Establishment and validation of a microfluidic capillary gel electrophoresis platform method for purity analysis of therapeutic monoclonal antibodies.

Capillary and microfluidic chip electrophoresis technologies are heavily utilized for development, characterization, release, and stability testing of biopharmaceuticals. Within the biopharmaceutical industry, CE-SDS and M-CGE are commonly used for purity determination by separation and quantitation of size-based variants. M-CGE is used primarily as an R&D tool for product and process development, while cGMP release and stability testing applications are commonly reserved for CE-SDS. This paper describes the establishment of an M-CGE platform method to be used for R&D and cGMP applications, including release and stability testing, for monoclonal antibodies. The M-CGE platform method enables testing for product development support and cGMP release and stability using the same method, and utilization of one CE technology for the entire lifecycle of a biopharmaceutical product. Critical method parameters were identified, and the analytical design space of those critical parameters was defined using design of experiments (DOE) studies. Once defined through DOE studies, the method design space was validated according to ICH Q2 (R1) guidelines. Additional molecules of the same validated class were verified for use in the method by experimental confirmation of accuracy, specificity, and stability indicating capabilities. The platform method model facilitates rapid utilization of the method in development and GMP testing environments, and eliminates the need for individual validations for assets of the same class entering early stage development.

A review of the knowledge base on healthy worksite culture.

OBJECTIVE: To identify the need for worksite cultures of health, the organizational factors that support worksite cultures of health, the tools that have been used to measure worksite cultures of health, and the research needs related to healthy worksite culture. METHODS: A cross-sectional survey involving a sample of 500 companies representing a broad spectrum of industries and business sectors. A literature review was conducted. RESULTS: Similar to a culture of safety that encourages safer behaviors and enables a safer workplace, a culture of health provides a supportive work leadership with a favorable work environment and health-related policies that promote employee health and result in substantial decrease in employee health risks and medical costs. CONCLUSION: Worksite policies and environments supporting a culture of health are important to helping employees adopt and maintain healthy behaviors.

Health information sources accessed by college females: differences between body-image distorted and non-body-image distorted.

This study examined and compared sources of health-related information accessed by female college students with and without body image distortions, and the believability of those sources. Survey data from the American College Health Association, National College Health Assessment were studied retrospectively (N = 27,648). Body image distorted (BID) and non-BID students' most frequent health information sources were parents (76.1% BID; 77.1% non-BID) and internet (70.3% BID; 69.5% non-BID). Believability was greatest for health educators (90.6% BID; 91.1% non-BID) and lowest for television (14.4% BID; 14.5% non-BID). Health intervention strategies for college women should market to parents and teach recognition of credible internet sources of health information.

Telephone-based diet and exercise coaching and a weight-loss supplement result in weight and fat loss in 120 men and women.

PURPOSE: Determine the effects of telephone-based coaching and a weight-loss supplement on the weight and body fat (BF) of overweight adults. DESIGN: Randomized, placebo-controlled experiment with assessments at baseline, 2 months, and 4 months. SETTING: Community. SUBJECTS: Sixty overweight or obese men and 60 overweight or obese women, 25 to 60 years INTERVENTION: Eleven 30-minute telephone coaching sessions were spaced throughout the study; the initial conversation lasted 60 to 90 minutes. Supplement or placebo capsules were taken daily over the 17 weeks. MEASURES: Weight was measured using an electronic scale, and BF was assessed using dual energy x-ray absorptiometry. RESULTS: Subjects taking the placebo lost 1.8 +/- 3.3 kg of weight and 0.7 +/- 2.2 kg of BF, whereas supplement users lost more: 3.1 +/- 3.7 kg of weight (F = 4.1, P = .045) and 1.7 +/- 2.6 kg of BF (F = 4.4, p = .039). Participants receiving no coaching lost 1.8 +/- 3.3 kg of weight and 0.7 +/- 2.2 kg of BF, whereas adults receiving coaching lost more: 3.2 +/- 3.6 kg of weight (F = 4.8, p = .032) and 1.6 +/- 2.5 kg of BF (F = 4.2, p = .044). Adults receiving both the supplement and coaching had the greatest losses of weight and BF, suggesting an additive effect (F = 3.2, p = .026; F = 2.9, p = .039, respectively). CONCLUSIONS: Both treatments, coaching and the supplement, viewed separately and in combination, worked to help subjects lose weight and BF. Adults can be educated and motivated via telephone to change behaviors leading to weight loss, and a weight-loss supplement can be included to increase success.

The association between mental health and acute infectious illness among a national sample of 18- to 24-year-old college students.

UNLABELLED: Poor mental health is associated with physical illness, but this association is poorly characterized among college students. OBJECTIVE AND PARTICIPANTS: Using American College Health Association-National College Health Assessment data, the authors characterized poor mental health (depression, anxiety, negative affect) and examined the relationship between poor mental health and acute infectious illnesses (bronchitis, ear infection, sinusitis, strep throat) among 47,202 US college students. METHODS: The authors used frequency and cross-tabulation analyses to characterize mental health and determine univariate associations among variables. They used binary logistic regression to determine the association between poor mental health and acute infectious illness, controlling for research-derived covariates. RESULTS: The prevalence of acute infectious illness ranged from 8% to 29%. The prevalence of anxiety and depression ranged from 12% to 20%, respectively. Depression, anxiety, and exhaustion were associated with acute infectious illness across all dependent measures, with odds ratios ranging from .56 to .91. CONCLUSIONS: Poor mental health is associated with acute infectious illness among college students.

Weight loss practices and body weight perceptions among US college students.

OBJECTIVE: The authors assessed associations between body weight perception and weight loss strategies. PARTICIPANTS: They randomly selected male and female college students (N = 38,204). METHODS: The authors conducted a secondary data analysis of the rates of weight loss strategies and body weight perception among students who completed the National College Health Assessment survey. RESULTS: Half of respondents (50%) were trying to lose weight, although only 28% of students were overweight or obese. Also, 12% of respondents had inaccurate body weight perception. Women and men with inaccurate body weight perception were significantly more likely to engage in inappropriate weight loss strategies than were those with accurate body weight perception. Of all students attempting to lose weight, 38% used both diet and exercise. CONCLUSIONS: These data show that college students are interested in weight loss and that body weight perception plays an important role in the desire to lose weight.

The association of multiple risk factors with fruit and vegetable intake among a nationwide sample of college students.

UNLABELLED: Few college students meet fruit and vegetable intake recommended requirements, and most receive no information from their institutions about this issue. The avoidable disease burden among students is large, the necessary information infrastructure exists, and Healthy People 2010 objectives indicate efforts should be taken to increase intake. OBJECTIVE: The authors examined the association of high-risk behaviors and fruit and vegetable intake to inform design of multiple risk factor interventions. PARTICIPANTS AND METHODS: The authors obtained data from a sample of 40,209 18- to 25-year-old college students who completed the American College Health Association-National College Health Assessment during the spring 2002 and 2003 semesters. RESULTS: Predictors of high fruit and vegetable intake for men and women included better: seatbelt and helmet use, physical activity, perceived health, sleep, self-care behaviors, and grades. Other notable predictors of high intake were reduced likelihood of cigarette smoking, alcohol use, drinking and driving, and feeling hopeless in both sexes; reduced likelihood of drinking and driving among men; and a greater likelihood of anorexia among women. CONCLUSIONS: The authors discuss implications of these findings.

Protective behavioral strategies and negative alcohol-related consequences in college students.

OBJECTIVE: Alcohol abuse among college students is associated with a quality of life burden. The current study replicated and extended previous research on protective behavioral strategies (PBS) by examining relationships between PBS use and negative alcohol-related consequences. METHOD: A national sample of 29,792 U.S. college students who completed the National College Health Assessment during spring 2004 was included. Using a retrospective analysis of cross-sectional data, relationships between PBS use and negative alcohol-related consequences were examined. RESULTS: Greater PBS use was associated with fewer negative alcohol-related consequences, while less frequent use of PBS was correlated with increased negative alcohol-related consequences. DISCUSSION: The current study findings strongly support expanded educational alcohol-intervention programs promoting greater PBS use aimed at reducing or completely alleviating negative alcohol-related consequences (e.g., BASICS, ASTP). Future research should further investigate such PBS-based intervention programs, examine the existence of latent PBS, and study use of combined PBS.

High-risk health and credit behavior among 18- to 25-year-old college students.

UNLABELLED: The number of students accumulating credit card debt--and the amount of debt itself--on college campuses is increasing. If high-risk credit and health behavior are associated, health behavior interventions might apply to high-risk credit behavior. OBJECTIVE: The authors' purpose was to examine these possible associations. PARTICIPANTS AND METHODS: They used a retrospective design with existing data from a sample of 45,213 US college students and several ordinal regression models, which corresponded with high priority college health issues. RESULTS: Students with high-risk credit behavior were more likely to have driven after drinking, used amphetamines in the previous 30 days, felt functionally impaired by depression in the previous 12 months, had a higher body mass index (BMI), or had a lower grade-point average (GPA). They were less likely to have participated in vigorous physical activity, used condoms for oral or vaginal sex in the prior 30 days, or used marijuana. The findings support the notion that high-risk health and credit behaviors are associated. CONCLUSIONS: Further research could clarify the nature of this relation.

The relationship between physical activity and mental health in a national sample of college females.

The objective of the present analysis was to examine the relationship between vigorous/moderate or strength training exercise, and mental health in a national sample of college females. Secondary data (n = 22,073) from the National College Health Assessment administered during the Spring 2002 and 2003 semesters were used in a cross-sectional design. Depression, anxiety, suicidal ideation, and perceived health were the dependent variables; and two measures of weekly exercise frequency were the independent variables. Vigorous/moderate exercise was associated with positively associated perceived health and modestly negatively associated with depression. Strength training exercise was positively associated with perceived health and modestly negatively associated with depression, anxiety, and suicidal ideation. These findings support an association between two forms of exercise and several indicators of mental health. Additional longitudinal research is needed prior to endorsing exercise as treatment for mental disorders.

Predicting 1-year change in body mass index among college students.

OBJECTIVE: Despite beliefs about weight gain in college, few researchers have evaluated this phenomenon. PARTICIPANTS: Participants were 18- to 31-year-old students at a midwestern university. The dependent variable was body mass index (BMI) change. METHODS: The authors extracted predictor variables from a Health Risk Appraisal. These included clinical, medical history, medical usage, medications, pain or chronic conditions, perceptual measures, and behavioral factors. The authors performed an ordinal regression technique separately by gender. RESULTS: No predictors were significant for men. Women in the BMI gain group were (1) more likely to consume alcohol, use maladaptive coping behaviors, eat foods low in fiber, and consume caffeine; and (2) less likely to be stress-free, to eat cruciferous vegetables, and to refrain from eating high-cholesterol foods. CONCLUSIONS: The lack of research on predictors of and interventions for reducing BMI gain among college students warrants more research.

The transtheoretical model as applied to dietary behaviour and outcomes.

The transtheoretical model (TTM) is a behavioural theory that describes behaviour change as occurring in five stages, ranging from precontemplation to maintenance. The purpose of the present paper is to review and synthesise the literature published since 1999 on applications of the TTM to dietary behaviour so that the evidence for the use of assessment tools and interventions based on this model might be evaluated. Six databases were identified and searched using combinations of key words. Sixty-five original, peer-reviewed studies were identified and summarised in one of three tables using the following categories: population (n 21), intervention (n 25) and validation (n 19). Internal validity ratings were given to each intervention, and the body of intervention studies as a whole was rated. The evidence for using stage-based interventions is rated as suggestive in the areas of fruit and vegetable consumption and dietary fat reduction. Valid and reliable staging algorithms are available for fruit and vegetable consumption and dietary fat intake, and are being developed for other dietary behaviours. Few assessment tools have been developed for other TTM constructs. Given the popularity of TTM-based assessments and interventions, more research is warranted to identify valid and reliable assessment tools and effective interventions. While the evidence supports the validity of the TTM to describe populations and to form interventions, evidence of the effectiveness of TTM-based interventions is not conclusive.

Applying the transtheoretical model to exercise: a systematic and comprehensive review of the literature.

Three questions guided a literature review of the transtheoretical model (TTM) as applied to exercise to address the evidence for stage-matched interventions, the description of priority populations, and the identification of valid TTM measurement tools. One-hundredand-fifty studies were reviewed. Results indicate preliminary support for the use of stage-matched exercise interventions. Most studies have focused on White, middle-class, female populations, limiting the generalizability of their findings. Valid and reliable measures exist for stage of change, decisional balance, processes of change, self-efficacy, and temptations to not exercise; however, more research is needed to refine these measures. Evidence for the construct validity of the TTM as applied to exercise is mixed. When designing and implementing TTM-based exercise interventions, practitioners and policy makers are encouraged to clearly define the term exercise, choose a valid and reliable staging tool, and employ all TTM constructs and not just stage membership.

Stages of change algorithm for calcium intake by male college students.

Using a sample of college-aged men, we evaluated the validity of a staging algorithm for dairy calcium intake that had been previously validated in a sample of college women. College-aged men enrolled at a private university in the United States were randomly selected to participate. The sample consisted of 180 male participants. Self-reported calcium intake was measured using a 26-item food frequency questionnaire. Stages of change classifications were based on a four-question algorithm for dairy calcium intake and a three-item self-efficacy questionnaire. Significant differences were found between dairy/calcium intake levels between pre-contemplation, contemplation/preparation, and action/maintenance groups. Results also showed that 46% of participants were in the action/maintenance stage. There was a significant difference in self-efficacy between members of the pre-action and action stages. The study suggests that this stage of change algorithm for dairy calcium intake is valid for use in a male college student population.

Purging and alcohol-related effects in college women.

OBJECTIVE: Previous research indicates that college students who purge are more likely to consume alcohol in an unhealthy manner. The current study replicates and extends a previous study but employs a much larger, national sample. This study addresses 2 questions: (a) Are 18-24-year-old college women who purge more likely to engage in high-risk alcohol behavior? (b) Are 18-24-year-old alcohol-drinking college women who purge more likely to report greater negative consequences of alcohol use. METHOD: 47,202 U.S. students completed the National College Health Assessment during Spring 2004. Alcohol consumption and negative alcohol-related consequences were compared in purging and nonpurging groups. RESULTS: Respondents who purged reported heavier alcohol use and more negative consequences. CONCLUSION: The current study expands previous research regarding the association between purging behaviors and consequences of alcohol use. Further research is necessary to elucidate the most effective prevention and treatment programs.

Application of the Transtheoretical Model to substance abuse: historical development and future directions.

As a growing literature has documented applications of the Transtheoretical Model (TTM) to substance abuse, the utility or futility of such an application has been debated widely. The purpose of this paper is to critically examine the TTM, and its conceptual and empirical applications to the field of substance abuse. This review focuses not only on the stage of change dimension of the TTM, but also the processes, decisional balance, and self-efficacy dimensions, which have received less attention in earlier reviews. Particular emphasis is placed on the measurement and conceptualization of the stage of change construct. Unanswered questions and directions for future research are identified. It is concluded that, to effectively determine the TTM's applicability to substance abuse, all dimensions must be more fully developed, validated and evaluated across a range of substance abuse problems. Further, prospective studies are needed to determine the predictive utility of the TTM, and evaluation of TTM-matched interventions will help to address the model's specificity.

Identifying the personality characteristics of healthy eaters and exercisers: a hierarchical model approach.

A study was performed to compare the personality characteristics of healthy eating and exercise behavior. The results revealed that a hierarchical model of personality accounted for significantly more variance than a version of the Five-Factor Model. The predictors of health and exercise behaviors were similar. In each case, the need for body resources and health motivation were positively associated with the outcome variables. In addition, exercise was also positively associated with the need for activity and creativity, and negatively related to agreeableness.

Applying the transtheoretical model to cancer screening behavior.

OBJECTIVE: To provide a comprehensive review of published research on the application of the transtheoretical model (TTM) to cancer screening behavior. METHODS: Studies were categorized by design, given an internal validity rating where appropriate, and rated. RESULTS: Forty-two studies were reviewed. Stage-matched mammography interventions were supported; however, the body of literature was of limited size. Research on the TTM as it applies to other cancer screenings is sparse. CONCLUSIONS: Stage-of-change and decisional balance appear to apply to mammography. More validation research is needed on the application of the TTM to all cancer screening behaviors.

Review of the studies cited in the DataBase section of the American Journal of Health Promotion.

PURPOSE OF THE REVIEW: To analyze the characteristics of the articles reviewed in the DataBase section of the American Journal of Health Promotion and to summarize this review in tabular format. DATA SOURCES: All 350 entries in the American Journal of Health Promotion DataBase section beginning with issue 1:3 (Winter 1987) through issue 17:3 (January/February 2003) were included in this review. STUDY INCLUSION AND EXCLUSION CRITERIA: Every study summarized in the DataBase section was included. Five duplicate sets of entries existed in the DataBase section. One entry from each set was excluded based upon author consensus. Thus, this review includes 345 unique entries. DATA EXTRACTION METHODS: All data reported in the DataBase section (e.g., sample sizes, measurement tools, study duration), as well as additional data derived directly from the studies (i.e., cross-sectional versus longitudinal study design, unit of analysis, and study topic) were entered in SPSS 11.5 for PC (SPSS, Inc, Chicago, Illinois). DATA SYNTHESIS: Data were synthesized to identify the frequency of entry by research question, research design and internal validity rating, unit of analysis, measurement tool(s), and health topics addressed. MAJOR CONCLUSIONS: The majority of articles included in the DataBase received the highest research design rating, had robust sample sizes, and were of a meaningful duration. Additionally, a wide variety of topics were addressed. Overall, these strengths indicate that a solid foundation of research has been established on many of the most critical issues facing the health promotion field.

Development and validation of a stages of change algorithm for calcium intake for college female students.

OBJECTIVES: The purpose of this study was to develop and validate a staging algorithm for calcium intake. METHODS: Three hundred seventy-six college-aged females at a private university were randomly selected to participate. After 8.5% of the data were omitted due to incomplete surveys, the sample consisted of 344 female participants. Calcium intake was measured as self-reported consumption with a 26-item food frequency questionnaire. Stages of change classifications were based on a four-item algorithm for calcium intake, and self-efficacy was measured with three items. RESULTS: Significant differences were found between calcium intake levels between precontemplation, contemplation/preparation and action/maintenance. Results also showed that 40% of the participants were in action/maintenance and were consuming the Dietary Reference Intake level of 1,000 mg of daily calcium. Participants in the action and maintenance stages had significantly higher self-efficacy than the preaction group. CONCLUSION: The study suggests that the stages of change algorithm may be used as an effective tool in assessing daily calcium intake among a college female population.