Computerized weight loss intervention optimizes staff time: the clinical and cost results of a controlled clinical trial conducted in a managed care setting.

OBJECTIVE: To evaluate the costs and effects of incremental components of a weight-loss program. DESIGN: A 3-arm, 12-month randomized controlled clinical trial to evaluate 3 incremental levels of intervention intensity. SUBJECTS/SETTING: The study included 588 individuals (BMI > 25 kg/m2) in a freestanding health maintenance organizalion and achieved an 81% completion rate. INTERVENTION: Using a cognitive behavioral approach for tailoring lifestyle modification goals, the incremental levels of intervention included a) a workbook alone, b) the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and c) the addition of both computers and staff consultation. MAIN OUTCOME MEASURES: Endpoints included weight parameters, lipid profile, plasma glucose, blood pressure, intervention costs, dietary intake, and physical activity. STATISTICAL ANALYSIS PERFORMED: Study endpoints were analyzed using analysis of variance for normally distributed variables and analysis of covariance to control for any baseline differences. Regression and correlation analysis assessed the relationship between weight loss and other variables. RESULTS: For the increasing levels of intervention intensity, the mean 12-month weight losses were 2.2, 4.7, and 7.4 pounds, with the respective cost per participant being $12.33, $41.99, and $133.74. The decreases in mean BMIs for these respective intervelation levels were 0.4, 0.9 and 1.2. All groups reported a decrease in energy and fat intake and an increase in blocks walked (P<.01). Intervention variables that correlated with weight loss included more computer log-ons, achieving computer-selected goals, more self-monitoring, increased walking, and decreased energy and fat intake, as well as higher attendance in staff consultation group sessions for that treatment condition. Weight loss correlated with decreases in fasting glucose and blood pressure. APPLICATIONS/CONCLUSIONS: In a weight-loss program, computers can facilitate selecting behavioral change goals. More frequent usage resulted in greater weight loss. Staff counseling to augment the computer intervention achieved the most weight loss.

Estimating software development costs for a patient multimedia education project.

The authors compare alternative methods of cost estimation for a patient multimedia education (PME) program, using a computerized weight-reduction PME project as an example. Data from the project planning and budgeting process and actual costs of the completed project are analyzed retrospectively to calculate three different estimates-pre-work, post-work, and actual work. Three traditional methods of estimating the cost of computer programs (the lines-of-code, function point, and task ratio analyses) underestimate costs in this example. A commercial program (Cost Xpert) that calculates the cost of developing a graphical user interface provided a better estimate, as did a tally reflecting the complexity and quality of media material in the project.

Electromyographic comparisons of the pelvic floor in women with dysesthetic vulvodynia and asymptomatic women.

OBJECTIVE: To compare surface electromyographic (EMG) studies of the pelvic floor in women diagnosed with dysesthetic vulvodynia to those of women with no urologic or gynecologic symptoms. STUDY DESIGN: Fifty women were chosen to participate and placed in one of two diagnostic categories, asymptomatic (no report of urogynecologic abnormalities, n = 25) and those diagnosed with dysesthetic vulvodynia (n = 25). Testing was completed utilizing electromyographic equipment; an inserted, single-user vaginal sensor; and the Glazer protocol. sEMG variables compared were pretest and posttest resting amplitudes, contractile amplitudes, contractile and resting stability, recruitment latency and recovery, and muscle contraction spectral analysis. RESULTS: The most reliable predictors of symptomatic women were pelvic floor contractile amplitudes of the tonic, phasic and endurance contractions, though 9 of the 15 variables tested proved significant. The phasic (three-second) contractions of the symptomatic group were 46% less than in the pain-free group. Tonic (12-second) contractions were 49% less, and endurance (60-second) contractions proved to be only 47% of those produced by those with no dysfunction. CONCLUSION: The results of EMG studies of the pelvic floor in women diagnosed with dysesthetic vulvodynia proved significantly different from those of their urogynecologically asymptomatic cohorts. Physiology of the pelvic floor is an essential piece of knowledge needed to further study the etiology and causative factors in dysesthetic vulvodynia. Though the sample size used in this study was not sufficient to quantify normal pelvic floor function, the study certainly suggests sufficient significant differences between the two groups to merit further study.

The DIET study: long-term outcomes of a cognitive-behavioral weight-control intervention in independent-living elders. Dietary Intervention: Evaluation of Technology.

OBJECTIVE: To describe the long-term outcomes of a cognitive-behavioral weight-control intervention implemented in a community-based sample of independent-living, older adults. DESIGN: A quasi-experimental design was used to compare an intervention community with a wait-listed control community. Comparisons between the communities were made at 40 weeks (J Am Diet Assoc. 1994;94:37-42). The controlled trial ended at 40 weeks; then both communities received 2 years of intervention. Two-year data from both communities were combined and are presented in this article. Three-year outcome data from the initial intervention community were available and are also presented. SUBJECTS: A total of 247 overweight (> 4.5 kg of age-adjusted weight), older (mean age = 71 years) adults in 2 independent-living retirement communities participated in the study. INTERVENTION: The Dietary Intervention: Evaluation of Technology (DIET) study consisted of an intensive 10-week psychoeducational approach focused on lifestyle change, followed by a less intensive 2-year phase focusing on relapse prevention and maintenance of lifestyle changes. OUTCOME MEASURES: Physiologic and behavioral variables were analyzed at baseline and at 2 years after baseline. This article reports the combined 2-year outcome data from both retirement communities. Results of an additional follow-up 1 year after intervention was withdrawn are reported for the initial intervention community. STATISTICAL ANALYSIS: A within-subjects repeated measures analysis of variance design was used to test for significant changes in weight and lipid values over time. RESULTS: At 2 years, 70% of those who started the intervention remained actively enrolled. This group showed significant decreases in body mass index (-1.2, P < .001) and glucose level (-0.80 mmol/L, P < .001). Although high-density lipoprotein cholesterol (HDL-C) levels had increased at 40 weeks after baseline, this was not maintained at 2 years. At the 3-year follow-up, changes in body mass index and glucose level were maintained. APPLICATIONS/CONCLUSIONS: The purpose of this article was to describe the long-term outcomes of a community-based weight-reduction intervention for older adults. The findings may be of interest to clinicians who design community or worksite weight-reduction programs. Although the intervention was designed to be a low-intensity program, attrition over the length of the study was still problematic. Nevertheless, our follow-up study indicates that this intervention was efficacious in maintaining reductions in weight and glucose levels for overweight older adults for 3 years.

Treatment of vulvar vestibulitis syndrome with electromyographic biofeedback of pelvic floor musculature.

Thirty-three women diagnosed as suffering from vulvar vestibulitis syndrome, marked by a significant history of long-term moderate to severe chronic introital dyspareunia and tenderness of the vulvar vestibule, were selected for treatment. Patients were given a computerized electromyographic evaluation of the pelvic floor muscles and were then provided with portable electromyographic biofeedback instrumentation and instructions on the conduct of daily, at-home, biofeedback-assisted pelvic floor muscle rehabilitation exercises. They received intermittent evaluations of pelvic floor muscles to ensure compliance and monitor their progress and symptom changes. The results show that after an average of 16 weeks of practice, pelvic floor muscle contractions increased 95.4%, resting tension levels decreased 68%, and the instability of the muscle at rest decreased by 62%. Subjective reports of pain decreased an average of 83%. Twenty-eight patients had abstained from intercourse for an average of 13 months. Twenty-two of these 28 patients resumed intercourse by the end of the treatment period. Six month follow-up indicated maintenance of therapeutic benefits.

A weight reduction intervention that optimizes use of practitioner's time, lowers glucose level, and raises HDL cholesterol level in older adults.

OBJECTIVE: The effects of a cognitive-behavioral weight control intervention were compared in two independent-living, older adult (mean age = 70.5 years) communities. DESIGN: The research design compared the experimental community (n = 163), which received the intervention, with the control community (n = 162). SUBJECTS: Overweight individuals (> 4.5 kg of age-adjusted weight according to height-weight tables) were recruited from both communities. INTERVENTION: Components of the Dietary Intervention: Evaluation of Technology (DIET) program included a video-tape, a workbook, computerized tracking of participants, a telephone hot line, educational group discussions, and individual consultation. OUTCOME MEASURES: Changes in body weight, body mass index, and lipid and glucose measures were selected to evaluate the effectiveness of the intervention. STATISTICAL ANALYSIS: One-way analysis of variance by group was done to compare changes in continuous variables between the intervention and control communities. RESULTS: Baseline body mass index and weight were 30.8 and 79.5 kg, respectively, in the experimental community and 28.8 and 75.8 kg, respectively, in the control community. Mean weight change in the experimental community was -3.2 kg after 40 weeks of intervention, compared with no weight change in the control community (P < .0001). Mean plasma glucose level decreased -0.3 mmol/L and mean high-density lipoprotein cholesterol level increased 0.15 mmol/L in the experimental community, compared with no change in lipid parameter and a +0.3 mmol increase in glucose level in the control community (P < .0001). APPLICATIONS: Our findings suggest that an intervention that optimizes use of the practitioner's time can achieve a moderate weight loss and metabolic improvement in a community of older adults.

The effect of dietary changes and intentional weight loss on high density cholesterol levels in older adults.

The effect of a behaviorally-oriented program to reduce calories and increase physical activity on HDL cholesterol level was evaluated in overweight older adult subjects (n = 31). HDL cholesterol increased from 45.8 to 52.1 mg/dl (p < .0003), and total mean cholesterol increased from 238.0 to 249.5 mg/dl (p < .05). Body weight decreased from 175.0 lbs to 172.6 lbs (p < .03). Analysis of baseline and 40 week food frequency questionnaires indicated that the mean caloric intake had decreased from 1535 to 1303 kcal/day (p < .02), and total fat intake decreased by 9.8 gm/day (p < .01). Weight loss accounted for 13% of the variance in HDL cholesterol change (p < .05). Decreasing fat intake resulted in a smaller increase in HDL cholesterol (F, (1,29) = 5.91, p < .03). Our findings provide further support that a prudent approach to weight reduction can be beneficial in an older adult population.

Effect of antihypertensives on sexual function and quality of life: the TAIM Study.

OBJECTIVE: To evaluate treatment of mild hypertension using combinations of diet and low-dose pharmacologic therapies. DESIGN: Multicenter, randomized, placebo-controlled clinical trial. SETTING: Three university-based tertiary care centers. PATIENTS: Patients (697) 21 to 65 years of age with diastolic blood pressure between 90 and 100 mm Hg as well as weight between 110% and 160% of ideal weight. INTERVENTION: Patients were stratified by clinical center and race and were randomly assigned to one of three diets (usual, low-sodium and high-potassium, weight loss) and one of three agents (placebo, chlorthalidone, and atenolol). MEASUREMENTS: Changes in measures of sexual problems, distress, and well-being after 6 months of therapy were analyzed. MAIN RESULTS: Low-dose chlorthalidone and atenolol produced few side effects, except in men. Erection-related problems worsened in 28% (95% CI, 15% to 41%) of men receiving chlorthalidone and usual diet compared with 3% (CI, 0% to 9%) of those receiving placebo and usual diet (P = 0.009) and 11% (CI, 2% to 20%) of those receiving atenolol and usual diet (P greater than 0.05). The weight loss diet ameliorated this effect. The low-sodium diet with placebo was associated with greater fatigue (34%; CI, 23% to 45%) than was either usual diet (18%; CI, 10% to 27%; P = 0.04) or weight reduction (15%; CI, 7% to 23%; P = 0.009). The low-sodium diet with chlorthalidone increased problems with sleep (32%; CI, 22% to 42%) compared with chlorthalidone and usual diet (16%; CI, 8% to 24%; P = 0.04). The weight loss diet benefited quality of life most, reducing total physical complaints (P less than 0.001) and increasing satisfaction with health (P less than 0.001). Total physical complaints decreased in 57% to 76% of patients depending on drug and diet group, and were markedly decreased by weight loss. CONCLUSION: In general, low-dose antihypertensive drug therapy (with chlorthalidone or atenolol) improves rather than impairs the quality of life; however, chlorthalidone with usual diet increases sexual problems in men.

Weight reduction in the prevention and treatment of hypertension: a review of representative clinical trials.

Elevated blood pressure is a risk factor for cardiovascular disease, and weight reduction is currently advocated as a nonpharmacologic approach for the management of hypertension. Results of clinical trials indicate weight reduction is effective in preventing and treating hypertension. Knowledge of the results of clinical trials is extremely important for health educators since: 1) these findings provide a scientific basis for educating other health professionals about the beneficial effects of dietary approaches to the management of hypertension; 2) discussion of these results with patients may provide a means for altering patients' expectations and achieving improved treatment compliance; and 3) the processes by which clinical trials have achieved their dietary goals can provide health educators with extensive clinical experience upon which to draw in working with nonstudy patients. The content and general results of clinical trial programs are reviewed as well as features associated with health promotion in clinical trial and behavioral weight loss research.

Trial of antihypertensive interventions and management. Design, methods, and selected baseline results.

The Trial of Antihypertensive Interventions and Management was a multicenter randomized, placebo-controlled trial designed to assess the effectiveness of various combinations of pharmacologic and dietary interventions in the treatment of mild hypertension (diastolic blood pressure 90-100 mmHg). The primary outcome was blood pressure change between baseline and 6 months. The study consisted of a 3 X 3 factorial design wherein participants were randomly allocated to nine drug-diet treatment groups. Drugs included placebo, diuretic, and beta-blocker. Diets were usual, weight loss, and low sodium/high potassium. The basic strategy was to address clinical questions of interest by comparing mean blood pressure changes of selected drug-diet combinations. This paper describes the study including experimental design, sample size considerations, statistical analysis, organizational structure, and baseline findings.

Reduction of physiological, behavioral, and self-report responses in type A behavior: a preliminary report.

Recent reports indicate that Type A Behavior may be reducible by behavioral and other psychotherapeutic methods. To date, however, there has been virtually no demonstration of reduction of the actual, observed behavior. Furthermore, the physiologic hyperresponsiveness that seems to characterize many Type A individuals when under stress, has received relatively little therapeutic attention. This preliminary, uncontrolled report describes a cognitive-behavioral group intervention program, before and after which patients underwent assessment on physiologic, behavioral, and self-report assessments. These included heart rate and blood pressure responsiveness under stressful conditions, trained observer ratings of Type A Behavior, and a variety of subjective measures of Type A Behavior and psychological distress and symptoms. Results showed limited improvement on most behavioral and self-report indices. Relatively greater reduction of Type A Behavior was associated with higher pre-treatment levels of Type A Behavior, with the absence of coronary artery disease and with male gender.