1. In a randomized controlled trial of over 600 overweight/obese breast cancer survivors, the use of a group-based, behavioral weight-loss intervention demonstrated significantly increased weight loss compared to standard intervention.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Advancements in the diagnosis and treatment of breast cancer have resulted in a significant increase in the number of breast cancer survivors in the United States, with estimates of up to 2.9 million women. In this population, obesity is associated increased breast cancer-specific and overall mortality in addition to significant cardiovascular and quality-of-life morbidities. However, there has been a paucity of large, randomized studies analyzing the effectiveness of weight-loss intervention among overweight or obese breast cancer survivors. The purpose of this large randomized control trial was to evaluate the effectiveness of a group-based, behavioral weight-loss intervention in this population.
The study randomized over 600 breast cancer survivors who are overweight/obese to either an intensive, group-based weight loss program combined with personal support for 4 months or usual care including counseling on weight loss and physical activity guidelines. At the conclusion of this randomized controlled trial, patients that received intensive, group-based behavioral weight loss intervention demonstrated significantly increased weight loss compared to the control group at 12 months follow-up. This weight loss difference was maintained at two-year follow-up as well. Furthermore, additional measures of cardiovascular health including blood pressure, activity level, and waist circumference also favored the intervention group at 12 months. The results of the study support the use of intensive behavioral weight-loss interventions in obese/overweight breast cancer survivors. However, the study is limited by the relatively-short follow-up period. Furthermore, the study population that was predominantly non-Hispanic white, which may limit the external validity of this study. Additional long-term prospective trials as well as trials focused on minority breast cancer survivors are needed to accurately determine the effectiveness of these weight-loss interventions.
In-Depth [randomized controlled trial]: The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) trial is a multicenter randomized controlled trial of intense group-based weight loss intervention compared to usual care among overweight/obese breast cancer survivors. The study recruited over 697 breast cancer survivors with a body mass index (BMI) of 25 to 45 across four centers in the United States. Patients were excluded for a history of non-breast malignancy, serious psychiatric illness, and any medical limitation of moderate exercise. Participants were randomized to either an intense, group-based regimen involving 4 months of weekly group sessions with personalized supports (Group 1) or provided usual weight management resources from the public domain, two sessions of individualized diet counseling, and optional seminars on diet and exercise (Group 2). The primary outcome was weight at 12- and 24-months after recruitment. Mean weight loss in group 1 was 6% and 3.7% at 12- and 24-months follow-up, respectively. This was significantly increased compared to 1.5% and 1.1% in the control arm at 12- and 24-months (p<0.05). Systolic and diastolic blood pressures were lower in group 1 at all follow-up visits except for the diastolic blood pressure at 12 months (p<0.05). Waist circumference was reduced in group 1 at 12 months (p=0.004) though not at 24 months. After multivariate analysis, only intervention assignment and age were associated with maintained weight loss at 24 months (p<0.001).
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