Learning and Developing Individual Exercise Skills (L.A.D.I.E.S.) for a Better Life: A Church-Based Physical Activity Intervention - Baseline Participant Characteristics.

OBJECTIVE: Physical activity (PA) is beneficial for health, yet most African American women do not achieve recommended levels. Successful, sustainable strategies could help to address disparities in health outcomes associated with low levels of PA. The Learning and Developing Individual Exercise Skills (L.A.D.I.E.S.) for a Better Life study compared a faith-based and a secular intervention for increasing PA with a self-guided control group. DESIGN SETTING AND PARTICIPANTS: This cluster randomized, controlled trial was conducted from 2010 - 2011 in African American churches (n=31) in suburban North Carolina. Participants were 469 self-identified low active African American women. MEASURES: Baseline data were collected on participant demographics, objective and self-reported PA, and constructs related to social ecological theory and social cognitive theory. RESULTS: Complete baseline data were available for 417 participants who were aged 51.4 ± 12.9 years, with average BMI (kg/m2) 35.8 ± 9.9; 73% of participants were obese (BMI >30). Participants averaged 3,990 ± 1,828 pedometer-assessed daily steps and 23.9 ± 37.7 accelerometer-assessed minutes of daily moderate-to-vigorous PA, and self-reported 25.4 ± 45.4 minutes of weekly walking and moderate- and vigorous-intensity PA. Baseline self-reported religiosity and social support were high. CONCLUSIONS: L.A.D.I.E.S. is one of the largest PA trials focused on individual behavior change in African American women. Baseline characteristics suggest participants are representative of the general population. Findings from the study will contribute toward understanding appropriate strategies for increasing PA in high-risk populations.

One-year postpartum outcomes following a weight management intervention in pregnant women with obesity.

OBJECTIVE: This analysis was focused on 1-year maternal and infant follow-up of a randomized trial that tested a weight management intervention conducted during pregnancy. METHODS: One hundred fourteen women with obesity (mean BMI 36.7 kg/m(2) ) were randomly assigned at a mean of 15 weeks gestation to a weight management intervention or usual care control condition. The intervention ended at delivery and resulted in less gestational weight gain and a lower proportion of large-for-gestational-age newborns among intervention compared with control participants. The primary outcome at 12 months postpartum was maternal weight. Secondary outcomes included infant weight-for-age and weight-for-length z-scores. RESULTS: At 1 year, mothers in the intervention group weighed 96.3 ± 18.6 kg and those in the control group 99.7 ± 19.2 kg. There was no significant difference between groups in change in weight from randomization to 1 year postpartum (b = -0.47, 95% CI: -4.03 to 3.08). There was a significant main effect of group for infant weight-for-age z-scores (b = -0.40, 95% CI: -0.75 to -0.05) but not infant weight-for-length z-scores (b = -0.20, 95% CI: -0.59 to 0.20). CONCLUSIONS: A gestational weight management intervention did not influence maternal weight or infant weight-for-length at 1 year postpartum. Future studies may be warranted to determine whether extending prenatal interventions into the postpartum period would be beneficial for maternal and infant outcomes.

Prepare, a randomized trial to promote and evaluate weight loss among overweight and obese women planning pregnancy: Study design and rationale.

BACKGROUND: Women who are overweight or have obesity at pregnancy onset, and those who gain excessive weight during pregnancy, are at increased risk of pregnancy-related complications and large for gestational age infants. OBJECTIVE: This report describes methodology for the Prepare study, a randomized, controlled clinical trial testing a preconception and pregnancy weight management program for women who are overweight or have obesity (BMI≥27kg/m(2)). OUTCOMES: This trial examines multiple pregnancy and neonatal outcomes, with the primary outcome being gestational weight gain (GWG). Secondary outcomes include change in weight before conception, offspring birth weight adjusted for gestational age, offspring weight for length, and pregnancy diet quality and physical activity level. METHODS: Nonpregnant women who anticipate becoming pregnant in the next 2years are randomly assigned to an intervention program or a usual care control condition. Intervention participants receive weight management counseling by telephone before and during pregnancy, with weekly contacts during the first 6months and monthly contacts for the next 18months. Intervention participants also have unlimited access to a study website that provides self-management tools. All participants who become pregnant are contacted at 20weeks' gestation to assess physical activity levels and dietary habits. All other outcome data are obtained from medical records. Intervention satisfaction is assessed via questionnaire. SUMMARY: This clinical trial tests the efficacy of an intervention program designed to help overweight and obese women achieve healthy lifestyle changes that will result in a healthy weight prior to pregnancy and appropriate weight gain during pregnancy.

Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial.

OBJECTIVE: Observational studies suggest that minimal gestational weight gain (GWG) may optimize pregnancy outcomes for obese women. This trial tested the efficacy of a group-based weight management intervention for limiting GWG among obese women. METHODS: One hundred and fourteen obese women (BMI [mean ± SD] 36.7 ± 4.9 kg/m(2) ) were randomized between 7 and 21 weeks' (14.9 ± 2.6) gestation to intervention (n = 56) or usual care control conditions (n = 58). The intervention included individualized calorie goals, advice to maintain weight within 3% of randomization and follow the Dietary Approaches to Stop Hypertension dietary pattern without sodium restriction, and attendance at weekly group meetings until delivery. Control participants received one-time dietary advice. Our three main outcomes were maternal weight change from randomization to 2 weeks postpartum and from randomization to 34 weeks gestation, and newborn large-for-gestational age (birth weight >90th percentile, LGA). RESULTS: Intervention participants gained less weight from randomization to 34 weeks gestation (5.0 vs. 8.4 kg, mean difference = -3.4 kg, 95% CI [-5.1-1.8]), and from randomization to 2 weeks postpartum (-2.6 vs. +1.2 kg, mean difference = -3.8 kg, 95% CI [-5.9-1.7]). They also had a lower proportion of LGA babies (9 vs. 26%, odds ratio = 0.28, 95% CI [0.09-0.84]). CONCLUSIONS: The intervention resulted in lower GWG and lower prevalence of LGA newborns.

Knowledge, attitudes, and beliefs that can influence infant feeding practices in American Indian mothers.

The promotion of healthy infant feeding is increasingly recognized as an important obesity-prevention strategy. This is relevant for American Indian populations that exhibit high levels of obesity and low compliance with infant feeding guidelines. The literature examining the knowledge, attitudes, and beliefs surrounding infant feeding within the American Indian population is sparse and focuses primarily on breastfeeding, with limited information on the introduction of solid foods and related practices that can be important in an obesity-prevention context. This research presents descriptive findings from a baseline knowledge, attitudes, and beliefs questionnaire on infant feeding and related behaviors administered to mothers (n=438) from five Northwest American Indian tribes that participated in the Prevention of Toddler Overweight and Teeth Health Study (PTOTS). Enrollment occurred during pregnancy or up to 6 months postpartum. The knowledge, attitudes, and beliefs questionnaire focused on themes of breastfeeding/formula feeding and introducing solid foods, with supplemental questions on physical activity. Knowledge questions were multiple choice or true/false. Attitudes and beliefs were assessed on Likert scales. Descriptive statistics included frequencies and percents and means and standard deviations. Most women knew basic breastfeeding recommendations and facts, but fewer recognized the broader health benefits of breastfeeding (eg, reducing diabetes risk) or knew when to introduce solid foods. Women believed breastfeeding to be healthy and perceived their social networks to agree. Attitudes and beliefs about formula feeding and social support were more ambivalent. This work suggests opportunities to increase the perceived value of breastfeeding to include broader health benefits, increase knowledge about solid foods, and strengthen social support.

Pacific Tracker 2 - expert system (PacTrac2-ES) behavioural assessment and intervention tool for the Pacific Kids DASH for Health (PacDASH) study.

The Pacific Tracker (PacTrac) is a computer program designed to analyse food intakes of individuals from the Pacific Region. PacTrac's original output included servings of daily intake of food groups according to the United States Food Guide Pyramid, nutrient intake recommendations, and a comparison to other national nutrition recommendations. PacTrac was made available for public use through the Hawaii Foods website (hawaiifoods.hawaii.edu). PacTrac2 is an updated and expanded version of PacTrac that uses the United States MyPyramid/MyPlate food groups in household units of daily intake, rather than servings. In addition, the PacTrac2 includes a physical activity analysis tool which quantifies minutes of physical activities and their intensities based on energy estimates from the compendium of physical activity and research on children. An Expert System (ES) - a computerised decision tree to guide behaviour change - was developed using information on self-efficacy and stage of readiness to change, and the fruit and vegetable intake and physical activity information from PacTrac2. The ES produces reports for the child, the parent/guardian, and the child's physician with child-specific strategies, targeted behavioural information, and feedback tailored to the child. PacTrac2-ES was designed for the Pacific Kids DASH for Health (PacDASH) intervention study, conducted in the Kaiser Permanente health care system in Hawaii. The intervention is based on the child's self-efficacy and stage of readiness to change intake of fruits and vegetables and physical activity, with a goal of maintaining body weight to prevent obesity. The intervention is complemented with stage-based mailers addressing the environment for physical activity and fruit and vegetable intake and newsletters that address related behaviours (sedentary activity and a DASH eating approach). This project is the first to expand the PacTrac to contain children's foods and physical activities from the Pacific Region and to use current US MyPyramid/MyPlate food and physical activity analysis and guidance systems, and to develop and implement an Expert System for fruits, vegetables and physical activity of 5-8-year-old children. The PacTrac2-ES was used in the PacDASH study and will be used for other programs to promote healthy eating and physical activity of children in the Pacific Region.

A community-based intervention to prevent obesity beginning at birth among American Indian children: study design and rationale for the PTOTS study.

Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that American Indian (AI) children have higher rates of overweight and obesity than children of other races/ethnicities. The Prevention of Toddler Obesity and Teeth Health Study (PTOTS) is a community-partnered randomized controlled trial designed to prevent obesity beginning at birth in AI children. PTOTS was developed to test the effectiveness of a multi-component intervention designed to: promote breastfeeding, reduce sugar-sweetened beverage consumption, appropriately time the introduction of healthy solid foods, and counsel parents to reduce sedentary lifestyles in their children. A birth cohort of 577 children from five AI tribes is randomized by tribe to either the intervention (three tribes) or the comparison condition (two tribes). The strengths and weaknesses of PTOTS include a focus on a critical growth phase, placement in the community, and intervention at many levels, using a variety of approaches.

Community-responsive interventions to reduce cardiovascular risk in American Indians.

American Indian and Alaska Native (AI/AN) populations bear a heavy burden of cardiovascular disease (CVD), and they have the highest rates of risk factors for CVD, such as cigarette smoking, obesity, and diabetes, of any U.S. population group. Yet, few randomized controlled trials have been launched to test potential preventive interventions in Indian Country. Five randomized controlled trials were initiated recently in AI/AN communities to test the effectiveness of interventions targeting adults and/or children to promote healthy behaviors that are known to impact biological CVD risk factors. This article provides a context for and an overview of these five trials. The high burden of CVD among AI/AN populations will worsen unless behaviors and lifestyles affecting CVD risk can be modified. These five trials, if successful, represent a starting point in addressing these significant health disparities.

Learning and Developing Individual Exercise Skills (L.A.D.I.E.S.) for a better life: a physical activity intervention for black women.

Physical activity (PA) is low among African American women despite awareness of its positive impact on health. Learning and Developing Individual Exercise Skills for a Better Life (L.A.D.I.E.S.) compares three strategies for increasing PA among African American women using a cluster randomized, controlled trial. Underactive adult women from 30 churches (n=15 participants/church) were recruited. Churches were randomized to a faith-based intervention, a non-faith based intervention, or an information only control group. Intervention groups will meet 25 times in group sessions with other women from their church over a 10-month period. Control group participants will receive standard educational material promoting PA. All participants will be followed for an additional 12 months to assess PA maintenance. Data will be collected at baseline, 10, and 22 months. The primary outcome is PA (steps/day, daily moderate-to-vigorous PA). We expect treatment effects indicating that assignment to either of the active interventions is associated with greater magnitude of change in PA compared to the control group. In exploratory analyses, we will test whether changes in the faith-based intervention group are greater than changes in the non-faith-based intervention group. L.A.D.I.E.S. focuses on a significant issue-increasing PA levels-in a segment of the population most in need of successful strategies for improving health. If successful, L.A.D.I.E.S. will advance the field by providing an approach that is successful for initiating and sustaining change in physical activity, which has been shown to be a primary risk factor for a variety of health outcomes, using churches as the point of delivery.

Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale.

BACKGROUND: Obesity and excessive weight gain during pregnancy are associated with adverse pregnancy outcomes. Observational studies suggest that minimal or no gestational weight gain (GWG) may minimize the risk of adverse pregnancy outcomes for obese women. OBJECTIVE: This report describes the design of Healthy Moms, a randomized trial testing a weekly, group-based, weight management intervention designed to help limit GWG to 3% of weight (measured at the time of randomization) among obese pregnant women (BMI≥30 kg/m(2)). Participants are randomized at 10-20 weeks gestation to either the intervention or a single dietary advice control condition. PRIMARY OUTCOMES: The study is powered for the primary outcome of total GWG, yielding a target sample size of 160 women. Additional secondary outcomes include weight change between randomization and one-year postpartum and proportion of infants with birth weight>90th percentile for gestational age. Statistical analyses will be based on intention-to-treat. METHODS: Following randomization, all participants receive a 45-minute dietary consultation. They are encouraged to follow the Dietary Approaches to Stop Hypertension diet without sodium restriction. Intervention group participants receive an individualized calorie intake goal, a second individual counseling session and attend weekly group meetings until they give birth. Research staff assesses all participants at 34-weeks gestation and at 2-weeks and one-year postpartum with their infants. SUMMARY: The Healthy Moms study is testing weight management techniques that have been used with non-pregnant adults. We aim to help obese women limit GWG to improve their long-term health and the health of their offspring.

Weight loss is associated with increased serum 25-hydroxyvitamin D in overweight or obese women.

Low circulating concentrations of vitamin D metabolites have been associated with increased risk for several diseases and clinical conditions. Large observational studies and surveys have shown that obesity is independently associated with lower serum 25-hydroxyvitamin D (25(OH)D) concentration. Few studies have examined the effect of weight loss on serum 25(OH)D concentration. The purpose of this study was to prospectively examine the effect of weight loss on serum 25(OH)D concentration. Data were collected from 383 overweight or obese women who participated in a 2-year clinical trial of a weight-loss program, in which 51% (N = 195) lost at least 5% of baseline weight by 24 months, 18% (N = 67) lost 5-10%, and 33% (N = 128) lost >10%. Women who did not lose weight at 24 months had an increase in serum 25(OH)D of 1.9 (9.7) ng/ml (mean (SD)); 25(OH)D increased by 2.7 (9.1) ng/ml for those who lost 5-10% of baseline weight; and 25(OH)D increased by 5.0 (9.2) ng/ml for those who lost >10% of baseline weight (P = 0.014). At baseline, 51% (N = 197) of participants met or exceeded the recommended serum concentration of 20 ng/ml. By study end, 64% (N = 230) of overweight or obese women met this goal, as well as 83% (N = 20) of those whose weight loss achieved a normal BMI. These findings suggest that weight loss, presumably associated with a reduction in body fat, is associated with increased serum 25(OH)D concentration in overweight or obese women.

Relationship between sleep quality and quantity and weight loss in women participating in a weight-loss intervention trial.

Evidence suggests that individuals who report fewer total hours of sleep are more likely to be overweight or obese. Few studies have prospectively evaluated weight-loss success in relation to reported sleep quality and quantity. This analysis sought to determine the association between sleep characteristics and weight loss in overweight or obese women enrolled in a randomized clinical trial of a weight-loss program. We hypothesized that in overweight/obese women, significant weight loss would be demonstrated more frequently in women who report a better Pittsburgh Sleep Quality Index (PSQI) Global Score or sleep >7 h/night as compared to women who report a worse PSQI score or sleep ≤7 h/night. Women of ages 45.5 ± 10.4 (mean ± SD) years and BMI of 33.9 ± 3.3 (n = 245) were randomized and completed PSQI at baseline and 6 months; 198 had weight change assessed through 24 months. At baseline, 52.7% reported PSQI scores above the clinical cutoff of 5. Better subjective sleep quality increased the likelihood of weight-loss success by 33% (relative risk (RR), 0.67; 95% confidence interval (CI), 0.52-0.86), as did sleeping >7 h/night. A worse Global Score at 6 months was associated with a 28% lower likelihood of continued successful weight loss at 18 months, but unassociated by 24 months. These results suggest that sleep quality and quantity may contribute to weight loss in intervention-based studies designed to promote weight control in overweight/obese adult women.

Poor physical health predicts time to additional breast cancer events and mortality in breast cancer survivors.

BACKGROUND: Health-related quality of life has been hypothesized to predict time to additional breast cancer events and all-cause mortality in breast cancer survivors. METHODS: Women with early-stage breast cancer (n=2967) completed the SF-36 (mental and physical health-related quality of life) and standardized psychosocial questionnaires to assess social support, optimism, hostility, and depression prior to randomization into a dietary trial. Cox regression was performed to assess whether these measures of quality of life and psychosocial functioning predicted time to additional breast cancer events and all-cause mortality; hazard ratios were the measure of association. RESULTS: There were 492 additional breast cancer events and 301 deaths occurred over a median 7.3 years (range: 0.01-10.8 years) of follow-up. In multivariate models, poorer physical health was associated with both decreased time to additional breast cancer events and all-cause mortality (p trend=0.005 and 0.004, respectively), while greater hostility predicted additional breast cancer events only (p trend=0.03). None of the other psychosocial variables predicted either outcome. The hazard ratios comparing persons with poor (bottom two quintiles) to better (top three quintiles) physical health were 1.42 (95% CI: 1.16, 1.75) for decreased time to additional breast cancer events and 1.37 (95% CI: 1.08, 1.74) for all-cause mortality. Potentially modifiable factors associated with poor physical health included higher body mass index, lower physical activity, lower alcohol consumption, and more insomnia (p<0.05 for all). CONCLUSION: Interventions to improve physical health should be tested as a means to increase time to additional breast cancer events and mortality among breast cancer survivors.

Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial.

CONTEXT: The prevalence of overweight and obesity in the United States remains high. Commercial weight loss programs may contribute to efforts to reduce the prevalence of overweight and obesity, although few studies have examined their efficacy in controlled trials. OBJECTIVE: To test whether a free prepared meal and incentivized structured weight loss program promotes greater weight loss and weight loss maintenance at 2 years compared with usual care. DESIGN, SETTING, AND PARTICIPANTS: A randomized controlled trial of weight loss and weight loss maintenance in 442 overweight or obese women (body mass index, 25-40) aged 18 to 69 years (mean age, 44 years) conducted at US institutions over 2 years with follow-up between November 2007 and April 2010. INTERVENTION: The program, which involves in-person center-based or telephone-based one-to-one weight loss counseling, was available over a 2-year period. Behavioral goals were an energy-reduced, nutritionally adequate diet, facilitated by the inclusion of prepackaged food items in a planned menu during the initial weight loss phase, and increased physical activity. Participants assigned to usual care received 2 individualized weight loss counseling sessions with a dietetics professional and monthly contacts. MAIN OUTCOME MEASURES: Weight loss and weight loss maintenance. RESULTS: Weight data were available at 24 months for 407 women (92.1% of the study sample). In an intent-to-treat analysis with baseline value substitution, mean weight loss was 7.4 kg (95% confidence interval [CI], 6.1-8.7 kg) or 7.9% (95% CI, 6.5%-9.3%) of initial weight at 24 months for the center-based group, 6.2 kg (95% CI, 4.9-7.6 kg) or 6.8% (95% CI, 5.2%-8.4%) for the telephone-based group, and 2.0 kg (95% CI, 0.6-3.3 kg) or 2.1% (95% CI, 0.7%-3.5%) for the usual care control group after 24 months (P < .001 for intervention effect). CONCLUSION: Compared with usual care, this structured weight loss program resulted in greater weight loss over 2 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00640900.

The TOTS community intervention to prevent overweight in American Indian toddlers beginning at birth: a feasibility and efficacy study.

Excess weight gain in American Indian/Alaskan native (AI/AN) children is a public health concern. This study tested (1) the feasibility of delivering community-wide interventions, alone or in combination with family-based interventions, to promote breastfeeding and reduce the consumption of sugar-sweetened beverages; and (2) whether these interventions decrease Body Mass Index (BMI)-Z scores in children 18-24 months of age. Three AI/AN tribes were randomly assigned to two active interventions; a community-wide intervention alone (tribe A; n = 63 families) or community-wide intervention containing a family component (tribes B and C; n = 142 families). Tribal staff and the research team designed community-tailored interventions and trained community health workers to deliver the family intervention through home visits. Feasibility and acceptability of the intervention and BMI-Z scores at 18-24 months were compared between tribe A and tribes B & C combined using a separate sample pretest, posttest design. Eighty-six percent of enrolled families completed the study. Breastfeeding initiation and 6-month duration increased 14 and 15%, respectively, in all tribes compared to national rates for American Indians. Breastfeeding at 12 months was comparable to national data. Parents expressed confidence in their ability to curtail family consumption of sugar-sweetened beverages. Compared to a pretest sample of children of a similar age 2 years before the study begun, BMI-Z scores increased in all tribes. However, the increase was less in tribes B & C compared to tribe A (-0.75, P = 0.016). Family, plus community-wide interventions to increase breastfeeding and curtail sugar-sweetened beverages attenuate BMI rise in AI/AN toddlers more than community-wide interventions alone.

Dental caries in American Indian toddlers after a community-based beverage intervention.

OBJECTIVE/SETTING: The Toddler Overweight and Tooth Decay Prevention Study (TOTS) was an overweight and early childhood caries (ECC) project in the Pacific Northwest. It targeted American Indian (AI) toddlers from birth, to effect changes in breastfeeding and sweetened beverage consumption. DESIGN/INTERVENTION/PARTICIPANTS: The intervention cohort was children born in three communities during 12 months; expectant mothers were identified through prenatal visits, and recruited by tribal coordinators. The local comparison cohorts were children in those communities who were aged 18-30 months at study start. A control longitudinal cohort consisted of annual samples of children aged 18-30 months in a fourth community, supplying secular trends. OUTCOME MEASURES: d1-2mfs was used to identify incident caries in intervention, comparison, and control cohorts after 18-to-30 months of follow-up in 2006. RESULTS: No missing or filled teeth were found. For d1t, all three intervention cohorts showed statistically significant downward intervention effects, decreases of between 0.300 and 0.631 in terms of the fraction of affected mouths. The results for d2t were similar but of smaller magnitudes, decreases of between 0.342 and 0.449; these results met the .05 level for significance in two of three cases. In light of an estimated secular increase in dental caries in the control site, all three intervention cohorts showed improvements in both d1t and d1t. CONCLUSION: Simple interventions targeting sweetened beverage availability (in combination with related measures) reduced high tooth decay trends, and were both feasible and acceptable to the AI communities we studied.

Overall and minority-focused recruitment strategies in the PREMIER multicenter trial of lifestyle interventions for blood pressure control.

Recruitment strategies employed by four clinical centers across the US and a coordinating center were examined to identify successful overall and minority-focused recruitment strategies for the PREMIER multicenter trial of lifestyle changes for blood pressure control. The goal was to recruit 800 adults (40% African Americans) with systolic blood pressure of 120-159 mm Hg and diastolic of 80-95 mm Hg, not taking antihypertensive medication. Clinical centers used combinations of mass distribution of brochures, mass media, email distribution lists, screening events, and a national website. Culturally appropriate strategies for African Americans were designed by a Minority Implementation (MI) committee. Diversity training was provided for study staff, and African Americans were included in the study design process. Main recruitment outcomes were number overall and number of African Americans recruited by each strategy. Of the 810 randomized PREMIER participants, 279 (34%) were African American with site-specific percentages of 56%, 46%, 27%, and 8%. Of African Americans recruited, 151 (54%) were from mass distribution of brochures (mailed letter, flyer included in Val-Pak coupons, or other), 66 (24%) from mass media (printed article, radio, TV story or ads, 52 (19%) from word of mouth, and 10 (3%) from email/website and screening events combined. Yields for Non-Hispanic Whites were 364 (69%) from brochures, 71 (13%) from mass media, 49 (9%) from word of mouth and 47 (9%) from email/website and screening events. Mass distribution of brochures was relatively more effective with Non-Hispanic Whites, while African Americans responded relatively better to other recruitment strategies.

Dietary pattern influences breast cancer prognosis in women without hot flashes: the women's healthy eating and living trial.

PURPOSE: To determine whether a low-fat diet high in vegetables, fruit, and fiber differentially affects prognosis in breast cancer survivors with hot flashes (HF) or without HF after treatment. PATIENTS AND METHODS: A secondary analysis was conducted on 2,967 breast cancer survivors, age 18 to 70 years, who were randomly assigned between 1995 and 2000 in a multicenter, controlled trial of a dietary intervention to prevent additional breast cancer events and observed through June 1, 2006. We compared the dietary intervention group with a group who received five-a-day dietary guidelines. RESULTS: Independent of HF status, a substantial between-group difference among those who did and did not receive dietary guidelines was achieved and maintained at 4 years in intake of vegetable/fruit servings per day (54% higher; 10 v 6.5 servings/d, respectively), fiber (31% higher; 25.5 v 19.4 g/d, respectively), and percent energy from fat (14% lower; 26.9% v 31.3%, respectively). Adjusting for tumor characteristics and antiestrogen treatment, HF-negative women assigned to the intervention had 31% fewer events than HF-negative women assigned to the comparison group (hazard ratio [HR] = 0.69; 95% CI, 0.51 to 0.93; P = .02). The intervention did not affect prognosis in the women with baseline HFs. Furthermore, compared with HF-negative women assigned to the comparison group, HF-positive women had significantly fewer events in both the intervention (HR = 0.77; 95% CI, 0.59 to 1.00; P = .05) and comparison groups (HR = 0.65; 95% CI, 0.49 to 0.85; P = .002). CONCLUSION: A diet with higher vegetable, fruit, and fiber and lower fat intakes than the five-a-day diet may reduce risk of additional events in HF-negative breast cancer survivors. This suggestive finding needs confirmation in a trial in which it is the primary hypothesis.

Telephone counseling helps maintain long-term adherence to a high-vegetable dietary pattern.

Achieving long-term adherence to a dietary pattern is a challenge in many studies investigating the relationship between diet and disease. The Women's Healthy Eating and Living Study was a multi-institutional randomized trial in 3088 women at risk for breast cancer recurrence. At baseline, the average participant followed a healthy dietary pattern of 7 vegetable and fruit servings, 21 g/d of fiber, and 28.7% energy from fat, although fat intake increased over the enrollment period. Using primarily telephone counseling, the intervention group was encouraged to substantially increase intakes of vegetables, fruits, and fiber while decreasing fat intake. Sets of 24-h dietary recalls were completed on 90% of eligible participants at 1 y and 86% at 4 y. Using a conservative imputation analysis, at 1 y, the intervention group consumed 38% more vegetable servings (100% when including juice) than the comparison group, 20% more fruit, 38% more fiber, 50% more legumes, and 30% more whole grain foods, with a 20% lower intake of energy from fat. At 4 y, the between-group differences were 65% for vegetables (including juice), 25% fruit, 30% fiber, 40% legumes, 30% whole grain foods, and 13% lower intake of energy from fat. The intervention effect on fat intake was similar for early vs. late enrollees. Plasma carotenoid concentrations on a random 28% sample validated self-reported vegetable and fruit intake, with a between-group difference of 66% at 1 y and over 40% at 4 y. This large change will allow testing of hypotheses on the role of dietary change in preventing additional breast cancer events.