Planned care for obesity and cardiovascular risk reduction using a stepped-down approach: A randomized-controlled trial.

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% CI, 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/m2) than EUC (36.0 [95% CI, 35.3 to 36.8] to 35.1 [95% CI, 34.3 to 35.9] kg/m2), 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.

Click "like" to change your behavior: a mixed methods study of college students' exposure to and engagement with Facebook content designed for weight loss.

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.

Text4Diet: a randomized controlled study using text messaging for weight loss behaviors.

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.

Promoting walking among older adults living in retirement communities.

The authors tested the feasibility and acceptability, and explored the outcomes, of 2 walking interventions based on ecological models among older adults living in retirement communities. An enhanced intervention (EI) was compared with a standard walking intervention (SI) among residents in 4 retirement facilities (N = 87 at baseline; mean age = 84.1 yr). All participants received a walking intervention including pedometers, printed materials, and biweekly group sessions. EI participants also received phone counseling and environmental-awareness components. Measures included pedometer step counts, activities of daily living, environment-related variables, physical function, depression, cognitive function, satisfaction, and adherence. Results indicated improvements among the total sample for step counts, neighborhood barriers, cognitive function, and satisfaction with walking opportunities. Satisfaction and adherence were high. Both walking interventions were feasible to implement among facility-dwelling older adults. Future studies can build on this multilevel approach.

Outcomes of a 12-month web-based intervention for overweight and obese men.

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.

Is Optimal Medical Therapy as Used in the COURAGE Trial Feasible for Widespread Use?

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.

Reliability and validity of brief psychosocial measures related to dietary behaviors.

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.

Effects of Caloric Intake and Aerobic Activity in Individuals with Prehypertension and Hypertension on Levels of Inflammatory, Adhesion and Prothrombotic Biomarkers-Secondary Analysis of a Randomized Controlled Trial.

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.

Latent growth curve modeling of adolescent physical activity: testing parallel process and mediation models.

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.

Randomized control trial of a behavioral intervention for overweight women: impact on depressive symptoms.

Phone and Internet-based interventions can improve the management of depression in primary care, and interventions using these communication channels are increasingly used to improve behaviors such as diet and physical activity. Increased physical activity has been shown to improve depressive symptoms, but to date there are no reports of the effects of a phone and Internet diet and exercise intervention on symptoms of depression in patients seen in primary care. This study assessed depressive symptoms in 401 participants in a randomized control trial of a 12-month primary care, phone and Internet-based behavioral intervention for overweight women. A one-way analysis of variance examining the mean change in Center for Epidemiological Studies Depression (CESD) score from baseline to 12 months, controlling for age, education, marital status, and employment showed that those receiving the intervention significantly decreased their CESD scores (P=.03) more than those receiving standard care. Although the intervention did not target depressed individuals or present material relating to mood management, those with probable depression (27% of the whole sample) showed clinically important improvements-a mean five-point change on the CESD short form. Participants who engaged more readily with the intervention were more likely to reduce their depression scores. A 1-year primary care based phone and Internet diet and exercise intervention can improve depressive symptoms in overweight women. Given the promise of phone and Internet-based interventions to improve both depression and lifestyle-related behaviors, and given that such interventions could extend the reach of primary care to many individuals at relatively low cost, these results suggest the need for further research, including the effects of additional mood management components.

A randomized trial of a multicomponent intervention for adolescent sun protection behaviors.

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.

Patterns and correlates of physical activity and nutrition behaviors in adolescents.

BACKGROUND: Knowledge of the prevalence, clustering, and correlates of multiple adolescent health behaviors can inform the design of health promotion interventions. METHODS: A cross-sectional design was used to assess 878 adolescents aged 11 to 15 years (53.6% girls, 58% non-Hispanic white) recruited in primary care clinics in 2001-2002. Adolescent physical activity (assessed with accelerometers), television viewing time (reported), percent calories from fat, and servings of fruits and vegetables (assessed with multiple 24-hour recalls) were dichotomized into meeting or not meeting national guidelines. Parent health behaviors were assessed with self-reported measures. Analyses were conducted in 2006. RESULTS: Fifty-five percent of adolescents did not meet the physical activity guideline, and 30% exceeded 2 hours daily of television viewing time, with boys more active and less sedentary than girls (p <0.01). The majority of the adolescents did not meet dietary guidelines. Nearly 80% had multiple risk behaviors and only 2% met all four guidelines. The number of risk behaviors was associated with being older and being at risk for overweight or being overweight, for boys and girls (p <0.05). Two parent health behaviors-history of smoking and failure to meet the fruits and vegetables guideline-were significantly associated with a higher number of risk behaviors for girls (p <0.05). CONCLUSIONS: Eight of ten adolescents in this sample failed to meet guidelines for two or more diet, physical activity, and sedentary risk behaviors. Some parent health behaviors, along with the adolescent's weight status and age, were associated with a higher number of adolescent health risk behaviors.

Patterns of sedentary behavior among adolescents.

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.

Psychosocial correlates of dietary intake among overweight and obese men.

OBJECTIVES: To investigate the relationship between theoretically based psychosocial constructs and dietary components among overweight men. METHODS: Participants were 441 men (BMI M = 34.2). Psychosocial constructs included self-efficacy, decisional balance, social support, and behavior change strategies. Dietary components were fat, fiber, and fruit and vegetable intake. RESULTS: All significant findings were in the expected direction. Multiple regression models indicated that the psychosocial factors accounted for the most variance in vegetable intake (R(2)=.13) and the least variance in fat (R(2)=.05). CONCLUSIONS: Theoretically based psychosocial constructs were related to overweight men's dietary intake and have potential for use in tailored behavior-change interventions.

Randomized controlled trial of a primary care and home-based intervention for physical activity and nutrition behaviors: PACE+ for adolescents.

OBJECTIVE: Many adolescents do not meet national guidelines for participation in regular moderate or vigorous physical activity (PA); limitations on sedentary behaviors; or dietary intake of fruits and vegetables, fiber, or total dietary fat. This study evaluated a health care-based intervention to improve these behaviors. DESIGN: Randomized controlled trial. SETTING: Primary care with follow-up at home. PARTICIPANTS: Eight hundred seventy-eight adolescent girls and boys aged 11 to 15 years. INTERVENTIONS: Two experimental conditions: (1) Primary care, office-based, computer-assisted diet and PA assessment and stage-based goal setting followed by brief health care provider counseling and 12 months of monthly mail and telephone counseling and (2) a comparison condition addressing sun exposure protection. MAIN OUTCOME MEASURES: Minutes per week of moderate plus vigorous PA measured by self-report and accelerometer; self-report of days per week of PA and sedentary behaviors; and percentage of energy from fat and servings per day of fruits and vegetables measured by three 24-hour diet recalls. Body mass index (calculated as weight in kilograms divided by the square of height in meters) was a secondary outcome. RESULTS: Compared with adolescents in the sun protection condition, girls and boys in the diet and PA intervention significantly reduced sedentary behaviors (intervention vs control change, 4.3 to 3.4 h/d vs 4.2 to 4.4 h/d for girls, respectively [P = .001]; 4.2 to 3.2 h/d vs 4.2 to 4.3 h/d for boys, respectively [P = .001]). Boys reported more active days per week (intervention vs control change: 4.1 to 4.4 d/wk vs 3.8 to 3.8 d/w, respectively [P = .01]), and the number of servings of fruits and vegetables for girls approached significance (intervention vs control change, 3.5 to 4.2 servings/d vs 3.5 to 3.9 servings/d, respectively [P = .07]). No intervention effects were seen with percentage of calories from fat or minutes of PA per week. Percentage of adolescents meeting recommended health guidelines was significantly improved for girls for consumption of saturated fat (intervention vs control change, 23.4% to 41.0% vs 18.5% to 31%, respectively [relative risk, 1.33; 95% confidence interval, 1.01-1.68]) and for boys' participation in d/wk of PA (intervention vs control change, 45.3% to 55.4% vs 41.9% to 38.0%, respectively [relative risk, 1.47; 95% confidence interval, 1.19-1.75]). No between-group differences were seen in body mass index. CONCLUSIONS: Improvements in some diet, PA, and sedentary behaviors in adolescents can be enabled through the use of a 1-year, integrated intervention using the computer, health provider counseling, mail, and telephone. The amount of intervention received may contribute to its efficacy.

Psychosocial correlates of fruit, vegetable, and dietary fat intake among adolescent boys and girls.

OBJECTIVE: This study examined whether hypothesized psychosocial correlates of behavior change (family/peer influence, pros, cons, self-efficacy, parent/child change strategies, and household eating rules) are associated with consumption of fruits, vegetables, and dietary fat among adolescent boys and girls. DESIGN: This cross-sectional study used questionnaires to assess psychosocial variables and multiple 24-hour recall interviews to assess dietary intake (daily servings of fruits and vegetables and percentage energy intake from dietary fat). SUBJECTS: In this study, 878 adolescents (53.6% female, 57.9% white, mean age 12.8 years, age range 11 to 15 years) completed questionnaires. STATISTICAL ANALYSES PERFORMED: Hierarchical linear regressions were conducted on the entire sample as well as on subgroups based on sex and age (young/old). RESULTS: Results indicated that child behavior change strategies, decisional balance, and household rules were related to percentage energy intake from total fat, whereas child behavior change strategies, family influence, and household rules were related to daily servings of fruit and vegetables. More psychosocial correlates were found for older than for younger adolescents. CONCLUSIONS: Both psychological and social correlates of adolescent eating behaviors were identified, and correlates differed somewhat by adolescent subgroup. Based on these findings, promising intervention strategies that include the following should be evaluated: helping adolescents alter decisional balance, teaching behavior-change strategies, and helping parents support children's dietary changes and institute supportive household rules.

Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial.

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).

Comparability and reliability of paper- and computer-based measures of psychosocial constructs for adolescent fruit and vegetable and dietary fat intake.

BACKGROUND: This study investigated the comparability and reliability of computer- and paper-based measures of psychosocial constructs related to fruit and vegetable and dietary fat intake among adolescents. METHODS: An ethnically diverse sample of 76 adolescents was studied (mean age 13 years). Scales measured use of change strategies, self-efficacy, decisional balance, family influences, and peer influences separately for the two dietary outcomes. RESULTS: Comparability analyses indicated that responses for each of the 12 diet-related scales were not significantly different between the computer- and paper-based surveys. Internal consistencies were generally high (alpha from .61 to .97) with slightly better reliability on the computer- vs paper-based surveys. Test-retest reliabilities were adequate to good for most multiple-item scales (interclass correlation coefficients from .43 to .85 and .48 to .90 for paper and computer formats, respectively). CONCLUSIONS: Computer- and paper-based measures of psychosocial constructs are appropriate and ready for use in either format for studies of dietary behaviors in young people.

Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model.

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.