Whole Systems Within Whole Systems: The Oregon Health Plan's Expansion of Services for Back and Neck Pain.

OBJECTIVES: The authors employ a Whole Systems framework to explore implementation of new guidelines for back and neck pain in Oregon's Medicaid system. Whole Systems research is useful for understanding the relationship between complementary and integrative health care (CIH) and conventional health care systems in real-world clinical and practice settings. DESIGN: Preliminary results are from an observational study designed to evaluate state-wide implementation of CIH and other non-pharmacological treatments for neck and back pain among Oregon Medicaid patients. This natural experiment, even in early stages, provides insight into the challenges of integrating Whole Systems oriented therapies into Medicaid billing and treatment. METHODS: Qualitative data are drawn from: (1) semi-structured interviews with representatives of each of the 16 coordinated care organizations (CCOs) responsible for administering the Oregon's Medicaid insurance through the Oregon Health Plan (OHP); and (2) open-ended survey responses from acupuncturists in all 16 CCO areas. RESULTS: Implementation of the new policy guidelines poses logistical and epistemological challenges. Differences in worldview, inadequate reimbursement, and simple lack of awareness of CIH among medical providers are some of the factors that pose barriers to merging CIH therapies into conventional frameworks. CONCLUSIONS: In this article, we explore the potential for a Whole Systems perspective to better explain the complexity of integrating CIH and other non-pharmacological services into a state financed health care system. Oregon's expansion of services for back and neck pain presents an opportunity to explore challenges and successes in melding multiple approaches to health and pain management into a managed system such as the OHP.

Implementation of tobacco cessation brief intervention in complementary and alternative medicine practice: qualitative evaluation.

BACKGROUND: This article presents findings from qualitative interviews conducted as part of a research study that trained Acupuncture, Massage, and Chiropractic practitioners' in Arizona, US, to implement evidence-based tobacco cessation brief interventions (BI) in their routine practice. The qualitative phase of the overall study aimed to assess: the impact of tailored training in evidence-based tobacco cessation BI on complementary and alternative medicine (CAM) practitioners' knowledge and willingness to implement BIs in their routine practice; and their patients' responses to cessation intervention in CAM context. METHODS: To evaluate the implementation of skills learned from a tailored training program, we conducted semi-structured qualitative interviews with 54 CAM practitioners in Southern Arizona and 38 of their patients. Interview questions focused on reactions to the implementation of tobacco cessation BIs in CAM practice. RESULTS: After participating in a tailored BI training, CAM practitioners reported increased confidence, knowledge, and motivation to address tobacco in their routine practice. Patients were open to being approached by CAM practitioners about tobacco use and viewed BIs as an expected part of wellness care. CONCLUSIONS: Tailored training motivated CAM practitioners in this study to implement evidence-based tobacco cessation BIs in their routine practice. Results suggest that CAM practitioners can be a valuable point of contact and should be included in tobacco cessation efforts.

Development and Validation of the EXPECT Questionnaire: Assessing Patient Expectations of Outcomes of Complementary and Alternative Medicine Treatments for Chronic Pain.

BACKGROUND: Patient expectations may be associated with outcomes of complementary and alternative medicine (CAM) treatments for chronic pain. However, a psychometrically sound measure of such expectations is needed. OBJECTIVES: The purpose of this study was to develop and evaluate a questionnaire to assess individuals' expectations regarding outcomes of CAM treatments for chronic low back pain (CLBP), as well as a short form of the questionnaire. METHODS: An 18-item draft questionnaire was developed through literature review, cognitive interviews with individuals with CLBP, CAM practitioners, and expert consultation. Two samples completed the questionnaire: (1) a community sample (n = 141) completed it via an online survey before or soon after starting a CAM treatment for CLBP, and (2) participants (n = 181) in randomized clinical trials evaluating CAM treatments for CLBP or fibromyalgia completed it prior to or shortly after starting treatment. Factor structure, internal consistency, test-retest reliability, and criterion validity were examined. RESULTS: Based on factor analyses, 10 items reflecting expectations (used to create a total score) and three items reflecting hopes (not scored) were selected for the questionnaire. The questionnaire had high internal consistency, moderate test-retest reliability, and moderate correlations with other measures of expectations. A three-item short form also had adequate reliability and validity. CONCLUSIONS: The Expectations for Complementary and Alternative Medicine Treatments (EXPECT) questionnaire can be used in research to assess individuals' expectations of treatments for chronic pain. It is recommended that the three hope questions are included (but not scored) to help respondents distinguish between hopes and expectations. The short form may be appropriate for clinical settings and when expectation measurement is not a primary focus.

Printed Educational Materials' Impact on Tobacco Cessation Brief Interventions in CAM Practice: Patient and Practitioner Experiences.

Printed educational materials (PEMs) have long demonstrated their usefulness as economical and effective media for health communication. In this article, we evaluate the impact of targeted tobacco cessation PEMS for use along with a brief intervention training designed for three types of complementary and alternative medicine (CAM) practitioners: chiropractic, acupuncture, and massage. We describe how PEMs in CAM practitioners' offices were perceived and used by practitioners and by patients. Semistructured qualitative interviews were conducted with 53 practitioners and 38 of their patients. This analysis specifically focused on developing and distributing project-related posters and pamphlets in CAM practice. Our findings indicate that materials (1) legitimated tobacco-related expertise among CAM practitioners and tobacco-related conversations as part of routine CAM practice, (2) increased practitioners' willingness to approach the topic of tobacco with patients, (3) created an effective way to communicate tobacco-related information and broaden the reach of brief intervention initiatives, and (4) were given to patients who were not willing to engage in direct discussion of tobacco use with practitioners.

Tobacco Cessation Training for Complementary and Alternative Medicine Practitioners: Results of a Practice-Based Trial.

INTRODUCTION: Brief behavioral intervention (BI) is a tobacco-cessation best practice well established among conventional healthcare practitioners. Complementary and alternative medicine (CAM) practitioners treat significant numbers of tobacco users, but do not systematically receive BI training. The CAM Reach study developed and evaluated a tobacco cessation BI training program/practice system intervention adapted specifically for CAM practitioners, and evaluated in real-world CAM practices. STUDY DESIGN: Single-arm intervention. Data were collected in 2010-2014 and analyzed in 2015. SETTING/PARTICIPANTS: Private practices of 30 chiropractors, 27 acupuncturists, 42 massage therapists (N=99), in metropolitan Tucson, Arizona. INTERVENTION: Eight-hour tobacco cessation BI continuing education workshop, in-office BI skills practice/assessment, and system intervention. Training tailored to the CAM practice setting addressed tobacco cessation best practices from the U.S. Public Health Service Guidelines. MAIN OUTCOME MEASURES: Seventeen items (assessing practitioner behavior, motivation, and self-efficacy with tobacco cessation) comprising three factors, Tobacco Cessation Activity, Tobacco Cessation Motivation, and Non-CAM Tobacco Cessation Comfort, were assessed at baseline and 3, 6, 9, and 12 months post-training by practitioner self-report. Research staff visited practices at approximately the same intervals to directly observe changes in clinical practice systems. RESULTS: At 3 months, there were significant increases in practitioners' tobacco cessation activities, motivation and confidence in helping patients quit tobacco, and comfort with providing information and referrals for guideline-based tobacco cessation aids (p<0.0001). Practitioners significantly increased rates of discussing cessation medications with patients (AOR=3.76, 95% CI=1.84, 7.68), and routinely asking about tobacco use in clinical practice (AOR=2.62, 95% CI=1.11, 6.20). Increases occurred across all three practitioner types and were sustained at 12 months-despite heterogeneity in professional training, practice patterns/organization, and practice business models. CONCLUSIONS: Results suggest CAM practitioners are willing and able to offer BIs, and are an important, yet overlooked channel for promoting tobacco cessation and use of evidence-based cessation aids.

Evaluating the use of gas discharge visualization to measure massage therapy outcomes.

BACKGROUND: The purpose of this study was to evaluate the short-term effects of massage therapy using gas discharge visualization (GDV), a computerized biophysical electrophoton capture (EPC), in tandem with traditional self-report measures to evaluate the use of GDV measurement to assess the bioenergetic whole-person effects of massage therapy. METHODS: This study used a single treatment group, pre-post-repeated measures design with a sample of 23 healthy adults. This study utilized a single 50-min full-body relaxation massage with participants. GDV measurement method, an EPC, and traditional paper-based measures evaluating pain, stress, muscle tension, and well-being were used to assess intervention outcomes. RESULTS: Significant differences were found between pre- and post-measures of well-being, pain, stress, muscle tension, and GDV parameters. Pearson correlations indicate the GDV measure is correlated with pain and stress, variables that impact the whole person. CONCLUSIONS: This study demonstrates that GDV parameters may be used to indicate significant bioenergetic change from pre- to post-massage. Findings warrant further investigation with a larger diverse sample size and control group to further explore GDV as a measure of whole-person bioenergetic effects associated with massage.

Intervention development for integration of conventional tobacco cessation interventions into routine CAM practice.

BACKGROUND: Practitioners of complementary and alternative medicine (CAM) therapies are an important and growing presence in health care systems worldwide. A central question is whether evidence-based behavior change interventions routinely employed in conventional health care could also be integrated into CAM practice to address public health priorities. Essential for successful integration are intervention approaches deemed acceptable and consistent with practice patterns and treatment approaches of different types of CAM practitioners - that is, they have context validity. Intervention development to ensure context validity was integral to Project CAM Reach (CAMR), a project examining the public health potential of tobacco cessation training for chiropractors, acupuncturists and massage therapists (CAM practitioners). This paper describes formative research conducted to achieve this goal. METHODS: Intervention development, undertaken in three CAM disciplines (chiropractic, acupuncture, massage therapy), consisted of six iterative steps: 1) exploratory key informant interviews; 2) local CAM practitioner community survey; 3) existing tobacco cessation curriculum demonstration with CAM practitioners; 4) adapting/tailoring of existing curriculum; 5) external review of adaptations; 6) delivery of tailored curriculum to CAM practitioners with follow-up curriculum evaluation. RESULTS: CAM practitioners identified barriers and facilitators to addressing tobacco use with patients/clients and saw the relevance and acceptability of the intervention content. The intervention development process was attentive to their real world intervention concerns. Extensive intervention tailoring to the context of each CAM discipline was found unnecessary. Participants and advisors from all CAM disciplines embraced training content, deeming it to have broad relevance and application across the three CAM disciplines. All findings informed the final intervention. CONCLUSIONS: The participatory and iterative formative research process yielded an intervention with context validity in real-world CAM practices as it: 1) is patient/client-centered, emphasizing the practitioner's role in a healing relationship; 2) is responsive to the different contexts of CAM practitioners' work and patient/client relationships; 3) integrates relevant best practices from US Public Health Service Clinical Practice Guidelines on treating tobacco dependence; and 4) is suited to the range of healing philosophies, scopes of practice and practice patterns found in participating CAM practitioners. The full CAMR study to evaluate the impact of the CAMR intervention on CAM practitioners' clinical behavior is underway.

Role of theory of mind in emotional awareness and alexithymia: Implications for conceptualization and measurement.

The goal of this study was to determine whether alexithymia, which is characterized by difficulty in recognizing and describing emotions, is associated with impairments in the ability to mentally represent emotional states. We studied 89 outpatients including 29 conversion disorder patients, 30 functional somatic syndrome [e.g. fibromyalgia] patients and 30 medical controls. Groups did not differ on affective or cognitive Theory of Mind (ToM) measures, the Levels of Emotional Awareness Scale (LEAS) or the Twenty-Item Toronto Alexithymia Scale (TAS-20) after adjusting for Positive and Negative Affect Scale (PANAS) variables. Across all patients, LEAS but not TAS-20 correlated positively with affective and cognitive ToM measures after adjusting for PANAS scores. Impairments in ToM functioning influence LEAS performance but not TAS-20 scores. These findings support the distinction between a milder "anomia" form of alexithymia associated with impaired emotion naming and a more severe "agnosia" form associated with impaired mental representation of emotion.

Tobacco brief intervention training for chiropractic, acupuncture, and massage practitioners: protocol for the CAM reach study.

BACKGROUND: Tobacco use remains the leading cause of morbidity and mortality in the US. Effective tobacco cessation aids are widely available, yet underutilized. Tobacco cessation brief interventions (BIs) increase quit rates. However, BI training has focused on conventional medical providers, overlooking other health practitioners with regular contact with tobacco users. The 2007 National Health Interview Survey found that approximately 20% of those who use provider-based complementary and alternative medicine (CAM) are tobacco users. Thus, CAM practitioners potentially represent a large, untapped community resource for promoting tobacco cessation and use of effective cessation aids. Existing BI training is not well suited for CAM practitioners' background and practice patterns, because it assumes a conventional biomedical foundation of knowledge and philosophical approaches to health, healing and the patient-practitioner relationship. There is a pressing need to develop and test the effectiveness of BI training that is both grounded in Public Health Service (PHS) Guidelines for tobacco dependence treatment and that is relevant and appropriate for CAM practitioners. METHODS/DESIGN: The CAM Reach (CAMR) intervention is a tobacco cessation BI training and office system intervention tailored specifically for chiropractors, acupuncturists and massage therapists. The CAMR study utilizes a single group one-way crossover design to examine the CAMR intervention's impact on CAM practitioners' tobacco-related practice behaviors. Primary outcomes included CAM practitioners' self-reported conduct of tobacco use screening and BIs. Secondary outcomes include tobacco using patients' readiness to quit, quit attempts, use of guideline-based treatments, and quit rates and also non-tobacco-using patients' actions to help someone else quit. DISCUSSION: CAM practitioners provide care to significant numbers of tobacco users. Their practice patterns and philosophical approaches to health and healing are well suited for providing BIs. The CAMR study is examining the impact of the CAMR intervention on practitioners' tobacco-related practice behaviors, CAM patient behaviors, and documenting factors important to the conduct of practice-based research in real-world CAM practices.

Description of a clinical stream of back-pain patients based on electronic medical records.

Back pain consists of a spectrum of conditions, with no common etiology and therefore no dominant method of treatment. The purpose of this study is to describe the complexity of a collection of 8000 back pain patients who appeared in an integrative medicine clinic, as a prelude to conducing comparative effectiveness research on CAM alternatives to conventional therapy. Approximately 23% of all clinic patients were diagnosed at some time with back pain. Nearly half had treatment periods of less than one month, while more than 25% were treated for back pain for more than two years. Women were represented more than twice as often as men. The initial diagnosis categories that occurred most frequently were lumbar symptoms, cervical symptoms, and a general category, with smaller numbers having lumbar anatomic, thoracic symptom, brachial neuritis, or sciatica diagnoses. There were few strong relationships between initial diagnosis pattern and length of back pain treatment period. While 77% of back pain patients presented with diagnoses in only a single category, there were many composite categories each of which was sparsely represented. Between 50% and 75% of patients used some CAM service, depending on their initial diagnosis pattern. Patients with complex initial diagnosis patterns strongly tended to chose CAM, and among CAM-users those with complex diagnoses tended toward chiropractic, as opposed to acupuncture or bodywork. The CAM usage patterns of men and women were highly similar. Again among CAM users, 82% used only a single type of CAM service, and multiple service uses tend to be combined at random. Between two-thirds and three-quarters of multiple CAM service users had very simple temporal patterns of use, dominated by use of one type of CAM at a time.

Narrative review of yoga intervention clinical trials including weight-related outcomes.

CONTEXT: Medical authorities have identified obesity as a causal factor in the development of diabetes, hypertension, and cardiovascular disease (CVD), and more broadly, of metabolic syndrome/insulin resistance syndrome. To provide solutions that can modify this risk factor, researchers need to identify methods of effective risk reduction and primary prevention of obesity. Research on the effectiveness of yoga as a treatment for obesity is limited, and studies vary in overall quality and methodological rigor. OBJECTIVE: This narrative review assessed the quantity and quality of clinical trials of yoga as an intervention for weight loss or as a means of risk reduction or treatment for obesity and diseases in which obesity is a causal factor. This review summarized the studies' research designs and evaluated the efficacy of yoga for weight loss via the current evidence base. DESIGN: The research team evaluated published studies to determine the appropriateness of research designs, comparability of programs' intervention elements, and standardization of outcome measures. The research team's literature search used the key terms yoga and obesity or yoga and weight loss in three primary medical-literature databases (PubMed, PsychInfo, and Web of Science). The study excluded clinical trials with no quantitative obesity related measure. Extracted data included each study's (1) design; (2) setting and population; (3) nature, duration, and frequency of interventions; (4) comparison groups; (5) recruitment strategies; (6) outcome measures; (7) data analysis and presentation; and (8) results and conclusions. The research team developed an overall evaluation parameter to compare disparate trials. OUTCOME MEASURES: The research team reviewed each study to determine its key features, each worth a specified number of points, with a maximum total of 20 points. The features included a study's (1) duration, (2) frequency of yoga practice, (3) intensity of (length of) each practice, (4) number of yogic elements, (5) inclusion of dietary modification, (6) inclusion of a residential component, (7) the number of weight-related outcome measures, and (8) a discussion of the details of the yogic elements. RESULTS: Overall, therapeutic yoga programs are frequently effective in promoting weight loss and/or improvements in body composition. The effectiveness of yoga for weight loss is related to the following key features: (1) an increased frequency of practice; (2) a longer intervention duration (3) a yogic dietary component; (4) a residential component; (5) the comprehensive inclusion of yogic components; (5) and a home-practice component. CONCLUSIONS: Yoga appears to be an appropriate and potentially successful intervention for weight maintenance, prevention of obesity, and risk reduction for diseases in which obesity plays a significant causal role.

Intervention in overweight children improves body mass index (BMI) and physical activity.

BACKGROUND: Childhood obesity is a growing epidemic in family medicine with few clinical treatment options. We implemented and evaluated a group office-visit intervention by family physicians for overweight children and their parents, emphasizing nutrition and physical activity within a resiliency psychosocial model. METHODS: The intervention lasted for 3 months, with half of the children crossing over to intervention after 6 months in the study. Participants included 35 children who met eligibility criteria of being in third through fifth grades and having a body mass index (BMI) above the 85th percentile. The 3-month, 12-session intervention, "Choices," included topics on nutrition, physical activity, and resiliency. The sessions were developed for delivery by a family physician and a nutritionist who received training in positive psychology and resilience skills. Main outcome measures were BMI z scores for age and sex and z scores for weight by age and sex, as well as qualitative interviews to understand individual and family processes. RESULTS: The intervention resulted in a significant effect on one primary outcome, BMI z score (-0.138 per 9 months [P = .017]) and a trend toward significance on the weight for age z score (-0.87 per 9 months [P = .09]). The net shift of activity from the low metabolic equivalents (METs) to the high METs had an intervention effect of 2.84 METs (P = .037). Families reported lasting changes in behaviors and attitudes. DISCUSSION: The innovative approach used in this study demonstrated modest efficacy in reducing BMI z score, changing physical activity levels, and possibly shifting family dynamics.

Hibiscus sabdariffa L. in the treatment of hypertension and hyperlipidemia: a comprehensive review of animal and human studies.

The effectiveness of Hibiscus sabdariffa L. (HS) in the treatment of risk factors associated with cardiovascular disease is assessed in this review by taking a comprehensive approach to interpreting the randomized clinical trial (RCT) results in the context of the available ethnomedical, phytochemical, pharmacological, and safety and toxicity information. HS decoctions and infusions of calyxes, and on occasion leaves, are used in at least 10 countries worldwide in the treatment of hypertension and hyperlipidemia with no reported adverse events or side effects. HS extracts have a low degree of toxicity with a LD50 ranging from 2,000 to over 5,000mg/kg/day. There is no evidence of hepatic or renal toxicity as the result of HS extract consumption, except for possible adverse hepatic effects at high doses. There is evidence that HS acts as a diuretic, however in most cases the extract did not significantly influence electrolyte levels. Animal studies have consistently shown that consumption of HS extract reduces blood pressure in a dose dependent manner. In RCTs, the daily consumption of a tea or extract produced from HS calyxes significantly lowered systolic blood pressure (SBP) and diastolic blood pressure (DBP) in adults with pre to moderate essential hypertension and type 2 diabetes. In addition, HS tea was as effective at lowering blood pressure as the commonly used blood pressure medication Captropril, but less effective than Lisinopril. Total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides were lowered in the majority of normolipidemic, hyperlipidemic, and diabetic animal models, whereas high-density lipoprotein cholesterol (HDL-C) was generally not affected by the consumption of HS extract. Over half of the RCTs showed that daily consumption of HS tea or extracts had favorable influence on lipid profiles including reduced total cholesterol, LDL-C, triglycerides, as well as increased HDL-C. Anthocyanins found in abundance in HS calyxes are generally considered the phytochemicals responsible for the antihypertensive and hypocholesterolemic effects, however evidence has also been provided for the role of polyphenols and hibiscus acid. A number of potential mechanisms have been proposed to explain the hypotensive and anticholesterol effects, but the most common explanation is the antioxidant effects of the anthocyanins inhibition of LDL-C oxidation, which impedes atherosclerosis, an important cardiovascular risk factor. This comprehensive body of evidence suggests that extracts of HS are promising as a treatment of hypertension and hyperlipidemia, however more high quality animal and human studies informed by actual therapeutic practices are needed to provide recommendations for use that have the potential for widespread public health benefit.

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.

Healthy lifestyles related to subsequent prevalence of age-related macular degeneration.

OBJECTIVE: To investigate the relationships between lifestyle behaviors of diet, smoking, and physical activity and the subsequent prevalence of age-related macular degeneration (AMD). METHODS: The population included 1313 participants (aged 55-74 years) in the Carotenoids in Age-Related Eye Disease Study, an ancillary study of the Women's Health Initiative Observational Study. Scores on a modified 2005 Healthy Eating Index were assigned using responses to a food frequency questionnaire administered at baseline of the Women's Health Initiative Observational Study (1994-1998). Physical activity and lifetime smoking history were queried. An average of 6 years later, stereoscopic fundus photographs were taken to assess the presence and severity of AMD; it was present in 202 women, 94% of whom had early AMD, the primary outcome. RESULTS: In multivariate models, women whose diets scored in the highest quintile compared with the lowest quintile on the modified 2005 Healthy Eating Index had 46% lower odds for early AMD. Women in the highest quintile compared with those in the lowest quintile for physical activity (in metabolic energy task hours per week) had 54% lower odds for early AMD. Although smoking was not independently associated with AMD on its own, having a combination of 3 healthy behaviors (healthy diet, physical activity, and not smoking) was associated with 71% lower odds for AMD compared with having high-risk scores (P < .001). CONCLUSION: Modifying lifestyles might reduce risk for early AMD as much as 3-fold, lowering the risk for advanced AMD in a person's lifetime and the social and economic costs of AMD to society.

Influence of stressors on breast cancer incidence in the Women's Health Initiative.

OBJECTIVE: To examine associations among life events stress, social support, and breast cancer incidence in a cohort of postmenopausal women. DESIGN AND MAIN OUTCOME MEASURE: Women's Health Initiative observational study participants, breast cancer free at entry, who provided assessment of stressful life events, social support, and breast cancer risk factors, were prospectively followed for breast cancer incidence (n = 84,334). RESULTS: During an average of 7.6 years of follow-up, 2,481 invasive breast cancers were diagnosed. In age-adjusted proportional hazards models, 1 stressful life event was associated with increased risk, but risk decreased with each additional stressful life event. After adjustment for confounders the decreasing risk was not significant. Stressful life events and social support appeared to interact in relation to breast cancer risk such that women who had greater number of stressful life events and low social support had a decreased risk of breast cancer. CONCLUSIONS: This study found no independent association between stressful life events and breast cancer risk. The results are compatible with a more complex model of psychosocial factors interacting in relation to breast cancer risk.

Using a website to build community and enhance outcomes in a group, multi-component intervention promoting healthy diet and exercise in adolescents.

OBJECTIVE: This article describes website use and behavioral outcomes in a multi-component lifestyle intervention promoting healthy diet and exercise. METHODS: A 2-year randomized clinical trial to improve bone density in 228 adolescent girls, the intervention included a website designed to enhance intervention adherence, retention of participants, and behavioral outcomes. Measures included diet and exercise recalls, surveys, and web-usage data. RESULTS: Website use was associated with increases in calcium intake (ss = 69.72, p =.01, ES = 0.15) and high-impact activity (ss = 10.93, p =.04, ES =.13). Use of web pages related to behavioral feedback and communications was not significantly associated with behavioral outcomes. The most visited website pages had content related to incentive points, caption contests, and fun facts. CONCLUSIONS: Web elements of a multi-component intervention may promote retention and engagement in target behaviors. Such websites may be most acceptable to adolescent participants if they blend fun and behavioral elements, rather than exclusively focusing on behavioral changes.

Vitamin A and retinol intakes and the risk of fractures among participants of the Women's Health Initiative Observational Study.

BACKGROUND: Excessive intakes of vitamin A have been shown to have adverse skeletal effects in animals. High vitamin A intake may lead to an increased risk of fracture in humans. OBJECTIVE: The objective was to evaluate the relation between total vitamin A and retinol intakes and the risk of incident total and hip fracture in postmenopausal women. DESIGN: A total of 75,747 women from the Women's Health Initiative Observational Study participated. The risk of hip and total fractures was determined using Cox proportional hazards models according to different intakes of vitamin A and retinol. RESULTS: In the analysis adjusted for some covariates (age; protein, vitamin D, vitamin K, calcium, caffeine, and alcohol intakes; body mass index; hormone therapy use; smoking; metabolic equivalents hours per week; ethnicity; and region of clinical center), the association between vitamin A intake and the risk of fracture was not statistically significant. Analyses for retinol showed similar trends. When the interaction term was analyzed as categorical, the highest intake of retinol with vitamin D was significant (P = 0.033). Women with lower vitamin D intake (< or =11 microg/d) in the highest quintile of intake of both vitamin A (hazard ratio: 1.19; 95% CI: 1.04, 1.37; P for trend: 0.022) and retinol (hazard ratio: 1.15; 95% CI: 1.03, 1.29; P for trend: 0.056) had a modest increased risk of total fracture. CONCLUSIONS: No association between vitamin A or retinol intake and the risk of hip or total fractures was observed in postmenopausal women. Only a modest increase in total fracture risk with high vitamin A and retinol intakes was observed in the low vitamin D-intake group.

Conjugated equine estrogens and colorectal cancer incidence and survival: the Women's Health Initiative randomized clinical trial.

BACKGROUND: In separate Women's Health Initiative randomized trials, combined hormone therapy with estrogen plus progestin reduced colorectal cancer incidence but estrogen alone in women with hysterectomy did not. We now analyze features of the colorectal cancers that developed and examine the survival of women following colorectal cancer diagnosis in the latter trial. PARTICIPANTS AND METHODS: 10,739 postmenopausal women who were 50 to 79 years of age and had undergone hysterectomy were randomized to conjugated equine estrogens (0.625 mg/d) or matching placebo. Colorectal cancer incidence was a component of the monitoring global index of the study but was not a primary study endpoint. Colorectal cancers were verified by central medical record and pathology report review. Bowel exam frequency was not protocol defined, but information on their use was collected. RESULTS: After a median 7.1 years, there were 58 invasive colorectal cancers in the hormone group and 53 in the placebo group [hazard ratio, 1.12; 95% confidence interval (95% CI), 0.77-1.63]. Tumor size, stage, and grade were comparable in the two randomization groups. Bowel exam frequency was also comparable in the two groups. The cumulative mortality following colorectal cancer diagnosis among women in the conjugated equine estrogen group was 34% compared with 30% in the placebo group (hazard ratio, 1.34; 95% CI, 0.58-3.19). CONCLUSIONS: In contrast to the preponderance of observational studies, conjugated equine estrogens in a randomized clinical trial did not reduce colorectal cancer incidence nor improve survival after diagnosis.