Abstract

Objective:This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA1c over 6 months in obese patients with type 2 diabetes.Research Design and Methods:One-hundred participants with a mean±s.d. age of 55.6±10.6 year, body weight of 102.9±18.4 kg and HbA1c of 7.7±1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DSME). Participants in the two groups were prescribed the same goals for energy intake (1250–1550 kcal per day) and physical activity (200 min per week).Results:While both groups produced significant improvements in weight and HbA1c after 6 months of treatment, PCD participants lost 7.3 kg [95% confidence interval (CI): −5.8 to −8.8 kg], compared with 2.2 kg (95% CI: −0.7 to −3.7 kg) in the DSME group (P<0.0001). Significantly more PCD than DSME participants lost ⩾5% of initial weight (54.0% vs 14.0%, P<0.0001) and ⩾10% (26.0% vs 6.0%, P<0.0001). HbA1c declined by 0.7% (95% CI: −0.4 to −1.0%) in the PCD group, compared with 0.4% (95% CI: −0.1 to −0.7%) in DSME (P<0.026). Across both groups, larger weight losses were associated with greater reductions in HbA1c (r=0.52, P<0.0001).Conclusions:These findings demonstrate that a commercially available portion-controlled meal plan can induce clinically meaningful improvements in weight and glycemic control in obese individuals with type 2 diabetes. These data have implications for the management of obesity in primary care, as now provided by the Centers for Medicare and Medicaid Services.

Highlights

  • A 5–10% reduction in initial weight dramatically decreases the risk of developing type 2 diabetes in overweight persons with impaired glucose tolerance[1,2] and improves glycemic control in individuals who already have diabetes.[3,4,5]

  • Participants remained standing while the tape was placed around the abdomen horizontally at the midpoint between the highest point of the iliac crest and the lowest part of the costal margin

  • Overweight and obese individuals typically are advised to lose of diabetes self-management education (DSME) that was associated with significant reductions in 5–10% of their initial weight to improve health complications.[3,30] weight and hemoglobin A1c (HbA1c)

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Summary

Introduction

A 5–10% reduction in initial weight dramatically decreases the risk of developing type 2 diabetes in overweight persons with impaired glucose tolerance[1,2] and improves glycemic control in individuals who already have diabetes.[3,4,5] Comprehensive programs of lifestyle modification reliably produce these improvements in weight (and glycemic control), but such interventions are often very intensive and limited to academic medical centers.[6,7,8] Less intensive yet structured weight-loss programs, which incorporate lifestyle modification and portioncontrolled meal replacement products potentially offer an important treatment option for overweight individuals with diabetes, as suggested by a recent study.[9]. The present 6-month randomized trial extends the prior study by standardizing the duration and intensity of the group treatment to isolate the effects of the portion-controlled diet (PCD) on the observed improvements in weight and glycemic control. To this end, overweight individuals with type 2 diabetes in each of the two treatment groups were prescribed the same calorie intake and physical activity goals and received the same number of group treatment sessions. We elected in the present study to decrease the intensity (frequency) of the lifestyle intervention, a change that potentially could increase the dissemination of this approach.[10]

Methods
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