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.