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Biomedical subjects

Victor J Stevens

Publications and source records attributed to Victor J Stevens.

14 recordsLinked to original sources
PubMed2003

Diet and sex hormones in girls: findings from a randomized controlled clinical trial.

BACKGROUND: Results of several studies have suggested that diet during adolescence may influence the risk of breast cancer in adulthood. We evaluated whether an intervention to lower fat intake among adolescent girls altered their serum concentrations of sex hormones that, in adults, are related to breast cancer development. METHODS: We conducted an ancillary hormone study among 286 of the 301 girls who participated between 1988 and 1997 in the Dietary Intervention Study in Children, in which healthy, prepubertal, 8- to 10-year-olds with elevated low-density lipoprotein cholesterol were randomly assigned to usual care or to a behavioral intervention that promoted a low-fat diet. Median time on the intervention was 7 years. Blood samples collected before randomization and at the year 1, year 3, year 5, and last visits were assayed to determine the girls' serum levels of sex hormones. All P values are two-sided. RESULTS: At the year 5 visit, girls in the intervention group had 29.8% (95% confidence interval [CI] = 5.4% to 47.9%; P =.02) lower estradiol, 30.2% (95% CI = 7.0% to 47.7%; P =.02) lower non-sex hormone binding globulin-bound estradiol, 20.7% (95% CI = 4.7% to 34.0%; P =.02) lower estrone, and 28.7% (95% CI = 5.1% to 46.5%; P =.02) lower estrone sulfate levels during the follicular phase of the menstrual cycle and 27.2% (95% CI = 5.7% to 53.1%; P =.01) higher testosterone levels during the luteal phase of the menstrual cycle than did girls in the usual care group. At the last visit, the luteal phase progesterone level was 52.9% (95% CI = 20.0% to 72.3%) lower for girls in the intervention group than for girls in the usual care group (P =.007). CONCLUSION: Modest reductions in fat intake during puberty are associated with changes in sex hormone concentrations that are consistent with alterations in the function of the hypothalamic-pituitary-ovarian axis. Whether these changes influence breast cancer risk is currently unknown.

Adolescent↗
PubMed2003

One-year results from a brief, computer-assisted intervention to decrease consumption of fat and increase consumption of fruits and vegetables.

BACKGROUND: Current cancer prevention recommendations include reducing consumption of fat and increasing consumption of fruits and vegetables. METHODS: Healthy women health maintenance organization members (n = 616) ages 40-70 were randomly assigned to either a nutrition intervention or a control intervention unrelated to diet. Intervention included two 45-min counseling sessions plus two brief follow-up telephone contacts. Counseling sessions included a 20-min, interactive, computer-based intervention using a touch-screen format. Intervention goals were reducing dietary fat and increasing fruit and vegetable consumption. Outcome measures included a food frequency questionnaire and the Fat and Fiber Behavior Questionnaire (FFBQ). Total serum cholesterol was also measured at baseline and 12 months. RESULTS: Twelve-month follow-up data showed improvements on all dietary outcome variables. Compared to the control, intervention participants reported significantly less fat consumption (3.75 points less for percentage of energy from fat), significantly greater consumption of fruit and vegetables combined (0.93 more servings per day), and a significant reduction in a behavioral measure of fat consumption (0.20 point change in the FFBQ). Group differences in total serum cholesterol, while in the desired direction, were not significant. CONCLUSIONS: In appropriate circumstances, moderate-intensity dietary interventions can show significant effects for periods of at least 1 year.

Adult↗
PubMed2003

Does methodology affect the ability to monitor tobacco control activities? implications for HEDIS and other performance measures.

BACKGROUND: It is unclear whether methodological differences in sample size, survey methods, and analysis approach significantly affect the ability to accurately monitor tobacco control activities and to make rate comparisons. METHODS: Questionnaires were sent to 64,764 members of nine health plans in diverse settings soon after their visit to a primary care clinician. Of these 41,677 completed responses were received. We compared responses received by mail and by telephone follow-up for the percentage of smokers, characteristics of smokers, and their rates of reporting physician cessation counseling. RESULTS: Overall, 10.2% were current cigarette smokers, but the proportion was 8.6% for mail responders and 17.2% for phone follow-up responders. Smokers identified by phone follow-up were different from mail responders in most demographic and smoking characteristics and their reports of clinical smoking cessation activities differed for six of nine clinician smoking cessation actions. Calculating advice rates as a proportion of visits produced lower rates with more dispersion among plan rates than doing so without accounting for visit variation. CONCLUSIONS: Smoking surveys using only mailed questionnaires dramatically undersample smokers, especially in some demographic groups. Comparisons of tobacco counseling among health plans can be improved by ensuring an adequate sample size and response rate and by analyzing by frequency of quit advice.

Adult↗
PubMed2003

Premier: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristics.

PURPOSE: To describe PREMIER, a randomized trial to determine the effects of multi-component lifestyle interventions on blood pressure (BP). METHODS: Participants with above optimal BP through stage 1 hypertension were randomized to: 1) a behavioral lifestyle (BLS) intervention that implements established recommendations, 2) a BLS intervention that implements established recommendations plus the DASH diet, or 3) an advice only standard of care group. The two BLS interventions consist of group and individual counseling sessions for 18 months. The primary outcome is systolic BP at 6 months. Additional outcomes include diastolic BP and homocysteine at 6 months; systolic and diastolic BP at 18 months; fasting lipids, glucose and insulin at 6 and 18 months; and effects in subgroup. CONCLUSION: Results from the PREMIER trial will provide scientific rationale for implementing multi-component behavioral lifestyle intervention programs to control BP and prevent CVD.

Blood Pressure↗
PubMed2003

A summary of results of the Dietary Intervention Study in Children (DISC): lessons learned.

Prevention of cardiovascular disease must begin in childhood, preferably before risk factors develop. Elevated low-density lipoprotein cholesterol levels in children are likely to track over time and become high-risk levels in adults. The Dietary Intervention Study in Children (DISC) was a multicenter, collaborative randomized trial in pre-adolescent children designed to test the efficacy and safety of a dietary intervention to lower saturated fat and cholesterol intake among growing children with elevated low-density lipoprotein cholesterol. Numerous DISC results, which include findings on lipids-lipoproteins, genetics, and nutrient adequacy, as well as descriptions of the behavioral intervention strategies, have been reported. A summary of practical findings and their potential clinical applications have not previously been published. Highlights of key lessons learned from DISC and translational applications of potential interest to nurses and other health care providers are presented.

Biomarkers↗
PubMed2002

Phase 1 and 2 trial of bexarotene gel for skin-directed treatment of patients with cutaneous T-cell lymphoma.

OBJECTIVE: To evaluate the safety, dose tolerance, and efficacy of topical bexarotene gel in patients with early-stage cutaneous T-cell lymphoma (CTCL). DESIGN: Phase 1 and 2, open-label, dose-escalation clinical trial of bexarotene gel. SETTING: Three university-based clinics. PARTICIPANTS: Sixty-seven adults with early-stage (TNM stages IA-IIA) CTCL. INTERVENTIONS: Bexarotene gel, 0.1%, 0.5%, and 1.0%, applied in incremental dose adjustments from 0.1% gel every day to 1.0% gel 4 times daily or the maximal tolerated dose. MAIN OUTCOME MEASURES: Patients were followed for efficacy and safety, and treatment continued as long as they benefited. Response (> or =50% improvement) was evaluated by the Physician's Global Assessment of cutaneous disease and by an overall severity assessment of cutaneous disease, including signs of CTCL and area involved. RESULTS: Most patients tolerated topical bexarotene at 1% gel twice daily for routine use. Adverse events were generally mild to moderate in severity and were confined to treatment sites. Treatment-limiting toxic effects were associated with skin irritation and increased with gel exposure. Patients achieved an overall response rate of 63% and a clinical complete response rate of 21%. Median projected time to onset of response was 20.1 weeks (range, 4.0-86.0 weeks), and the estimated median response duration from the start of therapy was 99 weeks. Patients with no previous therapy for mycosis fungoides responded at a higher rate (75%) than those who previously underwent topical therapies (67%). CONCLUSIONS: Bexarotene gel was well tolerated, was easily self-applied, and had a substantial response rate in treating patients with early-stage CTCL.

Adult↗
PubMed2002

Recruitment of older participants in frailty/injury prevention studies.

Despite the lifelong health benefits of physical activity, frailer older adults have typically been excluded from studies promoting more active lifestyles. This study documents the recruitment process and costs from a multisite study to identify effective strategies for recruiting older adults in frailty/injury prevention research. Randomized controlled clinical trials were conducted at 7 sites; an 8th site was a compliance study. Interventions reflected center- and home-based health promotion programs. Site objectives, eligibility criteria, and contact and screening methods were obtained from manuals of operation. Recruitment results (number screened, eligibility rates, randomized to screened ratios) were ascertained from recruitment data. Sites furnished estimated recruitment costs (nonlabor expenses, investigator and staff time, fringe benefits) up to signing the consent form. The sites targeted diverse populations and sample sizes. The majority revised recruitment methods to meet their recruitment goals. Most sites estimated costs of recruitment at over $300 per participant randomized. Recruitment costs were affected by staff time spent alleviating concerns about participants' health, essential interactions with family members, and arranging for transportation. Neither frailty nor intervention intensity was found to be a major predictor of recruitment outcomes. Recruitment expense was associated with selection criteria and frailty status of the target population. Older people can be successfully recruited into beneficial health promotion programs, but it is often challenging. In planning health promotion studies, investigators need to be aware of the numbers of older people they may need to screen and different strategies for increasing recruitment success.

Accidental Falls↗
PubMed2002

Promoting Healthy Lifestyles: Alternative Models' Effects (PHLAME).

The Promoting Healthy Lifestyles: Alternative Models' Effects (PHLAME) study evaluates the efficacy of two intervention strategies for improving nutrition and physical activity practices in fire fighters: a team-centered program and a one-on-one format targeting the individual. PHLAME compares these two behavior change models (the team-based versus the one-on-one approaches) against a usual-care control group. As a group, fire fighters have a concentration of the same harmful behaviors and health risks commonly afflicting the US population. Fire fighters have a unique work structure which is ideal for a team-centered model of behavior change. This strategy, based on Social Learning Theory, focuses on a team of fire fighters who work together on the same shift. If this team-centered model proves successful, it could provide a cost-effective method to impact behavior, and be disseminated among fire bureaus and in other team settings. The one-on-one intervention incorporates the Transtheoretical Model of behavior change, uses Motivational Interviewing for its counseling strategy and could be used in the more typical provider-client clinic setting. Findings from PHLAME will provide information about the process and outcomes of these models' ability to achieve health behavior change.

Diet↗
PubMed2002

Helicobacter pylori eradication in dyspeptic primary care patients: a randomized controlled trial of a pharmacy intervention.

OBJECTIVE: To determine the effectiveness of structured adherence counseling by pharmacists on the eradication of Helicobacter pylori when using a standard drug treatment regimen. DESIGN: Randomized controlled clinical trial. SETTING: Nonprofit group-practice health maintenance organization (HMO). PARTICIPANTS: HMO primary care providers referred 1,393 adult dyspeptic patients for carbon 14 urea breath testing (UBT). INTERVENTIONS: Those whose tests were positive for H pylori (23.3%) were provided a standard antibiotic regimen and randomly assigned to receive either usual-care counseling from a pharmacist or a longer adherence counseling session and a follow-up phone call from the pharmacist during drug treatment. All subjects were given the same 7-day course of omeprazole, bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (OBMT). Dyspepsia symptoms were recorded at baseline and following therapy. OUTCOMES: The main outcome was eradication of H pylori as measured by UBT at 3-month follow-up. Secondary outcomes were patient satisfaction and dyspepsia symptoms at 3-month follow-up. RESULTS: Of the 333 participants randomly assigned to treatment, 90.7% completed the 3-month follow-up UBT and questionnaires. Overall eradication rate with the OBMT regimen was 80.5% with no significant difference in eradication rates between the 2 groups (P=0.98). Conclusions In this study, additional counseling by pharmacists did not affect self-reported adherence to the treatment regimen, eradication rates, or dyspepsia symptoms but did increase patient satisfaction.

Adolescent↗
PubMed2002

Steps to soulful living (steps): a weight loss program for African-American women.

BACKGROUND: The disproportionate disease burden experienced by African-American women can be explained partially by the higher rates of obesity in this population. African-American women who can benefit from weight loss may be less likely to attempt it and may have relatively less success in using traditional weight loss programs compared to White women. Steps to Soulful Living (Steps) was a pilot study to test the effects of a culturally adapted weight loss program on weight loss in African-American women. METHODS: Sixty-six African-American women participated in a 6-month weight loss program that included weekly group meetings and supervised exercise sessions. Mean baseline body mass index was 39 kg/m2, and mean baseline weight was 107 kg. Cultural adaptations, defined as program adjustments, made in response to women's preferences as expressed in focus group interviews included changes in intervention format, the content of the group meetings, and the location and format of the exercise sessions. RESULTS: Seventy-six percent of the participants attended at least 50% of the 26 weekly sessions, and 56% attended at least 75% of the sessions. Average hours of exercise per week approximately doubled during the program in comparison to baseline levels. Mean weight loss at 26 weeks was 3.7 kg, categorizing those who were lost to follow-up as having zero weight loss. Participants who attended at least 75% of the group meetings lost a mean of 6.2 kg at six months. Those who attended fewer meetings lost a mean of 0.9 kg. CONCLUSIONS: This 6-month program was associated with relatively larger weight losses, particularly among participants with high attendance, than have usually been observed in culturally adapted programs for African-American women.

Adult↗
PubMedDate not supplied

Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial.

CONTEXT: Weight loss, sodium reduction, increased physical activity, and limited alcohol intake are established recommendations that reduce blood pressure (BP). The Dietary Approaches to Stop Hypertension (DASH) diet also lowers BP. To date, no trial has evaluated the effects of simultaneously implementing these lifestyle recommendations. OBJECTIVE: To determine the effect on BP of 2 multicomponent, behavioral interventions. DESIGN, SETTING, AND PARTICIPANTS: Randomized trial with enrollment at 4 clinical centers (January 2000-June 2001) among 810 adults (mean [SD] age, 50 [8.9] years; 62% women; 34% African American) with above-optimal BP, including stage 1 hypertension (120-159 mm Hg systolic and 80-95 mm Hg diastolic), and who were not taking antihypertensive medications. INTERVENTION: Participants were randomized to one of 3 intervention groups: (1) "established," a behavioral intervention that implemented established recommendations (n = 268); (2) "established plus DASH,"which also implemented the DASH diet (n = 269); and (3) an "advice only" comparison group (n = 273). MAIN OUTCOME MEASURES: Blood pressure measurement and hypertension status at 6 months. RESULTS: Both behavioral interventions significantly reduced weight, improved fitness, and lowered sodium intake. The established plus DASH intervention also increased fruit, vegetable, and dairy intake. Across the groups, gradients in BP and hypertensive status were evident. After subtracting change in advice only, the mean net reduction in systolic BP was 3.7 mm Hg (P<.001) in the established group and 4.3 mm Hg (P<.001) in the established plus DASH group; the systolic BP difference between the established and established plus DASH groups was 0.6 mm Hg (P =.43). Compared with the baseline hypertension prevalence of 38%, the prevalence at 6 months was 26% in the advice only group, 17% in the established group (P =.01 compared with the advice only group), and 12% in the established plus DASH group (P<.001 compared with the advice only group; P =.12 compared with the established group). The prevalence of optimal BP (<120 mm Hg systolic and <80 mm Hg diastolic) was 19% in the advice only group, 30% in the established group (P =.005 compared with the advice only group), and 35% in the established plus DASH group (P<.001 compared with the advice only group; P =.24 compared with the established group). CONCLUSION: Individuals with above-optimal BP, including stage 1 hypertension, can make multiple lifestyle changes that lower BP and reduce their cardiovascular disease risk.

Adult↗
PubMedDate not supplied

Randomized trial of a brief dietary intervention to decrease consumption of fat and increase consumption of fruits and vegetables.

PURPOSE: This study tested the efficacy of a computer-assisted counseling intervention to reduce diet-related cancer risk. DESIGN: Randomized controlled trial. SUBJECTS: Healthy women HMO members (n = 616) aged 40 to 70. INTERVENTION: Participants were randomly assigned to nutrition intervention or an attention-control intervention unrelated to diet. Intervention consisted of two 45-minute counseling sessions plus two 5- to 10-minute follow-up telephone contacts. Counseling sessions included a 20-minute, interactive, computer-based intervention using a touchscreen format. Intervention goals were reducing dietary fat and increasing consumption of fruit, vegetables, and whole grains. MEASURES: Twenty-four hour diet recalls and the Fat and Fiber Behavior Questionnaire (FFB). RESULTS: Four-month follow-up data were collected from 94% of the intervention participants and 91% of the controls. Testing with a multivariate general linear models analysis showed improvements on all dietary outcome variables. Compared to the control, intervention participants reported significantly less fat consumption (2.35 percentage points less for percentage of energy from fat), significantly greater consumption of fruit and vegetables combined (1.04 servings per day), and a significant reduction in a behavioral measure of fat consumption (.24 point change in the FFB). CONCLUSIONS: These 4-month results are comparable to several other moderate-intensity studies showing that, in the appropriate circumstances, moderate-intensity dietary interventions can be efficacious. Study limitations include the short follow-up period and the use of self-reported outcome measures.

Adult↗
PubMedDate not supplied

Tobacco-control policies in 11 leading managed care organizations: progress and challenges.

CONTEXT: Although evidence-based national guidelines for tobacco-dependence treatment have been available since 1996, translating these guidelines into clinical practice is challenging. PRACTICE PATTERN EXAMINED: Policies regarding tobacco-dependence treatment (e.g., written guidelines and coverage of pharmacotherapy) and implementation strategies of 11 U.S. managed care organizations known to have strong tobacco-control programs. DATA SOURCES: Detailed telephone interviews with multiple informants at each health plan and review of written treatment guidelines and policies for tobacco dependence. RESULTS: Although 10 of 11 plans had adopted tobacco-dependence treatment guidelines consistent with the national guideline, fewer had guidelines for special groups, such as adolescents (6 plans), parents (5 plans), pregnant women (5 plans), and hospitalized smokers (3 plans). Most plans offered clinician training and recommended office systems to support provider efforts; however, fewer actively facilitated their implementation. Most plans provided other support for tobacco treatment, including dedicated budgets, designated staff, and an oversight committee. All plans offered some coverage for tobacco-cessation pharmacotherapy and behavioral counseling, although not to the extent recommended by the national guideline. CONCLUSION: Implementation of national tobacco-treatment guidelines is feasible in closed-panel managed care organizations. However, even these leading health plans could do more to comply with national practice guidelines on tobacco-dependence treatment and make it easier for clinicians to help patients stop smoking (e.g., through increased training and expanded coverage of tobacco-dependence treatment).

Evidence-Based Medicine↗