NEW ORLEANS – Overweight and obese patients with inadequately controlled type 2 diabetes have a new evidence-based treatment option in the form of the standard commercial Weight Watchers program enhanced by telephone and email consultations with a certified diabetes educator.
This intervention resulted in clinically meaningful improvements in glycemic control and weight loss, compared with a control group on standard care in a 12-month randomized clinical trial conducted at 16 U.S. centers, Patrick M. O’Neil, PhD, reported at Obesity Week 2016.Dr. O’Neil, professor of psychiatry and behavioral sciences and director of the Weight Management Center at the Medical University of South Carolina, Charleston.
“Patients and providers alike need a broader arsenal of treatment options for managing diabetes; in particular, options that are more accessible to the majority of people with diabetes,” he said. “The number of adults with diabetes is large and growing, and a variety of accessible treatment approaches is needed. The results of this and related trials suggest that adapted, nationally available weight loss programs emphasizing lifestyle changes may represent accessible and effective adjunctive health management resources for people with overweight or obesity and type 2 diabetes.”
Dr. O’Neil reported on a racially and geographically diverse group of 563 overweight or obese adults with inadequately controlled type 2 diabetes who were randomized to the off-the-shelf commercial Weight Watchers program featuring regular community meetings and online tools enhanced with telephone and email consultation with a certified diabetes educator, or to a control group who got an initial face-to-face diabetes nutrition counseling visit with follow-up written information materials.
Control group participants received current standard care, although national survey data indicate that only about 55% of patients with diabetes get any diabetes education at all at diagnosis, he observed.
At enrollment, all study participants were already receiving treatment for their diabetes from a physician not connected to the randomized trial. Ninety-five percent of them were on one or more diabetes medications. Yet their baseline hemoglobin A1clevel was 7%-11% and their body mass index was 27-50 kg/m2.
Both weight loss and improvement in HbA1c were significantly greater in the Weight Watchers group than controls at each of the prespecified interim follow-ups at 13, 26, and 39 weeks.
When the study concluded at 52 weeks, the Weight Watchers group averaged a 0.32% reduction from baseline in HbA1c, and 24% of patients in that study arm had achieved an HbA1c below 7.0%. In contrast, the control group averaged a 0.16% increase in HbA1c, and only 14% of controls got their HbA1c below 7.0%, even though all participants continued to received ongoing background diabetes management from their outside physician throughout the study.
While the 0.48% difference in HbA1c between the Weight Watchers group and controls may not be jaw-dropping, it is equivalent to the placebo-subtracted decrease in HbA1c seen in 2-year long clinical trials of obesity medications in overweight or obese patients with type 2 diabetes, Dr. O’Neil said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
The Weight Watchers group averaged a 4% weight loss at 52 weeks, significantly greater than the 1.9% reduction in controls.
Twenty-six percent of the Weight Watchers group had reduced their diabetes medications at the 52-week mark, compared with 12% of controls. Of the 213 patients on insulin for their type 2 diabetes at baseline, 9 in the Weight Watchers group and 4 controls on standard care were no longer on insulin at 52 weeks. That’s an important secondary outcome because insulin promotes weight gain.
Turning to changes in cardiovascular risk factors, Dr. O’Neil noted that the Weight Watchers group averaged a 3.7-cm reduction in waist circumference from a baseline of 116.3 cm, significantly better than the mean 1.4-cm reduction in controls. C-reactive protein levels dropped significantly in the Weight Watchers group over the course of a year, from 7.3 to 6.3 mg/L, but rose by 0.53 mg/L in the control arm. However, the two groups didn’t differ over time in blood pressure or lipid levels.
Simultaneous with Dr. O’Neil’s presentation, the study findings were published online in the journal Obesity (2016 Nov 2. doi:10.1002/oby.21616).
The study was funded by Weight Watchers International. Dr. O’Neil reported receiving a research grant from the company and serving on advisory boards for several pharmaceutical companies.