Survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED): a randomized controlled trial.

OBJECTIVE: The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to evaluate an intervention for ECS to promote weight loss and a healthy lifestyle. METHODS: Early stage overweight and obese (body mass index ≥ 25) ECS (N=75) were randomized to a 6-month lifestyle intervention (LI) or usual care (UC). The LI group received education and counseling for six months (10 weekly followed by 6 bi-weekly sessions). Weight change at 12 months was the primary endpoint. Secondary outcomes included fruit/vegetable servings/day and physical activity (PA). Multiple imputations were used for missing data and mixed models were used to analyze changes from baseline. RESULTS: Adherence was 84% and follow-up data were available from 92% of participants at 6 months and 79% at 12 months. Mean [95% CI] difference in weight change between LI and UC groups at 6 months was -4.4 kg [-5.3, -3.5], p<0.001 and at 12 months was -4.6 kg [-5.8, -3.5], p<0.001. Mean [95% CI] difference in PA minutes between groups at 6 months was 100 [6, 194], p=0.038 and at 12 months was 89 [14, 163], p=0.020. Mean difference in kilocalories consumed was -217.8 (p<0.001) at 6 months and -187.2 (p<0.001) at 12 months. Mean [95% CI] difference in fruit and vegetable servings was 0.91 servings/day at 6 months and 0.92 at 12 months (p<0.001). CONCLUSIONS: Behavior change and weight loss are achievable in overweight and obese ECS, however, the clinical implications of these changes are unknown and require a larger trial with longer follow-up.

The effects of an oral supplement enriched with fish oil, prebiotics, and antioxidants on nutrition status in Crohn's disease patients.

BACKGROUND: Research in the treatment of Crohn's disease (CD) supports anti-inflammatory benefits of n-3 fatty acids from fish oil, prebiotics, and antioxidants. A nutritionally balanced inflammatory bowel disease nutrition formula (IBDNF) enriched with these compounds has the potential to improve nutrition status and disease activity in CD. METHODS: This is an open-label pilot study investigating the effects of IBDNF on nutrition status in CD patients. Twenty-eight patients with active CD on stable medication were asked to consume 16 oz of IBDNF/d for 4 months. Nutrition status was assessed with dual-energy X-ray absorptiometry scans and serum micronutrient levels. Disease activity and quality of life were measured using the Crohn's Disease Activity Index (CDAI) and the Inflammatory Bowel Disease Questionnaire (IBDQ). RESULTS: Twenty patients completed the final visit. After 4 months, there was a significant decrease in plasma phospholipid levels of arachidonic acid with increases in eicosapentaenoic acid (EPA) and docosahexaenoic acid. Ten patients had a final EPA concentration of >2%. There was improvement in fat-free and fat mass in patients with final EPA >2% (P = .014 and P = .05). Vitamin D (25-OH) levels improved in all patients (18.5-25.9 ng/mL, P < .001). Those with EPA >2% had significantly lower CDAI (116 ± 94.5 vs 261.8 ± 86.5; P = .005) and higher IBDQ (179.1 ± 26.6 vs 114.6 ± 35.9, P < .001) compared to those with EPA <2%. CONCLUSIONS: IBDNF has the potential to deposit fat-free and fat mass, improve vitamin D status, and improve quality of life in CD patients.

Feasibility of a lifestyle intervention for ovarian cancer patients receiving adjuvant chemotherapy.

OBJECTIVES: This study aimed to assess the feasibility of a lifestyle intervention for promoting physical activity (PA) and diet quality during adjuvant chemotherapy for ovarian cancer. METHODS: Patients were enrolled post-operatively and received PA and nutrition counseling, at every chemotherapy visit for six cycles. Quality of life (QoL) was measured with the Functional Assessment of Cancer Therapy (FACT-G), PA with the Leisure Score Index (LSI), dietary intake with 3-day food records, and symptom severity/distress by the Memorial Symptom Assessment Scale (MSAS). Pedometer step count was collected during chemotherapy cycles. RESULTS: Recruitment was 73% with 27 patients enrolled. Mean [95% confidence interval] change in minutes of PA from cycle #3 to following cycle #6 was 61 min [-3, 120] p=0.063, and from baseline to after cycle #6 was 73 min [-10, 15]; p=0.082. Mean change in total fruit and vegetable consumption between baseline and during chemotherapy was 0.56 [-0.09, 0.64]; p=0.090. FACT-G increased from 75.4 at baseline to 77.6 during chemotherapy and 83.9 following chemotherapy (p=0.001 for change from baseline to post-chemotherapy). Mean total MSAS score was 20.6 at baseline, 26.6 at cycle #3 and decreased to 17.0 following chemotherapy (p=0.01 comparison of cycle #3 and following chemotherapy). Increased moderate to strenuous PA was correlated with higher physical well-being during chemotherapy (r=0.48, p=0.037). CONCLUSIONS: Lifestyle counseling during adjuvant chemotherapy for ovarian cancer is feasible and may improve PA and diet quality. Randomized controlled trials examining the effects of lifestyle counseling on quality of life and treatment outcomes in ovarian cancer patients are warranted.

Lifestyle challenges in endometrial cancer survivorship.

OBJECTIVE: To examine lifestyle behaviors that may contribute to endometrial cancer survivor morbidity and to identify associations with quality of life. METHODS: Patients with early-stage (I or II) endometrial cancer with a body mass index of at least 25 kg/m2 completed questionnaires on smoking, physical activity, fruit and vegetable intake, and the Functional Assessment of Cancer Therapy (FACT) and Short-Form medical outcomes (SF-36) quality-of-life surveys. Behaviors were compared with American Cancer Society 2006 guidelines for cancer survivors (150 min/wk of moderate-to-vigorous physical activity; five servings fruit and vegetables per day; no smoking). Effect size (d) was calculated for the difference in means between meeting and not meeting guidelines (d=0.5 moderate effect). RESULTS: A total of 120 participants were enrolled. Of those, 43% had hypertension, 35% osteoarthritis, 33% metabolic syndrome, 21% type 2 diabetes mellitus, and 93% abdominal obesity. Only 12% of participants were meeting physical activity guidelines. Fifteen percent reported five or more servings of fruit and vegetables per day; mean intake was 2.6 servings per day. Seventy-four percent of participants were nonsmokers. Only 1% of participants met all three American Cancer Society guidelines; 22% met none of the recommendations. The emotional well-being (mean 17.4 [±4.1] compared with 20.1 [±4.1]; d=0.66) and fatigue scores (mean 34.6 [±9.5] compared with 40.5 [±9.6]; d=0.62) indicate that those who do not meet the guidelines had lower emotional well-being and increased fatigue. CONCLUSION: Endometrial cancer survivors have unhealthy lifestyles that put them at risk for morbidity. This survivor group should be offered multi-behavioral lifestyle interventions after diagnosis. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT 00420979 and NCT00732173. LEVEL OF EVIDENCE: II.

A randomized trial of a lifestyle intervention in obese endometrial cancer survivors: quality of life outcomes and mediators of behavior change.

BACKGROUND: To examine the effects of a 6 month lifestyle intervention on quality of life, depression, self-efficacy and eating behavior changes in overweight and obese endometrial cancer survivors. METHODS: Early stage endometrial cancer survivors were randomized to intervention (n = 23) or usual care (n = 22) groups. Chi-square, Student's t-test and repeated measures analysis of variance were used in intent-to-treat analyses. Outcomes were also examined according to weight loss. RESULTS: Morbidly obese patients had significantly lower self-efficacy, specifically when feeling physical discomfort. There was a significant improvement for self-efficacy related to social pressure (p = .03) and restraint (p = .02) in the LI group. There was a significant difference for emotional well-being quality of life (p = .02), self-efficacy related to negative emotions (p < .01), food availability (p = .03), and physical discomfort (p = .01) in women who lost weight as compared to women who gained weight. Improvement in restraint was also reported in women who lost weight (p < .01). CONCLUSION: This pilot lifestyle intervention had no effect on quality of life or depression but did improve self-efficacy and some eating behaviors. TRIAL REGISTRATION: http://www.clinicaltrials.gov; NCT00420979.

Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: a randomized trial.

OBJECTIVE: The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to assess feasibility of a lifestyle intervention program for promoting weight loss, change in eating behaviors, and increased physical activity in obese ECS. STUDY DESIGN: Early stage ECS (n=45) were randomized to a 6-month lifestyle intervention (LI; n=23) or usual care (UC; n=22). The LI group received group and individual counseling for 6 months. The primary endpoint was weight change. Secondary endpoints were physical activity, [Leisure score index (LSI)] and nutrient intake (3-day food records). Quantitative vitamin C and folate intake were used to assess fruit/vegetable intake. RESULTS: Recruitment was 29%, adherence (LI group) was 73% and 84% of participants completed follow-up assessments. At 12 months, the intervention group lost 3.5 kg compared to a 1.4 kg gain in the control group [mean difference=-4.9 kg; 95% CI: -9.0 to -0.9 kg; p=.018] and had an increased LSI score of 16.4 versus -1.3 in the control group from baseline [mean group difference=17.8; 95% CI=7.1 to 28.4; p=.002]. There were no differences in vitamin C and folate intake. The LI group had lower intake of kilocalories, although differences were not significant. CONCLUSION(S): A lifestyle intervention program in obese ECS is feasible and can result in sustained behavior change and weight loss over a 1-year period.

Improving albumin levels among hemodialysis patients: a community-based randomized controlled trial.

BACKGROUND: Low albumin level is a strong predictor of mortality and morbidity among hemodialysis patients, yet few interventions are available to improve albumin levels. Moreover, the relative importance of nutritional barriers versus inflammation in contributing to hypoalbuminemia is unclear. We sought to determine whether targeting specific nutritional barriers will improve albumin levels. METHODS: We conducted a randomized controlled trial involving 180 patients with baseline albumin levels less than 3.7 g/dL (<37 g/L) at 44 long-term hemodialysis facilities. Study coordinators identified and intervened on specific barriers present among intervention patients, whereas control patients continued to receive the usual care. Barriers targeted included poor nutritional knowledge, poor appetite, help needed with shopping or cooking, low fluid intake, inadequate dialysis dose, depression, difficulty chewing, difficulty swallowing, gastrointestinal symptoms, and acidosis. RESULTS: At baseline, intervention and control patients had similar albumin levels, dietary intakes, levels of inflammatory markers, and numbers of nutritional barriers. After 12 months, intervention patients had greater increases in albumin levels compared with control patients (+0.21 versus +0.06 g/dL [+2.1 versus +0.6 g/L]; P < 0.01), as well as greater increases in energy intake (+4.1 versus -0.6 Kcal/d/kg; P < 0.001) and protein intake (+0.13 versus -0.06 g/d/kg; P < 0.001). The intervention appeared most effective for barriers related to poor nutritional knowledge, help needed with shopping or cooking, and difficulty swallowing. About half the subjects had elevated levels of inflammatory markers, but there was no relationship between change in levels of albumin and inflammatory markers. CONCLUSION: A nutrition intervention tailored to patient-specific barriers resulted in modest improvements in albumin levels regardless of levels of inflammatory markers.

Body composition in preterm infants who are fed long-chain polyunsaturated fatty acids: a prospective, randomized, controlled trial.

The objective of this study was to evaluate growth and body composition of premature infants who were fed formulas with arachidonic acid (ARA; 20:4n6) and docosahexaenoic acid (DHA; 22:6n3) to 1 y of gestation-corrected age (CA). Preterm infants (750-1800 g birth weight and <33 wk gestational age) were assigned within 72 h of first enteral feeding to one of three formulas: control (n = 22), DHA+ARA from fish/fungal oil [DHA+ARA(FF); n = 20], or DHA+ARA from egg/fish oil [DHA+ARA(EF); n = 18]. Human milk feeding was allowed on the basis of the mother's choice. Infants were fed breast milk and/or preterm formulas with or without 0.26% DHA and 0.42% ARA to term CA followed by breast milk or postdischarge preterm formulas with or without 0.16% DHA and 0.42% ARA to 12 mo CA. Body composition was measured by dual-energy x-ray absorptiometry. There were no significant differences among the three study groups at any time point in weight, length, or head circumference. Bone mineral content and bone mineral density did not differ among groups. At 12 mo CA, infants who were fed DHA+ARA-supplemented formulas had significantly greater lean body mass (p < 0.05) and significantly less fat mass (p < 0.05) than infants who were fed the unsupplemented control formula. The DHA+ARA-supplemented formulas supported normal growth and bone mineralization in premature infants who were born at <33 wk gestation. Preterm formulas that had DHA+ARA at the levels and ratios in this study and were fed to 1 y CA led to increased lean body mass and reduced fat mass by 1 y of age.

Cocaine, anemia, and neurodevelopmental outcomes in children: a longitudinal study.

This longitudinal study investigated the rates of iron-deficiency (ID) and iron-deficiency anemia (IDA) among prenatally cocaine-exposed and nonexposed two- and four-year-old children and assessed their relationships to neurodevelopmental outcomes. The sample consisted of 143 two-year-old (70 exposed and 73 nonexposed) and 274 four-year-old (139 exposed and 135 nonexposed) low socioeconomic status children recruited from an ongoing longitudinal study. Hematological assessments included hemoglobin, serum ferritin, mean corpuscular volume, transferrin saturation, and blood lead levels. The neurodevelopmental outcomes consisted of the Bayley Mental (MDI) and Motor (PDI) Development indices at two years, and the Wechsler Preschool and Primary Scales of Intelligence (WPPSI) and the Peabody Developmental Motor Scales (PDMS) at four years. The rate of IDA in four-year-old children was significantly greater among the cocaine-exposed compared to the nonexposed group (p =.026), while the rates at two years were not significant. Exposure to IDA at two years was associated with a significant decrease in concurrent motor scores (p =.011) after adjustment for relevant covariates. Peak exposure to IDA, defined as being anemic at 2 and/or 4 years of age, was associated with a significant (p <.05) decrease in Full Scale IQ after adjustment. Cocaine exposure was not a significant predictor of Full Scale IQ with the inclusion of peak IDA and lead in the model. These findings indicate the need for greater pediatric surveillance of IDA and lead in cocaine-exposed infants, in order to reduce long-term neuropsychological deficits.

Decreased bone resorption with soy isoflavone supplementation in postmenopausal women.

OBJECTIVE: To investigate the effect of soy isoflavone supplementation on bone mineral density (BMD) and markers of bone turnover in postmenopausal women. METHODS: In this randomized, placebo-controlled clinical trial, we used a crossover design to test the effect of soy isoflavone (110 mg/day) (1.3:1.0:0.22 ratio of genistein/daidzein/ glycitein) on bone formation, bone resorption, bone mineral content (BMC), and BMD for 6 months. RESULTS: Postmenopausal women (n = 19), mean age 70.6 +/- 6.3 years and mean time since menopause 19.1 +/- 5.5 years, were given isoflavone supplements for 6 months. There was a 37% decrease in urinary concentrations of type 1 collagen alpha1-chain helical peptide (HP), a marker of bone resorption, during the isoflavone supplementation compared with baseline (p < 0.05) and a significant difference in mean (SE) HP excretion levels when isoflavone was compared with placebo (43.4 +/- 5.2 vs. 56.3 +/- 7.2 microg/mmol creatinine [cr], p < 0.05). With isoflavone supplementation, mean spine BMD at L2 and L3 was significantly greater when treatment was compared with control, with a difference between means of 0.03 +/- 0.04 g and 0.03 +/- 0.04 g (p < 0.05), respectively. There were nonsignificant increases from baseline for total spine BMC (3.5%), total spine BMD (1%), total hip BMC (3.6%), and total hip BMD (1.3%) with the isoflavone treatment. CONCLUSIONS: Soy isoflavone, in isolated form, was effective in this study to significantly decrease bone resorption in postmenopausal women. Further investigation needs to be done to evaluate the long-term effects of soy isoflavone on bone mass and fracture risk.