The Quiet Research That Led to a Resounding Success in Diabetes Prevention

The following originally appeared on The Upshot (copyright 2016, The New York Times Company).

More than 86 million people, including 22 million people 65 or older, have pre-diabetes, which increases their risk of heart disease, strokes or diabetes. As we’ve watched that number grow, it has somehow felt that despite billions of dollars of research and intervention, there’s little we can do.

That feeling shifted last week when Sylvia Mathews Burwell, the secretary of health and human services, announced that Medicare was planning to pay for lifestyle interventions focusing on diet and physical activity to prevent Type 2 diabetes. It’s an example of small-scale research efforts into health services that have worked and that have expanded to reach more people.

Articles appear every day on “major breakthroughs,” which later never pan out, while this one, full of successes, rarely made the news. This is the curse of health services research, which seeks to improve population health through improvements in access or delivery of care. When most people think of diabetes research, they’re thinking about a cure or a new medication. Those grand slams are exciting, but they rarely happen. Nevertheless, people want to see them. Donors want to support them. Organizations hire people to go after them.

Health services research is more about hitting singles, day after day. There’s no billion dollar payoff, no fame, no Nobel Prize. But it gets the job done, and it’s often more likely to change the health of most Americans.

This announcement is based on work at an Indianapolis Y.M.C.A. by a social ecologist named David Marrero, who works with me at the Indiana University School of Medicine. The other collaborator, a physician named Ron Ackermann, once shared a cubicle with me when we were both fellows, and also did much of this work at Indiana University.

The Diabetes Prevention Program grew out of extensive research on weight management and behavioral learning. More than 3,200 patients age 25 to 75 with pre-diabetes were randomized to one of three groups. The first group was given an intensive lifestyle intervention. By focusing on a low-fat, low-calorie diet with the addition of exercise through brisk walking or a similar intensity activity, it encouraged people to lose at least 7 percent of their body weight and maintain that over the course of the trial.

The backbone of the intervention involved 16 one-hour face-to-face meetings that helped each individual participant set and achieve goals to improve health habits. The second group was treated with metformin, a medication that can lower blood glucose, and the third was the control group, provided with a placebo medication.

The trial was ended early because the results were so compelling. Those in the medication arm had a 31 percent reduction in the risk of developing diabetes. More important, those in the lifestyle intervention saw a 58 percent reduction in their risk. Moreover, if you were 60 or older at the beginning of the study, your reduction was 71 percent. A later meta-analysis confirmed that these results for lifestyle interventions were replicable across numerous different studies.

Unfortunately, this was a perfect example of where efficacy did not necessarily translate into effectiveness. Identifying patients with pre-diabetes was sometimes difficult. Physicians weren’t reimbursed for doing it, so many didn’t test for it. As those barriers were overcome, a larger one remained: There was no real-world, widespread mechanism to start the intensive intervention the prevention program required. At $1,476 a patient, it was just too expensive and impractical to run in physician offices.

It was at this point that Dr. Ackermann and Mr. Marrero thought of contacting the Y.M.C.A., or the Y, as it is now known. As a large, nationwide community organization, they figured, the Y might just be able to bring the lifestyle intervention to scale. There are more than 2,700 Ys in the United States, and more than 46 million people live within three miles of one of them. They engaged the Y of Greater Indianapolis in 2003 just as the organization was looking for innovative strategies to expand beyond the Y’s reputation as a “gym and swim” place primarily for health seekers.

As the behavioral expert, Mr. Marrero worked with the Y to reshape all 16 core intervention lessons and several maintenance lessons into a group-based format led by instructors who were Y employees. The new intervention was about $205 per person, a fraction of the original cost.

In 2004, Dr. Ackermann (with Mr. Marrero as his key collaborator) received funding from the National Institutes of Health for the Deploy Study, which was designed to test this new Y Model for delivery of the intervention. Those in the intervention group had a 6 percent decrease in weight, compared with 2 percent in the control group. Their cholesterol also dropped 22 mg/dL, while cholesterol levels in the control group rose 6 mg/dL. More important, these differences were sustained after 28 months.

The study showed that the Y might be a promising channel for wide-scale dissemination of the intervention program. Further studies found that primary care clinics could put in pre-diabetes screening using easy-to-perform hemoglobin A1c testing in the office. Patients who were found to be at high risk were referred to a Y coordinator, who offered them the opportunity to take part in the Y program at no charge.

Over the 29 months of the next study, about 18,000 primary care patients were screened for diabetes, and about 29 percent of them were determined to be at high risk. More than 500 of them participated in the program. Those who were offered it achieved about five pounds more in weight loss over a year. Those who attended at least half the classes achieved almost 12 more pounds of weight loss than those who were managed in the clinic only.

Despite these strong research studies, the Y’s program still remained hidden to most Americans. In 2009, Dr. Ackermann and Mr. Marrero presented their research, as well as the research of other investigators, at a national meeting with the Centers for Disease Control and National Institutes of Health. The meeting, attended by a host of government health organizations and several private health system purchasers and payers, catalyzed a new partnership between the Y and UnitedHealth Group, a major health insurance company. The C.D.C. and others later joined in this effort, which involved scaling the Y’s program to over 43 states and the District of Columbia.

Their research was behind the Diabetes Prevention Act of 2009. This act, later passed as a component of the Affordable Care Act, appropriated money to the C.D.C. for the National Diabetes Prevention Program, which provides training and recognition for organizations like the Y that seek third-party payment for the program.

In 2012, the Center for Medicare and Medicaid Innovation granted the Y about $12 million to start a pilot program to evaluate whether Medicare payment for its program might be cost-effective. Among several other sources of data, the actuaries at the Centers for Medicare and Medicaid Services used findings from Dr. Ackermann’s study of UnitedHealthcare clients that were offered the Y’s program to discover that the intervention offered cost savings. They estimate that if the Y program were expanded to all Medicare beneficiaries, the government might save about $2,650 per participant over 15 months, much more than the program cost.

I spend too much time here at The Upshot complaining that our health policy fails to be based on research, or that things we do don’t work. It’s nice once in a while to have the opposite be true.


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