: This went from August of 2001 through April of 2004. It was also tailored to keep insulin-using participants to less than 30% of the study group.

Interventions That Were Compared: Participants were randomly assigned to an "intensive lifestyle intervention" study arm or a "support and education" study arm.  The intensive group received weekly group and individual counseling for six months that subsequently tapered over the subsequent duration of the study. The counseling included a 1200-1800 calorie diet plus 175 minutes of moderate physical activity per week that was aimed at achieving a weight loss of at least 7% of body weight.  The support group got only three group sessions per year. Medicines and their doses were generally left to the primary care provider.

Outcomes Studied: Participants' waist circumference, weight, blood pressure, medications and exercise tolerance were assessed once a year. Hospital and other medical records were reviewed to assess the number of deaths and cardiovascular events, such has heart attack or stroke.

The Study Population: 5,124 persons were enrolled; 2570 were randomly assigned to the intensive group while 2575 were assigned to the support group. The average age was 59 years, 60% were women, the median duration of the diabetes diagnosis was 5 years and the average body mass index was a hefty 36. Only 4% were lost to follow-up.

Outcomes:  After a median of 9.6 years of follow-up......

• patients assigned to the intensive group lost approximately three cm. from their waist and six kg. in weight vs. zero cm. and four kg., respectively, in the support group. This translated to a weight loss of 6% of body weight (vs. the target of 7%) in the intensive group vs. about 3.5% in the support group.

• the A1c, which is a test of overall blood sugar control, was about two tenths of a point (7.4% vs. 7.2%) lower (i.e. better) in the intensive group. LDL cholesterol was also lower. Better control of the diabetes meant that the persons in the intensive group were taking fewer medicines at lower doses.

• But it was all for naught.  During the course of the study, there were 403 cardiovascular deaths, non-fatal heart attacks or heart-related ("angina") hospitalizations in the intensive group, vs. 418 in the support group. The calculated rates of 1.8 vs. 1.9 events per 100 person years was too small to be statistically significant and was more likely the result of chance or randomness.

The Disease Management Care Blog's take?

The early painful lesson of the "disease management" industry was that a broad life-style intervention applied to a large group of diabetics was not going to meaningfully improve outcomes. Critics believed that while the interventions were conceptually sound (diet, exercise, weight loss), the delivery was flawed. 

This just published NEJM study would suggest the intervention itself is futile. If so, that is bad news.

"Not so fast!" says the DMCB.

In addition to renaming itself (now "population health"), the industry responded to the science and the critics by retooling.  It learned to channel tailored interventions at population sub-segments who are most likely to experience a specific benefit. Instead of an "intensive" weight loss intervention for all overweight diabetics, population health can use baseline survey, insurance or clinical data to spot (risk stratify) those diabetics who are most likely to achieve a specific benefit that could range from (for example) a sustained 7% weight loss to reduced readmissions.

This NEJM study tried to benefit all diabetics.  A better approach is to find which diabetics will benefit.

As an aside there were some other issues with the study to bring up when debating the study with colleagues and foes:

The BMI of 36 suggests this was a very obese study population that lost only 6% of their body weight during the course of the study.  Since weight was still a health risk at the end of the study, the DMCB wonders if the intervention would have shown more benefit with a less heavy population.

The support group also lost weight and lowered their A1c, which could have obscured the clinically significant benefit in the intervention group. 

This accompanying editorial points out that lower statin and ACE drug use in the intervention group could have paradoxically increased their risk, since these drugs are known to lower the incidence of stroke and heart attack.

The editorial also points out that spin-off studies have already shown that the intervention group benefitted from higher quality of life.

Usual Telephonic Outreach To Get Patients To Change Their Minds About Refusing Preventive Services Doesn't Work

Pick up the phone, will ya?

It's a no brainer, isn't it?  Patients who don't submit to being immunized, mammogramed, pap'd, colonscopied, blood-worked or pricked, poked or imaged by other inconvenient, uncomfortable and icky preventive tests only need to be "educated."  And once they are enlightened, the average person will stampede toward their recommended testings faster than legislators going to the White House for some serious budget scolding, right?

Not so fast.  Stephen Persell and colleagues at Northwestern University culled 407 patients with refusals for 520 recommended preventive services from a large internal medicine clinic in Chicago, Illinois.  In this particular practice, physicians were committed to promoting prevention among their patients and, what's more, they recorded when patients said "no."  Unless the physician refused permission or there was an active medical or psychosocial reason not to, a case manager telephoned (with up to three attempts) the 407 refusniks with some added "education," helped remove any potential barriers, arranged additional referrals if necessary and, if it would help, got the doctor re-involved.

And six months later, what happened?  19% of the patients were not called based on what was written in the medical record, 11% of the patients were not called based on physician feedback and only 11% of the patients answered the phone. Compared to a parallel control group of refusniks who were not called, there was no statistically significant improvement in the receipt of preventive services: 6.1% of intervention group cooperated versus 4.8% in the control group.  While the authors didn't mention it, caller ID probably helped patients to not answer the phone.

While the study may have been statistically hobbled by a low number of observations (making any conclusions about the lack of statistical significance less trustworthy) the authors concluded that one-on-one educational outreach may not sufficient to overcome patient refusals for preventive services.  The DMCB, based on its own professional experience agrees: tracking persons down outside the clinic can be difficult and if patients are willing to say "no" to their doctor, it's unlikely that they'll say "yes" to someone else.

This speaks to the possibility that in any population, there is going to be a percent that refuse preventive services and that there is little that physicians can ultimately do about it.  This has implications for the assumptions that underlie many quality reporting and provider pay-for performance programs.

This also has implications for the population health and disease management service providers.  While this study used a "nonclinician case manager" to provide the education, the DMCB has to wonder if the intervention was hobbled by not using state-of-the-art "engagement" strategies that are configured for behavior change that delivered by credentialed nurse health professionals.  If correct, it's possible that a commercial prevention program would have compared more favorably to the "usual care" telephonic outreach described by Northwestern. 

That's another research study for another day.

Why Health Reform's Medicare Prevention Provisions For Diabetes Are As Inadequate As Octogenarian Moon Walking

The Disease Management Care Blog often invites feedback from the DMCB spouse. With her usual discerning eye, she critically appraised yesterday's Part 2 post and characterized it as "bleh bleh disease management blah prevention blah blah blah Medicare personalized prevention plan bleh Pam Anderson bleh blah prevention."

Guilty as charged, but the DMCB forges on with this Part 3 post on the topic of prevention and health reform, while drawing more inspiration from another Dancing With The Stars contestant, Buzz Aldrin. The octogenarian, former jet pilot and moon-walking astronaut did a remarkable job of competing against a much younger field, but his future appearances on that show are numbered. The DMCB agrees with judge Bruno Tonioli: he moved like he still had his moon boots on.

And so does Medicare when it comes to prevention. The DMCB explains.

In the (allegedly off-topic) prior post, it was pointed out that the published science takes a dim view of 1) physician-led and 2) non-selective exercise and obesity prevention programs. That doesn't mean that ALL programs are a waste of time, as amply demonstrated in employer based programs and by Silver Sneakers.

What makes them different than the plodding non-evidence-based approach now included in Federal health reform? They a) don't rely on the patient-physician dyad and b) target their interventions.

Consider the need for preventing diabetes mellitus, where is good news. This randomized prospective New England Journal of Medicine study published back in 2001 showed nutritionist-led "detailed" dietary advice with food record review, along with regular, supervised and tailored exercise sessions reduced the incidence of diabetes in persons at risk to 11%, versus a 23% in the control group, over 4 years.

And check out this Diabetes Prevention Program study that was published the following year, also in the New England Journal. Persons at risk for diabetes were randomly allocated to either a) "life style recommendations," b) receipt of the same recommendations plus taking a drug called metformin (which was thought to possess some preventive potential) or c) a far more rigorous "intensive program of lifestyle modification." The latter arm of the study was designed....

"....to achieve and maintain weight reduction of at least 7 percent of initial body weight through a healthy low-calorie, low-fat diet and to engage in physical activity of moderate intensity, such as brisk walking, for at least 150 minutes per week. A 16-lesson curriculum covering diet, exercise, and behavior modification was designed to help the participants achieve these goals. The curriculum, taught by case managers on a one-to-one basis during the first 24 weeks after enrollment, was flexible, culturally sensitive, and individualized. Subsequent individual sessions (usually monthly) and group sessions with the case managers were designed to reinforce the behavioral changes" (bolding from the DMCB).

After just less than 3 years, the incidence of diabetes was 4.8% in the intensive group versus 7.8% in the metformin group and 11% in the life style recommendations group. A follow-up study showed that the beneficial effect continued after ten years. That's pretty impressive with a number needed to treat of about 20 to prevent one case of diabetes.

So what can be concluded from the success of employer based wellness programs, Silver Sneakers and these New England Journal diabetes prevention studies?

1) Employer based programs succeed because they typically focus their interventions on segments of the population that stand to gain the greatest benefit. They use health risk assessment surveys to identify those persons at risk and to ascertain willingness to participate. The DMCB thinks it may be possible for physicians to also do this during a 1-on-1 personalized prevention plan encounter, but - based on physicians' lack of confidence and perceptions about their patients described in the prior post - that'll be the exception and not the rule.

2) Silver Sneakers succeeds without requiring a physician office visit as a condition of participation. Patients show up at the gym and there are fitness coordinators that tailor programs, much like the interventions described in the New England Journal.

3) The diabetes prevention studies described above, Silver Sneakers and employer-based wellness programs succeed by relying on non-physicians such as nutritionists, fitness trainers and case managers to do the "heavy lifting" of patient engagement and supervision.

And finally, it should be pointed out that fee-for-service Medicare still doesn't cover the actual preventive care by nuritionists, fitness experts or case managers. As of yesterday's health reform signing ceremony, the only that's covered is the physician-based "planning."

Which is why the admiring DMCB regretfully thinks dancing Buzz Aldrin is symbolic of an aging and plodding Medicare. In their prime, Buzz and Medicare were truly remarkable. As the years have gone on, both still deserve utmost respect but let's face it: neither are up to their assigned tasks. This latest bill's prevention provisions is much like Buzz's shuffling moon walk last night: decades late and unable to adapt to the rhythms of a modern age.

In the last installment of this series tomorrow, the DMCB will speculate about what could be done in health reform to take full advantage of what science tells us about prevention. As for Buzz, there is little the DMCB can do, but it wishes his coaching dance partner much luck.

With Health Reform, Medicare Now Covers a Prevention Visit With A Doctor: A Look At the Scientific Evidence, Part 2

In yesterday's post, the pernickety Disease Management Care Blog contrasted Speaker Pelosi's victory speech description of the newly passed health bill's prevention provisions with the actual legislative language. While her characterization bordered on bombastic, it's clear that there's a lot of grant money and new government being devoted to prevention. What really caught the DMCB's attention, however, was the decision for Medicare to now pay for an annual visit devoted to the creation of a "personalized prevention plan."

Sounds good right? Imagine being ushered in from the waiting room and huddling with your personal physician, Dr. Nowpaidenuf. Dream about reviewing, sharing and discussing how little you exercise, how much you eat and how unwilling you are to get a colonscopy. Then visualize exiting the clinic with a plan, being thankful that your version of Medicare is under the stewardship of an enlightened political leadership and resolving to eat more vegetables. And fruit.

Sound too good to be true? There's plenty of research to say that it probably is.

While there are plenty of studies (for example) that show that physicians could do better when it comes to counseling their patients about prevention, it turns out that lack of payment has been only a small part of the story, compared to other issues, such as their own lack of confidence or patient barriers that include socioeconomic issues, competing medical conditions, and the lack of motivation. If physicians wade in anyway, their advice can be wrong and, even if they're right, the benefit that patients may get typically decays over time. No wonder the U.S. Preventive Services Task Force has concluded there is no evidence that primary care counseling works to meaningfully increase physical activity and that a very thorough review of the medical scientific literature found no evidence to support the notion that counseling alone has any sustained impact on obesity.

While the DMCB is thankful, that's because a certain Ms. Anderson has thrown her hat, plus ample amounts of fruit, into the ring of Dancing With The Stars. Armed with that inspiration, the DMCB thinks it's ironic that, just when Medicare is emphasizing value based purchasing, Congress has created an additional entitlement that, by itself, has little apparent value.

But all is not lost. The DMCB ultimately thinks that there is plenty of value to be had in prevention counseling. More on that in a Part 3 post tomorrow.

The House Passes Health Reform: What Does It REALLY Say about Prevention?

The Disease Management Care Blog watched last night's speechifying that accompanied the House's health reform and was struck by Speaker Pelosi's repeating the 'prevention' refrain:

"...the list goes on and on about the health care reforms that are in this legislation: insure 32 million more people... end insurance company discrimination .....creating a healthier America through prevention, through wellness and innovation, create 4 million jobs in the life of the bill and doing all of that by saving the taxpayer $1.3 trillion dollars" (bolding from the DMCB).

Which begs the question: now that reform is at hand, will our new and improved health insurance system now pay for preventive care?

To find out, the trusting but verifying DMCB blew tanks, dove through the House's legislative language posted here and uncovered this quote:

The CMS Administrator would conduct an assessment of the diseases and conditions that are the most cost-intensive for the Medicare program. The assessment would inform research priorities within HHS in order to improve the prevention, or treatment or cure, of such diseases and conditions. Not later than January 1, 2011, the Administrator would submit the report to the Secretary of Health and Human Services and the Secretary would transmit the report to the Congress.

So, a more more accurate interpretation of the legislation that was passed by the House may be that it would create prevention research for a healthier America.

But then the DMCB paddled back to the Senate's language and looked for more. It found that that creates an Independent Medicare Advisory Board that is charged with making cost-saving recommendations that promote prevention, a National Prevention Health Promotion and Public Health Council to coordinate prevention, a Preventive Services Task Force to make recommendations about prevention, a national private-public partnership to raise awareness about prevention and a web site on prevention. In addition, there are provisions for research grants and contracts that fund health teams so that they can counsel patients about prevention, grants to States to test prevention programs in Medicaid as well as fund community programs, offers of technical assistance to employers for wellness programs and establishment of a "Prevention and Public Health Fund" that would invest in prevention and public health programs. Last but not least, Medicare would cover an annual visit that creates a "personalized prevention plan."

So, a really really more accurate description of this legislative bundle is that it would fund research, contracts, assistance and grants on prevention, create various bureaucracies devoted to prevention and include coverage for provider visits devoted to counseling about prevention.

As its prior posts may indicate, the DMCB has been skeptical about Feds' ability to deliver on their health reform promises. However, 1) it's now the law of the land, 2) all still remains right with the universe because the Orange are hanging in there and 3) some solace was within reach yesterday thanks to this mixed with a version of this. Who knows, maybe some good will come of reform, especially if some of the folks running things in DC read this blog once in a while.

In the meantime, it appears to the DMCB that the short answer to the question at the beginning of this post is that, outside of lots of Federal largesse and bureaucracies, the health insurance system will now cover provider counseling on prevention for consumers. In tomorrow's post, we'll examine in greater detail whether that is really as wonderful as Ms. Pelosi's speech implied.