- Email: [email protected]
obese endometrial cancer survivors
e-SPEN, the European e-Journal of Clinical Nutrition and Metabolism 4 (2009) e143–e147
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Original Article
Effects of a lifestyle intervention on nutrient intake in overweight/obese endometrial cancer survivors Mary Beth Kavanagh a, *, Vivian E. von Gruenigen b, Kerry S. Courneya c, Heidi E. Gibbons b, Steven E. Waggoner b, Edith Lerner a a b c
Department of Nutrition, Case Western Reserve University, 10900 Euclid Avenue, School of Medicine, WG 48, Cleveland, OH 44106, USA Case Western Reserve University, University Hospitals Case Medical Center, Division of Gynecologic Oncology, 11100 Euclid Avenue, Room 7128, Cleveland, OH 44106, USA E488 Van Vliet Center, University of Alberta, Edmonton, Alberta, T6G 2H9, Canada
a r t i c l e i n f o
s u m m a r y
Article history: Received 9 September 2008 Accepted 27 February 2009
Background & aims: Our group previously reported positive effects of a lifestyle intervention on weight loss and physical activity in overweight/obese endometrial cancer survivors (ECS). Here we report the effects on quantitative nutrient intake.
Keywords: Endometrial cancer survivors Lifestyle intervention Obesity
Methods: This was a randomized controlled trial in which the Lifestyle Intervention (LI) group (n ¼ 23) received 6 months of group nutrition/physical activity counseling while the Usual Care (UC) group (n ¼ 22) received an informational brochure. Results: At 3 months, LI had significantly lower intakes of kilocalories (mean LI ¼ 1451.3, UC ¼ 1734.6, p ¼ 0.042), total fat (mean LI ¼ 53.3 g, UC ¼ 69.7 g, p ¼ 0.033), and MUFA (mean LI ¼ 16.1 g, UC ¼ 21.0 g, p ¼ 0.039) and a higher intake of lycopene (mean LI ¼ 2423.9 mcg, UC ¼ 810.5 mcg, p ¼ 0.001). Dietary cholesterol intake trended towards a lower intake in LI (mean LI ¼ 181.0 mg, UC ¼ 253.1 mg, p ¼ 0.075). Lycopene trended towards a higher intake in LI at 6 months (mean LI ¼ 1673.5 mg, UC ¼ 496.4 mg, p ¼ 0.055). At 12 months, a higher intake of potassium was observed in LI (mean LI ¼ 1382.7 mg, UC ¼ 578.2 mg, p ¼ 0.064). Conclusions: Results of this study indicate that this lifestyle intervention was effective in improving the intake of some nutrients in obese/overweight ECS. Ó 2009 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.
1. Introduction In 2007, it was estimated that there were 580,000 endometrial cancer survivors (ECS) in the United States.1 Endometrial cancer is the most common gynecologic cancer with 5 year survival rates of 96, 67, and 23% respectively for stages I, II and III.2 The most significant and well-established risk factor for endometrial cancer is obesity.3–5 Obese ECS have higher mortality from causes unrelated to cancer6; one study with 714 subjects found deaths were due primarily to cardiovascular disease (CVD).7 Lifestyle intervention studies have been conducted with survivors of other cancers.8–11 Observational studies of overweight/ obese ECS have been conducted.6,12,13 However, our group is
Abbreviations: ECS, endometrial cancer survivors; LI, Lifestyle Intervention group; UC, Usual Care group. * Corresponding author. Tel.: þ1 216 368 3231; fax: þ1 216 368 6644. E-mail address: [email protected] (M.B. Kavanagh).
unaware of any published lifestyle intervention studies with ECS. Research is clearly needed in this under-studied population at high risk for morbidity and mortality due to their overweight/obesity. We previously reported14 a lifestyle intervention that resulted in greater weight loss in the Lifestyle Intervention group (LI) versus the Usual Care (UC) group. At 12 months the LI group lost 3.5 kg as compared to a 1.4-kg gain in the UC group (p ¼ >0.02). The LI group also increased their physical activity 16.4 metabolic equivalents (METS) compared to a decrease of 1.3 METS in the UC group (p < 0.01). The purpose of this paper is to report the effects of the lifestyle intervention on quantitative nutrient intake. 2. Materials and methods This was a randomized controlled trial of overweight/obese ECS in which the Lifestyle Intervention (LI) group received 6 months of nutrition and physical activity group counseling and the Usual Care (UC) group received an informational brochure (‘‘Better Health and You’’, Weight Control Information Network, June 2004.) The weight
1751-4991/$ - see front matter Ó 2009 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.eclnm.2009.02.003
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loss goal, or the clinically important difference, was to achieve at least a 5% weight loss in 6 months.15,16 The target for the nutrition component was choosing nutrient dense foods per USDA My Pyramid Food Guidance System17: 2 cups of fruit, 2 1/2 cups vegetables, three low fat dairy servings, and three whole grains per day. The physical activity component emphasized gradual increases in walking at a moderate pace to a goal of 5 days a week for 45 min. Eligibility criteria and enrollment procedures for this study are described elsewhere Fig. 1.14 Participants were assigned to LI or UC by use of stratified blocked randomization according to BMI (25–39.9 versus 40) in order to achieve comparability between the study groups based on BMI.18 The study was approved by the University Hospitals Case Medical Center Institutional Review Board. The intervention was developed by a multidisciplinary team: an RD, a gynecologic oncologist, an exercise physiologist, and a psychologist. It was based on strategies outlined by social cognitive theory which indicate that the optimal intervention should focus on establishing short-term goals and tailoring guidance to the individual’s readiness to change health behaviors.19
Self-monitoring, goal setting, and cognitive behavioral strategies were emphasized in the group sessions. During the 6-month intervention, the LI group met weekly for 6 weeks, biweekly for 1 month, and monthly for 3 months. The study RD facilitated all of the group sessions with the exception of a weight loss readiness discussion and a stress management session which were facilitated by the study psychologist. Topics included: setting realistic weight loss goals; gradually increasing physical activity; increasing intake of nutrient dense foods based on USDA My Pyramid Guidance System; negative thinking; eating out; reading food labels; and strategies for eating in social situations. Participants were contacted by the study RD either by phone, email, or newsletter every week the group did not meet. Newsletter topics included: increasing intake of specific nutrients such as calcium vitamin D, and dietary fiber; decreasing sodium; decreasing red and processed meats; and recipes that emphasized fruit and vegetable intake. Participants kept weekly food and physical activity records which were important tools for self-monitoring. At the beginning of every group session, the study RD weighed each participant in
156 Letters sent to patients from tumor registry
Enrollment Randomization Stratified by BMI > 40 vs. BMI < 40)
Allocated to intervention (n = 23) Received allocated intervention (n = 18) Received partial allocation of the intervention (n = 5) Give reasons: unknown
n = 62 Patients responded n = 49 Attended informational session n =13 Refused (distance too far to travel) n = 4 Refused (unknown reasons) n = 45 Patients eligible and consented
Allocated to control (n = 22) Allocation
Lost to follow-up (n = 4) Give reasons: unknown
Lost to follow-up (n = 3) Give reasons: unknown Follow-Up Discontinued intervention (n = 5) Give reasons: time constraints
Analyzed (n = 16) Excluded from analysis (n = 2) Give reasons: Subjects did not return 3 day food record
Analysis
Fig. 1. CONSORT flow chart.
Analyzed (n =18) Excluded from analysis (n= 4) Give reasons: Subjects did not return 3 day food records
98.4 (443.4, 246.7) 0.695 6.1 (25.7, 13.5) 0.597 2.9 (10.5, 4.7) 0.484 0.8 (6.3, 4.8) 0.721 1.2 (5.2, 2.7) 0.695 74.8 (166.3, 16.8) 0.266 1177.1 (37.2, 2391.4) 0.055 270.6 (326.7, 868.0) 0.403 26.7 (24.3, 77.7) 0.294 2.5 (2.0, 7.1) 0.403 8.8 (262.5, 244.9) 0.825 1.3 (1.8, 4.4) 0.551 62.5 (140.5, 15.4) 0.164
1458.3 (541.4) 51.3 (23.4) 16.7 (8.9) 14.6 (8.3) 9.4 (4.9) 388.8 (869.1) 2526.9 (3822.4) 1382.7 (1238.9) 224.6 (85.5) 18.8 (6.8) 752.3 (467.9) 4.4 (6.4) 246.8 (92.3)
1547.5 (500.3) 59.4 (24.7) 20.7 (9.6) 16.9 (7.1) 9.9 (6.0) 234.5 (107.8) 3289.5 (3865.2) 578.2 (360.9) 241.6 (128.4) 16.1 (9.9) 763.8 (387.8) 3.0 (2.9) 348.2 (259.9)
89.3 8.1 4.0 2.3 0.5 154.3 762.6 804.5 17.1 2.7 11.5 1.4 101.4
(453.2, 274.7) 0.551 (24.9, 8.8) 0.330 (10.5, 2.4) 0.164 (7.7, 3.1) 0.297 (4.4, 3.4) 0.986 (265.8, 574.4) 0.175 (3453.7, 1928.6) 0.506 (183.0, 1426.1) 0.064 (94.3, 60.2) 0.656 (3.3, 8.7) 0.187 (310.5, 287.5) 0.878 (2.0, 4.8) 0.986 (241.2, 38.4) 0.403
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1501.2 56.7 18.6 17.0 9.9 208.0 1673.5 2592.1 252.7 20.2 802.8 3.9 274.8 283.4 (645.7, 79.0) 0.042 15.8 (33.9, 2.2) 0.033 5.3 (12.2, 1.58) 0.198 5.0 (11.5, 1.5) 0.039 2.2 (5.7, 1.3) 0.187 72.1 (142.2, 1.9) 0.075 1613.5 (10.7, 3237.6) 0.001 147.1 (490.4, 784.6) 0.721 1.2 (59.0, 56.7) 0.932 1.1 (3.0, 5.2) 0.772 51.4 (216.9, 319.6) 0.798 0.5 (1.9, 0.9) 0.237 122.7 (236.6, 8.8) 0.059 *p value for Mann–Whitney test. a LI (n ¼ 16); UC (n ¼ 18).
1734.6 (536.5) 69.7 (26.7) 23.2 (11.2) 21.0 (9.2) 11.8 (5.2) 253.1 (116.4) 810.5 (1995.0) 2528.6 (809.9) 233.9 (82.2) 17.6 (5.3) 834.5 (392.3) 2.7 (1.9) 363.4 (197.0) 1451.3 (496.6) 53.3 (24.6) 17.9 (8.1) 16.1 (9.3) 9.6 (4.9) 181.0 (78.1) 2423.9 (683.4) 2675.8 (1013.3) 232.8 (83.3) 18.7 (6.4) 885.9 (72.7) 2.1 (2.1) 240.7 (111.9) Kilocalories Total fat (g) Saturated fat (g) MUFA (g) PUFA (g) Cholesterol Lycopene (mcg) Potassium (mg) Magnesium (mg) Dietary fiber (g) Calcium (mg) Vitamin D (mcg) Folate (mcg)
LI UC
Mean group difference (95% CI) p value* LI
(385.6) (25.3) (9.6) (8.6) (4.5) (74.7) (2348.4) (941.5) (79.5) (6.8) (292.4) (6.3) (63.3)
1599.5 (571.2) 62.7 (30.1) 22.3 (11.9) 17.8 (7.4) 11.1 (6.5) 282.8 (165.2) 496.4 (894.4) 2321.5 (767.6) 226.0 (66.4) 17.7 (6.2) 811.6 (414.6) 2.6 (1.4) 337.4 (140.8)
UC LI UC
Mean group difference (95% CI) p value*
12 months 6 months
Forty-five patients were enrolled; 23 were randomized to the LI group and 22 to the UC group. Mean age was 55 years, mean BMI was 42.2. Ninety-eight percent were Caucasian, 57% were married, and 80% were educated beyond the twelfth grade. There were no significant differences between the two groups. Fifty-five percent of all participants had class III obesity, 19% had class II, and 21% had class I per NHLBI classification.24 At baseline, 25% of the women in this study reported taking a calcium supplement and 22% reported taking a multivitamin with minerals. Sixteen percent reported taking vitamin E, and 9% reported taking vitamin C. Ten participants reported taking more than four dietary supplements. Forty-four percent reported that they did not take any dietary supplements. Five participants (11%) had bariatric surgery anywhere from 3 to 6 years prior to enrollment in the study. Their baseline BMIs were 50.7, 40.2, 39.6, 38.7, and 36.2. Twenty-three participants (51%) in this study had a baseline BMI that would qualify them for bariatric surgery. Table 1 shows select nutrient intakes from food for 16 participants in the LI group and 18 in the UC group who returned 3-day food records. As reported previously,14 two participants withdrew on randomization to the control group and five withdrew during the intervention for unknown reasons. Four participants did not complete food records but did complete other measures. Comparison of data at 3, 6, and 12 months between groups revealed that at 3 months, the LI group had significantly lower mean intakes of kilocalories (p ¼ 0.042), total fat (p ¼ 0.033), and MUFA (p ¼ 0.039) as compared to the UC group and a significantly higher mean intake of lycopene (p ¼ 0.001). Dietary cholesterol trended towards a significantly lower intake in the LI group (p ¼ 0.075). Lycopene intake was significantly higher in the LI group at 6 months
3 months
3. Results
Table 1 Comparison of mean intakes (SD) from food of select nutrients between the LI and UC groupsa at 3, 6 and 12 months.
private and provided individualized feedback for new nutrition and physical activity goals based on the participant’s food and activity record. The RD made recommendations for calcium and vitamin D supplementation as needed if participants were not achieving dietary goals. Participants in both the LI and the UC groups saw the gynecologic oncologist for an office visit at 3, 6, and 12 months. The LI participants received specific reinforcement of the group session topics; for example increasing intake of fruit and vegetables. The UC participants received general health advice such as ‘‘eat a healthful diet.’’ Quantitative nutrient intake was measured using 3-day food records at 3, 6 and 12 months.20,21,22 Baseline nutrient intake was collected from the LI group but not the UC group due to a clerical error. Nutrient intake was determined using Nutritionist Pro version 2.5 First Data Bank, 8/2005. If a food was not found in the database, information was used from the Nutrition Facts label or a comparable food was substituted. Patient demographic, clinical variables and baseline values were compared between groups by either independent samples t-test or chi-square test for proportions. Mann–Whitney (non-parametric) tests were used to compare intake of nutrients at 3-, 6-, and 12-month time points between groups. In addition, LI participants were compared to themselves using paired t-test or Wilcoxonsigned rank test to examine changes over time. Three paired tests (baseline to 3 months, baseline to 6 months and baseline to12 months) were performed. All analyses were done according to intention-to-treat principles. Missing data for participants who did not complete all study assessments were imputed according to the last and next method (average of last and next known values) or previous row mean method (mean of person’s previous known values) for those patients who had completed more than one assessment time point.23
Mean group difference (95% CI) p value*
M.B. Kavanagh et al. / e-SPEN, the European e-Journal of Clinical Nutrition and Metabolism 4 (2009) e143–e147
93.2 (280.1. 93.7) 0.305 16.0 (24.3, 7.6) 0.001 4.3 (7.0, 1.6) 0.004 7.2 (10.4, 4.0) <0.001 2.7 (5.5, 0.20) 0.066 175.9 (274.3, 626.2) 0.418 762.3 (1888.2, 3412.8) 0.549 783.3 (1456.7, 109.8) 0.026 34.1 (3.8, 72.0) 0.075 4.9 (1.5, 8.3) 0.008 92.3 (122.3, 307.0) 0.374 2.8 (0.9, 6.4) 0.125 36.7 (39.2, 112.5) 0.315 50.3 (119.3, 219.9) 0.537 10.6 (2.0, 19.2) 0.020 2.4 (0.5, 5.2) 0.095 4.8 (0.3, 9.3) 0.038 2.1 (0.5, 4.8) 0.101 4.8 (51.9, 61.5) 0.859 91.1 (1898.6, 2080.9) 0.924 426.1 (870.7, 18.4) 0.059 62.2 (106.3, 18.0) 0.009 6.4 (10.1, 2.6) 0.003 142.8 (343.4, 57.7) 0.150 2.3 (5.9, 1.4) 0.204 58.5 (6.3, 123.2) 0.073 100.3 (251.7, 51.1) 0.178 14.0 (22.5, 5.4) 0.003 3.1 (6.1. 0.1) 0.045 5.8 (9.6, 1.9) 0.006 2.4 (4.0 0.9) 0.004 31.8 (81.6, 18.0) 0.194 659.3 (1181.5, 2500.0) 0.457 509.8 (138.3, 881.2) 0.010 42.3 (4.8, 79.8) 0.029 4.8 (1.4, 8.1) 0.008 225.9 (75.6, 376.3) 0.006 0.6 (0.2, 1) 0.134 11.6 (48.3, 71.5) 0.682 1458.3 (541.4) 51.3 (23.4) 16.7 (8.9) 14.6 (8.3) 9.4 (4.9) 388.8 (869.1) 2526.9 (3822.4) 1382.7 (1238.9) 224.6 (85.5) 18.8 (6.8) 752.3 (467.9) 4.4 (6.4) 246.8 (92.3) 1501.2 (385.6) 56.7 (25.3) 18.6 (9.6) 17.0 (8.6) 9.9 (4.55) 208.0 (74.7) 1673.5 (2348.4) 2592.1 (941.5) 252.7 (79.5) 20.2 (6.8) 802.8 (292.4) 3.9 (6.3) 274.8 (63.3) 1451.3 (496.6) 53.3 (24.6) 17.9 (8.1) 16.1 (9.3) 9.6 (4.9) 181.0 (78.1) 2423.9 (683.4) 2675.8 (1013.3) 232.8 (83.3) 18.7 (6.4) 885.9 (72.7) 2.5 (1.8) 240.7 (111.9) 1551.5 (496.9) 67.3 (25.5) 21.0 (9.1) 21.8 (8.8) 12.0 (6.1) 212.9 (83.4) 1764.7 (2348.9) 2166.0 (797.1) 190.5 (80.0) 13.9 (4.7) 660.0 (412.0) 1.6 (2.0) 219.8 (82.8) Kilocalories Total fat (g) Saturated fat (g) MUFA (g) PUFA (g) Cholesterol Lycopene (mcg) Potassium (mg) Magnesium (mg) Dietary fiber (g) Calcium (mg) Vitamin D (mcg) Folate (mcg)
Change B to 6 months (95% CI) p value Change B to 3 months (95% CI) p value 12 months 6 months
As reported elsewhere,14 the lifestyle intervention resulted in a significant weight loss in the LI group as compared to the UC group (mean loss of 3.5 kg LI vs 1.4 kg gain UC) and a significant difference in physical activity (increase of 16.4 METS in LI vs decrease of 1.3 METS in UC group). In the present report, we found that the lifestyle intervention delivered by an RD was effective in improving intake of some nutrients over the short term in overweight/obese ECS. While the most significant improvements in nutrient intake in the LI group occurred from baseline to 3 months, the mean intakes from food for folate, potassium, magnesium, calcium, and vitamin D were still below the DRI for these nutrients in both groups at all time points. The small percentage of participants who were using a multivitamin (22%) or calcium supplement (25%) to bridge this gap is of special concern. Recently, a systematic review of vitamin and mineral supplementation among US adults after cancer diagnosis found 75–85% of breast cancer survivors using any vitamin or mineral supplement.26 A much smaller percentage was found in this study of ECS. Future studies should identify supplement use by brand, dose, and frequency to provide total intake from both food and supplements. Dietetic professionals and physicians should continue to evaluate dietary supplement use in cancer survivors and assist in developing evidence-based guidelines for supplement use in this population. The mean intake of saturated fat in both the LI and UC groups was >10% of total kilocalories at all time points. Since mortality for ECS was shown in one study to be primarily from CVD,7 future interventions should specifically target and reinforce strategies to reduce saturated fat and other nutrients associated with increased CVD risk. While this intervention had low attrition and good adherence, the findings are limited by the small number of participants (34/45, 76%) for whom food records were available for analysis. Some participants may have found the food records to be too burdensome. The use of 3-day food records for measuring nutrient intake may have altered participants’ intakes and therefore their overall nutrient intake may not be accurately represented. Under-reporting of intake has been found to be especially prevalent in obese persons.27 Future
3 months
4. Discussion
Baseline
(p ¼ 0.055) and potassium intake was significantly higher in the LI group at 12 months (p ¼ 0.064). Table 2 shows the results when LI participants were compared to themselves using paired t-test to examine changes over time. There were significant changes from baseline to 3 months: decreased total fat (p ¼ 0.003), saturated fat (p ¼ 0.045), MUFA (p ¼ 0.006), and PUFA (p ¼ 0.004) and increased potassium (p ¼ 0.010), magnesium (p ¼ 0.029), dietary fiber (p ¼ 0.008), and calcium (p ¼ 0.006). From baseline to 6 months decreased intakes of total fat (p ¼ 0.020) and MUFA (p ¼ 0.038), and increased potassium (p ¼ 0.59), magnesium (p ¼ 0.009), and dietary fiber intakes (p ¼ 0.031) were observed. The change in nutrient intake from baseline to 12 months in the LI group was significant for decreased total fat (p ¼ 0.001), saturated fat (p ¼ 0.004), decreased MUFA (p < 0.001), decreased potassium intake (p ¼ 0.026), and increased magnesium (p ¼ 0.075) and dietary fiber (p ¼ 0.008). Similar results were observed when non-parametric Wilcoxonsigned rank tests were performed. Mean intakes of select micronutrients from food at 12 months in both groups were examined and compared to the DRI for women 51 to 70 years of age.25 Mean intakes of vitamin D and potassium were especially low (36% of the EAR and 20% of the AI respectively.) The mean intake of iron was 240% of the EAR value and 96.6% of the women met or exceeded the EAR value. Mean calcium intake was 63% of the AI. The percentage of women who were meeting the AI for calcium and vitamin D was less than 20%.
Change B to 12 months (95% CI) p value
M.B. Kavanagh et al. / e-SPEN, the European e-Journal of Clinical Nutrition and Metabolism 4 (2009) e143–e147
Table 2 Changes in nutrient intake from food of 16 ECS in LI group from baseline to 3 months, from 3 months to 6 months, from 6 to 12 months, and from baseline to 12 months.
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studies might use the USDA Multiple Pass Method for 24-h recalls, both announced and unannounced, along with 3-day food records in order to most accurately assess nutrient intake. Baseline 3-day food records were not obtained from the UC group due to a clerical error. This prohibited comparison of baseline nutrient intake between the LI and UU groups. It is not known if there was any significant difference in baseline nutrient intakes of the two groups but it is clear that the LI group improved their intake of some nutrients, especially from baseline to 3 months. Significant improvements were also found at 12 months: decreased total fat, saturated fat, and increased dietary fiber. Socialdesirability bias in self-reports of fat intake was recently found in a large NIH study.28 Future studies could increase the number of group sessions to see if nutrient intake improvements would be maintained with increased group and RD contact and use multiple 24-h recalls to most accurately assess dietary intake. The participants in this study were almost exclusively Caucasian. There is evidence that the incidence of endometrial cancer is lower in African American women but the age-adjusted mortality is higher.29 Interventions that target African American and other ethnically diverse ECS are necessary. Health professionals should be aware of the prevalence and potential for bariatric surgery in this population of overweight/ obese ECS. The five participants who had bariatric surgery prior to the intervention still had high BMIs and these individuals continue to be candidates for lifestyle interventions. ECS are at increased risk for morbidity and mortality because of their overweight/obesity. There is the potential for increasing rates of endometrial cancer due to the current obesity epidemic. Multidisciplinary teams are uniquely positioned to design and deliver lifestyle interventions for ECS and other cancer survivors as the number of cancer survivors continues to increase.30 The results of this study show positive effects of the LSI on the nutrient intakes of ECS. These positive changes, if maintained, have the potential to decrease morbidity and mortality in these subjects. Programs such as this that encourage healthy eating and exercise should be initiated in all cancer survivors whose cancer is related to obesity. Conflict of interest There are no conflicts of interest to disclose for any of the authors. Acknowledgements This study was funded by a grant from The Lance Armstrong Foundation. The Foundation had no involvement in the study design, collection, analysis, or interpretation of the data; there was no involvement in the writing of the manuscript nor in the decision to submit for publication. The authors acknowledge Lillian Pinault and Anna Taylor who completed data entry for the nutrition analysis of 3-day food records. There was no outside assistance with writing the manuscript. VVG conceived of the study. MBK, VVG, KC, HG, SW and EL participated in the design of the study. MBK, EL, VVG, and HG developed the intervention protocol. MBK delivered the intervention. HG provided statistical analysis. MBK and EL drafted the manuscript and all authors read and approved the final manuscript. References 1. National Cancer Institute Website. Estimated US cancer prevalence. Available at: http://cancercontrol.cancer.gov.ocs.prevalence.html#allsites (accessed June 6, 2007). 2. American Cancer Society. Cancer facts and figures 2007. Available at: http://www. cancer.org/downloads/STT/CAFF2007PWSsecured.pdf (accessed June 6, 2007).
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A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: the Women’s Healthy Eating and Living (WHEL) study. Control Clin Trials 2002;23:728–56. 12. Courneya KS, Karvinen KH, Campbell KL, Pearcey RG, Dundas G, Capstick V, et al. Associations among exercise, body weight, and quality of life in a populationbased sample of endometrial cancer survivors. Gynecol Oncol 2005;97:422–30. 13. Von Gruenigen VE, Gil KM, Frasure HE, Grandon M, Hopkins MP, Jenison El. Complementary medicine use, diet and exercise in endometrial cancer survivors. J Cancer Integr Med 2005;3:13–8. 14. Von Gruenigen VE, Courneya KS, Gibbons HE, Kavanagh MB, Waggoner SE, Lerner E. Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: a randomized trial. Gynecol Oncol 2008;109(1):19–26. 15. McTigue KM, Harris R, Hemphill B, Lux L, Sutton S, Bunton AJ, et al. Screening and interventions for obesity in adults: summary of the evidence for the US preventive services task force. Ann Intern Med 2003;139:933–49. 16. Jakicic JM, Wing RR, Winters-Hart C. Relationship of physical activity to eating behaviors and weight loss in women. Med Sci Sports Exerc 2002;34:1653–9. 17. US Department of Agriculture. My pyramid food guidance system. Available at: http://www.mypyramid.gov (accessed May 2005). 18. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 3rd ed. New York: Springer; 1998. 19. Bandura A. Health promotion by social cognitive means. Health Educ Behav 2004;31:143–64. 20. Lee RD, Nieman DC. Nutritional Assessment. 4th ed. New York: The McGraw-Hill Companies; 2006. 21. Block G. Human dietary assessment: methods and issues. Prev Med 1998;18: 653–60. 22. Vuckovic N, Rirtenbaugh C, Taren DL, Tobar M. A qualitative study of participant’s experiences with dietary assessment. J Am Diet Assoc 2000;100:1023–8. 23. Engels JM, Diehr P. Imputation of missing longitudinal data: a comparison of methods. J Clin Epidemiol 2003;56:968–76. 24. National Heart Lung and Blood Institute. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: the evidence report. Available at http://www.nhlbi.nih.gov/guidelines/obesity/ob_ gdlns.htm (accessed April 20, 2007). 25. Food and Nutrition Board, Institute of Medicine. Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. Dietary reference intakes for vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc (2001); Dietary reference intakes for water, potassium, sodium, chloride, and sulfate (2004). Washington, DC: National Academies Press; 1997. 26. Velicer CM, Ulrich CM. Vitamin and mineral supplement use among US adults after cancer diagnosis. J Clin Oncol 2008;26:665–73. 27. Kretsch MJ, Fong AK, Green MW. Behavioral and body size correlates of energy intake underreporting by obese and normal-weight women. J Am Diet Assoc 1999;99:411–8. 28. Hebert JR, Hurley TG, Peterson KE, Resnicow K, Thompson FE, Yaroch AL, et al. Social desirability trait influences on self-reported dietary measures among divers participants in a multicenter multiple risk factor trial. J Nutr 2008;138:226S–34. 29. Madison T, Schottenfeld D, James SA, Schwartz AG, Gruber SB. Endometrial cancer: socioeconomic status and racial/ethnic differences in stage at diagnosis, treatment and survival. Am J Public Health 2004;94:2104–11. 30. Stull VB, Snyder DC, Demark-Wahnefried W. Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr 2007;137:243–8.
Contents lists available at ScienceDirect
e-SPEN, the European e-Journal of Clinical Nutrition and Metabolism journal homepage: http://intl.elsevierhealth.com/journals/espen
Original Article
Effects of a lifestyle intervention on nutrient intake in overweight/obese endometrial cancer survivors Mary Beth Kavanagh a, *, Vivian E. von Gruenigen b, Kerry S. Courneya c, Heidi E. Gibbons b, Steven E. Waggoner b, Edith Lerner a a b c
Department of Nutrition, Case Western Reserve University, 10900 Euclid Avenue, School of Medicine, WG 48, Cleveland, OH 44106, USA Case Western Reserve University, University Hospitals Case Medical Center, Division of Gynecologic Oncology, 11100 Euclid Avenue, Room 7128, Cleveland, OH 44106, USA E488 Van Vliet Center, University of Alberta, Edmonton, Alberta, T6G 2H9, Canada
a r t i c l e i n f o
s u m m a r y
Article history: Received 9 September 2008 Accepted 27 February 2009
Background & aims: Our group previously reported positive effects of a lifestyle intervention on weight loss and physical activity in overweight/obese endometrial cancer survivors (ECS). Here we report the effects on quantitative nutrient intake.
Keywords: Endometrial cancer survivors Lifestyle intervention Obesity
Methods: This was a randomized controlled trial in which the Lifestyle Intervention (LI) group (n ¼ 23) received 6 months of group nutrition/physical activity counseling while the Usual Care (UC) group (n ¼ 22) received an informational brochure. Results: At 3 months, LI had significantly lower intakes of kilocalories (mean LI ¼ 1451.3, UC ¼ 1734.6, p ¼ 0.042), total fat (mean LI ¼ 53.3 g, UC ¼ 69.7 g, p ¼ 0.033), and MUFA (mean LI ¼ 16.1 g, UC ¼ 21.0 g, p ¼ 0.039) and a higher intake of lycopene (mean LI ¼ 2423.9 mcg, UC ¼ 810.5 mcg, p ¼ 0.001). Dietary cholesterol intake trended towards a lower intake in LI (mean LI ¼ 181.0 mg, UC ¼ 253.1 mg, p ¼ 0.075). Lycopene trended towards a higher intake in LI at 6 months (mean LI ¼ 1673.5 mg, UC ¼ 496.4 mg, p ¼ 0.055). At 12 months, a higher intake of potassium was observed in LI (mean LI ¼ 1382.7 mg, UC ¼ 578.2 mg, p ¼ 0.064). Conclusions: Results of this study indicate that this lifestyle intervention was effective in improving the intake of some nutrients in obese/overweight ECS. Ó 2009 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.
1. Introduction In 2007, it was estimated that there were 580,000 endometrial cancer survivors (ECS) in the United States.1 Endometrial cancer is the most common gynecologic cancer with 5 year survival rates of 96, 67, and 23% respectively for stages I, II and III.2 The most significant and well-established risk factor for endometrial cancer is obesity.3–5 Obese ECS have higher mortality from causes unrelated to cancer6; one study with 714 subjects found deaths were due primarily to cardiovascular disease (CVD).7 Lifestyle intervention studies have been conducted with survivors of other cancers.8–11 Observational studies of overweight/ obese ECS have been conducted.6,12,13 However, our group is
Abbreviations: ECS, endometrial cancer survivors; LI, Lifestyle Intervention group; UC, Usual Care group. * Corresponding author. Tel.: þ1 216 368 3231; fax: þ1 216 368 6644. E-mail address: [email protected] (M.B. Kavanagh).
unaware of any published lifestyle intervention studies with ECS. Research is clearly needed in this under-studied population at high risk for morbidity and mortality due to their overweight/obesity. We previously reported14 a lifestyle intervention that resulted in greater weight loss in the Lifestyle Intervention group (LI) versus the Usual Care (UC) group. At 12 months the LI group lost 3.5 kg as compared to a 1.4-kg gain in the UC group (p ¼ >0.02). The LI group also increased their physical activity 16.4 metabolic equivalents (METS) compared to a decrease of 1.3 METS in the UC group (p < 0.01). The purpose of this paper is to report the effects of the lifestyle intervention on quantitative nutrient intake. 2. Materials and methods This was a randomized controlled trial of overweight/obese ECS in which the Lifestyle Intervention (LI) group received 6 months of nutrition and physical activity group counseling and the Usual Care (UC) group received an informational brochure (‘‘Better Health and You’’, Weight Control Information Network, June 2004.) The weight
1751-4991/$ - see front matter Ó 2009 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.eclnm.2009.02.003
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loss goal, or the clinically important difference, was to achieve at least a 5% weight loss in 6 months.15,16 The target for the nutrition component was choosing nutrient dense foods per USDA My Pyramid Food Guidance System17: 2 cups of fruit, 2 1/2 cups vegetables, three low fat dairy servings, and three whole grains per day. The physical activity component emphasized gradual increases in walking at a moderate pace to a goal of 5 days a week for 45 min. Eligibility criteria and enrollment procedures for this study are described elsewhere Fig. 1.14 Participants were assigned to LI or UC by use of stratified blocked randomization according to BMI (25–39.9 versus 40) in order to achieve comparability between the study groups based on BMI.18 The study was approved by the University Hospitals Case Medical Center Institutional Review Board. The intervention was developed by a multidisciplinary team: an RD, a gynecologic oncologist, an exercise physiologist, and a psychologist. It was based on strategies outlined by social cognitive theory which indicate that the optimal intervention should focus on establishing short-term goals and tailoring guidance to the individual’s readiness to change health behaviors.19
Self-monitoring, goal setting, and cognitive behavioral strategies were emphasized in the group sessions. During the 6-month intervention, the LI group met weekly for 6 weeks, biweekly for 1 month, and monthly for 3 months. The study RD facilitated all of the group sessions with the exception of a weight loss readiness discussion and a stress management session which were facilitated by the study psychologist. Topics included: setting realistic weight loss goals; gradually increasing physical activity; increasing intake of nutrient dense foods based on USDA My Pyramid Guidance System; negative thinking; eating out; reading food labels; and strategies for eating in social situations. Participants were contacted by the study RD either by phone, email, or newsletter every week the group did not meet. Newsletter topics included: increasing intake of specific nutrients such as calcium vitamin D, and dietary fiber; decreasing sodium; decreasing red and processed meats; and recipes that emphasized fruit and vegetable intake. Participants kept weekly food and physical activity records which were important tools for self-monitoring. At the beginning of every group session, the study RD weighed each participant in
156 Letters sent to patients from tumor registry
Enrollment Randomization Stratified by BMI > 40 vs. BMI < 40)
Allocated to intervention (n = 23) Received allocated intervention (n = 18) Received partial allocation of the intervention (n = 5) Give reasons: unknown
n = 62 Patients responded n = 49 Attended informational session n =13 Refused (distance too far to travel) n = 4 Refused (unknown reasons) n = 45 Patients eligible and consented
Allocated to control (n = 22) Allocation
Lost to follow-up (n = 4) Give reasons: unknown
Lost to follow-up (n = 3) Give reasons: unknown Follow-Up Discontinued intervention (n = 5) Give reasons: time constraints
Analyzed (n = 16) Excluded from analysis (n = 2) Give reasons: Subjects did not return 3 day food record
Analysis
Fig. 1. CONSORT flow chart.
Analyzed (n =18) Excluded from analysis (n= 4) Give reasons: Subjects did not return 3 day food records
98.4 (443.4, 246.7) 0.695 6.1 (25.7, 13.5) 0.597 2.9 (10.5, 4.7) 0.484 0.8 (6.3, 4.8) 0.721 1.2 (5.2, 2.7) 0.695 74.8 (166.3, 16.8) 0.266 1177.1 (37.2, 2391.4) 0.055 270.6 (326.7, 868.0) 0.403 26.7 (24.3, 77.7) 0.294 2.5 (2.0, 7.1) 0.403 8.8 (262.5, 244.9) 0.825 1.3 (1.8, 4.4) 0.551 62.5 (140.5, 15.4) 0.164
1458.3 (541.4) 51.3 (23.4) 16.7 (8.9) 14.6 (8.3) 9.4 (4.9) 388.8 (869.1) 2526.9 (3822.4) 1382.7 (1238.9) 224.6 (85.5) 18.8 (6.8) 752.3 (467.9) 4.4 (6.4) 246.8 (92.3)
1547.5 (500.3) 59.4 (24.7) 20.7 (9.6) 16.9 (7.1) 9.9 (6.0) 234.5 (107.8) 3289.5 (3865.2) 578.2 (360.9) 241.6 (128.4) 16.1 (9.9) 763.8 (387.8) 3.0 (2.9) 348.2 (259.9)
89.3 8.1 4.0 2.3 0.5 154.3 762.6 804.5 17.1 2.7 11.5 1.4 101.4
(453.2, 274.7) 0.551 (24.9, 8.8) 0.330 (10.5, 2.4) 0.164 (7.7, 3.1) 0.297 (4.4, 3.4) 0.986 (265.8, 574.4) 0.175 (3453.7, 1928.6) 0.506 (183.0, 1426.1) 0.064 (94.3, 60.2) 0.656 (3.3, 8.7) 0.187 (310.5, 287.5) 0.878 (2.0, 4.8) 0.986 (241.2, 38.4) 0.403
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1501.2 56.7 18.6 17.0 9.9 208.0 1673.5 2592.1 252.7 20.2 802.8 3.9 274.8 283.4 (645.7, 79.0) 0.042 15.8 (33.9, 2.2) 0.033 5.3 (12.2, 1.58) 0.198 5.0 (11.5, 1.5) 0.039 2.2 (5.7, 1.3) 0.187 72.1 (142.2, 1.9) 0.075 1613.5 (10.7, 3237.6) 0.001 147.1 (490.4, 784.6) 0.721 1.2 (59.0, 56.7) 0.932 1.1 (3.0, 5.2) 0.772 51.4 (216.9, 319.6) 0.798 0.5 (1.9, 0.9) 0.237 122.7 (236.6, 8.8) 0.059 *p value for Mann–Whitney test. a LI (n ¼ 16); UC (n ¼ 18).
1734.6 (536.5) 69.7 (26.7) 23.2 (11.2) 21.0 (9.2) 11.8 (5.2) 253.1 (116.4) 810.5 (1995.0) 2528.6 (809.9) 233.9 (82.2) 17.6 (5.3) 834.5 (392.3) 2.7 (1.9) 363.4 (197.0) 1451.3 (496.6) 53.3 (24.6) 17.9 (8.1) 16.1 (9.3) 9.6 (4.9) 181.0 (78.1) 2423.9 (683.4) 2675.8 (1013.3) 232.8 (83.3) 18.7 (6.4) 885.9 (72.7) 2.1 (2.1) 240.7 (111.9) Kilocalories Total fat (g) Saturated fat (g) MUFA (g) PUFA (g) Cholesterol Lycopene (mcg) Potassium (mg) Magnesium (mg) Dietary fiber (g) Calcium (mg) Vitamin D (mcg) Folate (mcg)
LI UC
Mean group difference (95% CI) p value* LI
(385.6) (25.3) (9.6) (8.6) (4.5) (74.7) (2348.4) (941.5) (79.5) (6.8) (292.4) (6.3) (63.3)
1599.5 (571.2) 62.7 (30.1) 22.3 (11.9) 17.8 (7.4) 11.1 (6.5) 282.8 (165.2) 496.4 (894.4) 2321.5 (767.6) 226.0 (66.4) 17.7 (6.2) 811.6 (414.6) 2.6 (1.4) 337.4 (140.8)
UC LI UC
Mean group difference (95% CI) p value*
12 months 6 months
Forty-five patients were enrolled; 23 were randomized to the LI group and 22 to the UC group. Mean age was 55 years, mean BMI was 42.2. Ninety-eight percent were Caucasian, 57% were married, and 80% were educated beyond the twelfth grade. There were no significant differences between the two groups. Fifty-five percent of all participants had class III obesity, 19% had class II, and 21% had class I per NHLBI classification.24 At baseline, 25% of the women in this study reported taking a calcium supplement and 22% reported taking a multivitamin with minerals. Sixteen percent reported taking vitamin E, and 9% reported taking vitamin C. Ten participants reported taking more than four dietary supplements. Forty-four percent reported that they did not take any dietary supplements. Five participants (11%) had bariatric surgery anywhere from 3 to 6 years prior to enrollment in the study. Their baseline BMIs were 50.7, 40.2, 39.6, 38.7, and 36.2. Twenty-three participants (51%) in this study had a baseline BMI that would qualify them for bariatric surgery. Table 1 shows select nutrient intakes from food for 16 participants in the LI group and 18 in the UC group who returned 3-day food records. As reported previously,14 two participants withdrew on randomization to the control group and five withdrew during the intervention for unknown reasons. Four participants did not complete food records but did complete other measures. Comparison of data at 3, 6, and 12 months between groups revealed that at 3 months, the LI group had significantly lower mean intakes of kilocalories (p ¼ 0.042), total fat (p ¼ 0.033), and MUFA (p ¼ 0.039) as compared to the UC group and a significantly higher mean intake of lycopene (p ¼ 0.001). Dietary cholesterol trended towards a significantly lower intake in the LI group (p ¼ 0.075). Lycopene intake was significantly higher in the LI group at 6 months
3 months
3. Results
Table 1 Comparison of mean intakes (SD) from food of select nutrients between the LI and UC groupsa at 3, 6 and 12 months.
private and provided individualized feedback for new nutrition and physical activity goals based on the participant’s food and activity record. The RD made recommendations for calcium and vitamin D supplementation as needed if participants were not achieving dietary goals. Participants in both the LI and the UC groups saw the gynecologic oncologist for an office visit at 3, 6, and 12 months. The LI participants received specific reinforcement of the group session topics; for example increasing intake of fruit and vegetables. The UC participants received general health advice such as ‘‘eat a healthful diet.’’ Quantitative nutrient intake was measured using 3-day food records at 3, 6 and 12 months.20,21,22 Baseline nutrient intake was collected from the LI group but not the UC group due to a clerical error. Nutrient intake was determined using Nutritionist Pro version 2.5 First Data Bank, 8/2005. If a food was not found in the database, information was used from the Nutrition Facts label or a comparable food was substituted. Patient demographic, clinical variables and baseline values were compared between groups by either independent samples t-test or chi-square test for proportions. Mann–Whitney (non-parametric) tests were used to compare intake of nutrients at 3-, 6-, and 12-month time points between groups. In addition, LI participants were compared to themselves using paired t-test or Wilcoxonsigned rank test to examine changes over time. Three paired tests (baseline to 3 months, baseline to 6 months and baseline to12 months) were performed. All analyses were done according to intention-to-treat principles. Missing data for participants who did not complete all study assessments were imputed according to the last and next method (average of last and next known values) or previous row mean method (mean of person’s previous known values) for those patients who had completed more than one assessment time point.23
Mean group difference (95% CI) p value*
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93.2 (280.1. 93.7) 0.305 16.0 (24.3, 7.6) 0.001 4.3 (7.0, 1.6) 0.004 7.2 (10.4, 4.0) <0.001 2.7 (5.5, 0.20) 0.066 175.9 (274.3, 626.2) 0.418 762.3 (1888.2, 3412.8) 0.549 783.3 (1456.7, 109.8) 0.026 34.1 (3.8, 72.0) 0.075 4.9 (1.5, 8.3) 0.008 92.3 (122.3, 307.0) 0.374 2.8 (0.9, 6.4) 0.125 36.7 (39.2, 112.5) 0.315 50.3 (119.3, 219.9) 0.537 10.6 (2.0, 19.2) 0.020 2.4 (0.5, 5.2) 0.095 4.8 (0.3, 9.3) 0.038 2.1 (0.5, 4.8) 0.101 4.8 (51.9, 61.5) 0.859 91.1 (1898.6, 2080.9) 0.924 426.1 (870.7, 18.4) 0.059 62.2 (106.3, 18.0) 0.009 6.4 (10.1, 2.6) 0.003 142.8 (343.4, 57.7) 0.150 2.3 (5.9, 1.4) 0.204 58.5 (6.3, 123.2) 0.073 100.3 (251.7, 51.1) 0.178 14.0 (22.5, 5.4) 0.003 3.1 (6.1. 0.1) 0.045 5.8 (9.6, 1.9) 0.006 2.4 (4.0 0.9) 0.004 31.8 (81.6, 18.0) 0.194 659.3 (1181.5, 2500.0) 0.457 509.8 (138.3, 881.2) 0.010 42.3 (4.8, 79.8) 0.029 4.8 (1.4, 8.1) 0.008 225.9 (75.6, 376.3) 0.006 0.6 (0.2, 1) 0.134 11.6 (48.3, 71.5) 0.682 1458.3 (541.4) 51.3 (23.4) 16.7 (8.9) 14.6 (8.3) 9.4 (4.9) 388.8 (869.1) 2526.9 (3822.4) 1382.7 (1238.9) 224.6 (85.5) 18.8 (6.8) 752.3 (467.9) 4.4 (6.4) 246.8 (92.3) 1501.2 (385.6) 56.7 (25.3) 18.6 (9.6) 17.0 (8.6) 9.9 (4.55) 208.0 (74.7) 1673.5 (2348.4) 2592.1 (941.5) 252.7 (79.5) 20.2 (6.8) 802.8 (292.4) 3.9 (6.3) 274.8 (63.3) 1451.3 (496.6) 53.3 (24.6) 17.9 (8.1) 16.1 (9.3) 9.6 (4.9) 181.0 (78.1) 2423.9 (683.4) 2675.8 (1013.3) 232.8 (83.3) 18.7 (6.4) 885.9 (72.7) 2.5 (1.8) 240.7 (111.9) 1551.5 (496.9) 67.3 (25.5) 21.0 (9.1) 21.8 (8.8) 12.0 (6.1) 212.9 (83.4) 1764.7 (2348.9) 2166.0 (797.1) 190.5 (80.0) 13.9 (4.7) 660.0 (412.0) 1.6 (2.0) 219.8 (82.8) Kilocalories Total fat (g) Saturated fat (g) MUFA (g) PUFA (g) Cholesterol Lycopene (mcg) Potassium (mg) Magnesium (mg) Dietary fiber (g) Calcium (mg) Vitamin D (mcg) Folate (mcg)
Change B to 6 months (95% CI) p value Change B to 3 months (95% CI) p value 12 months 6 months
As reported elsewhere,14 the lifestyle intervention resulted in a significant weight loss in the LI group as compared to the UC group (mean loss of 3.5 kg LI vs 1.4 kg gain UC) and a significant difference in physical activity (increase of 16.4 METS in LI vs decrease of 1.3 METS in UC group). In the present report, we found that the lifestyle intervention delivered by an RD was effective in improving intake of some nutrients over the short term in overweight/obese ECS. While the most significant improvements in nutrient intake in the LI group occurred from baseline to 3 months, the mean intakes from food for folate, potassium, magnesium, calcium, and vitamin D were still below the DRI for these nutrients in both groups at all time points. The small percentage of participants who were using a multivitamin (22%) or calcium supplement (25%) to bridge this gap is of special concern. Recently, a systematic review of vitamin and mineral supplementation among US adults after cancer diagnosis found 75–85% of breast cancer survivors using any vitamin or mineral supplement.26 A much smaller percentage was found in this study of ECS. Future studies should identify supplement use by brand, dose, and frequency to provide total intake from both food and supplements. Dietetic professionals and physicians should continue to evaluate dietary supplement use in cancer survivors and assist in developing evidence-based guidelines for supplement use in this population. The mean intake of saturated fat in both the LI and UC groups was >10% of total kilocalories at all time points. Since mortality for ECS was shown in one study to be primarily from CVD,7 future interventions should specifically target and reinforce strategies to reduce saturated fat and other nutrients associated with increased CVD risk. While this intervention had low attrition and good adherence, the findings are limited by the small number of participants (34/45, 76%) for whom food records were available for analysis. Some participants may have found the food records to be too burdensome. The use of 3-day food records for measuring nutrient intake may have altered participants’ intakes and therefore their overall nutrient intake may not be accurately represented. Under-reporting of intake has been found to be especially prevalent in obese persons.27 Future
3 months
4. Discussion
Baseline
(p ¼ 0.055) and potassium intake was significantly higher in the LI group at 12 months (p ¼ 0.064). Table 2 shows the results when LI participants were compared to themselves using paired t-test to examine changes over time. There were significant changes from baseline to 3 months: decreased total fat (p ¼ 0.003), saturated fat (p ¼ 0.045), MUFA (p ¼ 0.006), and PUFA (p ¼ 0.004) and increased potassium (p ¼ 0.010), magnesium (p ¼ 0.029), dietary fiber (p ¼ 0.008), and calcium (p ¼ 0.006). From baseline to 6 months decreased intakes of total fat (p ¼ 0.020) and MUFA (p ¼ 0.038), and increased potassium (p ¼ 0.59), magnesium (p ¼ 0.009), and dietary fiber intakes (p ¼ 0.031) were observed. The change in nutrient intake from baseline to 12 months in the LI group was significant for decreased total fat (p ¼ 0.001), saturated fat (p ¼ 0.004), decreased MUFA (p < 0.001), decreased potassium intake (p ¼ 0.026), and increased magnesium (p ¼ 0.075) and dietary fiber (p ¼ 0.008). Similar results were observed when non-parametric Wilcoxonsigned rank tests were performed. Mean intakes of select micronutrients from food at 12 months in both groups were examined and compared to the DRI for women 51 to 70 years of age.25 Mean intakes of vitamin D and potassium were especially low (36% of the EAR and 20% of the AI respectively.) The mean intake of iron was 240% of the EAR value and 96.6% of the women met or exceeded the EAR value. Mean calcium intake was 63% of the AI. The percentage of women who were meeting the AI for calcium and vitamin D was less than 20%.
Change B to 12 months (95% CI) p value
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Table 2 Changes in nutrient intake from food of 16 ECS in LI group from baseline to 3 months, from 3 months to 6 months, from 6 to 12 months, and from baseline to 12 months.
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studies might use the USDA Multiple Pass Method for 24-h recalls, both announced and unannounced, along with 3-day food records in order to most accurately assess nutrient intake. Baseline 3-day food records were not obtained from the UC group due to a clerical error. This prohibited comparison of baseline nutrient intake between the LI and UU groups. It is not known if there was any significant difference in baseline nutrient intakes of the two groups but it is clear that the LI group improved their intake of some nutrients, especially from baseline to 3 months. Significant improvements were also found at 12 months: decreased total fat, saturated fat, and increased dietary fiber. Socialdesirability bias in self-reports of fat intake was recently found in a large NIH study.28 Future studies could increase the number of group sessions to see if nutrient intake improvements would be maintained with increased group and RD contact and use multiple 24-h recalls to most accurately assess dietary intake. The participants in this study were almost exclusively Caucasian. There is evidence that the incidence of endometrial cancer is lower in African American women but the age-adjusted mortality is higher.29 Interventions that target African American and other ethnically diverse ECS are necessary. Health professionals should be aware of the prevalence and potential for bariatric surgery in this population of overweight/ obese ECS. The five participants who had bariatric surgery prior to the intervention still had high BMIs and these individuals continue to be candidates for lifestyle interventions. ECS are at increased risk for morbidity and mortality because of their overweight/obesity. There is the potential for increasing rates of endometrial cancer due to the current obesity epidemic. Multidisciplinary teams are uniquely positioned to design and deliver lifestyle interventions for ECS and other cancer survivors as the number of cancer survivors continues to increase.30 The results of this study show positive effects of the LSI on the nutrient intakes of ECS. These positive changes, if maintained, have the potential to decrease morbidity and mortality in these subjects. Programs such as this that encourage healthy eating and exercise should be initiated in all cancer survivors whose cancer is related to obesity. Conflict of interest There are no conflicts of interest to disclose for any of the authors. Acknowledgements This study was funded by a grant from The Lance Armstrong Foundation. The Foundation had no involvement in the study design, collection, analysis, or interpretation of the data; there was no involvement in the writing of the manuscript nor in the decision to submit for publication. The authors acknowledge Lillian Pinault and Anna Taylor who completed data entry for the nutrition analysis of 3-day food records. There was no outside assistance with writing the manuscript. VVG conceived of the study. MBK, VVG, KC, HG, SW and EL participated in the design of the study. MBK, EL, VVG, and HG developed the intervention protocol. MBK delivered the intervention. HG provided statistical analysis. MBK and EL drafted the manuscript and all authors read and approved the final manuscript. References 1. National Cancer Institute Website. Estimated US cancer prevalence. Available at: http://cancercontrol.cancer.gov.ocs.prevalence.html#allsites (accessed June 6, 2007). 2. American Cancer Society. Cancer facts and figures 2007. Available at: http://www. cancer.org/downloads/STT/CAFF2007PWSsecured.pdf (accessed June 6, 2007).
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