Predictors of Retention among African Americans in a Randomized Controlled Trial to Test the Healthy Eating and Active Living in the Spirit (HEALS) Intervention.

INTRODUCTION: Retention of racial/ethnic minority groups into research trials is necessary to fully understand and address health disparities. This study was conducted to identify participants' characteristics associated with retention of African Americans (AAs) in a randomized controlled trial (RCT) of a behavioral intervention. METHODS: Using data from an RCT conducted from 2009 to 2012 among AAs, participant-level factors were examined for associations with retention between three measurement points (ie, baseline, 3-month, and 12-month). Chi-square tests and logistic regression analyses were conducted to compare retained participants to those who were not retained in order to identify important predictors of retention. RESULTS: About 57% of participants (n=238) were retained at 12 months. Baseline characteristics that showed a statistically significant association with retention status were age, marital status, body mass index (BMI), intervention group, enrollment of a partner in the study, and perceived stress score (PSS). Multivariable logistic regression that adjusted for age, BMI, and PSS showed the odds of being retained among participants who enrolled with a partner was 2.95 (95% CI: 1.87-4.65) compared with participants who had no study partner enrolled. The odds of being retained among participants who were obese and morbidly obese were .32 and .27 (95% CI: .14-.74 and .11-.69), respectively, compared with participants who had normal weight. CONCLUSION: Having a partner enrolled in behavioral interventions may improve retention of study participants. Researchers also need to be cognizant of participants' obesity status and potentially target retention efforts toward these individuals.

Plasma carotenoids and tocopherols in relation to prostate-specific antigen (PSA) levels among men with biochemical recurrence of prostate cancer.

BACKGROUND: Although men presenting with clinically localized prostate cancer (PrCA) often are treated with radical prostatectomy or radiation therapy with curative intent, about 25-40% develop biochemically recurrent PrCA within 5 years of treatment, which has no known cure. Studies suggest that carotenoid and tocopherol intake may be associated with PrCA risk and progression. We examined plasma carotenoid and tocopherol levels in relation to prostate-specific antigen (PSA) levels among men with PSA-defined biochemical recurrence of PrCA. METHODS: Data analyzed were from a 6-month diet, physical activity and stress-reduction intervention trial conducted in South Carolina among biochemically recurrent PrCA patients (n=39). Plasma carotenoids and tocopherol levels were measured using high-performance liquid chromatography (HPLC). Linear regression was used to estimate least-square means comparing PSA levels of men with high versus low carotenoid/tocopherol levels, adjusting for covariates. RESULTS: After adjusting for baseline PSA level, plasma cis-lutein/zeaxanthin level at 3 months was related inversely to PSA level at 3 months (P=0.0008), while α-tocopherol (P=0.01), ß-cryptoxanthin (P=0.01), and all-trans-lycopene (P=0.004) levels at 3 months were related inversely to PSA levels at 6-months. Percent increase in α-tocopherol and trans-ß-carotene levels from baseline to month 3 were associated with lower PSA levels at 3 and 6 months. Percent increase in ß-cryptoxanthin, cis-lutein/zeaxanthin and all-trans-lycopene were associated with lower PSA levels at 6 months only. CONCLUSIONS: Certain plasma carotenoids and tocopherols were related inversely to PSA levels at various timepoints, suggesting that greater intake of foods containing these micronutrients might be beneficial to men with PSA-defined PrCA recurrence.

A randomized controlled trial of mindfulness-based stress reduction for women with early-stage breast cancer receiving radiotherapy.

PURPOSE: To testthe relative effectiveness of a mindfulness-based stress reduction program (MBSR) compared with a nutrition education intervention (NEP) and usual care (UC) in women with newly diagnosed early-stage breast cancer (BrCA)undergoing radiotherapy. METHODS: Datawere available from a randomized controlled trialof 172 women, 20 to 65 years old, with stage I or II BrCA. Data from women completing the 8-week MBSR program plus 3 additional sessions focuses on special needs associated with BrCA were compared to women receiving attention control NEP and UC. Follow-up was performed at 3 post-intervention points: 4 months, and 1 and 2 years. Standardized, validated self-administered questionnaires were used to assess psychosocial variables. Descriptive analyses compared women by randomization assignment. Regression analyses, incorporating both intention-to-treat and post hoc multivariable approaches, were used to control for potential confounding variables. RESULTS: A subset of 120 women underwent radiotherapy; 77 completed treatment prior to the study, and 40 had radiotherapy during the MBSR intervention. Women who actively received radiotherapy (art) while participating in the MBSR intervention (MBSR-art) experienced a significant (P < .05) improvement in 16 psychosocial variables compared with the NEP-art, UC-art, or both at 4 months. These included health-related, BrCA-specific quality of life and psychosocial coping, which were the primary outcomes, and secondary measures, including meaningfulness, helplessness, cognitive avoidance, depression, paranoid ideation, hostility, anxiety, global severity, anxious preoccupation, and emotional control. CONCLUSIONS: MBSR appears to facilitate psychosocial adjustment in BrCA patients receiving radiotherapy, suggesting applicability for MBSR as adjunctive therapy in oncological practice.

Suppression of DNA damage in human peripheral blood lymphocytes by a juice concentrate: a randomized, double-blind, placebo-controlled trial.

Chronic inflammation contributes to many prevalent diseases worldwide, and it is widely accepted that inflammatory molecules contribute to DNA damage. In this ancillary study, we investigated the influence of an encapsulated fruit and vegetable juice powder concentrate on peripheral blood lymphocytes (PBL) DNA damage. Using a double-blind, placebo-controlled approach, subjects were randomly assigned capsules containing placebo, or one of two formulations of the juice powder. Blood was drawn at baseline and after 60 days of capsule consumption. We found DNA damage in isolated PBL is suppressed after consumption of the encapsulated juice powder, and damage was correlated with the level of systemic inflammation. These data suggest a potential health benefit by consuming the juice concentrate capsules through their ability to suppress DNA damage as measured in surrogate tissues (PBL).

A diet, physical activity, and stress reduction intervention in men with rising prostate-specific antigen after treatment for prostate cancer.

BACKGROUND: Nearly 35% of men treated for prostate cancer (PrCA) will experience biochemically defined recurrence, noted by a rise in PSA, within 10 years of definitive therapy. Diet, physical activity, and stress reduction may affect tumor promotion and disease progression. METHODS: A randomized trial of an intensive diet, physical activity, and meditation intervention was conducted in men with rising post-treatment PSA after definitive treatment for PrCA. Intention-to-treat methods were used to compare usual care to the intervention in 47 men with complete data. Signal detection methods were used to identify dietary factors associated with PSA change. RESULTS: The intervention and control groups did not differ statistically on any demographic or disease-related factor. Although the intervention group experienced decreases of 39% in intakes of saturated fatty acid (SFA as percent of total calories) (p<0.0001) and 12% in total energy intake (218 kcal/day, p<0.05)], no difference in PSA change was observed by intervention status. Signal detection methods indicated that in men increasing their consumption of fruit, 56% experienced no rise in PSA (vs. 29% in men who did not increase their fruit intake). Among men who increased fruit and fiber intakes, PSA increased in 83% of participants who also increased saturated fatty acid intake (vs. 44% in participants who decreased or maintained saturated fatty acid intake). CONCLUSION: Results are discussed in the context of conventional treatment strategies that were more aggressive when this study was being conducted in the mid-2000s. Positive health changes in a number of lifestyle parameters were observed with the intervention, and both increased fruit and reduced saturated fat intakes were associated with maintaining PSA levels in men with biochemically recurrent disease.

The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial.

The aim of this study was determine the effectiveness of a mindfulness-based stress-reduction (MBSR) program on quality of life (QOL) and psychosocial outcomes in women with early-stage breast cancer, using a three-arm randomized controlled clinical trial (RCT). This RCT consisting of 172 women, aged 20-65 with stage I or II breast cancer consisted of the 8-week MBSR, which was compared to a nutrition education program (NEP) and usual supportive care (UC). Follow-up was performed at three post-intervention points: 4 months, 1, and 2 years. Standardized, validated self-administered questionnaires were adopted to assess psychosocial variables. Statistical analysis included descriptive and regression analyses incorporating both intention-to-treat and post hoc multivariable approaches of the 163 women with complete data at baseline, those who were randomized to MBSR experienced a significant improvement in the primary measures of QOL and coping outcomes compared to the NEP, UC, or both, including the spirituality subscale of the FACT-B as well as dealing with illness scale increases in active behavioral coping and active cognitive coping. Secondary outcome improvements resulting in significant between-group contrasts favoring the MBSR group at 4 months included meaningfulness, depression, paranoid ideation, hostility, anxiety, unhappiness, and emotional control. Results tended to decline at 12 months and even more at 24 months, though at all times, they were as robust in women with lower expectation of effect as in those with higher expectation. The MBSR intervention appears to benefit psychosocial adjustment in cancer patients, over and above the effects of usual care or a credible control condition. The universality of effects across levels of expectation indicates a potential to utilize this stress reduction approach as complementary therapy in oncologic practice.

Serum IGF-1 concentrations change with soy and seaweed supplements in healthy postmenopausal American women.

Insulin-like growth factor 1 (IGF-1) is an anabolic hormone important for growth and development. However, high-circulating serum concentrations in adults are associated with increased risk of postmenopausal breast cancer. Nutritional status and specific foods influence serum IGF-1 concentrations. Breast cancer incidence is typically low in Asian countries where soy is commonly consumed. Paradoxically, soy supplement trials in American women have reported significant increases in IGF-1. Seaweed also is consumed regularly in Asian countries where breast cancer risk is low. We investigated the possibility that seaweed could modify soy-associated increases in IGF-1 in American women. Thirty healthy postmenopausal women (mean age 58 yr) participated in this 14-wk double-blinded, randomized, placebo-controlled crossover clinical trial. Participants consumed 5 g/day placebo or seaweed (Alaria esculenta) in capsules for 7 wk. During the 7th wk, a high-soy protein isolate powder was added (2 mg/kg body weight aglycone equivalent isoflavones). Overnight fasting blood samples were collected after each intervention period. Soy significantly increased serum IGF-1 concentrations compared to the placebo (21.2 nmol/L for soy vs. 16.9 nmol/L for placebo; P = 0.0001). The combination of seaweed and soy significantly reduced this increase by about 40% (21.2 nmol/L for soy alone vs. 19.4 nmol/L; P = 0.01). Concurrent seaweed and soy consumption may be important in modifying the effect of soy on IGF-1 serum concentrations.

Systemic inflammatory load in humans is suppressed by consumption of two formulations of dried, encapsulated juice concentrate.

Chronic inflammation contributes to an increased risk for developing chronic conditions such as cardiovascular disease, diabetes, and cancer. A high "inflammatory load" is defined as elevated inflammation markers in blood or other tissues. We evaluated several markers of systemic inflammation from healthy adults and tested the hypothesis that two formulations of encapsulated fruit and vegetable juice powder concentrate with added berry powders (FVB) or without (FV) could impact markers of inflammatory load. Using a double-blind, placebo-controlled approach, 117 subjects were randomly assigned to receive placebo, FV, or FVB capsules. Blood was drawn at baseline and after 60 d of capsule consumption. We measured inflammatory markers (high sensitivity C-Reactive Protein, Monocyte Chemotactic Protein-1, Macrophage Inflammatory Protein 1-ß, and Regulated upon Activation, Normal T cell Expressed and Secreted), superoxide dismutase, and micronutrients (ß-carotene, vitamin C, and vitamin E). Results showed Monocyte Chemotactic Protein-1, Macrophage Inflammatory Protein 1-ß, and RANTES levels were significantly reduced and superoxide dismutase and micronutrient levels were significantly increased in subjects consuming both FV and FVB, relative to placebo. Data suggest a potential health benefit by consuming either formulation of the encapsulated juice concentrates through their anti-inflammatory properties.

Dietary seaweed modifies estrogen and phytoestrogen metabolism in healthy postmenopausal women.

Seaweed and soy foods are consumed daily in Japan, where breast cancer rates for postmenopausal women are significantly lower than in the West. Likely mechanisms include differences in diet, especially soy consumption, and estrogen metabolism. Fifteen healthy postmenopausal women participated in this double-blind trial of seaweed supplementation with soy challenge. Participants were randomized to 7 wk of either 5 g/d seaweed (Alaria) or placebo (maltodextrin). During wk 7, participants also consumed a daily soy protein isolate (2 mg isoflavones/kg body weight). After a 3-wk washout period, participants were crossed over to the alternate supplement schedule. There was an inverse correlation between seaweed dose (mg/kg body weight) and serum estradiol (E2) (seaweed-placebo = y = -2.29 x dose + 172.3; r = -0.70; P = 0.003), [corrected] which was linear across the range of weights. Soy supplementation increased urinary daidzein, glycitein, genistein, and O-desmethylangolensin (P = 0.0001) and decreased matairesinol and enterolactone (P < 0.05). Soy and seaweed plus soy (SeaSoy) increased urinary excretion of 2-hydroxyestrogen (2-OHE) (P = 0.0001) and the ratio of 2-OHE:16alpha-hydroxyestrone (16alphaOHE(1)) (P = 0.01). For the 5 equol excretors, soy increased urinary equol excretion (P = 0.0001); the combination of SeaSoy further increased equol excretion by 58% (P = 0.0001). Equol producers also had a 315% increase in 2:16 ratio (P = 0.001) with SeaSoy. Seaweed favorably alters estrogen and phytoestrogen metabolism and these changes likely include modulation of colonic bacteria.

Baseline design elements and sample characteristics for seven sites participating in the Nutrition Working Group of the Behavior Change Consortium.

The purpose of this article is to describe the baseline design elements and sample characteristics of the Behavior Change Consortium (BCC) Dietary Measurement studies for each of the 7 sites that comprised the BCC Nutrition Working Group (NWG). This article summarizes the project designs, including descriptions of diverse study populations, primary assessment methods, and study outcomes. Common measures used across sites included the National Cancer Institute (NCI) Fruit and Vegetable Screener, NCI Percentage Energy from Fat Screener, 24-h dietary recalls, and a single- or 2-item fruit and vegetable measure. Data on sociodemographic characteristics, body weight and height, smoking status, and serum carotenoids were also collected. Study design information such as assessment time points, as well as baseline sample characteristics, is also described. This paper provides the overall framework and descriptive information and serves as the reference for the BCC NWG special supplement.

Use of signal detection methodology to identify subgroups of dietary supplement use in diverse populations.

Despite widespread use of dietary supplements, little is known about correlates and determinants of their use. Using a diverse sample from 7 interventions participating in the Behavior Change Consortium (n = 2539), signal detection methodology (SDM) demonstrated a method for identifying subgroups with varying supplement use. An SDM model was explored with an exploratory half of the entire sample (n = 1268) and used 5 variables to predict dietary supplement use: cigarette smoking, fruit and vegetable intake, dietary fat consumption, BMI, and stage of change for physical activity. A comparison of rates of supplement use between the exploratory model groups and comparably identified groups in the reserved, confirmatory sample (n = 1271) indicates that these analyses may be generalizable. Significant indicators of any supplement use included smoking status, percentage of energy from fat, and fruit and vegetable consumption. Although higher supplement use was associated with healthy behaviors overall, many of the identified groups exhibited mixed combinations of healthy and unhealthy behaviors. The results of this study suggest that patterns of dietary supplement use are complex and support the use of SDM to identify possible population characteristics for targeted and tailored health communication interventions.

Seaweed and soy: companion foods in Asian cuisine and their effects on thyroid function in American women.

Seaweeds and soy are two commonly eaten foods in Asia. Both have been reported to affect thyroid function, seaweed because of its iodine content and soy because of its goitrogenic effect. Twenty-five healthy postmenopausal women (mean age 58 years) completed a double-blinded randomized crossover study. Ten capsules (5 g/day) of placebo or seaweed (Alaria esculenta), providing 475 microg of iodine/day, were consumed daily for 7 weeks. A powdered soy protein isolate (Solae Co., St. Louis, MO), providing 2 mg of isoflavones/kg of body weight, was given daily during the last week of each treatment arm. On average, this provided 141.3 mg of isoflavones/day and 67.5 g of protein/day. Blood samples and 48-hour urine samples were collected before and after each intervention period, and urinary I/C (microg of iodine/g of creatinine) and serum thyroxine, free thyroxine index, total triiodothyronine, and thyroid stimulating hormone (TSH) were measured. Seaweed ingestion increased I/C concentrations (P < .0001) and serum TSH (P < .0001) (1.69 +/- 0.22 vs. 2.19 +/- 0.22 microU/mL, mean +/- SE). Soy supplementation did not affect thyroid end points. Seven weeks of 5 g/day seaweed supplementation was associated with a small but statistically significant increase in TSH. Soy protein isolate supplementation was not associated with changes in serum thyroid hormone concentrations.