Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis.

BACKGROUND: After a single-center trial and observational studies suggesting that early, goal-directed therapy (EGDT) reduced mortality from septic shock, three multicenter trials (ProCESS, ARISE, and ProMISe) showed no benefit. This meta-analysis of individual patient data from the three recent trials was designed prospectively to improve statistical power and explore heterogeneity of treatment effect of EGDT. METHODS: We harmonized entry criteria, intervention protocols, outcomes, resource-use measures, and data collection across the trials and specified all analyses before unblinding. After completion of the trials, we pooled data, excluding the protocol-based standard-therapy group from the ProCESS trial, and resolved residual differences. The primary outcome was 90-day mortality. Secondary outcomes included 1-year survival, organ support, and hospitalization costs. We tested for treatment-by-subgroup interactions for 16 patient characteristics and 6 care-delivery characteristics. RESULTS: We studied 3723 patients at 138 hospitals in seven countries. Mortality at 90 days was similar for EGDT (462 of 1852 patients [24.9%]) and usual care (475 of 1871 patients [25.4%]); the adjusted odds ratio was 0.97 (95% confidence interval, 0.82 to 1.14; P=0.68). EGDT was associated with greater mean (±SD) use of intensive care (5.3±7.1 vs. 4.9±7.0 days, P=0.04) and cardiovascular support (1.9±3.7 vs. 1.6±2.9 days, P=0.01) than was usual care; other outcomes did not differ significantly, although average costs were higher with EGDT. Subgroup analyses showed no benefit from EGDT for patients with worse shock (higher serum lactate level, combined hypotension and hyperlactatemia, or higher predicted risk of death) or for hospitals with a lower propensity to use vasopressors or fluids during usual resuscitation. CONCLUSIONS: In this meta-analysis of individual patient data, EGDT did not result in better outcomes than usual care and was associated with higher hospitalization costs across a broad range of patient and hospital characteristics. (Funded by the National Institute of General Medical Sciences and others; PRISM ClinicalTrials.gov number, NCT02030158 .).

Ecological Momentary Assessment in Behavioral Research: Addressing Technological and Human Participant Challenges.

BACKGROUND: Ecological momentary assessment (EMA) assesses individuals' current experiences, behaviors, and moods as they occur in real time and in their natural environment. EMA studies, particularly those of longer duration, are complex and require an infrastructure to support the data flow and monitoring of EMA completion. OBJECTIVE: Our objective is to provide a practical guide to developing and implementing an EMA study, with a focus on the methods and logistics of conducting such a study. METHODS: The EMPOWER study was a 12-month study that used EMA to examine the triggers of lapses and relapse following intentional weight loss. We report on several studies that informed the implementation of the EMPOWER study: (1) a series of pilot studies, (2) the EMPOWER study's infrastructure, (3) training of study participants in use of smartphones and the EMA protocol and, (4) strategies used to enhance adherence to completing EMA surveys. RESULTS: The study enrolled 151 adults and had 87.4% (132/151) retention rate at 12 months. Our learning experiences in the development of the infrastructure to support EMA assessments for the 12-month study spanned several topic areas. Included were the optimal frequency of EMA prompts to maximize data collection without overburdening participants; the timing and scheduling of EMA prompts; technological lessons to support a longitudinal study, such as proper communication between the Android smartphone, the Web server, and the database server; and use of a phone that provided access to the system's functionality for EMA data collection to avoid loss of data and minimize the impact of loss of network connectivity. These were especially important in a 1-year study with participants who might travel. It also protected the data collection from any server-side failure. Regular monitoring of participants' response to EMA prompts was critical, so we built in incentives to enhance completion of EMA surveys. During the first 6 months of the 12-month study interval, adherence to completing EMA surveys was high, with 88.3% (66,978/75,888) completion of random assessments and around 90% (23,411/25,929 and 23,343/26,010) completion of time-contingent assessments, despite the duration of EMA data collection and challenges with implementation. CONCLUSIONS: This work informed us of the necessary preliminary steps to plan and prepare a longitudinal study using smartphone technology and the critical elements to ensure participant engagement in the potentially burdensome protocol, which spanned 12 months. While this was a technology-supported and -programmed study, it required close oversight to ensure all elements were functioning correctly, particularly once human participants became involved.

Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic.

OBJECTIVES: To automatically populate the case report forms (CRFs) for an international, pragmatic, multifactorial, response-adaptive, Bayesian COVID-19 platform trial. METHODS: The locations of focus included 27 hospitals and 2 large electronic health record (EHR) instances (1 Cerner Millennium and 1 Epic) that are part of the same health system in the United States. This paper describes our efforts to use EHR data to automatically populate four of the trial's forms: baseline, daily, discharge, and response-adaptive randomization. RESULTS: Between April 2020 and May 2022, 417 patients from the UPMC health system were enrolled in the trial. A MySQL-based extract, transform, and load pipeline automatically populated 499 of 526 CRF variables. The populated forms were statistically and manually reviewed and then reported to the trial's international data coordinating center. CONCLUSIONS: We accomplished automatic population of CRFs in a large platform trial and made recommendations for improving this process for future trials.

Longitudinal relationship between physical activity and cardiometabolic factors in overweight and obese adults.

Few studies have reported longitudinal relationships between physical activity (PA) and cardiometabolic risk factors over time using repeated assessments in overweight or obese adults. We conducted a longitudinal study in 127 participants (81% with body mass index > 30 kg/m(2)) who completed a 12-month behavioral intervention for weight loss between 2003 and 2005 in Pittsburgh, PA, USA. Using absolute change scores from baseline to each time point (i.e., 6 and 12 months) for all studied variables (Delta = time point - baseline), we performed mixed effects modeling to examine relationships between PA and cardiometabolic risk factors, after adjusting for body weight, energy intake and other covariates (i.e., age, gender, and ethnicity). PA was assessed as energy expenditure (kcal/week) using the Paffenbarger activity questionnaire. Over the 12-month period, energy expenditure increased (Delta1,370 kcal/week at 6 months vs. Delta886 kcal/week at 12 months); body weight decreased (Delta8.9 kg at 6 months vs. Delta8.4 kg at 12 months). The average increase in energy expenditure over 12 months was significantly and independently related to reductions in total cholesterol (F = 6.25, p = 0.013), low-density lipoprotein cholesterol (LDL-C) (F = 5.08, p = 0.025) and fasting blood glucose (F = 5.10, p = 0.025), but not to other risk factors (i.e., fasting insulin, high-density lipoprotein cholesterol, triglycerides, and waist circumference). In conclusion, among overweight and obese adults undergoing a weight loss intervention, increased energy expenditure over 12 months may improve total cholesterol and LDL-C, important coronary risk factors, and fasting blood glucose, a metabolic risk factor.

A descriptive study of past experiences with weight-loss treatment.

BACKGROUND: Overweight and obesity affect more than 60% of the adult population in the United States. Most adults who are overweight have a history of previous weight-loss treatment. Exploring individuals' past experiences with weight-loss treatment may allow improvements to the current approach to treatment. OBJECTIVE: To examine individuals' prior experiences with weight-loss treatment, their treatment preferences, and what they found to be most and least satisfying. DESIGN: Cross-sectional descriptive study. SUBJECTS/SETTING: Individuals (N=155) who had registered for a weight-loss study wait list and met standard criteria for a weight-loss program (aged 18 to 55 years and body mass index between 25 and 42). METHODS: Questionnaire packets were mailed to participants. STATISTICAL ANALYSES PERFORMED: Descriptive analyses of the participants' past history with weight-loss treatment, treatment preference, self-efficacy, therapeutic efficacy, barriers to adherence to weight-loss treatment, barriers to healthy eating, and experiences associated with following a low-fat diet. RESULTS: One hundred ten participants (71%) returned completed questionnaire packets. The sample (82% white, 84% female, aged 42.6+/-8.5 years, and body mass index 33.5+/-5.3) was representative of those who seek weight-loss treatment in research settings. Participants were, on average, aged 21.1+/-8.9 years when they first tried a weight-loss program; 96.3% had tried to lose weight since that first time. The two most frequently tried programs were doing it on their own (93.5%) and commercial programs (70.8%). Barriers included having trouble controlling what I eat when hungry (71.3%), difficulty motivating myself to eat appropriately (66.2%), and using food as a reward (59.3%). Preferred weight-loss regimens were doing it on their own (30.6%) and a research program (22.4%). CONCLUSIONS: Participants were not seeking their preferred treatment. These data can be used to improve weight-loss programs by tailoring programs to meet the needs and preferences of participants.

Using instrumented paper diaries to document self-monitoring patterns in weight loss.

Self-monitoring of eating is associated with successful weight loss, but adherence is imperfect and deteriorates over time. Moreover, intentionally or not, many individuals have difficulty keeping faithful records. We used instrumented paper diaries (IPDs) to study self-monitoring in randomly chosen participants in the PREFER trial, a behavioral treatment for weight-loss study. The diaries they used to self-report eating were periodically replaced with IPDs at various times during an 18-month weight-loss program, consisting of three successive phases: intense treatment (n=35), less-intense treatment (n=13), and maintenance (n=16). We compared electronically documented self-monitoring data, showing when and how often IPDs were used, with self-reported data, then compared the electronically validated adherence and weight loss. Self-reported diary usage exceeded IPD-documented usage while the electronic data demonstrated a significant decline in self-monitoring over time. Diary recording often was not timely. Percentage weight lost correlated significantly with frequency of IPD use (p=.001) and the number of diary entries made within 15 min of opening the IPD (p=.002). This is the first study to document patterns of self-monitoring among participants in a weight-loss program, which demonstrated that individuals may falsify the times and frequency of self-monitoring. Furthermore, our results showed that adherence to self-monitoring and the timeliness of recording significantly correlate with improved weight loss.

Changes in self-efficacy and dietary adherence: the impact on weight loss in the PREFER study.

Findings from studies examining self-efficacy and its relationship to weight loss have been inconsistent. We examined self-efficacy specific to changing eating behaviors in the PREFER trial, an 18-month behavioral weight-loss study, to determine if self-efficacy and dietary adherence were associated with weight change, and what impact self-efficacy had on weight change after controlling for adherence. Measurements included the weight efficacy lifestyle (WEL) questionnaire, body weight, self-reported fat gram intake, kilocalorie intake, and adherence to kilocalorie and fat gram goals at baseline, 6, 12, and 18 months. The sample (N = 170) was 88.2% female and 70.0% Caucasian; the mean age was 44.1 years (SD = 8.8). Mean weight loss at 18 months was 4.64% (SD = 6.24) of baseline body weight and the mean increase in self-efficacy was 11.70% (SD = 38.61). Self-efficacy improved significantly over time (p = 0.04) and was associated with weight loss (p = 0.02). Adherence to the fat gram goal was associated with weight loss (p = 0.0003), and self-efficacy remained associated with weight loss after controlling for fat gram adherence (p = 0.0001). Consistent with self-efficacy theory, improvement in self-efficacy over time supported greater weight loss. Adherence to the fat gram goal also influenced weight loss.

Effects of a vegetarian diet and treatment preference on biochemical and dietary variables in overweight and obese adults: a randomized clinical trial.

BACKGROUND: A vegetarian diet may lead to numerous health benefits, including weight loss. OBJECTIVE: We examined the joint effects of personal preference of dietary treatment and a calorie-restricted, low-fat lactoovovegetarian diet (LOV-D) compared with a standard calorie-restricted, low-fat omnivorous diet (STD-D) on changes in weight, total cholesterol, ratio of LDL to HDL cholesterol (LDL:HDL cholesterol), triacylglycerols, insulin resistance, and macronutrient intake during an 18-mo study. DESIGN: This was a randomized clinical trial of 176 overweight and obese adults who were recruited and randomly assigned first to 1 of 2 preference conditions (yes or no). If assigned to Preference-No, they were randomly assigned to 1 of the 2 diet conditions (STD-D or LOV-D). If assigned to Preference-Yes, they were assigned to the diet they indicated as preferred at screening. The 12-mo intervention was followed by a 6-mo maintenance phase. RESULTS: Participants were mainly women (86.9%) and white (70.5%); 75% completed the 18-mo study. A significant interaction between preference and dietary treatment was not observed for any of the outcome variables. However, participants in the Preference-No groups significantly decreased their triacylglycerols (P = 0.04). The only effect observed for diet was a borderline significant decrease in LDL:HDL cholesterol for the LOV-D group (P = 0.06). Within the LOV-D groups, those who were 100% adherent to the LOV-D had significant and marginally significant reductions in monounsaturated fat (P = 0.02) and total fat (P = 0.05) intakes at 18 mo. CONCLUSIONS: Our findings suggest that neither prescribing a vegetarian diet nor allowing persons to choose their preferred diet had a significant effect on outcome measures. However, all participants had a significant reduction in total energy and fat intakes and an increase in energy expenditure, which was reflected in reduced body weight. This clinical trial was registered at www.clinicaltrials.gov as NCT00330629.

The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring.

Self-monitoring (SM) of food intake is central to weight loss treatment. Technology makes it possible to reinforce this behavior change strategy by providing real-time feedback (FB) tailored to the diary entry. To test the feasibility of providing 1-4 daily FB messages tailored to dietary recordings via a smartphone, we conducted a 12-week pilot randomized clinical trial in Pittsburgh, PA in US in 2015. We compared 3 groups: SM using the Lose It! smartphone app (Group 1); SM + FB (Group 2); and SM + FB + attending three in-person group sessions (Group 3). The sample (N = 39) was mostly white and female with a mean body mass index of 33.76 kg/m2. Adherence to dietary SM was recorded daily, weight was assessed at baseline and 12 weeks. The mean percentage of days adherent to dietary SM was similar among Groups 1, 2, and 3 (p = 0.66) at 53.50% vs. 55.86% vs. 65.33%, respectively. At 12 weeks, all groups had a significant percent weight loss (p < 0.05), with no differences among groups (- 2.85% vs. - 3.14% vs. - 3.37%) (p = 0.95); 26% of the participants lost ≥ 5% of their baseline weight. Mean retention was 74% with no differences among groups (p = 0.37). All groups adhered to SM at levels comparable to or better than other weight loss studies and lost acceptable amounts of weight, with minimal intervention contact over 12 weeks. These preliminary findings suggest this 3-group approach testing SM alone vs. SM with real-time FB messages alone or supplemented with limited in-person group sessions warrants further testing in a larger, more diverse sample and for a longer intervention period.

Ancillary study to the PREFER trial: a descriptive study of participants' patterns of self-monitoring--rationale, design and preliminary experiences.

BACKGROUND: The treatment of obesity, marked by a high rate of recidivism, lacks strategies that sustain the improved lifestyle behaviors that led to the weight loss. Self-monitoring, a behavioral strategy to increase awareness of one's behavior, is the cornerstone of behavioral treatment in weight loss management. However, adherence to self-monitoring is less than ideal. The actual patterns of self-monitoring of eating behaviors in weight loss treatment programs have not been studied previously; if done, these data could provide information on how self-monitoring patterns affect weight loss and if interventions can be developed that address deficits in self-monitoring. Technology now permits an instrumented paper-and-pencil diary to record the real time of individuals' self-monitoring behaviors (invivodata, inc.), thus providing more information about self-reported behaviors. This technology differs from PDA based products (ex. e-diary, e-trials, logpad, PICS) because, to the user, it is no different from a standard paper-and-pencil diary. METHODS: The purposes of this ancillary study are: (1) to describe the electronically recorded patterns of self-monitoring of eating behaviors by weight-loss study participants; (2) compare reported vs. electronically recorded self-monitoring; and (3) examine the relationship between the electronically validated adherence to self-monitoring goals and success in weight loss in a sub-sample of participants in the PREFER study. This paper describes the design, methods and preliminary 6-month results. RESULTS: Preliminary results reveal that participants frequently report recording their eating behavior during times when the binder was not opened. Two examples of data are shown that demonstrate the lack of concordance between the self-reported and the electronically recorded data. CONCLUSIONS: These unobtrusively collected electronic data can lead to the development of strategies that can promote improved adherence to self-monitoring.

PREFER study: a randomized clinical trial testing treatment preference and two dietary options in behavioral weight management--rationale, design and baseline characteristics.

BACKGROUND: Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach to the treatment of obesity is standard behavioral treatment. This approach includes behavior modification related to eating and activity habits. The purpose of this paper is to describe the rationale, design, methods and baseline sample characteristics of a randomized controlled trial of a behavioral intervention in weight loss management, referred to as the PREFER study. METHODS: The PREFER study, using a four-group design, includes: (1) a randomization scheme that permits participants to indicate a preferred dietary treatment approach, and (2) two dietary options, one of which is a lacto-ovo-vegetarian diet that has demonstrated potential for long-term adherence. The intervention (32 treatment sessions) is delivered over 12 months and is followed by a 6-month maintenance phase; final assessment occurs at 18 months. RESULTS: We screened 932 individuals and randomized 197 to the study: Treatment Preference-Yes (n=84) and Treatment Preference-No (n=98). To maintain a balance across the four treatment groups, 15 subjects who preferred the standard diet had to be discarded from the Treatment Preference-Yes group. Retention at 18 months for the first of three cohorts was 82%. CONCLUSIONS: The PREFER study is a single center study and is the first randomized controlled trial examining a lacto-ovo-vegetarian diet as part of weight loss treatment. The ethnically diverse sample includes males and females with a body mass index of 27 to 43. The study has the potential to make a contribution to understanding the role of treatment preference and the potential of a lacto-ovo-vegetarian diet for long-term weight loss.

Self-monitoring dietary intake: current and future practices.

This article reviews the literature on the use of paper diaries for self-monitoring food intake, identifies the strengths and limitations of paper-and-pencil diaries and their new counterpart, the electronic diary or personal digital assistant (PDA), and reports how participants were trained to use a PDA with dietary software in two pilot studies--one with hemodialysis patients and the other with participants in a weight loss study. The report of the pilot studies focuses on the practical issues encountered in training participants in the use of a PDA and addresses the pros and cons of different dietary software programs. Six hemodialysis patients were trained in the first study and seven participants attempting to lose or maintain their weight were trained in the second pilot study. The training focused on how to use a PDA and how to navigate the dietary software to self-monitor food intake. The goals of using the PDA were to improve adherence to the therapeutic diets and to self-monitoring. Lessons learned from the pilot studies are shared.

The SELF trial: A self-efficacy-based behavioral intervention trial for weight loss maintenance.

OBJECTIVE: The SELF Trial examined the effect of adding individual self-efficacy (SE) enhancement sessions to standard behavioral weight loss treatment (SBT). METHODS: Participants were randomly assigned to SBT or SBT plus SE sessions (SBT+SE). Outcome measures were weight loss maintenance, quality of life, intervention adherence, and self-efficacy at 12 and 18 months. RESULTS: The sample (N = 130) was female (83.08%) with a mean (SD) body mass index of 33.15 (4.11) kg m(2) . There was a significant time effect for percent weight change (P = 0.002) yet no significant group or group-by-time effects. The weight loss for the SBT+SE group was 8.38% (7.48) at 12 months and 8.00% (7.87) at 18 months, with no significant difference between the two time points (P = 0.06). However, weight loss for the SBT group was 6.95% (6.67) at 12 months and 5.96% (7.35) at 18 months, which was significantly different between the two time points (P = 0.005), indicating that the SBT group had significant weight regain. CONCLUSIONS: Both groups achieved clinically significant weight loss. The group receiving an intervention targeting enhanced self-efficacy had greater weight loss maintenance whereas the SBT group demonstrated significant weight regain possibly related to the greater attention provided to the SBT+SE group.

Salivary gonadal and adrenal hormone differences in boys and girls with and without disruptive behavior disorders: Contextual variants.

Hormone differences by psychopathology group and gender may have implications for understanding disruptive behavior disorders (DBDs) and complexities of treatment outcomes. Current theoretical models emphasize contextual differences as moderators of hormone-behavior relations. This baseline report examined: (a) hormone differences in youth with and without DBD, and (b) contextual factors as moderators of behavior problems and hormones. 180 children and adolescents were enrolled (141 boys, mean 9.0+/-1.7 years). DBD participants met criteria for conduct disorder (CD) and/or oppositional defiant disorder (ODD) (n=111); 69 were recruited as healthy comparisons (HC). Saliva was collected for testosterone, cortisol, dehydroepiandrosterone and androstenedione. DBD youth had significantly higher androstenedione than the HC group. There was a group by gender interaction for basal cortisol mean with DBD boys and HC girls having lower cortisol. Moderating effects of contextual variables (e.g., family functioning, delinquent peers) were noted for cortisol and adrenal androgens. Findings argue for considering hormones as an influence on DBD beyond simple direct one-to-one associations.

Adherence to a behavioral weight loss treatment program enhances weight loss and improvements in biomarkers.

OBJECTIVES: To describe participants' adherence to multiple components (attendance, energy intake, fat gram, exercise goals, and self-monitoring eating and exercise behaviors) of a standard behavioral treatment program (SBT) for weight loss and how adherence to these components may influence weight loss and biomarkers (triglycerides, low density lipoproteins [LDL], high density lipoprotein, and insulin) during the intensive and less-intensive intervention phases. METHODS: A secondary analysis of a randomized clinical trial consisting of a SBT with either fat-restricted standard or lacto-ovo vegetarian diet. The 12-month intervention was delivered in 33 group sessions. The first six months reflected the intensive phase; the second six months, the less-intensive intervention phase. We conducted the analysis without regard to treatment assignment. Eligible participants included overweight/obese adults (N = 176; mean body mass index = 34.0 kg/m(2)). The sample was 86.9% female, 70.5% White, and 44.4 +/- 8.6 years old. The outcome measures included weight and biomarkers. RESULTS: There was a significant decline in adherence to each treatment component over time (P < 0.0001). In the first six months, adherence to attendance, self-monitoring and the energy goal were significantly associated with greater weight loss (P < 0.05). Adherence to attendance and exercise remained significantly associated with weight loss in the second six months (P < 0.05). Adherence to attendance, self-monitoring and exercise had indirect effects through weight loss on LDL, triglycerides, and insulin (P < 0.05). CONCLUSIONS: We observed a decline in adherence to each treatment component as the intervention intensity was reduced. Adherence to multiple treatment components was associated with greater weight loss and improvements in biomarkers. Future research needs to focus on improving and maintaining adherence to all components of the treatment protocol to promote weight loss and maintenance.

SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings.

BACKGROUND: The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA). This paper describes the design, methods, intervention, and baseline sample characteristics of the SMART trial. METHODS: The SMART trial used a 3-group design to determine the effects of different modes of self-monitoring on short- and long-term weight loss and on adherence to self-monitoring in a 24-month intervention. Participants were randomized to one of three conditions (1) use of a standard paper record (PR); (2) use of a PDA with dietary and physical activity software (PDA); or (3), use of a PDA with the same software plus a customized feedback program (PDA + FB). RESULTS: We screened 704 individuals and randomized 210. There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure. At 24 months, retention rate for the first of three cohorts was 90%. CONCLUSIONS: To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component.

A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management: preliminary results of the impact of diet at 6 months--PREFER study.

OBJECTIVE: The PREFER study objectives were to examine potential differences in weight loss during a standard behavioral intervention between subjects assigned to one of two calorie- and fat-restricted diets [standard behavior treatment (SBT) and lacto-ovo-vegetarian ([SBT+LOV)], with or without regard to their preferred dietary treatment. This article reports the differences in outcomes between diet groups after the first 6 months of the intervention. RESEARCH METHODS AND PROCEDURES: The study used a four-group design. Subjects (n = 182) were randomized to a treatment preference group and then to a dietary treatment group. For this report, preference groups were combined to permit comparisons by dietary treatment only (SBT, n = 98; SBT+LOV, n = 84). Additional analyses compared SBT+LOV subjects who were 100% adherent (did not consume any meat, fish, or poultry, n = 47) to those who were <100% adherent (n = 24). RESULTS: Significant differences were seen in the baseline to 6-month change scores between the two groups for carbohydrate consumption (p = 0.013), protein consumption (p < 0.001), polyunsaturated-to-saturated fat ratio (p = 0.009), and low-density lipoprotein-cholesterol (LDL-C) level (p = 0.013). Among SBT+LOV subjects, those who were 100% adherent experienced greater reductions in weight (p < 0.001), total cholesterol (p = 0.026), LDL-C (p = 0.034), and glucose (p = 0.002) and consumed less fat (p = 0.030) compared with those who were <100% adherent. DISCUSSION: Differences between dietary treatment groups at 6 months were minimal, most likely because one-third of the SBT+LOV group did not follow the vegetarian diet and because both groups had the same calorie and fat restrictions. SBT+LOV subjects who were 100% adherent were more successful at both weight loss and cholesterol reduction than those who were <100% adherent, suggesting that vegetarian diets are efficacious for weight and cholesterol control.

Evaluation of the shortened Cholesterol-Lowering Diet Self-Efficacy Scale.

Specificity in the self-efficacy construct requires that instruments assess domain-specific behaviors. The objectives of the study were to (1) reexamine and shorten the original 57-item Cholesterol-Lowering Diet Self-Efficacy Scale (CLDSES), (2) estimate reliability and validity of the short form CLDSES (CLDSES-SF), (3) examine the dimensionality of the CLDSES-SF, (4) examine discriminant validity of the scale by its ability to differentiate between adherence and nonadherence to saturated fat intake guidelines, and (5) examine the CLDSES-SF's sensitivity and specificity. A sample of 238 patients being treated for hypercholesterolemia completed three instruments: the CLDSES, the Connor Diet Habit Survey (DHS) and a Three-Day Food Record. Internal consistency for the CLDSES-SF was .95. The inter-correlation coefficients among the seven sub-scales ranged from .28 to .62, and for the total to sub-scales .58 - .87, significant at p < .001. Evidence for criterion validity was shown in the correlations between the CLDSES-SF and the Connor DHS scores and between the CLDSES-SF and the Three-Day Food Record. Factor analysis showed a one-factor model that fits the data with a sufficient amount of total variance explained among the seven subscale items in each subscale, providing evidence of the uni-dimensionality of each subscale. Sensitivity (76%) and specificity (63%) for the CLDSES-SF were good with 88% positive predictive value for adherence. The shortened CLDSES retained its good psychometric properties and remains comprehensive in its assessment of self-efficacy for adherence to a cholesterol-lowering diet.