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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- (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.

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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. FUNDING: The National Heart, Lung, and Blood Institute of the National Institutes of Health (U01 HL096715).

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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.

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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.

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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.

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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.

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BACKGROUND: This study assessed the effect of a 1-year internet-based weight loss intervention for men. METHODS: Four hundred forty-one overweight and obese men were randomized to intervention or delayed treatment. Participants completed a Web-based assessment of diet and physical activity behaviors and weekly tailored Web modules addressing weight-related behaviors. RESULTS: At 12 months compared to controls, intervention men decreased percent of energy from saturated fat and increased grams of fiber and fruit/vegetable servings per 1.000 kcal (p values < 0.001) and walked 16 min more per day (p < 0.05). No between-group differences in body mass index (BMI), weight, or waist circumference were seen, but among completers, men in the highest tertile of intervention participation had lower weight (98.74 vs. 102.37 kg), BMI (32.38 vs. 33.46), and waist circumference (42.17 vs. 43.47 cm) compared to men who participated less often. CONCLUSIONS: The intervention improved diet and activity behaviors, but weight loss occurred only for those with the highest adherence.

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BACKGROUND: Overweight and obesity are established risk factors for insulin resistance in youth. A number of behavioral recommendations have been publicized with the goal of improving glycemic control. However, there is limited information about whether meeting these behavioral recommendations actually reduces insulin resistance. FINDINGS: 92 youths 11 - 16 years with BMI ≥ 85% underwent oral glucose tolerance testing. HOMA-IR and AUCInsulin/AUCGlucose were calculated as measures of insulin resistance. Dietary and physical activity (PA) measures were performed. Assessments included whether or not participants met recommended levels of diet, PA and sedentary behaviors.62% youths met criteria for insulin resistance. 82% (75/92) met at least one behavioral recommendation. Participants who met ≥ 1 dietary, sedentary, or PA recommendations had significantly reduced insulin resistance as compared with youth who did not. This relationship remained significant in multivariate modeling of insulin resistance adjusting for age, sex, and BMI. CONCLUSIONS: Even relatively minor behavior change may reduce insulin resistance in youth at risk for diabetes. Our findings support the relevance of current behavioral interventions for glycemic control. TRIALS REGISTRATION: Clinical Trials #NCT00412165.

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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.

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BACKGROUND: Sedentary behavior is related to obesity, but measures of sedentary behaviors are lacking for adults. The purpose of this study was to examine the reliability and validity of the Sedentary Behavior Questionnaire (SBQ) among overweight adults. METHODS: Participants were 49 adults for the 2 week test-retest reliability study (67% female, 53% white, mean age = 20) and 401 overweight women (mean age = 41, 61% white) and 441 overweight men (mean age = 44, 81% white) for the validity study. The SBQ consisted of reports of time spent in 9 sedentary behaviors. Outcomes for validity included accelerometer measured inactivity, sitting time (International Physical Activity Questionnaire), and BMI. Intraclass correlation coefficients (ICCs) assessed reliability and partial correlations assessed validity. RESULTS: ICCs were acceptable for all items and the total scale (range = .51-.93). For men, there were significant relationships of SBQ items with IPAQ sitting time and BMI. For women, there were relationships between the SBQ and accelerometer inactivity minutes, IPAQ sitting time, and BMI. CONCLUSIONS: The SBQ has acceptable measurement properties for use among overweight adults. Specific measures of sedentary behavior should be included in studies and population surveillance.

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BACKGROUND: Measures of psychosocial constructs are required to assess dietary interventions. This study evaluated brief psychosocial scales related to 4 dietary behaviors (consumption of fat, fiber/whole grains, fruits, and vegetables). METHODS: Two studies were conducted. Study 1 assessed two-week reliability of the psychosocial measures with a sample of 49 college students. Study 2 assessed convergent and discriminant validity of the psychosocial measures with dietary nutrient estimates from a Food Frequency Questionnaire on 441 men and 401 women enrolled in an Internet-based weight loss intervention study. RESULTS: Study 1 test-retest reliability ICCs were strong and ranged from .63 to .79. In study 2, dietary fat cons, fiber/whole grain cons and self-efficacy, fruit and vegetable cons and self-efficacy, and healthy eating social support, environmental factors, enjoyment, and change strategies demonstrated adequate correlations with the corresponding dietary nutrient estimates. CONCLUSIONS: Brief psychosocial measures related to dietary behaviors demonstrated adequate reliability and in most cases validity. The strongest and most consistent scales related to dietary behaviors were healthy eating change strategies and enjoyment. Consistent convergent validity was also found for the cons of change scales. These measures can be used in intervention studies to evaluate psychosocial mediators of dietary change in overweight and obese individuals.

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This study builds upon the current literature investigating the relationship between individuals' physical activity and the built environment. This prospective study of two lifestyle interventions in adults explores the moderating effect of the built environment measured both objectively and by self-report. Results show that overweight men in an intervention group increased their walking significantly more if they lived in less walkable neighborhoods. Overweight women were more likely to increase their physical activity over time if they perceived better safety from traffic. This study suggests that psychosocial interventions can help men overcome environmental barriers to walking.

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OBJECTIVES: This paper describes the medical therapy used in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial and its effect on risk factors. BACKGROUND: Most cardiovascular clinical trials test a single intervention. The COURAGE trial tested multiple lifestyle and pharmacologic interventions (optimal medical therapy) with or without percutaneous coronary intervention in patients with stable coronary disease. METHODS: All patients, regardless of treatment assignment, received equivalent lifestyle and pharmacologic interventions for secondary prevention. Most medications were provided at no cost. Therapy was administered by nurse case managers according to protocols designed to achieve predefined lifestyle and risk factor goals. RESULTS: The patients (n = 2,287) were followed for 4.6 years. There were no significant differences between treatment groups in proportion of patients achieving therapeutic goals. The proportion of smokers decreased from 23% to 19% (p = 0.025), those who reported <7% of calories from saturated fat increased from 46% to 80% (p < 0.001), and those who walked >or=150 min/week increased from 58% to 66% (p < 0.001). Body mass index increased from 28.8 +/- 0.13 kg/m(2) to 29.3 +/- 0.23 kg/m(2) (p < 0.001). Appropriate medication use increased from pre-randomization to 5 years as follows: antiplatelets 87% to 96%; beta-blockers 69% to 85%; renin-angiotensin-aldosterone system inhibitors 46% to 72%; and statins 64% to 93%. Systolic blood pressure decreased from a median of 131 +/- 0.49 mm Hg to 123 +/- 0.88 mm Hg. Low-density lipoprotein cholesterol decreased from a median of 101 +/- 0.83 mg/dl to 72 +/- 0.88 mg/dl. CONCLUSIONS: Secondary prevention was applied equally and intensively to both treatment groups in the COURAGE trial by nurse case managers with treatment protocols and resulted in significant improvement in risk factors. Optimal medical therapy in the COURAGE trial provides an effective model for secondary prevention among patients with chronic coronary disease. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657).

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Data from a randomized clinical trial were used to examine the extent to which a health promotion intervention affected changes in psychosocial constructs and if so whether these in turn explained changes in physical activity (PA). PA and psychosocial data on 878 adolescents (ages 11-15) recruited through primary care providers (age M = 12.7 years, SD = 1.3; 58% white non-Hispanic) were measured at baseline, six and 12 months. Parallel process latent growth curve analyses found positive relationships between the growth trajectories of behavior change strategies, self-efficacy, family support, peer support and the growth trajectory of PA. However, mediation analyses did not reveal statistically significant intervention-mediated effects.

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BACKGROUND: Knowledge about the prevalence, co-occurrence, and correlates of lifestyle related behaviors of overweight women is needed to inform the design of health promotion interventions for weight loss. METHODS: Cross-sectional study involves 394 overweight and obese women, aged 18 to 55 (mean age=41.26), 39% from minority backgrounds, recruited through primary care clinics for a weight loss trial. Dependent variables were the proportion meeting recommended levels of physical activity (measured with an Actigraph), percent calories from fat, and servings of fruits and vegetables (assessed with a Food Frequency Questionnaire, FFQ) and accumulating less than 8 h/day of sedentary time for sedentary behavior (Actigraph). Covariates included socio-demographics, psychosocial variables, diet behaviors, and depression. RESULTS: Seventy-five percent of the sample did not engage in at least 30 min/day of physical activity, and 56% spent less than 8 h/day in sedentary activities. About 76% and 79% of the sample did not meet the dietary fat, and fruits and vegetable consumption guidelines, respectively. Two-thirds of the sample had three or more risk factors. Being employed full-time, lower education level, less use of physical activity change strategies, and low levels of social support were associated with higher likelihood of having a greater total number of health risk behaviors. CONCLUSION: Nearly 80% of the sample had multiple lifestyle risk behaviors. Poor dietary behaviors were present in all of the most prevalent risk behavior combinations. Lower socioeconomic and educational status and family and employment obligations characterize overweight and obese women with unhealthy activity and dietary behaviors in need of health promotion interventions.

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PURPOSE: This study examined covariation among changes in dietary, physical activity, and sedentary behaviors over 12 months among adolescents participating in a health behavior intervention. Evidence of covariation among behaviors would suggest multi-behavior interventions could have synergistic effects. METHODS: Prospective analyses were conducted with baseline and 12-month assessments from a randomized controlled trial to promote improved diet, physical activity, and sedentary behaviors (experimental condition) or SUN protection behaviors (comparison condition). Participants were adolescent girls and boys (N = 878) aged 11-15 years on entry. The main outcomes were: diet, based on multiple 24-hour recalls (total fat, grams of fiber, servings of fruit and vegetables, total calories); average daily energy expenditure (kcals/kg) based on 7-day physical activity recall interviews; daily minutes of moderate-vigorous physical activity minutes from accelerometery; and self-reported daily hours of sedentary behavior. RESULTS: Covariation was found between fat and calories (r = .16), fiber and calories (r = .53), fiber and fruit/vegetables (r = .53), calories and fruit/vegetables (r = .34), and fruit and vegetables and sedentary behavior (r = -.12) for the total sample (all p values < .01). The pattern of findings was similar for most subgroups defined by gender and study condition. CONCLUSIONS: The strongest covariation was observed for diet variables that are inherently related (calories and fat, fiber, and fruit/vegetables). Little covariation was detected within or between other diet, physical activity and sedentary behavior domains suggesting that interventions to improve these behaviors in adolescents need to include specific program components for each target behavior of interest.

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OBJECTIVE: To evaluate a multicomponent primary care-based intervention to increase sun protection behaviors among adolescents. Excessive sun exposure in childhood increases the lifetime risk of melanomas and other forms of skin cancer. Interventions to improve sun protection behaviors in childhood have been based primarily in school and community settings, with little attention to the role of primary care physicians. DESIGN: A 2-year randomized controlled trial. SETTING: Primary care physician offices and participant homes. PARTICIPANTS: Eight hundred nineteen adolescents aged 11 to 15 years. INTERVENTIONS: At the study onset and the 12-month follow-up, the adolescents engaged in an office-based expert system assessment of sun protection behaviors followed by brief stage-based counseling from the primary care provider. Participants also received up to 6 expert system-generated feedback reports, a brief printed manual, and periodic mailed tip sheets. Participants randomized to the comparison condition received a physical activity and nutrition intervention. MAIN OUTCOME MEASURE: A self-reported composite measure of sun protection behavior. RESULTS: A random-effects repeated-measures model indicated a greater adoption of sun protection behaviors over time in the intervention group compared with the control group. The intervention effect corresponded to between-group differences at 24 months in avoiding the sun and limiting exposure during midday hours and using sunscreen with a sun protection factor of at least 15. Secondary analysis indicated that, by 24 months, more adolescents in the intervention group had moved to the action or the maintenance stage of change than those in the control group (25.1% vs 14.9%; odds ratio, 1.74; 95% confidence interval, 1.13-2.68). Sun protection behavior was also found to be positively associated with the completion of more intervention sessions (P = .002). CONCLUSION: Primary care counseling coupled with a minimal-intensity expert system intervention can improve adolescents' sun protection behaviors.

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OBJECTIVE: Reducing certain sedentary behaviors (e.g., watching television, using a computer) can be an effective weight loss strategy for youth. Knowledge about whether behaviors cluster together could inform interventions. STUDY DESIGN: Estimates of time spent in 6 sedentary behaviors (watching television, talking on the telephone, using a computer, listening to music, doing homework, reading) were cluster analyzed for a sample of 878 adolescents (52% girls, mean age = 12.7 years, 58% Caucasian). MAIN OUTCOME MEASURES: The clusters were based on the sedentary behaviors listed above and compared on environmental variables (e.g., household rules), psychosocial variables (e.g., self-efficacy, enjoyment), and health behaviors (e.g., physical activity, diet). RESULTS: Four clusters emerged: low sedentary, medium sedentary, selective high sedentary, and high sedentary. Analyses revealed significant cluster differences for gender (p < .002), age (p < .002), body mass index (p < .001), physical activity (p < .01), and fiber intake (p < .01). CONCLUSIONS: Results suggest a limited number of distinct sedentary behavior patterns. Further study is needed to determine how interventions may use cluster membership to target segments of the adolescent population.

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