Intervention Control Condition Research Articles

Scaling-up an efficacious school-based physical activity intervention: Study protocol for the 'Internet-based Professional Learning to help teachers support Activity in Youth' (iPLAY) cluster randomized controlled trial and scale-up implementation evaluation.

BackgroundDespite the health benefits of regular physical activity, most children are insufficiently active. Schools are ideally placed to promote physical activity; however, many do not provide children with sufficient in-school activity or ensure they have the skills and motivation to be active beyond the school setting. The aim of this project is to modify, scale up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving children’s physical activity, fundamental movement skills and cardiorespiratory fitness. The ‘Internet-based Professional Learning to help teachers support Activity in Youth’ (iPLAY) study will focus largely on online delivery to enhance translational capacity.Methods/DesignThe intervention will be implemented at school and teacher levels, and will include six components: (i) quality physical education and school sport, (ii) classroom movement breaks, (iii) physically active homework, (iv) active playgrounds, (v) community physical activity links and (vi) parent/caregiver engagement. Experienced physical education teachers will deliver professional learning workshops and follow-up, individualized mentoring to primary teachers (i.e., Kindergarten – Year 6). These activities will be supported by online learning and resources. Teachers will then deliver the iPLAY intervention components in their schools. We will evaluate iPLAY in two complementary studies in primary schools across New South Wales (NSW), Australia. A cluster randomized controlled trial (RCT), involving a representative sample of 20 schools within NSW (1:1 allocation at the school level to intervention and attention control conditions), will assess effectiveness and cost-effectiveness at 12 and 24 months. Students’ cardiorespiratory fitness will be the primary outcome in this trial. Key secondary outcomes will include students’ moderate-to-vigorous physical activity (via accelerometers), fundamental movement skill proficiency, enjoyment of physical education and sport, cognitive control, performance on standardized tests of numeracy and literacy, and cost-effectiveness. A scale-up implementation study guided by the RE-AIM framework will evaluate the reach, effectiveness, adoption, implementation, and maintenance of the intervention when delivered in 160 primary schools in urban and regional areas of NSW.DiscussionThis project will provide the evidence and a framework for government to guide physical activity promotion throughout NSW primary schools and a potential model for adoption in other states and countries.Trial registrationAustralia and New Zealand Clinical Trials Registry (ACTRN12616000731493). Date of registration: June 3, 2016.

Safety and Health Support for Home Care Workers: The COMPASS Randomized Controlled Trial.

To determine the effectiveness of the COMmunity of Practice And Safety Support (COMPASS) Total Worker Health intervention for home care workers. We randomized 16 clusters of workers (n = 149) to intervention or usual-practice control conditions. The 12-month intervention was scripted and peer-led, and involved education on safety, health, and well-being; goal setting and self-monitoring; and structured social support. We collected measures at baseline, 6 months, and 12 months, which included workers' experienced community of practice (i.e., people engaged in a common activity who interact regularly for shared learning and improvement). Implementation occurred during 2013 and 2014 in Oregon. In an intent-to-treat analysis, relative to control, the intervention produced significant and sustained improvements in workers' experienced community of practice. Additional significant improvements included the use of ergonomic tools or techniques for physical work, safety communication with consumer-employers, hazard correction in homes, fruit and vegetable consumption, lost work days because of injury, high-density lipoprotein cholesterol, and grip strength. Consumer-employers' reports of caregiver safety behaviors also significantly improved. COMPASS was effective for improving home care workers' social resources and simultaneously impacted both safety and health factors.

A comparison of personality factors emerging within different English-speaking cultures

This pilot randomized controlled trial examined the feasibility and efficacy of a physical activity behavior change intervention for improving restless legs syndrome (RLS) severity and secondary sleep outcomes among a sample of adults with multiple sclerosis (MS).Participants with MS(N=15) were randomly assigned into intervention(n=8) or waitlist control(n=7) conditions. The physical activity intervention was delivered over a 16-week period and outcomes were assessed at baseline and immediately following the 16-week period in both conditions.There was a significant, positive effect of the intervention on overall RLS severity (p=.01;ηρ2=.43), severity during the night(p=.03,ηρ2=.35), severity during the day while resting(p=.01,ηρ2=.44), and severity during the day while active(p<.01,ηρ2=.61), and non-significant improvements in RLS severity while falling asleep (p=.33,ηρ2=.09). There were significant positive effects on sleep satisfaction(p<.01,ηρ2=.49) and non-significant improvements in self-reported global sleep quality(p=.35,ηρ2=.08). There was a significant intervention effect on self-reported time in bed(p=.03,ηρ2=.37) and total sleep time(p=.03,ηρ2=.36), and non-significant improvements in self-reported sleep latency (p=.08,ηρ2=.25), sleep efficiency(p=.27,ηρ2=.11), and daytime sleepiness (p=.52,ηρ2=.04;p=.35,ηρ2=.08;p=.51,ηρ2=.04). There was no significant effect of the intervention on device-measured sleep quality.We provide preliminary evidence for the feasibility and efficacy of a physical activity intervention for reducing RLS severity and potentially improving self-reported sleep outcomes in adults with MS.NCT04061681

A pilot randomized controlled trial of the e-couch anxiety and worry program in schools

The aim of this pilot study was to evaluate the acceptability and feasibility of delivering an online anxiety prevention program in schools, and to assess the effectiveness of the intervention in reducing symptoms of anxiety. Three schools located in South Australia and the Australian Capital Territory were recruited to participate in the trial, with classes randomly allocated to the intervention or wait-list control condition. All participants (N=225) were invited to complete a pre-intervention, post-intervention and 3-month follow-up questionnaire. Participants in the intervention condition completed the online e-couch Anxiety and Worry program during one class period a week for six weeks. No significant differences were found between the intervention and control conditions at post-intervention or 3-month follow-up for generalised anxiety (Cohen's d=−0.09–0.08), social anxiety (d=0.09 & −0.26), anxiety sensitivity (d=0.19 & −0.15), depressive symptoms (d=0.01 & 0.08) or mental wellbeing (d=0.17 & 0.30). Online anxiety prevention programs are acceptable and can be feasibly delivered in schools. Although not significant, the sizes of some of the effects obtained in this pilot trial are consistent with earlier studies, and warrant further investigation in a larger trial.

Family-focused prevention with Latinos: What about sisters and brothers?

Using a randomized, intent-to-treat design, this pilot study examined the feasibility and short-term effects of Siblings Are Special (SIBS) with a sample of 54 low-income Latino families (91% Mexican-origin). Participants were older (M = 10.8 years; SD = .46) and younger siblings (M = 8.4 years; SD = 1.13), and their parents (94% biological mothers), who were randomly assigned within school to the intervention (n = 28) or no-attention control (n = 26) condition. The intervention condition included 12 weekly afterschool sessions (90 min each) for sibling pairs and 3 family nights for parents and siblings (2 hr each). SIBS was designed to enhance sibling relationships via 2 primary intervention targets: (a) children’s capacities that underlie positive sibling dynamics, including relationship skills, cognitions, and shared activities; and (b) parenting of siblings, specifically, enhancing positive guidance and involvement and discouraging authoritarian control. Pre- and posttest data were gathered from siblings and parents. Recruitment and implementation data revealed high rates of attendance and completion, and high ratings of parent satisfaction with the program. Further, analyses suggested the program had positive effects of small to modest magnitude on posttest measures of sibling and parent–child relationship quality, parenting of siblings, older siblings’ emotional efficacy, and parents’ depressive symptoms and parenting stress, controlling for pretest levels of all outcomes and family background characteristics. Discussion addresses the feasibility of sibling-focused programs with low-income Latino families and makes recommendations for future research.

Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States.

To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = -0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers.

Effect of a stress management program on subjects with neck pain: A pilot randomized controlled trial.

Studies have shown that stress is implicated in the cause of neck pain (NP). The purpose of this study is to examine the effect of a simple, zero cost stress management program on patients suffering from NP. This study is a parallel-type randomized clinical study. People suffering from chronic non-specific NP were chosen randomly to participate in an eight week duration program of stress management (N= 28) (including diaphragmatic breathing, progressive muscle relaxation) or in a no intervention control condition (N= 25). Self-report measures were used for the evaluation of various variables at the beginning and at the end of the eight-week monitoring period. Descriptive and inferential statistic methods were used for the statistical analysis. At the end of the monitoring period, the intervention group showed a statistically significant reduction of stress and anxiety (p= 0.03, p= 0.01), report of stress related symptoms (p= 0.003), percentage of disability due to NP (p= 0.000) and NP intensity (p= 0.002). At the same time, daily routine satisfaction levels were elevated (p= 0.019). No statistically significant difference was observed in cortisol measurements. Stress management has positive effects on NP patients.

Reducing Internalizing Symptoms Among High-Risk, Hispanic Adolescents: Mediators of a Preventive Family Intervention

Familias Unidas is a family-focused preventive intervention that has been found to reduce drug use and sexual risk behaviors among Hispanic adolescents. In some trials, Familias Unidas has also been found to be efficacious in reducing adolescent internalizing symptoms (i.e., depressive and anxiety symptoms), even though the intervention did not specifically target internalizing symptoms. This study examines potential mediators or mechanisms by which Familias Unidas influences internalizing symptoms, specifically the role of intervention-targeted improvements in parent-adolescent communication and reductions in youth externalizing behaviors. A total of 213 Hispanic eighth grade students with a history of externalizing behavior problems and their primary caregivers were recruited from the public school system. Participants, with a mean age of 13.8years, were randomized into the Familias Unidas intervention or community practice control condition and assessed at baseline, 6, 18, and 30months post-baseline. A cascading mediation model was tested in which the Familias Unidas intervention was hypothesized to decrease adolescent internalizing symptoms through two mediators: improvements in parent-adolescent communication leading to decreases in externalizing behaviors. Findings show that the intervention had significant direct effects on youth internalizing symptoms at 30months post-baseline. In addition, the cascading mediation model was supported in which the Familias Unidas intervention predicted significant improvements in parent-adolescent communication at 6months, subsequently decreasing externalizing behaviors at 18months, and ultimately reducing youth internalizing symptoms at 30months post-baseline. Implications for prevention interventions are discussed.

HYPERTHERMIA AND THE IMPROVEMENT OF ASD SYMPTOMS

The observation that some ASD patients manifest clinical improvement in response to fever suggests that symptoms may be modulated by immune-inflammatory factors. The febrile hypothesis of ASD stems from this observation, and could be due to [1] the direct effect of temperature; [2] a resulting change in the immune inflammatory system function associated with the infection of fever; and/or [3] an increase in the functionality of a previously dysfunctional locus coeruleus-noradrenergic (LC-NA) system. We completed a double blind crossover study of 15 children with ASD (5 to 17 years) using two treatment conditions, hyperthermia condition (102 °F) and control condition (98 °F) in a HydroWorx aquatic therapy pool. Five children with ASD without fever response acted as controls, completing only the hyperthermia condition, to ensure safety and feasibility. Safety measures and Social Responsiveness Scale (SRS) were collected. Ten patients with ASD and history of fever response were enrolled and received both treatment conditions. Vital signs, temperature monitoring and clinical observations were completed throughout their time in the pool. Parents completed the SRS and RBS-R. Pupillometry biomarker and buccal swabs for DNA and RNA extraction were collected pre and post pool entry. Five control subjects without a history of fever completed the hyperthermia condition at 102 °F, and demonstrated the safety and feasibility of the study. Ten subjects with ASD and a history of fever response were enrolled and completed the hyperthermia condition (102 °F) and control condition (98 °F) at the aquatic therapy pool. Improvement in social cognition and repetitive/restrictive behaviors were observed at the hyperthermia condition (102 °F) on parent (SRS, RBS-R) and rater (CGI-I) assessments. Pupillometry biomarker and gene expression can be correlated with clinical improvement. Side effects were minimal, and were the same as those observed in a hot tub/sauna (redness, nausea). We demonstrated improvement of socialization and repetitive and restricted behaviors at the hyperthermia condition (102 °F), and that we could reliably and safely increase children’s temperatures into the fever range (mean max temperature of 101.7 °F). This temperature increase was observed to cause significant and convergent improvement on clinician ratings (CGI-I) and parent ratings (SRS, RBS-R), both of which were kept blinded to the temperature of the pool. Interestingly, each child’s fever response history was correlated with the improvements observed at the elevated temperature. Those with a history of marked fever response had the most observable behavior changes. Behavior changes observed for each child were similar to those observed by parents during febrile episodes, including increased cooperation, communication and social reciprocity and decreased hyperactivity and inappropriate vocalizations. Although multiple rationales have been posited, this is the first study looking at the direct effect of temperature on ASD symptomatology. This study explores the direct effects of temperature on ASD symptoms and offers a window into understanding mechanisms involved in the improvement of ASD symptoms during febrile episodes. Future analyses will help to determine the genetic pathways involved in fever response, the role of the LC-NA system, and other immune-inflammatory pathways in mediating ASD symptoms.

Parent Use and Efficacy of a Self-Administered, Tablet-Based Parent Training Intervention: A Randomized Controlled Trial.

BackgroundParent training programs are traditionally delivered in face-to-face formats and require trained facilitators and weekly parent attendance. Implementing face-to-face sessions is challenging in busy primary care settings and many barriers exist for parents to attend these sessions. Tablet-based delivery of parent training offers an alternative to face-to-face delivery to make parent training programs easier to deliver in primary care settings and more convenient and accessible to parents. We adapted the group-based Chicago Parent Program (CPP) to be delivered as a self-administered, tablet-based program called the ez Parentprogram.ObjectiveThe purpose of this study was to (1) assess the feasibility of the ez Parentprogram by examining parent satisfaction with the program and the percent of modules completed, (2) test the efficacy of the ez Parentprogram by examining the effects compared with a control condition for improving parenting and child behavior in a sample of low-income ethnic minority parents of young children recruited from a primary care setting, and (3) compare program completion and efficacy with prior studies of the group-based CPP.MethodsThe study used a two-group randomized controlled trial (RCT) design with repeated measures follow up. Subjects (n=79) were randomly assigned to an intervention or attention control condition. Data collection was at baseline and 12 and 24 weeks post baseline. Parents were recruited from a large, urban, primary care pediatric clinic. ez Parentmodule completion was calculated as the percentage of the six modules completed by the intervention group parents. Attendance in the group-based CPP was calculated as the percentage of attendance at sessions 1 through 10. Satisfaction data were summarized using item frequencies. Parent and child data were analyzed using a repeated measures analysis of variance (RM-ANOVA) with simple contrasts to determine if there were significant intervention effects on the outcome measures. Effect sizes for between group comparisons were calculated for all outcome variables and compared with CPP group based archival data.Results ez Parentmodule completion rate was 85.4% (34.2/40; 95% confidence interval [CI] = 78.4%-93.7%) and was significantly greater ( P<.05) than face-to-face CPP group attendance (135.2/267, 50.6%) attendance of sessions; 95% CI = 46.8%-55.6%). ez Parentparticipants reported the program as very helpful (35/40, 88.0%) and they would highly recommend the program (33/40, 82.1%) to another parent. ez Parentparticipants showed greater improvements in parenting warmth (F1,77 = 4.82, P<.05) from time 1 to 3. No other significant differences were found. Cohen’s d effect sizes for intervention group improvements in parenting warmth, use of corporal punishment, follow through, parenting stress, and intensity of child behavior problems were comparable or greater than those of the group-based CPP.ConclusionsData from this study indicate the feasibility and acceptability of the ez Parentprogram in a low-income, ethnic minority population of parents and comparable effect sizes with face-to-face delivery for parents.

Smartphone Technology and Text Messaging for Weight Loss in Young Adults: A Randomized Controlled Trial.

Using smartphone technology and text messaging for health is a growing field. This type of technology is well integrated into the lives of young adults. However, few studies have tested the effect of this type of technology to promote weight loss in young adults OBJECTIVE:: The purpose of this study is to test the effectiveness of a behaviorally based smartphone application for weight loss combined with text messaging from a health coach on weight, body mass index (BMI), and waist circumference in young adults as compared with a control condition. Sixty-two young adults, aged 18 to 25 years, were randomized to receive (1) a smartphone application + health coach intervention and counseling sessions or (2) control condition with a counseling session. All outcome measures were tested at baseline and 3 months. These included weight, BMI, waist circumference, dietary habits, physical activity habits, and self-efficacy for healthy eating and physical activity. The sample was 71% female and 39% white, with an average age of 20 years and average BMI of 28.5 kg/m. Participants in the smartphone + health coach group lost significantly more weight (P = .026) and had a significant reduction in both BMI (P = .024) and waist circumference (P < .01) compared with controls. The results of this weight loss trial support the use of smartphone technology and feedback from a health coach on improving weight in a group of diverse young adults.

Relative Effects of a Comprehensive Versus Reduced Training for Head Start Teachers Who Serve Spanish-Speaking English Learners

ABSTRACTWith increased demand for improved early childhood education services, it is important to better understand the essential professional development resources that have the greatest impact on both teacher and child outcomes. This study compared the effectiveness of two teacher-training models in bilingual Migrant and Seasonal Head Start and Head Start classrooms. Both conditions included the use of a technology-based student progress-monitoring tool. The progress monitoring provided detailed feedback on students’ progress 15 across the academic year and helped organize instructional groupings. The comprehensive treatment condition included biweekly professional development sessions, in-class mentoring, and provision of classroom materials, whereas the treatment-control condition included only the provision of a limited set of classroom materials. Across multiple sites in Texas, 49 pretest and posttest teacher observations and bilingual child assessments were collected on a subsample of students (n = 387). Research Findings: Improvements in teaching behaviors were observed in both experimental conditions; no significant differences were observed between teachers across conditions. Three measures of child language and literacy growth differed significantly, favoring the comprehensive treatment model, but most outcomes did not differ significantly between groups. Practice or Policy: Implications of these mixed findings and future research directions are discussed.

Changes in cannabis use among psychotic clients without specialised substance use treatment

The need to address substance use among people with psychosis has been well established. However, treatment studies targeting substance use in this population have reported mixed results. Substance users with psychosis in no or minimal treatment control groups achieve similar reductions in substance use compared to those in more active substance use treatment, suggesting a role for natural recovery from substance use. This meta-analysis aims to quantify the amount of natural recovery from substance use within control groups of treatment studies containing samples of psychotic substance users, with a particular focus on changes in cannabis use. A systematic search was conducted to identify substance use treatment studies. Meta-analyses were performed to quantify reductions in the frequency of substance use in the past 30days. Significant but modest reductions (mean reduction of 0.3–0.4 SD across the time points) in the frequency of substance use were found at 6 to 24months follow up. The current study is the first to quantify changes in substance use in samples enrolled in no treatment or minimal treatment control conditions. These findings highlight the potential role of natural recovery from substance use among individuals with psychosis, although they do not rule out effects of regression to the mean. Additionally, the results provide a baseline from which to estimate likely changes or needed effects sizes in intervention studies. Future research is required to identify the processes underpinning these changes, in order to identify strategies that may better support self-management of substance use in people with psychosis.

Effects of a worksite tobacco control intervention in India: the Mumbai worksite tobacco control study, a cluster-randomised trial

ObjectivesWe assessed a worksite intervention designed to promote tobacco control among workers in the manufacturing sector in Greater Mumbai, India.MethodsWe used a cluster-randomised design to test an integrated health promotion/health...

Striatal dopamine D2/3 receptor regulation by stress inoculation in squirrel monkeys

Intermittent mildly stressful situations provide opportunities to learn, practice, and improve coping in a process called stress inoculation. Stress inoculation also enhances cognitive control and response inhibition of impulsive motivated behavior. Cognitive control and motivation have been linked to striatal dopamine D2 and/or D3 receptors (DRD2/3) in rodents, monkeys, and humans. Here, we study squirrel monkeys randomized early in life to stress inoculation with or without maternal companionship and a no-stress control treatment condition. Striatal DRD2/3 availability in adulthood was measured in vivo by [11C]raclopride binding using positron emission tomography (PET). DRD2/3 availability was greater in caudate and putamen compared to ventral striatum as reported in PET studies of humans and other non-human primates. DRD2/3 availability in ventral striatum was also consistently greater in stress inoculated squirrel monkeys compared to no-stress controls. Squirrel monkeys exposed to stress inoculation in the presence of their mother did not differ from squirrel monkeys exposed to stress inoculation without maternal companionship. Similar effects in different social contexts extend the generality of our findings and together suggest that stress inoculation increases striatal DRD2/3 availability as a correlate of cognitive control in squirrel monkeys.

The Effect of Changes in Cardiorespiratory Fitness and Weight on Obstructive Sleep Apnea Severity in Overweight Adults with Type 2 Diabetes

To examine the effect of changes in cardiorespiratory fitness on obstructive sleep apnea (OSA) severity prior to and following adjustment for changes in weight over the course of a 4-y weight loss intervention. As secondary analyses of a randomized controlled trial, 263 overweight/obese adults with type 2 diabetes and OSA participated in an intensive lifestyle intervention or education control condition. Measures of OSA severity, cardiorespiratory fitness, and body weight were obtained at baseline, year 1, and year 4. Change in the apnea-hypopnea index (AHI) served as the primary outcome. The percentage change in fitness (submaximal metabolic equivalents [METs]) and change in weight (kg) were the primary independent variables. Primary analyses collapsed intervention conditions with statistical adjustment for treatment group and baseline METs, weight, and AHI among other relevant covariates. At baseline, greater METs were associated with lower AHI (B [SE] = -1.48 [0.71], P = 0.038), but this relationship no longer existed (B [SE] = -0.24 [0.73], P = 0.75) after adjustment for weight (B [SE] = 0.31 [0.07], P < 0.0001). Fitness significantly increased at year 1 (+16.53 ± 28.71% relative to baseline), but returned to near-baseline levels by year 4 (+1.81 ± 24.48%). In mixed-model analyses of AHI change over time without consideration of weight change, increased fitness at year 1 (B [SE] = -0.15 [0.04], P < 0.0001), but not at year 4 (B [SE] = 0.04 [0.05], P = 0.48), was associated with AHI reduction. However, with weight change in the model, greater weight loss was associated with AHI reduction at years 1 and 4 (B [SE] = 0.81 [0.16] and 0.60 [0.16], both P < 0.0001), rendering the association between fitness and AHI change at year 1 nonsignificant (B [SE] = -0.04 [0.04], P = 0.31). Among overweight/obese adults with type 2 diabetes, fitness change did not influence OSA severity change when weight change was taken into account. ClinicalTrials.gov identification number NCT00194259.

Study on Degeneration of Potato Seed in Terai Region of Nepal

Field experiments were conducted in the experimental field of Regional Agriculture Research Station (RARS), Parwanipur, and Bara, Nepal. The objective of study was to evaluate the rate of degeneration due to viral diseases in Cardinal and Kufri Jyoti. The experimental plot design was Randomized Complete Block Design with 3 replication and 5 treatments considering each farmer as a replication. There were 10 treatment combinations consisting 2 varieties. DAS-ELISA was done to find out the degree of virus infection. Result showed a significant (P<0.01) effect of virus in yield loss of potato. Data of three different years were compared to find out the percentage loss due to damage cause by virus. Field observation was done for other insects and pest. The DAS ELISA results revealed that during third year the presence of PVM and PVY was highest in Cardinal under and Kufri Jyoti under control treatment condition respectively. Yield data of three different year showed that there is serious loss (27–46%) on an average in the subsequent year in the productivity of potato. To decrease the rate of degeneration insect proof net can be used which is cheaper and environment friendly resulting the satisfactory yield in the subsequent generation.

Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis

The Guidelines for Exercise in Multiple Sclerosis (GEMS) program is a randomized controlled trial (RCT) examining the feasibility and efficacy of a home-based exercise training program based on recent physical activity guidelines and principles of behavior change for improving symptoms and health-related quality of life (HRQOL) in adults with multiple sclerosis (MS). The primary aim is to assess program feasibility in the four domains of process (e.g., recruitment, retention, and adherence), resources (e.g., communication, staff requirements, and monetary costs), management (e.g., time and accuracy in data collection/entry, and reporting of adverse events) and scientific outcomes (e.g., safety, burden, participant feedback and efficacy/outcomes). The trial will recruit individuals with mild-to-moderate MS-related disability across the United States who will be randomized into intervention or waitlist control conditions. All participants will complete home-based assessments (including wearing an accelerometer for 7days and completion of a questionnaire booklet) prior to and upon completion of the 4-month program. Participants in the intervention will receive a 4-month home-based exercise program emphasizing aerobic and resistance training. Participants will be provided with exercise equipment, a DVD, a manual and a log-book. The exercise program will be supplemented with periodic newsletters in the mail highlighting principles of behavior change, and video-chats with an exercise specialist to provide motivation and social accountability. This trial serves to inform development of Phase II and III RCTs which can determine the actual efficacy and effectiveness of home-based exercise based on the MS-specific physical activity guidelines for improving symptoms and HRQOL.

Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial.

The purpose of this study is to evaluate the efficacy of a behavioral self-regulation intervention vs. active control condition using a parallel-group randomized clinical trial with a sample of center hemodialysis patients with chronic kidney disease. Participants were recruited from 8 hemodialysis treatment centers in the Midwest. Eligible patients were (a) fluid nonadherent as defined by an interdialytic weight gain >2.5kg over a 4-week period, (b) >18years of age, (c) English-speaking without severe cognitive impairment, (d) treated with center-based hemodialysis for >3months, and (e) not living in a care facility in which meals were managed. Medical records were used to identify eligible patients. Patients were randomly assigned to either a behavioral self-regulation intervention or active control condition in which groups of 3-8 patients met for hour-long, weekly sessions for 7weeks at their usual hemodialysis clinic. Primary analyses were intention-to-treat. Sixty-one patients were randomized to the intervention while 58 were assigned to the attention-placebo support and discussion control. Covariate-adjusted between-subjects analyses demonstrated no unique intervention effect for the primary outcome, interdialytic weight gain (β = 0.13, p = 0.48). Significant within-subjects improvement over time was observed for the intervention group (β = -0.32, p = 0.014). The present study found that participation in a behavioral self-regulation intervention resulted in no unique intervention effect on a key indicator of adherence for those with severe chronic kidney disease. There was, however, modest within-subjects improvement in interdialytic weight gain for the intervention group which meshes with other evidence showing the utility of behavioral interventions in this patient population. ClinicalTrials.gov Identifier: NCT01066949.

A feasibility study of home-based contingency management with adolescent smokers of rural Appalachia.

Cigarette smoking among adolescents remains a significant public health concern. This problem is compounded in regions such as rural Appalachia where rates of smoking are consistently higher than national averages and access to treatments is limited. The current research evaluated a home-based contingency management program completed over the Internet with adolescent smokers recruited from rural Appalachia. Participants (N = 62) submitted 3 video recordings per day showing their breath carbon monoxide (CO) levels using a handheld CO monitor. Participants were assigned to either an active treatment condition (AT; n = 31) in which reductions in breath CO were reinforced or a control treatment condition (CT; n = 31) in which providing timely video recordings were reinforced with no requirement to reduce breath CO. Results revealed that participants in the AT condition reduced their breath CO levels significantly more so during treatment than participants in the CT condition. Within-group comparisons revealed that participants in both conditions significantly reduced their breath CO, self-reported smoking, and nicotine dependence ratings during treatment. However, only participants in the AT condition significantly reduced urinary cotinine levels during treatment, and only participants in this condition maintained all reductions until 6-week post treatment. Participants in the CT condition only maintained self-reported smoking reductions until posttreatment assessments. These results support the feasibility and initial efficacy of this incentive-based approach to smoking cessation with adolescent smokers living in rural locations.