Background: Cardiopulmonary fitness and low calorie diets have been shown to reduce inflammation but few studies have been conducted in individuals with elevated blood pressure (BP) in a randomized intervention setting. Thereby, adhesion biomarkers, e.g., soluble intercellular adhesion molecule (sICAM)-3, have not been examined so far. Methods: Sixty-eight sedentary prehypertensive and mildly hypertensive individuals (mean age ± SEM: 45 ± 1 years; mean BP: 141/84 ± 1/1 mmHg) were randomized to one of three 12-week intervention groups: cardio training and caloric reduction, cardio training alone, or wait-list control group. Plasma levels of inflammatory, adhesion and prothrombotic biomarkers were assessed. In a second step, intervention groups were combined to one sample and multivariate regression analyses were applied in order to account for exercise and diet behavior changes. Results: There were no significant differences among the intervention groups. In the combined sample, greater caloric reduction was associated with a larger increase of sICAM-3 (p = 0.026) and decrease of C-reactive protein (p = 0.018) as a result of the interventions. More cardio training was associated with increases of sICAM-3 (p = 0.046) as well as interleukin-6 (p = 0.004) and a decrease of tumor necrosis factor-α (p = 0.017) levels. Higher BP predicted higher plasminogen activator inhibitor (PAI)-1 (p = 0.001), and greater fitness predicted lower PAI-1 levels (p = 0.006) after the intervention. Conclusions: In prehypertensive and hypertensive patients, plasma levels of the adhesion molecule sICAM-3 and inflammatory biomarkers have different response patterns to cardio training with and without caloric reduction. Such anti-inflammatory and anti-thrombotic effects may have implications for the prevention of atherothrombotic cardiovascular disease among individuals at increased risk.

Primary care-based approaches to address concurrent obesity and cardiovascular disease risk factors (CVDRFs) that begin with a high intensity intervention that is subsequently decreased (i.e., stepped-down) if weight loss is achieved have not been rigorously examined. Our study is a 20-month, single-blind randomized controlled trial at five primary care clinics in San Diego, CA, in 2013, where 262 obese adults (aged 25-70 years; 32.1% male; 59.2% white) with at least one CVDRF were enrolled into planned care for obesity and risk reduction (PCORR) using a stepped-down approach or enhanced usual care (EUC). All patients received physician recommendations for weight loss and CVDRFs. EUC patients (n = 132) received an individual session with a health educator every 4 months. PCORR patients (n = 130) received individual and group sessions (in-person, mail, telephone, and email) in three steps, characterized by less contact if success was achieved. At 20 months, 40.7%, 23.8%, and 15.4% of PCORR patients were in steps 1, 2, and 3, respectively (25.2% were lost to follow-up). PCORR resulted in a between-group difference in reduction in body weight of 6.1% [95% Cl, 5.3 to 6.9] compared to EUC 2.8% [95% CI, 2.0 to 3.6] p = 0.007, with a greater reduction in BMI (35.2 [95% CI, 34.4 to 35.9] to 33.7 [95% CI, 32.9 to 34.5] kg/m(2)) than EUC (36.0 [95% CI, 35.3 to 36.8] to 35.1 [95% CI, 34.3 to 35.9] kg/m(2)), as indicated by a significant treatment by time interaction (p = 0.009). PCORR resulted in greater weight loss over 20 months than EUC. Trial Registration: ClinicalTrials.gov, NCT01134029

Background Few weight loss interventions are evaluated for longer than a year, and even fewer employ social and mobile technologies commonly used among young adults. We assessed the efficacy of a 2 year, theory-based, weight loss intervention that was remotely and adaptively delivered via integrated user experiences with Facebook, mobile apps, text messaging, emails, a website, and technology-mediated communication with a health coach (the SMART intervention).Methods In this parallel-group, randomised, controlled trial, we enrolled overweight or obese college students (aged 18-35 years) from three universities in San Diego, CA, USA. Participants were randomly assigned (1:1) to receive either the intervention (SMART intervention group) or general information about health and wellness (control group). We used computer-based permuted-block randomisation with block sizes of four, stratified by sex, ethnicity, and college. Participants, study staff, and investigators were masked until the intervention was assigned. The primary outcome was objectively measured weight in kg at 24 months. Differences between groups were evaluated using linear mixed-effects regression within an intention-to-treat framework. Objectively measured weight at 6, 12, and 18 months was included as a secondary outcome. The trial is registered with ClinicalTrials. gov, number NCT01200459.Findings Between May 18, 2011, and May 17, 2012, 404 individuals were randomly assigned to the intervention (n=202) or control (n=202). Participants' mean (SD) age was 22.7 (3.8) years. 284 (70%) participants were female and 125 (31%) were Hispanic. Mean (SD) body-mass index at baseline was 29.0 (2.8) kg/m(2). At 24 months, weight was assessed in 341 (84%) participants, but all 404 were included in analyses. Weight, adjusted for sex, ethnicity, and college, was not significantly different between the groups at 24 months (-0.79 kg [ 95% CI -2.02 to 0 . 43], p=0.204). However, weight was significantly less in the intervention group compared with the control group at 6 months (-1.33 kg [95% CI -2.36 to -0.30], p=0.011) and 12 months (-1.33 kg [-2.30 to -0.35], p=0 .008), but not 18 months (-0.67 kg [95% CI -1.69 to 0.35], p=0.200). One serious adverse event in the intervention group (gallstones) could be attributable to rapid and excessive weight loss.Interpretation Social and mobile technologies did not facilitate sustained reductions in weight among young adults, although these approaches might facilitate limited short-term weight loss.

Advances in information technology and near ubiquity of the Internet have spawned novel modes of communication and unprecedented insights into human behavior via the digital footprint. Health behavior randomized controlled trials (RCTs), especially technology-based, can leverage these advances to improve the overall clinical trials management process and benefit from improvements at every stage, from recruitment and enrollment to engagement and retention. In this paper, we report the results for recruitment and retention of participants in the SMART study and introduce a new model for clinical trials management that is a result of interdisciplinary team science. The MARKIT model brings together best practices from information technology, marketing, and clinical research into a single framework to maximize efforts for recruitment, enrollment, engagement, and retention of participants into a RCT. These practices may have contributed to the study's on-time recruitment that was within budget, 86% retention at 24 months, and a minimum of 57% engagement with the intervention over the 2-year RCT. Use of technology in combination with marketing practices may enable investigators to reach a larger and more diverse community of participants to take part in technology-based clinical trials, help maximize limited resources, and lead to more cost-effective and efficient clinical trial management of study participants as modes of communication evolve among the target population of participants.

Treatment for stable ischemic heart disease may include guideline-directed pharmacologic therapy, coronary revascularization, and lifestyle and behavioral changes, including structured exercise. Of these, regular exercise is arguably one of the most cost-effective yet underused interventions. Most patients with stable ischemic heart disease are eligible for secondary prevention programs, which should include exercise training regimens, but participation in such programs remains suboptimal. This review emphasizes the importance of education for both patients and providers to enhance participation in lifestyle physical activity, structured exercise, or both.

Introduction: Unhealthy weight loss practices are common among female college students. It is unknown if these practices are also most common among women in the subset of overweight or obese college students or if these practices are related to depression. We examined the relationship between gender, depression, and unhealthy weight loss practices among overweight or obese college students.Methods: Students (body mass index between 25.0 and 34.9 kg/m(2)) from three Southern California universities (M-age = 22 years, SD = 4; 70% women) were recruited from May 2011 to May 2012 for participation in a weight loss clinical trial (N = 404). Logistic regressions were performed with baseline data to assess the cross-sectional relationship between self-reported unhealthy weight loss practices and gender and depression as measured by the Center for Epidemiologic Studies Depression short form.Results: Twenty-nine percent of participants reported engaging in at least one unhealthy weight loss behavior (e.g., fasting, purging) over the last 30 days, with no differences by gender. Self-report of at least one unhealthy weight loss behavior was associated with report of symptoms of depression (e(B) = 1.14 [confidence interval, Cl: 1.08-1.201), adjusting for potential confounders. Interactions between gender and depression were not significant (e(B) = 1.04 [CI: 0.93-1.16]).Conclusion: Among an overweight or obese sample of college students, unhealthy weight loss practices were equally common in both genders, and students with depressive symptomatology were at greatest risk. Obesity interventions targeting overweight or obese college students should educate both men and women about the dangers of unhealthy weight loss practices. In addition, screening for depression can help identify students who would benefit from additional supportive and coping strategies and resources. (C) 2014 Elsevier Ltd. All rights reserved.

Background: Overweight or obesity is prevalent among college students and many gain weight during this time. Traditional face-to-face weight loss interventions have not worked well in this population. Facebook is an attractive tool for delivering weight loss interventions for college students because of its popularity, potential to deliver strategies found in successful weight loss interventions, and ability to support ongoing adaptation of intervention content. Objective: The objective of this study was to describe participant exposure to a Facebook page designed to deliver content to overweight/obese college students in a weight loss randomized controlled trial (N=404) and examine participant engagement with behavior change campaigns for weight loss delivered via Facebook. Methods: The basis of the intervention campaign model were 5 self-regulatory techniques: intention formation, action planning, feedback, goal review, and self-monitoring. Participants were encouraged to engage their existing social network to meet their weight loss goals. A health coach moderated the page and modified content based on usage patterns and user feedback. Quantitative analyses were conducted at the Facebook post- and participant-level of analysis. Participant engagement was quantified by Facebook post type (eg, status update) and interaction (eg, like) and stratified by weight loss campaign (sequenced vs nonsequenced). A subset of participants were interviewed to evaluate the presence of passive online engagement or “lurking.” Results: The health coach posted 1816 unique messages to the study’s Facebook page over 21 months, averaging 3.45 posts per day (SD 1.96, range 1-13). In all, 72.96% (1325/1816) of the posts were interacted with at least once (eg, liked). Of these, approximately 24.75% (328/1325) had 1-2 interactions, 23.39% (310/1325) had 3-5 interactions, 25.13% (333/1325) had 6-8 interactions, and 41 posts had 20 or more interactions (3.09%, 41/1325). There was significant variability among quantifiable (ie, visible) engagement. Of 199 participants in the final intervention sample, 32 (16.1%) were highly active users and 62 (31.2%) never visibly engaged with the intervention on Facebook. Polls were the most popular type of post followed by photos, with 97.5% (79/81) and 80.3% (386/481) interacted with at least once. Participants visibly engaged less with posts over time (partial r=–.33; P<.001). Approximately 40% of the participants interviewed (12/29, 41%) reported passively engaging with the Facebook posts by reading but not visibly interacting with them. Conclusions: Facebook can be used to remotely deliver weight loss intervention content to college students with the help of a health coach who can iteratively tailor content and interact with participants. However, visible engagement with the study’s Facebook page was highly variable and declined over time. Whether the level of observed engagement is meaningful in terms of influencing changes in weight behaviors and outcomes will be evaluated at the completion of the overall study.

Background: Obese adolescents are at risk for type 2 diabetes mellitus (T2DM). Obesity interventions delivered through media, such as the web and text messages [short message service (SMS)] may be beneficial when targeting obese adolescents. Methods: A randomized controlled trial, Pace-Internet for Diabetes Prevention Intervention (PACEi-DP), compared three forms of an obesity intervention to usual care (UC): (a) website only (W); (b) website, monthly group sessions, and follow-up calls (WG); and (c) website and SMS (WSMS). Participants were overweight or obese adolescents at risk for T2DM ( n = 101; age 12–16 years; mean body mass index (BMI) percentile = 97.6; 74.3% Hispanic). In addition to the website, WSMS participants received SMS supporting intervention goals and behavioral strategies and communicated via SMS with a case manager. WG participants had additional group activities related to weight loss and received follow-up calls from a health coach. UC participants were given printed materials and encouraged to attend three initial group sessions. Repeated measures mixed model regression analyses tested treatment effects for anthropometric, behavioral, and behavioral change strategy outcomes. Results: There were no treatment effects for BMI, adiposity, physical activity, or diet at 12 months. Treatment effects were observed for sedentary behavior, with the W arm having a greater decrease in sedentary behavior (4.9 to 2.8 h/day) than the UC arm ( p = .006). Conclusion: Although not sufficient to produce weight loss, the combination of web intervention and group sessions with telephone follow-up yielded improvements in sedentary behavior and in the use of behavior change strategies expected to lead to behavior change.

Objective. Interventions to promote physical activity (PA) and healthy diet that are (a) conducted in a primary care setting, (b) based on theories of behavioral change, and (c) of long duration (>1 year) are recommended but few exist. We tested the effect, after 2 years of treatment, of a multicomponent intervention designed to promote PA and healthy diet among 819 adolescents between the ages of 11 and 15 years from San Diego. Methods. Treatment effects were assessed using sex-specific repeated-measures mixed model analyses. All behaviors measured were based on self-report. Results. After 2 years of treatment, boys in the intervention group maintained improved consumption of fruits and vegetables whereas the control group did not ( P = .006). Two-year treatment effects were also observed for sedentary behaviors in both boys ( P < .0001) and girls ( P = .012). Satisfaction with the program was high and of the intervention components, counselor calls were most liked, parental guidance was perceived as most valuable, and tip sheets were the most used. Conclusion: Two years of a primary care–based intervention that focus on behavioral change strategies, counselor calls, and parental guidance reduced sedentary behavior and increased boys’ fruit and vegetable consumption.

Objective: To investigate predictors of exercise adherence to a 12-week exercise intervention for sedentary women and men with elevated blood pressure (BP). Methods: Fifty-one otherwise healthy and unmedicated adults (27 women and 24 men) with elevated BP (>= 120/80 mmHg but <179/109 mmHg) participated in a 12-week exercise intervention involving cardiovascular and strength training. Participants kept weekly exercise logs detailing minutes spent exercising each week. The following were assessed before and after the intervention: cardiorespiratory fitness (in mL/kg/min), body mass index (BMI), level of habitual physical activity, physical fatigue, self-efficacy for exercise habits, and social support. Results: Regression analysis revealed that mean exercise minutes/week were predicted by higher age (p < .05), higher cardiorespiratory fitness (p < .05), and a gender by physical fatigue interaction (p < .01; R-2 = 0.34, F = 3.248, p < .01). Women who reported higher physical fatigue prior to the intervention spent more time exercising during the 12-week intervention than those with lower levels of physical fatigue. This relationship persisted after controlling for age, BMI, cardiorespiratory fitness, level of habitual physical activity prior to the intervention, self-efficacy for exercise habits, and social support (p < .01). The gender by physical fatigue interaction explained 13.9% of the variance in mean minutes exercised/week above and beyond the effects of covariates. Conclusion: Both gender and fatigue should be considered when developing exercise interventions, such that more initial physical fatigue in women is associated with a tendency to devote greater amounts of time to exercising.

A hypercoagulable state is a potential mechanism linking elevated blood pressure (BP), adiposity and a sedentary lifestyle to development of coronary heart disease (CHD). We examined relationships among aerobic fitness and adiposity in 76 sedentary subjects with elevated BP. Blood levels of plasminogen activator inhibitor-1 (PAI-1), D-dimer, von Willebrand factor (vWF) and thrombomodulin were assessed as biomarkers of coagulation. In individuals with elevated BP, percent body fat and fitness were associated with biomarkers indicative of a hypercoagulable state, even after demographic and metabolic factors were considered. D-dimer was positively associated with percent body fat (beta=0.37, p=0.003). PAI-1 was higher in men than in women (beta=-0.31, p=0.015) and associated with lower VO2peak (beta=-0.35, p=0.024). Thrombomodulin was positively associated with VO2peak (beta=0.56, p< 0.01). vWF was not significantly associated with fitness or adiposity. Our results emphasise that both percent body fat and physical fitness are important in the maintenance of haemostatic balance.

Objective. Text-messaging shows promise as a health intervention. This randomized controlled trial evaluated a daily text-messaging weight loss intervention.Methods. Overweight and obese adults (n = 170) in California were randomized to receive daily interactive and personally weight-relevant text-messages or monthly e-newsletters. Participants were measured at baseline, 6 and 12 months. Group differences were assessed in weight loss. Relation of text-messaging adherence to weight loss and change in pedometer steps was examined.Results. There were no group differences in weight loss over 6 (1.53 lb vs 3.72 lb) or 12 months (2.27 lb vs 3.64 lb; control vs intervention). Text-messaging adherence was moderately strong (60-69%). Participants with greater adherence lost more weight at 6 (p = .039) and 12 months (p = .023) than those who were less adherent. Intervention participants' steps increased almost 3000 steps/day over time (p<.05), and higher step counts were associated with greater weight loss (p<.05). Text-messaging satisfaction was moderate to high, and pedometer-related satisfaction was associated with greater weight loss (p<.05).Conclusions. Although text-messaging had no effect on weight, adherence was associated with improvement in weight-related behaviors and weight outcomes. Text-messages could be a useful adjunct to weight loss treatments. (c) 2012 Elsevier Inc. All rights reserved.

BACKGROUND:Psychosocial factors have been related to physical activity (PA) and are used to evaluate mediation in PA interventions.METHODS:Brief theory-based psychosocial scales were compiled from existing measures and evaluated. Study 1 assessed factor structure and construct validity with self-reported PA and accelerometry in overweight/obese men (N = 441) and women (N = 401). Study 2 assessed 2-week reliability and internal consistency in 49 college students.RESULTS:Confirmatory factor analysis indicated good fit in men and women (CFI = .90; RMSEA = .05). Construct validity was supported for change strategies (r = .29-.46), self-efficacy (r = .19-.22) and enjoyment (r = .21-.33) in men and women, and for cons in women (r = -.19 to -.20). PA pros (r = -.02 to .11) and social support (r = -.01 to .12) were not supported for construct validity. Test-retest reliability ICCs ranged from .49-.81. Internal consistency alphas ranged from .55-.90. Reliability was supported for most scales with further testing needed for cons (alphas = .55-.63) and enjoyment (ICC = .49).CONCLUSIONS:Many of the brief scales demonstrated adequate reliability and validity, while some need further development. The use of these scales could advance research and practice in the promotion of PA.

OPINION STATEMENT:Medical therapy is the foundation upon which all treatment for patients with stable coronary artery disease (CAD) is based, regardless of whether revascularization is performed. Although professional societies recommend comprehensive lifestyle and pharmacologic interventions with specific risk factor targets, in practice this does not usually occur. The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial tested multiple simultaneous lifestyle and pharmacologic interventions (referred to as "optimal medical therapy" [OMT]) with or without percutaneous coronary intervention (PCI) in patients with stable CAD. Nurse case managers were trained to counsel patients according to protocols designed to achieve predefined lifestyle and risk factor goals. Medications were provided at no cost to patients. Adherence to lifestyle and medication prescription was very high and resulted in significant improvement in risk factor targets. COURAGE found no benefit from the addition of PCI to OMT in the primary outcome of death or myocardial infarction. OMT as delivered in COURAGE has been praised but it has also been criticized as not achievable in "real world" clinical practice. The authors, all COURAGE investigators, believe that the delivery of OMT in COURAGE represents a viable model for secondary prevention that can be translated to real practice, but acknowledge that it is difficult to do so in our fee-for-service health care system. New models of team-based healthcare to achieve evidence-based treatment targets and improved clinical outcomes are needed. Successful translation of COURAGE OMT to everyday practice will require a health care system that rewards quality of care.