Who Benefits from School-Based Teen Pregnancy Prevention Programs? Examining Multidimensional Moderators of Program Effectiveness Across Four Studies.

Recent research has suggested the importance of understanding for whom programs are most effective (Supplee et al., 2013) and that multidimensional profiles of risk and protective factors may moderate the effectiveness of programs (Lanza & Rhoades, 2012). For school-based prevention programs, moderators of program effectiveness may occur at both the individual and school levels. However, due to the relatively small number of schools in most individual trials, integrative data analysis across multiple studies may be necessary to fully understand the multidimensional individual and school factors that may influence program effectiveness. In this study, we applied multilevel latent class analysis to integrated data across four studies of a middle school pregnancy prevention program to examine moderators of program effectiveness on initiation of vaginal sex. Findings suggest that the program may be particularly effective for schools with USA-born students who speak another language at home. In addition, findings suggest potential positive outcomes of the program for individuals who are lower risk and engaging in normative dating or individuals with family risk. Findings suggest potential mechanisms by which teen pregnancy prevention programs may be effective.

Replication of It's Your Game Keep It Real! in Southeast Texas.

Despite the recent efforts of the Office of Adolescent Health to replicate programs with demonstrated efficacy, there are still few evidence-based HIV, sexually transmitted infection (STI), and teen pregnancy prevention programs that have been replicated in "real-world" settings. To test the effectiveness of It's Your Game…Keep It Real! (IYG), an evidence-based STI and pregnancy prevention program for middle schools, the curriculum was implemented by teachers in urban and suburban middle schools in Southeast Texas from 2012 to 2015. IYG was evaluated using a group-randomized wait-list controlled effectiveness trial design in which 20 middle schools in nine urban and suburban school districts in Southeast Texas were randomized equally, using a multi-attribute randomization protocol, to either the intervention condition (received IYG) (n = 10 schools comprising 1936 eligible seventh graders) or the comparison condition (received usual care) (n = 10 schools comprising 1825 eligible seventh graders). All students were blinded to condition prior to administering the baseline survey. The analytic sample comprised 1543 students (n = 804, intervention; n = 739, comparison) who were followed from baseline (seventh grade) to the 24-month follow-up (ninth grade). Multilevel regression analyses were conducted to assess behavioral and psychosocial outcomes at follow-up. There were no significant differences in initiation of vaginal or oral sex between study conditions at follow-up. However, at 12-month follow-up, compared with students in the comparison condition, students in the intervention condition reported increased knowledge, self-efficacy, and perceived favorable norms related to HIV/STIs, condoms, and/or abstinence; decreased intentions to have sex; and increased intentions to use birth control. Knowledge outcomes were statistically significant at 24-month follow-up. This IYG effectiveness trial did not replicate the behavioral effects of the original IYG efficacy trials. However, it adds to the growing literature on the replication of evidence-based programs, and underscores the need to better understand how variations in implementation, setting, and measurement affect the behavioral impact of such programs.Clinical trial registration clinicaltrials.gov (NCT03533192).

It's Your Game Keep It Real in South Carolina: A Group Randomized Trial Evaluating the Replication of an Evidence-Based Adolescent Pregnancy and Sexually Transmitted Infection Prevention Program.

OBJECTIVES: To evaluate the effectiveness of an evidence-based HIV/sexually transmitted infection (STI)/pregnancy prevention program for middle schools implemented by school staff in South Carolina. METHODS: Twenty-four schools, representing 3143 youths, participated in a randomized trial from 2011 to 2014. Students completed surveys before programming (fall of seventh grade), after completing the 2-year It's Your Game…Keep It Real program (spring of eighth grade), and 1-year postprogram (spring of ninth grade). RESULTS: There was no statistically significant effect on initiation of vaginal sex between baseline and eighth grade. Significantly fewer students in the comparison condition reported initiating sex at ninth grade, relative to the intervention condition. No group differences existed on other behavioral outcomes that addressed sexual activity in the past 3 months at ninth grade. Seven of 26 psychosocial outcomes (3 knowledge, 1 attitude, 1 self-efficacy, 2 personal limits) were positively affected at eighth grade; 4 remained significant at ninth grade. CONCLUSIONS: The original studies' behavioral effects were not replicated in this population, possibly as a result of this being an effectiveness trial instead of an efficacy trial, counterfactual exposure design issues, or postprogram exposure to evidence-based programming.

The Nature of the Association between Anxiety Sensitivity and Pain-Related Anxiety: Evidence from Correlational and Intervention Studies.

High anxiety sensitivity (AS) has been associated with elevated pain-related anxiety in anxiety and pain samples. The present study investigated (a) the associations among the lower order dimensions of AS and pain-related anxiety, using a robust measure of AS, and (b) the pain-related anxiety outcomes of a telephone-delivered cognitive behavioural treatment (CBT) designed to reduce high AS. Participants were 80 anxiety treatment-seeking participants with high AS (M age = 36 years; 79% women). After providing baseline data on AS and pain-related anxiety, participants were randomly assigned to an eight-week telephone CBT or a waiting list control. At baseline, bivariate correlations showed AS physical and cognitive, but not social, concerns were significantly associated with pain-related fear and arousal but not escape/avoidance behaviours. Multiple regression revealed that after accounting for emotional distress symptoms, AS physical, but not cognitive or social, concerns uniquely predicted pain-related anxiety. Multilevel modelling showed that the AS-targeted CBT reduced pain-related anxiety and treatment-related changes in global AS and AS physical concerns mediated changes in pain-related anxiety. Results suggest that an AS-targeted intervention may have implications for reducing pain-related anxiety. Further research is needed in a chronic pain sample.

Evaluating a Future-Oriented Positive Youth Development Intervention to Reduce Sexual Risk Among Highly Mobile Youth: Results and Challenges.

PURPOSE: Youth experiencing or at risk of experiencing homelessness need tailored prevention programming to prevent unplanned pregnancy and sexually transmitted infections. This study evaluated the efficacy of a small-group, future-oriented positive youth development (PYD) intervention to reduce sexual risk behaviors. METHOD: Youth aged 14-19 (n = 483) experiencing or at risk of experiencing homelessness were recruited at youth-serving agencies and in alternative schools. Each cohort enrolled was randomized either to a 10-session, 5-week group future-oriented intervention to support them in adopting health-promoting behaviors such as using contraception, including condom use (n = 244) or to a no-treatment condition where they received usual services/schooling (n = 239). We assessed at baseline and 3-month and 9-month follow-up (1) vaginal intercourse without consistent contraception use, (2) vaginal and anal intercourse without consistent condom use, and (3) sexual risk behaviors, including current (last 3 months) effective contraception use by females who did not report current use at baseline. RESULTS: There was no significant difference between treatment and control conditions for most outcomes. However, among females not currently using contraception at baseline, 34% in the treatment condition compared to 12.9% in the control condition reported using contraception in the 3 months before the 9-month survey, a statistically significant difference. DISCUSSION: This sexual risk reduction intervention, grounded in PYD theory and tailored to address the needs of marginalized groups of youth, demonstrated efficacy at increasing contraceptive uptake among females. The need for PYD interventions that can be delivered in a variety of nontraditional school and service settings are discussed.

Evidence-based review on the effect of normal dietary consumption of fructose on blood lipids and body weight of overweight and obese individuals.

Although some investigators have hypothesized that ingestion of fructose from foods and beverages is responsible for the development of hyperlipidemia or obesity, a recent evidence-based review demonstrated that there was no relationship between the consumption of fructose in a normal dietary manner and the development of hyperlipidemia or increased weight in normal weight individuals. Because overweight and obese individuals may exhibit metabolic abnormalities such as insulin resistance, impaired glucose tolerance, hyperlipedemia, and/or alterations in gut hormones involved in appetite regulation, the findings of fructose studies performed in normal weight subjects may not be particularly relevant for overweight or obese subjects. A systematic assessment of the strength and quality of the studies and their relevance for overweight or obese humans ingesting fructose in a normal dietary manner has not been performed. The purpose of this review was to critically evaluate the existing database for a causal relationship between the ingestion of fructose in a normal, dietary manner and the development of hyperlipidemia or increased body weight in overweight or obese humans, using an evidence-based approach. The results of the analysis indicate that there is no evidence which shows that the consumption of fructose at normal levels of intake causes biologically relevant changes in triglycerides (TG) or body weight in overweight or obese individuals.

Evidence-based review on the effect of normal dietary consumption of fructose on development of hyperlipidemia and obesity in healthy, normal weight individuals.

In recent years, there has been episodic speculation that an increase in consumption of fructose from foods and beverages is an underlying factor responsible for the relatively recent increase in obesity and obesity-related diseases such as diabetes. Reports in support of this hypothesis have been published, showing that concentrations of triglycerides (TG) are higher and concentrations of insulin and hormones associated with satiety are lower in animals following the ingestion of fairly large quantities of fructose, compared to other carbohydrates. However, results from human studies are inconsistent. A possible reason for the inconsistent results is that they are dependent on the particular study population, the design of the studies, and/or the amount of fructose administered. A systematic assessment of the strength and quality of the studies and their relevance for healthy, normal weight humans ingesting fructose in a normal dietary manner has not been performed. The purpose of this review was to critically evaluate the existing database for a causal relationship between the ingestion of fructose in a normal, dietary manner and the development of hyperlipidemia or increased body weight in healthy, normal weight humans, using an evidence-based approach. The results of the analysis indicate that fructose does not cause biologically relevant changes in TG or body weight when consumed at levels approaching 95th percentile estimates of intake.

Distributing free fresh fruit and vegetables at school: results of a pilot outcome evaluation.

OBJECTIVES: Consumption of fruit and vegetables among children is generally below recommended levels. This evaluation addressed two questions: (1) To what extent did children's attitudes toward, familiarity with, and preferences for fruit and vegetables change during the school year? and (2) To what extent did children's consumption of fruit and vegetables change during the school year? METHODS: During the 2004-2005 school year, the Mississippi Department of Education, Child Nutrition Programs initiated a pilot program to distribute free fruit and vegetables to students (kindergarten through 12th grade) during the school day. Data were collected in 2004-2005 within a one-group pretest/posttest design using a self-report questionnaire (n=725) and 24-hour dietary recalls (n=207) with a sample of students from five schools in Mississippi. Data were analyzed in 2006-2007. RESULTS: Results showed greater familiarity with fruit and vegetables at all grade levels (p<0.05) and increased preferences for fruit among eighth- and 10th-grade students (p<0.01). Eighth-grade students also reported more positive attitudes toward eating fruit and vegetables (p<0.01), increased perceived self-efficacy to eat more fruit (p<0.01), and increased willingness to try new fruit. Finally, results showed increased consumption of fruit, but not vegetables, among eighth- and 10th-grade students (p<0.001). CONCLUSIONS: Distributing free fruit and vegetables at school may be a viable component of a more comprehensive approach for improving students' nutrition attitudes and behaviors. More program emphasis is needed on ways to promote vegetable consumption.

Psychopathy and offence severity in sexually aggressive and violent youth.

BACKGROUND: A large proportion of violent crimes are committed by youths. Youths with psychopathic traits may have a higher risk for recidivism and violence. AIMS/HYPOTHESES: Our aim was to compare sexually aggressive with violent young men on offence severity and psychopathy. Three hypotheses were proposed: first, young men with previous offences would display a progressive increase in seriousness of offence during their criminal career; secondly, the sexually aggressive and violent young men would not differ in scores on the Hare Psychopathy Checklist: Youth Version (PCL:YV); but, thirdly, PCL:YV scores would be positively correlated with the severity of the index crime, as measured by the Cormier-Lang System for Quantifying Criminal History. METHODS: Information was collected from the files of 40 young men in conflict with the law, and the PCL:Youth Version (YV) rated from this by trained raters. RESULTS: The offences of these young men became more serious over time, but we found no association between PCL:YV scores and offence type or seriousness. CONCLUSIONS AND IMPLICATIONS: This exploratory research suggests the importance of understanding the progression in offending careers, but a limited role for the PCL:YV in doing so. Given the small sample size, however, and the limit on access to information about details of age, the findings need replication.

Effect of novel maize-based dietary fibers on postprandial glycemia and insulinemia.

BACKGROUND: Postprandial hyperglycemia has been associated with increased oxidative stress and the development of diabetes, heart disease and all-cause mortality. OBJECTIVE: To assess the effect of novel maize-based dietary fibers on postprandial glycemia and to assess the correlation between a rapid in vitro digestibility system and the blood glucose response. METHODS: In a clinical study, 12 healthy volunteers were fed seven test beverages containing maize-based fiber ingredients (25g total carbohydrate) along with 2 control meals on separate occasions in random order. Capillary blood samples were obtained and the relative glycemic and insulinemic responses were assessed by calculating the incremental area under the 2 h blood response curves. In vitro digestibility studies of the test fibers and control were also undertaken to determine if these correlated with the clinical findings. RESULTS: All test fibers resulted in significantly lower glycemic and insulinemic responses for the incremental area under the curve (iAUC) and at all time points compared with the control (P < 0.05). The in vitro digestibility curves were comparable to the cumulative in vivo iAUCs. In vitro data expressed as percent digestion correlated significantly with the in vivo iAUC for the first 30min of the test meal (P < 0.05). CONCLUSION: These novel maize-based dietary fibers all produce lower postprandial glycemic and insulinemic responses than the control. While further assessment is necessary in beverage and foods containing these fibers, they may be effective in applications for dietary strategies to control diabetes and other chronic diseases. In addition, the in vitro digestibility assay correlated well with in vivo data and may be useful in guiding product development.

A simulation-based biodefense and disaster preparedness curriculum for internal medicine residents.

AIMS: Disaster and bioterrorism preparedness is poorly integrated into the curricula of internal medicine residency programs. Given that victims may present to a variety of healthcare venues, including primary care practices, inpatient hospital wards, and intensive care units, we developed a curriculum to address this need. METHODS: The curriculum consisted of four didactic sessions with supplemental readings covering biologic, chemical, and radiologic agents, as well as public health infrastructure. All 30 internal medicine resident participants also underwent a four hour training seminar at a high fidelity human simulation center. Instruction included the use of personal protective equipment (PPE)and participation in simulated scenarios utilizing technologically sophisticated mannequins with monitoring and interactive capability. Sessions were videotaped, reviewed with participants, and followed by self-evaluation and constructive feedback. RESULTS: Compared to a control group of residents who did not undergo training, the participants' level of knowledge was significantly better, with mean objective test scores of 66.8%+/-11.8% SD vs. 50%+/-13.1% SD, p < 0.0001. Although there was a trend toward increasing knowledge with increasing level of training in the control group, this difference was not significant. Subjective preparedness was also significantly better in the intervention group (p < 0.0001). Objective improvements were not maintained after one year. CONCLUSIONS: In this pilot study, a disaster-preparedness curriculum including simulation-based training had a positive effect on residents' knowledge base and ability to respond to disaster. However, this effect had diminished after one year, indicating the need for reinforcement at regular intervals.

Estimates of Intraclass Correlation Coefficients From Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs.

INTRODUCTION: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the intraclass correlation coefficient (ICC)-the degree to which outcomes of individuals clustered within groups (e.g., schools) are correlated. ICC estimates vary widely depending on outcome, population, and setting, and small changes in ICCs can have large effects on the sample size needed to estimate intervention effects. This study addresses a gap in the literature by providing estimates of ICCs for adolescent sexual risk-taking outcomes under a range of study conditions. METHOD: Multilevel regression analyses were applied to existing data from four federally funded GRTs of school-based HIV/STI/pregnancy prevention programs to obtain a variety of ICC estimates. RESULTS: ICCs ranged from 0 to 0.15, with adjustment for covariates and repeated measurements reducing the ICC in the majority of cases. Minimum detectable effect sizes with 80% power and 0.05 significance levels ranged from small to medium Cohen's d (0.13 to 0.53) assuming 20 schools of 100 students each. CONCLUSIONS: This study provides the first known set of ICC estimates for investigators to use when planning studies of school-based programs to prevent sexual risk behaviors in youth. The results provide further evidence of the importance of using the appropriate adjusted ICC estimate at the design stage to maximize resources in costly GRTs.

Effect of soy protein on endogenous hormones in postmenopausal women.

BACKGROUND: The long-term clinical effects of soy protein containing various concentrations of isoflavones on endogenous hormones are unknown. OBJECTIVE: We examined the effects of ingestion of soy protein containing various concentrations of isoflavones on hormone values in postmenopausal women. DESIGN: Seventy-three hypercholesterolemic, free-living, postmenopausal women participated in a 6-mo double-blind trial in which 40 g protein as part of a National Cholesterol Education Program Step I diet was provided as casein from nonfat dry milk (control), isolated soy protein (ISP) containing 56 mg isoflavones (ISP56), or ISP containing 90 mg isoflavones (ISP90). Endogenous hormone concentrations were measured at baseline and at 3 and 6 mo. RESULTS: The concentration of thyroxine and the free thyroxine index were higher in the ISP56 group, and the concentration of thyroid-stimulating hormone was higher in the ISP90 group than in the control group at 3 and 6 mo (P < 0.05). Triiodothyronine was significantly higher in the ISP90 group only at 6 mo. Thyroxine, free thyroxine index, and thyroid-stimulating hormone at 6 mo were inversely associated with measures of baseline estrogenicity. No significant differences were found for endogenous estrogens, cortisol, dehydroepiandrosterone sulfate, insulin, glucagon, or follicle-stimulating hormone after baseline hormone values were controlled for. CONCLUSIONS: This study does not provide evidence that long-term ingestion of soy protein alters steroid hormone values, but it suggests that soy protein may have small effects on thyroid hormone values that are unlikely to be clinically important. The thyroid effects are, however, consistent with previous findings in animals and highlight the need for future research investigating possible mechanisms of action.

Using data to improve fidelity when implementing evidence-based programs.

In fall 2011, the South Carolina Campaign to Prevent Teen Pregnancy (SC Campaign), with funding from Office of Adolescent Health, began replicating an evidence-based curriculum, It's Your Game, Keep It Real in 12 middle schools across South Carolina. Fidelity of the curriculum was monitored by the use of lesson fidelity logs completed by curriculum facilitators and lesson observation logs submitted by independent classroom observers. These data were monitored weekly to identify possible threats to fidelity. The innovative model Fidelity Through Informed Technical Assistance and Training was developed by SC Campaign to react to possible fidelity threats in real time, through a variety of technical assistance modalities. Fidelity Through Informed Technical Assistance and Training guided the 55 hours of technical assistance delivered by the SC Campaign during the first year of It's Your Game, Keep It Real implementation to 18 facilitators across 12 SC middle schools, and achieved 98.4% curriculum adherence and a high quality of implementation scores.

What works? Process evaluation of a school-based fruit and vegetable distribution program in Mississippi.

BACKGROUND: During the 2004-2005 school year, the Mississippi Department of Education, Office of Child Nutrition, initiated a pilot program to distribute free fruit and vegetable snacks to students during the school day. This article describes the first-year implementation of the Mississippi Fruit and Vegetable Pilot Program. METHODS: The process evaluation addressed where, when, and how produce was distributed; what was distributed; challenges and successes; and recommended modifications. Five of the 25 program schools were selected to participate in the evaluation; selection was based on grade levels served and demographic characteristics. Data were collected from program staff (N = 11) and administrators (N = 6) via interviews and logs; student (N = 42) and parent (N = 19) focus groups; student questionnaires (N = 660); and school staff questionnaires (N = 207). RESULTS: Distributing fresh fruit and vegetable snacks at school was well received by staff and students. Most schools distributed the fresh fruit and vegetable snacks at morning break in classrooms or a central courtyard. Twenty-two types of fresh fruit, 4 types of dried fruit, and 7 types of vegetables were served to students during the program year. Commonly distributed fruit included apples, oranges, pears, bananas, and tangerines. Carrots were the staple vegetable, followed by celery. Key challenges included getting students to try new foods and receiving the produce in a timely manner without spoiling. Main successes included seeing students try new fruit and vegetable snacks, having the program run smoothly, and teacher support. CONCLUSIONS: The program fit well within the school structure and could be an effective component of a multifaceted approach to enhancing child nutrition.

Impact of an intervention to improve contraceptive use through follow-up phone calls to female adolescent clinic patients.

CONTEXT: Adolescent females often have questions or concerns about their contraceptive methods, and they may discontinue use if these questions are not answered. Little evidence exists on whether follow-up phone calls to address young women's concerns can help sustain contraceptive use. METHODS: Between 2005 and 2007, a total of 805 females aged 14-18 attending a reproductive health clinic in San Francisco were randomly assigned to receive either regular clinic services or regular clinic services plus nine follow-up phone calls over 12 months. The young women were surveyed at baseline and roughly six, 12 and 18 months later to measure condom and contraceptive use, rates of pregnancy and STDs, and other outcomes and mediators. Multiple linear and logistic regression repeated measures analyses were used to assess the program's effects. RESULTS: Clinic counselors completed only 2.7 calls per patient, and made 7.8 attempts for every completed call. Although contraceptive use increased from baseline to follow-up at six months in both groups, levels of condom and contraceptive use, and rates of pregnancy and STDs, did not differ between the intervention and control groups at any of the follow-up assessments. Moreover, the intervention did not improve clinic utilization or satisfaction or have consistent positive effects on participants' attitudes. CONCLUSIONS: Reaching young women by phone after a clinic visit for contraception is challenging and does not appear to provide significant benefits beyond those provided by basic clinic services. More intensive interventions may be needed to markedly change adolescent sexual and contraceptive behavior.

Promoting elementary physical education: results of a school-based evaluation study.

Using a quasiexperimental design, the authors examine whether fourth- and fifth-grade students exposed to a developmental physical education (PE) curriculum, Michigan's Exemplary Physical Education Curriculum (EPEC), demonstrated stronger motor skill-specific self-efficacy and perceptions of physical activity competence, physical activity levels, motor skills, and physical fitness than did students exposed to existing PE curricula. The authors conducted a multilevel regression analysis with data from 1,464 students in the fourth and fifth grades. Data were collected using a student survey, an activity checklist, and motor and fitness assessments. Compared to students receiving standard PE, students exposed to EPEC showed significantly stronger results in motor skills but not fitness outcomes. The authors found significant positive intervention effects on indicators of motor skill self-efficacy and physical activity levels among the fourth-grade cohort. EPEC was more effective than standard PE curricula at improving motor skill performance (fourth- and fifth-grade cohorts) and at increasing self-reported motor skill-specific self-efficacy and physical activity (fourth-grade cohort).

Dietary soy beta-conglycinin (7S globulin) inhibits atherosclerosis in mice.

Although beta-conglycinin (7S globulin), a major soy storage protein, stimulates the expression of LDL receptors and the degradation of LDL by hepatocytes in vitro, the in vivo effects of dietary beta-conglycinin on the cardiovascular system are unknown. We assessed the effects of dietary beta-conglycinin and other soy peptide fractions on the development of atherosclerosis in atherosclerosis-susceptible mice. At 6 wk of age, male and ovariectomized female apolipoprotein (apo) E-null mice and LDL receptor-null, apoB transgenic mice were assigned randomly to treatment groups that differed only in the source of dietary protein: 1) casein/lactalbumin, 2) isoflavone-containing soy protein isolate, 3) beta-conglycinin, 4) glycinin (11S globulin, another major soy storage protein), 5) beta-conglycinin-devoid soy protein, and 6) W008 (a peptide fraction produced by hydrolysis and precipitation of soy protein isolate). After 4 mo, aortic atherosclerosis (cholesteryl ester content) and plasma lipoprotein cholesterol concentrations were quantified using GLC. Relative to mice fed casein/lactalbumin-based diets, the extent of atherosclerosis was reduced in ovariectomized female mice fed all soy protein-containing diets. Relative to mice fed isoflavone-containing soy protein isolate, atherosclerosis was reduced only in mice fed the beta-conglycinin-containing diet. Mean reductions were 39 and 67% (all P <0.05) in male and ovariectomized female apoE null mice and 66% (P < 0.05) in male LDL receptor null mice. These effects were unrelated to variation in isoflavone content of the protein source and only minimally related to plasma lipoprotein cholesterol concentrations. We conclude that a diet rich in beta-conglycinin has atheroprotective effects that greatly exceed those of isoflavone-containing soy protein isolate and do not depend on LDL receptors or influences on plasma lipoproteins.

Dietary soy and soy isoflavones have gender-specific effects on plasma lipids and isoflavones in golden Syrian f(1)b hybrid hamsters.

The specific components of soy responsible for its beneficial effects on plasma lipids are unknown. Golden Syrian F(1)B Hybrid hamsters (75 male, 74 female) were evaluated for the effect of dietary soy and soy isoflavones on plasma lipids. They were fed the following diets for 16 wk: casein/lactalbumin (C/L), soy protein with isoflavones [Soy(+)], soy protein with isoflavones removed [Soy(-)], Soy(-) plus isoflavone extract (IF), and C/L + IF. At necropsy, plasma total cholesterol, HDL cholesterol (HDLC), LDL + VLDL cholesterol (LDL + VLDLC), isoflavones, and uterine and accessory gland weights were measured. Male hamsters fed the three soy-containing diets had lower LDL + VLDLC concentrations than those fed the two C/L diets (P < 0.01), and those fed Soy(-) + IF did not differ from those fed Soy(+). In females, diet did not affect plasma LDL + VLDLC concentration. Females fed Soy(+) or Soy(-) had higher HDLC (P < 0.05) than those fed C/L. HDLC was not affected by diet in males. Due to higher equol production (P < 0.01), males had greater plasma isoflavone concentrations (P < 0.01) than females. There was a positive association between plasma total isoflavones and LDL + VLDLC (r = 0.65, P < 0.05) in females. These data suggest gender differences in plasma lipid and isoflavone responses to soy- based diets in Syrian F(1)B Hybrid hamsters, which offer an opportunity to explore effects of sex hormones on isoflavone metabolism and the effects of isoflavones on lipid metabolism.