diagnosis diet, exercise regimen, and body size have yet to be iden- ... 1 Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, ..... glucose, and hsCRP were measured via an Integra 400 Plus auto-.
Obesity
Original Article CLINICAL TRIALS: BEHAVIOR, PHARMACOTHERAPY, DEVICES, SURGERY
A Pilot Randomized Controlled Trial of a Commercial Diet and Exercise Weight Loss Program in Minority Breast Cancer Survivors Heather A. Greenlee1,2,3, Katherine D. Crew1,2,3, Jennie M. Mata2, Paula S. McKinley4, Andrew G. Rundle1,3, Wenfei Zhang5, Yuyan Liao1, Wei Y. Tsai3,5 and Dawn L. Hershman1,2,3
Objective: Obesity is associated with poorer breast cancer outcomes and losing weight postdiagnosis may improve survival. As Hispanic and black women have poorer breast cancer prognosis than non-Hispanic whites diagnosed at similar age and stage, and have higher rates of obesity, effective weight loss strategies are needed. We piloted a randomized, waitlist-controlled, crossover study to examine the effects and feasibility of the commercial Curves weight loss program among Hispanic, African American and AfroCaribbean breast cancer survivors. Design and Methods: Women with stage 0–IIIa breast cancer 6 months posttreatment, sedentary, and BMI 25 kg/m2 were randomized to the immediate arm (IA): 6 months of the Curves program followed by 6 months of observation; or the waitlist control arm (WCA): 6 months of observation followed by 6 months of the Curves program. The Curves program uses a 30-min exercise circuit and a highvegetable/low-fat/calorie-restricted diet. Results: A total of 42 women enrolled (79% Hispanic, 21% black), mean age 51 (range 32–69) and mean BMI 33.2(65.9) kg/m2; 91% were retained at month 12. At month 6, women in the IA lost an average 3.3% (63.5%) of body weight (range: 1.7% gain to 10.6% loss), as compared with 1.8% (62.9%) weight loss in the WCA (P ¼ 0.04). At month 12, on average women in the IA regained some but not all of the weight lost during the first 6 months (P ¼ 0.02). Conclusions: Minority breast cancer survivors were recruited and retained in a weight loss study. Six months of the Curves program resulted in moderate weight loss, but weight loss was not maintained postintervention. Future interventions should identify methods to increase uptake and maintenance of weight loss behaviors. Obesity (2013) 21, 65-76. doi:10.1038/oby.2012.177
Introduction There are currently over 2.5 million breast cancer survivors, an estimated 64% of whom are overweight (BMI 25–30 kg/m2) or obese (BMI >30 kg/m2) (1,2). Obesity is associated with metabolic and hormonal profiles that may stimulate BC growth (3,4) and obesity at the time of diagnosis has been associated with decreased breast cancer survival (5). Many women gain a substantial amount of weight during BC treatment and few return to their prediagnosis weight (6). Observational studies have suggested that lean body mass and regular exercise after a breast cancer diagnosis may improve breast cancer survival, though it is unknown if weight loss among overweight and obese women with breast cancer will improve survival (3,4,5,7).
Studies of the effect of dietary change after diagnosis on survival have yielded conflicting results (8,9). The optimal post-breast cancer diagnosis diet, exercise regimen, and body size have yet to be identified, and may differ by population. Breast cancer incidence rates and prognosis differ by race/ethnicity. In the US, non-Hispanic white women have higher breast cancer incidence rates when compared with African American and Hispanic women (1). However, Hispanic and black breast cancer survivors have poorer prognosis than non-Hispanic whites when diagnosed at similar age and stage (10,11). When compared with non-Hispanic whites, Hispanic women and black women (both African American and Afro-Caribbean) have lifestyle patterns that may contribute to
1
Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA 2 Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA 3 Herbert Irving Comprehensive Cancer Center, Columbia University, New York, New York, USA 4 Department of Psychiatry and Behavioral Medicine, College of Physicians and Surgeons, Columbia University, New York, New York, USA 5 Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, New York, USA Disclosure: The authors declared no conflict of interest. See the online ICMJE Conflict of Interest Forms for this article. Received: 7 July 2011 Accepted: 21 May 2012 First published online by Nature Publishing Group on behalf of The Obesity Society 2 August 2012. doi:10.1038/ oby.2012.177
www.obesityjournal.org
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A Pilot Randomized Controlled Trial Greenlee et al.
their poorer breast cancer survival. When compared with non-Hispanic whites, Hispanic and black women have higher rates of obesity (21.8%, compared with 29.4% and 39.2%, respectively), lower rates of meeting physical activity guidelines (19.0%, compared with 12.5% and 17.5%, respectively), and lower intake of three or more servings of fruits and vegetables per day (27.7%, compared with 19.7% and 21.9%, respectively) (12,13,14). Many Hispanic and black women who live in densely populated urban areas, such as New York City, have limited access to healthy foods and leisure time physical activity due to lack of financial and community resources (15,16). Low-income minority breast cancer survivors may benefit from a weight loss intervention that is financially affordable and easily accessible in their communities. To reduce recurrence risk and to improve survival, current cancer prevention guidelines for cancer survivors recommend engaging in 30–60 min of moderate-vigorous physical activity 5–7 days per week, eating a diet high in fruits and vegetables, and maintaining a BMI less than 25 kg/m2 (17,18). Many studies have examined the ability and effects of various dietary and physical activity interventions to change lifestyle behaviors among breast cancer survivors (19,20), including a growing body of literature specifically examining various approaches to weight loss (20). To date, there is a very limited literature on lifestyle modification and weight loss studies specifically targeting Hispanic and African American breast cancer survivors (21,22,23). There is a need to identify comprehensive interventions targeting diet, physical activity, and body size that are translatable to the real world setting, sustainable over time, and culturally appropriate and accessible to minority populations. We conducted a pilot and feasibility study to examine the effects of the commercial Curves weight loss program among urban, Hispanic, and black breast cancer survivors, which are the two predominant minority patient populations at our academic medical center. Curves is a large fitness chain in the United States and centers are located throughout many areas of the United States, including urban areas that are ethnically diverse. Membership fees are priced at $50/month. The Curves Weight Management Program promotes weight loss through physical activity at their centers and dietary change using a standardized program. The dietary change program is taught to members via a 6-week nutrition course led by Curves staff using a book, DVDs, and an instructor’s manual. The La Vida Activa/An Active Life study was a randomized, crossover, waitlist-controlled pilot and feasibility study to test the effects of 6 months of the Curves weight loss program among Hispanic and black breast cancer survivors. The primary aims of this pilot study were to assess whether this community-situated approach to weight loss was acceptable to Hispanic and black breast cancer survivors and if the program resulted in clinically meaningful weight loss after 6 months. An additional 6 months of follow-up allowed us to observe whether women in the immediate arm were able to maintain and/or continue their weight loss after the active intervention period, as well as allow data collection on the effects of the intervention in the waitlist control group. We hypothesized that this moderately priced, community-situated, standardized weight loss program would appeal to urban minority breast cancer survivors. Here, we report the main study outcomes, including feasibility, adherence, weight loss, and changes in metabolic biomarkers.
Methods and Procedures Participants Women were recruited from the Columbia University Medical Center (CUMC) breast oncology clinic. Potentially eligible women were
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referred by their breast oncologists to be screened by study staff for the following eligibility criteria: age 21–70 years; self-identified as Hispanic or of African descent (African American or Caribbean); diagnosis of stage 0–IIIa breast cancer; completed surgery, chemotherapy, and radiation therapy at least 6 months prior; no evidence of recurrent or metastatic disease; BMI >25 kg/m2; sedentary (defined as physically active to the point of sweating
