Failing to Change Behavior

According to the July 11, 2013 issue of The New England Journal of Medicine, the Look AHEAD trial has been canceled on the “basis of a futility analysis” after 9.6 years of follow-up. It was designed to study whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among overweight or obese patients with Type 2 diabetes. Short of interning people in exercise camps, it is hard to imagine a more intensive intervention.

The 5,145 participants were randomly assigned to either a control group or an intensive lifestyle intervention group. The control group received the usual information about behavioral strategies for adopting standard recommendations about how to eat right and exercise.

The intensive lifestyle intervention group met with extensively trained, culturally sensitive, lifestyle counselors 4 times a month in the first year. Its members received individualized weight loss goals, specific per day calorie intake goals, meal replacements that were provided free of charge and detailed exercise goals for each week. Weight loss drugs were offered if participants failed to meet their goal in the first 6 months. During years 2-4 each participant had a monthly individual meeting with a phone or email follow-up two weeks later. They kept goal sheets, food, and activity records. Monthly meetings were available, and prizes were awarded if people met specific goals such as losing 5 pounds or walking 400,000 steps. There were 16 centers, and they competed against each other to reach weight loss and activity goals.

After 9.6 years there was no difference in cardiovascular events in the two groups. Standard clinical measures of health had improved more for the intervention group than for the control group, though some of the improvements were small.

At the end of four years, Wadden et al. (2012) reported that the control group had lost an average of 1.3 kg (almost 3 pounds) while the intensive intervention group had lost an average of 4.9 kg (almost 11 pounds). By the end of the trial, the control group had lost an average of 3 percent of body weight while the intervention group had lost an average of 6 percent. For a 5 foot 7 inch woman weighing 180 pounds at baseline, a 6 percent loss would be 10.8 pounds. A 3 percent loss would be 3.4 pounds.

Separately, Sullivan et al. (2013) reported that people who received diabetes counseling and education services in a matched retrospective cohort study at a large managed care organization achieved A1c levels of 7.2 percent after 1 year. People in a control group received no services and had an A1c of 7.7 percent. The treatment group had more inpatient visits and more ambulatory visits. They were also more likely to have a hypoglycemic event. Their increased health service use cost $2,388 a year, with $827 higher diabetes-related costs.

Comments (11)

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  1. August says:

    Finally, a cost figure to weigh this stuff against.

    “Their increased health service use cost $2,388 a year, with $827 higher diabetes-related costs.”

    • Baker says:

      And with that comes the complete non result:

      “An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes.”

  2. Buster says:

    Very few preventive medical services are money-saving. Most increase the cost of insuring a population.

    • Sal says:

      Not sure that means preventative care is all ineffective, just how it’s being implemented perhaps.

      • Linda Gorman says:

        In the face of evidence like this, it is up to you to provide a preventive care example, other than immunizations, for which there is strong evidence that implementing it in the general population both prevents disease and reduces overall health system costs.

        Otherwise it’s just talk and a way to waste (other people’s) money.

  3. Cory says:

    So what does this mean for the United States? You can’t help people live healthier lives?

  4. JJM says:

    Failing to change outcomes seems to be what is actually reported. The failure to change outcomes may have been due to failure to change behavior, but what I read here and in the NEJM summary is that outcomes failed to change. If behavior failed to change, it would be interesting to get details on that.

  5. Dr. Don Crawford says:

    Yes, it isn’t clear whether the problem is failing to improve behavior or whether changed behavior doesn’t make a medical difference long term. Clearly behavior didn’t change much if weight loss was limited over a couple of years to 3 to 10 pounds. To tease out the question, what if you selected the people who actually did lose significant amounts of weight and significantly exercised, etc? Looked at just the successes. Then look at the successes and see if medical outcomes were better, and/or less costly. If those people didn’t have improvements, then there really is no point in pursuing “preventative care.” In the meantime I’m working on my N of 1: weight is down 30 lbs in one year and A1c is down from 9.6 to 5.9 in a year. taking one less medication now.