Health Education Control Condition Research Articles

549 A Nationwide Pilot Study Testing a Remotely-Delivered Prolonged Nightly Fasting Intervention in Stressed Midlife Adults Living with Obesity and Memory Decline

OBJECTIVES/GOALS: Cognitive decline is associated with obesity, stress, poor sleep, and circadian rhythm misalignment, which are themselves functionally intertwined. Irregular food intake timing exacerbates these all. Prolonged nightly fasting (PNF) aligns food intake with innate circadian rhythms. METHODS/STUDY POPULATION: A nationwide, remotely-delivered, 2-arm randomized controlled trial was conducted to assess feasibility and 8-week outcomes of cognition, stress, sleep, eating behaviors, and general eating habits, after a PNF intervention (14-hr nightly fast, 6 nights/week, no calories after 8pm) compared to a health education control (HEC) condition. Eligible participants were living with obesity, stress (Perceived stress scale-4 (PSS-4) total score ≥5), and memory “not as good as it used to be.” Data were collected via Zoom meetings with participants and trained staff and entered into REDCap. All participants had weekly staff check-in calls to report fasting times (PNF group only) and feedback. RESULTS/ANTICIPATED RESULTS: Eligible participants were enrolled from 37 of 50 US states; N=58, 86% women, 71% white, 93% non-Latinx, mean (SD) 50.1 (5.1) years of age, BMI 35.6 (3.6) kg/m^2. No group differences existed at baseline. Linear mixed-effects models were used to compare group differences across all outcome changes. Compared to the HEC condition, the PNF intervention was associated with improved sleep quality (Pittsburgh Sleep Quality Index; B = -2.52; SE = 0.90; 95% CI-4.30 to -0.74; p=0.006). Stress, everyday cognition, and emotional eating behavior significantly changed over time (p<0.02), but there were no group differences. Analysis of feasibility outcomes are on-going. DISCUSSION/SIGNIFICANCE: Changing food intake timing 6 days per week, to exclude nighttime eating without mandating food quality/quantity change, may benefit many individuals living with obesity, stress and memory decline to improve their sleep. Improved sleep quality may lead to more health benefits over time.

Study protocol for a comparative randomized controlled trial of Tai Chi and conventional exercise training on alleviating depression in older insomniacs

BackgroundInsomnia and depression are prevalent mental disorders that are often comorbid among older adults. Lifestyle intervention strategies incorporating Tai Chi or conventional exercise have been shown to alleviate symptoms of insomnia and depression. However, the comparative efficacy of these exercise modalities in individuals with both disorders has yet to be determined. Therefore, the aim of this study is to examine the efficacy of Tai Chi and conventional exercise for reducing depressive symptoms in older adults with chronic insomnia and depressive symptoms, when compared to a health education control. MethodsThis study is a prospective, assessor-blinded, three-arm, parallel group, randomized controlled trial. Older adults aged ≥60 years with a diagnosis of chronic insomnia and depressive symptoms will be randomly assigned to a Tai Chi, conventional exercise or health education control condition on a 1:1:1 basis. Interventions will last for 3 months, with a 6-month follow-up period. The primary outcome is depressive symptoms, assessed using the Hospital Anxiety and Depression Scale. Secondary outcomes include subjective sleep quality, 7-day actigraphy, 7-day sleep diary, anxiety symptoms, quality of life, medication usage and physical function. All measurements will be conducted at baseline, 3 months and 9 months by outcome assessors who are blinded to group allocation. DiscussionThis study will compare the efficacy of Tai Chi and conventional exercise in improving depression outcomes in older adults with chronic insomnia and depressive symptoms. Our results will shed light on the clinical potential of these interventions for combating insomnia and depression in older adults.

Dissonance-based prevention of eating pathology in non-Western cultures: A randomized controlled trial of the Body Project among young Saudi adult women

The aims of this study were to determine the effectiveness of an adapted version of the Body Project for young Saudi women, and to determine the impact of compliance (i.e. adherence to homework and attendance) on outcomes. A randomized controlled trial was used, allocating Saudi undergraduate females (N = 92; mean age = 20.48 years; SD = 2.28) to either a culturally-adapted version of the Body Project or a health education control condition. Participants completed self-report measures of eating pathology, body image, depression and social anxiety before and following the interventions and at three-month follow-up. Interaction terms showed that, relative to the control group, the intervention group had significantly reduced levels of eating concerns, body dissatisfaction and depression, but social anxiety did not change significantly in either group. Levels of session attendance and homework completion did not influence outcomes. Thus, the Body Project was effective for Saudi women in reducing eating pathology, body image dissatisfaction, and depression, though not social anxiety. This outcome indicates the value of the Body Project as a prevention tool when adapted to non-Western cultures.

Feasibility Pilot: Problem Adaptation Therapy for Emotion Regulation in Community-Dwelling Older Adults

Emotion regulation (ER) difficulties in older adults are associated with increased depression and decreased resiliency to stressful life events. In general, maladaptive ER is a transdiagnostic risk factor for a range of psychological and physical problems across the lifespan. Thus, interventions targeting ER may be valuable in reducing risk for a range of late-life pathologies. The present study evaluated and adapted an existing ER-focused treatment (i.e., Problem Adaptation Therapy (PATH)) for community older adults. We completed a small clinical pilot study to assess the feasibility of the adapted protocol and initial signals of effect of the intervention on ER, depression, and resiliency. Participants were recruited using an online survey, which was used to then identify participants scoring in the highest and lowest quartiles for ER. Individuals in the lowest ER quartile (N=27) were randomly assigned to the PATH condition or a physical health education (PHET) control condition. Of the 27 participants in the low ER group, four participants (3 PATH, 1 PHET) dropped out of the intervention. A paired samples t-tests revealed significant decreases in depressive symptoms, significant increases in self-reported ER skill, and improvements in resiliency (all ps<.05) for the PATH condition. For the PHET condition, only significant increases in self-reported ER skill (t(12) = -2.68, p = .020) were observed. In sum, the intervention protocol proved feasibility and demonstrated initial signals of effect in the expected directions. Future studies will examine mechanisms of action and the efficacy of the adapted PATH protocol.

The Impact of Tai Chi Exercise on Health Care Utilization and Imputed Cost in Residents of Low-Income Senior Housing.

Background/ObjectivesThis study was designed to test the impact of Tai Chi (TC) on healthcare utilization and cost in older adults living in low-income senior housing. We hypothesized that TC would improve overall health enough to reduce the use of emergency department (ED) and inpatient services.DesignCluster randomized controlled trial with randomization at the housing site level.SettingGreater Boston, Massachusetts.ParticipantsThe study includes 6 sites with 75 individuals in the TC treatment condition and 6 sites with 67 individuals in the health education control condition.InterventionMembers of the treatment group received up to a year-long intervention with twice weekly, in-person TC exercise sessions along with video-directed exercises that could be done independently at home. The comparison group received monthly, in-person healthy aging education classes (HE). Study recruitment took place between August, 2015 and October, 2017. Key outcomes included acute care utilization (inpatient stays, observation stays and emergency department visits). In addition, the cost of utilization was estimated using the age, sex and race adjusted allowed amount from Medicare claims for a geographically similar population aged ≥ 65.ResultsThe results suggested a possible reduction in the rate of ED visits in the TC group vs. controls (rate ratio = 0.476, p-value = 0.06), but no findings achieved statistical significance. Adjusted estimates of imputed costs of ED and hospital care were similar between TC and HE, averaging approximately $3,000 in each group.ConclusionED utilization tended to be lower over 6 to 12 months of TC exercises compared to HE in older adults living in low-income housing, although estimated costs of care were similar.

Collaborative co‐design of an active and healthy ageing program using mobile technology to reduce dementia risk in older Aboriginal Australians

AbstractBackgroundHigh rates of dementia have been observed in Aboriginal Australians and dementia risk reduction is a priority in this population. The Koori Active and Healthy Ageing Project aimed to develop new, effective, culturally appropriate healthy brain ageing approaches in collaboration with older Aboriginal people and partner communities in regional and urban Australia.MethodInitially, 34 semi‐structured interviews and 2 yarning (focus) groups were conducted with older Aboriginal participants to understand perceptions regarding community health priorities, preferences for healthy ageing programs and acceptability of technology as a platform for program delivery. Following consultation and development, a pilot randomised control trial (RCT) was conducted over 16 weeks, to evaluate the feasibility of a new program versus a health education control condition in 30 Aboriginal people aged 45+ years. The primary outcome included dual‐task walking. Trial registration ID: ACTRN12619001130156.ResultQualitative interviews identified key health concerns including memory loss, mobility, depression, and access to healthcare services. Using self‐directed technology for healthy ageing was widely supported, however, the importance of maintaining social group connections was emphasised. StandingTall is an unsupervised balance exercise program delivered using mobile technology for older people and was the preferred option selected in yarning groups. With further consultation, this program was redeveloped to provide a culturally inclusive interface, and incorporate cognitive‐motor (dual‐task) activities to boost potential benefits for healthy brain ageing and maintaining functional independence. Eighteen participants were enrolled and completed the RCT (8 intervention, 10 control). Users rated the StandingTall program as easy and enjoyable to use. There was no significant effect of intervention observed on dual‐task walking in intention to treat analysis (F(1,16)=0.14, p=0.71). However, adherence was highly variable and likely affected outcomes; three participants did not engage with the program and five reached a median of 33.4 minutes per week (max=130.7).ConclusionBy implementing a technological platform, this program has strong potential to improve access to dementia prevention strategies, enable low‐cost individualised program tailoring and facilitate transferability across diverse community settings. Understanding the factors related to program adherence is critical and a larger trial is needed to examine the effectiveness of the program in this population.

Brief Enhanced Partner Notification and Risk Reduction Counseling to Prevent Sexually Transmitted Infections, Cape Town, South Africa.

Evidence-based interventions are needed to stem sexually transmitted infections (STIs). Clinic-delivered counseling remains an important avenue for effective STI prevention. A 3-arm randomized clinical trial compared (a) STI health education control condition, (b) risk reduction counseling, and (c) enhanced partner notification counseling. Men and women (n = 1050) were recruited from an STI clinic in Cape Town, South Africa. After baseline assessments, participants were randomly allocated to receive 1 of the 3 single-session counseling interventions and were followed up for 9 months of behavioral assessments and 12 months of electronic medical records abstraction for STI clinic services. Sexual risk reduction counseling reported greater condom use than did the other 2 conditions during the 3 and 6 months follow-ups. In addition, women receiving risk reduction counseling were significantly less likely to have returned for STI clinic services but did not differ in the number of STI clinic visits over the year. Brief single-session STI prevention counseling demonstrates significant targeted outcomes. The findings suggest that counseling approaches to both increase condom use and enhance partner notification may offer more robust and sustained outcomes and should be tested in future research.

Metabolic and Neurocognitive Changes Following Lifestyle Modification: Examination of Biomarkers from the ENLIGHTEN Randomized Clinical Trial.

Previous studies have demonstrated that aerobic exercise (AE) and the Dietary Approaches to Stop Hypertension (DASH) diet can improve neurocognition. However, the mechanisms by which lifestyle improves neurocognition have not been widely studied. We examined the associations between changes in metabolic, neurotrophic, and inflammatory biomarkers with executive functioning among participants from the Exercise and Nutritional Interventions for Neurocognitive Health Enhancement (ENLIGHTEN) trial. To examine the association between changes in metabolic function and neurocognition among older adults with cognitive impairment, but without dementia (CIND) participating in a comprehensive lifestyle intervention. ENLIGHTEN participants were randomized using a 2×2 factorial design to receive AE, DASH, both AE+DASH, or a health education control condition (HE) for six months. Metabolic biomarkers included insulin resistance (homeostatic model assessment [HOMA-IR]), leptin, and insulin-like growth factor (IGF-1); neurotrophic biomarkers included brain derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF); and inflammatory biomarkers included interleukin-6 (IL-6) and C-Reactive Protein (CRP). Participants included 132 sedentary older adults (mean age = 65 [SD = 7]) with CIND. Results demonstrated that both AE (d = 0.48, p = 0.015) and DASH improved metabolic function (d = 0.37, p = 0.039), without comparable improvements in neurotrophic or inflammatory biomarkers. Greater improvements in metabolic function, including reduced HOMA-IR (B = -2.3 [-4.3, -0.2], p = 0.033) and increased IGF-1 (B = 3.4 [1.2, 5.7], p = 0.004), associated with increases in Executive Function. Changes in neurocognition after lifestyle modification are associated with improved metabolic function.

Usefulness of a Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity After an Acute Coronary Syndrome

Most patients are not able to achieve recommended levels of physical activity following an acute coronary syndrome (ACS). Existing interventions to promote activity have not focused on promoting psychological well-being, which is independently linked to superior cardiac health. To address this gap, we developed and tested a combined positive psychology-motivational interviewing (PP-MI) intervention in post-ACS patients to assess its feasibility and explore potential benefits in an initial randomized trial. We compared a 12-week, phone-delivered, PP-MI intervention to an attention-matched, MI-based health education control condition among 47 post-ACS patients with low baseline health behavior adherence. Feasibility/acceptability were assessed through rates of session completion and participant session ratings; we also explored between-group differences in positive affect, other self-reported outcomes, and accelerometer-measured physical activity, through mixed effects regression models, at 12 and 24 weeks. PP-MI participants completed a mean of 10.0 (standard deviation 2.2) sessions (84%), and mean participant ratings of sessions' ease/utility were >8/10, above a priori thresholds for success. Compared with the control condition, PP-MI was associated with greater improvements in positive affect at 12 and 24 weeks (12 weeks: estimated mean difference [EMD] = 3.90 [SE = 1.95], p = 0.045, effect size [ES] = 0.56; 24 weeks: EMD = 7.34 [SE = 2.16], p <0.001, ES = 1.12). PP-MI was also associated with more daily steps at 12 weeks (EMD = 1842.1 steps/day [SE = 849.8], p = 0.030, ES = 0.76) and greater moderate-vigorous activity at 24 weeks (EMD = 15.1 minutes/day [SE = 6.8], p = 0.026, ES = 0.81). In conclusion, PP-MI was feasible in post-ACS patients and showed promising effects on well-being and physical activity; additional studies are needed to confirm these findings.

Project ACCEPT: Evaluation of a Group-Based Intervention to Improve Engagement in Care for Youth Newly Diagnosed with HIV.

ACCEPT is a gender-specific, group-based intervention aimed at addressing factors that impact engagement in care for youth newly diagnosed with HIV, including stigma, disclosure, healthy relationships, substance use, and future life planning. To test the efficacy of ACCEPT, we enrolled 103 youth and randomly assigned 57 to the ACCEPT condition and 46 to a health education control condition (HEALTH). Acceptability ratings were very high for both conditions. Over the 12months post-intervention, the ACCEPT group was associated with an odds ratio of 2.33 greater likelihood of self-reported use of HIV medications compared to the HEALTH group (OR=2.33 95% CI 1.29-4.21, p=0.005) as well as declining viral load over time (-0.14 (0.07), p=0.041). The group-based ACCEPT intervention can improve engagement in care with corresponding positive health outcomes among HIV+youth. Despite the efficacy of ARV treatment, behavioral interventions are still valuable to promote engagement in care as well as adherence to medication.

Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors

Breast cancer is the most commonly diagnosed non-skin cancer in women and the leading cause of death among Hispanic women living in the United States. Relative to non-Hispanic white women, Hispanic women report poorer health related quality of life (HRQoL) after treatment. Although eHealth interventions delivered via Smartphones are a viable approach to addressing supportive care accessibility issues while also integrating multidisciplinary approaches for improving HRQoL, few eHealth interventions have been developed that specifically target Hispanic breast cancer survivors (BCS). This manuscript describes the methodology of a multi-site, randomized controlled behavioral trial investigating the feasibility and preliminary efficacy of a Smartphone application aimed at improving HRQoL and cancer-specific distress among Hispanic BCS. Participants will be randomized to receive the intervention application, My Guide (psychoeducation & self-management program), or the health education control condition application, My Health (health education), for six weeks. All participants will also receive weekly telecoaching to enhance adherence to both control and intervention conditions. We will measure the study's primary outcomes, general and disease-specific HRQoL and cancer-specific distress, at three time points: prior to, immediately after the intervention, and eight weeks after initial application use. My Guide may have the potential to improve HRQoL, and to address issues of limited access to supportive care among Hispanic women recovering from breast cancer treatment.

A developmental-based motivational intervention to reduce alcohol and marijuana use among non-treatment-seeking young adults: a randomized controlled trial.

To test the hypothesis that among non-treatment-seeking emerging adults (EA) who both use marijuana and have alcohol binges, a brief, longitudinally delivered, developmentally based motivational intervention would show greater reductions in the use of these two substances compared with a health education control condition. Parallel, two-group, randomized controlled trial with follow-up interventions conducted at 1, 3, 6 and 9months and final assessments at 12 and 15months. Hospital-based research unit in the United States. Community-based 18-25-year-olds who reported at least monthly binge drinking and at least weekly marijuana use. Motivational intervention (EA-MI) focused primarily on themes of emerging adulthood (identity exploration, instability, self-focus, feeling in-between, a sense of possibilities) and the subjects' relationship to substance use (n=110) compared with an attention-matched health education control condition (n=116). The primary outcomes were days of binge alcohol, marijuana and dual use day as measured using the timeline follow-back method analysing the treatment by time interaction to determine relative differences in the rate of change between intervention arms. At baseline, the mean rate (days/30) of binge drinking was 5.23 (± 4.31) of marijuana use was 19.4 (± 10.0) and of dual (same day) use was 4.11 (± 4.13). Relative to baseline, there were reductions in the rate of binge alcohol use, marijuana use and days of combined binge alcohol and marijuana use (P<0.001) at all follow-up assessments. However, the treatment× time interaction was not statistically significant for alcohol (P=0.37), for marijuana (P=0.07) or for dual use (P=0.55). Averaged over all follow-ups, mean reductions in binge, marijuana and dual use days were 1.16, 1.45 and 1.08, respectively, in the health education arm, and 1.06, 1.69 and 0.96 in EA-MI. Bayes factors were < 0.01 for frequency of binge alcohol use and frequency of dual binge alcohol and marijuana and 0.016 for marijuana use. A brief, longitudinally delivered, developmentally based motivational intervention for young adults did not produce reductions in binge alcohol, marijuana use or dual use days relative to a control condition.

Mindfulness-Based Relapse Prevention for Stimulant Dependent Adults: A Pilot Randomized Clinical Trial

In light of the known associations between stress, negative affect, and relapse, mindfulness strategies hold promise as a means of reducing relapse susceptibility. In a pilot randomized clinical trial, we evaluated the effects of Mindfulness Based Relapse Prevention (MBRP), relative to a health education control condition (HE) among stimulant dependent adults receiving contingency management. All participants received a 12-week contingency management (CM) intervention. Following a 4-week CM-only lead in phase, participants were randomly assigned to concurrently receive MBRP (n=31) or HE (n=32). Stimulant dependent adults age 18 and over. A university based clinical research center. The primary outcomes were stimulant use, measured by urine drug screens weekly during the intervention and at 1-month post-treatment, negative affect, measured by the Beck Depression Inventory and Beck Anxiety Inventory, and psychiatric severity, measured by the Addiction Severity Index. Medium effect sizes favoring MBRP were observed for negative affect and overall psychiatric severity outcomes. Depression severity changed differentially over time as a function of group, with MBRP participants reporting greater reductions through follow-up (p=0.03; Effect Size=0.58). Likewise, the MBRP group evidenced greater declines in psychiatric severity, (p=0.01; Effect Size=0.61 at follow-up). Among those with depressive and anxiety disorders, MBRP was associated with lower odds of stimulant use relative to the control condition (Odds Ratio= 0.78, p=0.03 and OR=0.68, p=0.04). MBRP effectively reduces negative affect and psychiatric impairment, and is particularly effective in reducing stimulant use among stimulant dependent adults with mood and anxiety disorders.

Changes in Stress Reactivity among Stimulant Dependent Adults After Treatment with Mindfulness Based Relapse Prevention: Results from a Pilot Randomized Clinical Trial

Background: In light of recent evidence suggesting the presence of stress processing deficits in stimulant users, coupled with laboratory studies demonstrating an association between stress reactivity and relapse to stimulant use, interventions that target stress-induced craving and stress reactivity may reduce relapse risk in this population. Objective: This study examines changes in stress reactivity among adults with stimulant use disorders (N=22) in response to an 8 week Mindfulness Based Relapse Prevention (MBRP) intervention. Methods: Study participants were enrolled in a in a pilot randomized clinical trial, evaluating the efficacy of MBRP, relative to a health education control condition (HE). At baseline and treatment-end, biological and subjective responses to a laboratory psychosocial stress task (i.e., the Trier Social Stress Task) were measured. Results: MBRP participants evidenced significantly lower levels of salivary cortisol in response to the posttreatment laboratory stress provocation, relative to those in the HE condition. Likewise, HE participants evidenced disproportionately greater increases in subjective stress, anxiety and stimulant cravings in response to the posttreatment stress provocation, relative to those who received MBRP. Conclusion: Results of this pilot investigation suggest that MBRP effectively attenuates stress reactivity among adults with stimulant use disorders. This approach may have utility as an adjunct to comprehensive programs treating stimulant addiction. Future research evaluating the impact of changes in stress reactivity on post-treatment relapse to stimulant use and the long-term effects of MBRP on stress reactivity is warranted.

Civic Engagement Curriculum: a Strengths-Based Intervention Serving African American Youth in a Context of Toxic Stress

Chronic stress in under-resourced urban communities has been linked to negative outcomes for youth, warranting interventions to enhance resilience, an assets-building approach. This study assessed the effects of the Civic Engagement Curriculum (CEC) intervention on enhancing resilience. Data were collected from 82 low-income urban African American youth (M age = 12.92, SD = 0.80, 53.7 % female). Three schools participated in either the CEC or a health education control condition. Regression analyses revealed a positive main effect of the CEC on leadership, while bootstrap analyses revealed CEC moderation effects on leadership, life satisfaction, and coping under certain conditions of neighborhood and ethnic identity. This study underscores the value of understanding resilience-promoting factors for low-income urban youth facing chronic toxic stress. Language: en

Yoga reduces inflammatory signaling in fatigued breast cancer survivors: A randomized controlled trial

Yoga is a popular mind-body therapy that has demonstrated beneficial effects on psychological, behavioral, and functional outcomes. However, few studies have investigated effects on inflammatory processes. This study tested the hypothesis that an Iyengar yoga intervention specifically designed for fatigued breast cancer survivors would lead to decreases in inflammation-related gene expression and circulating markers of proinflammatory cytokine activity. Breast cancer survivors with persistent cancer-related fatigue were randomized to a 12-week Iyengar yoga intervention (n=16) or a 12-week health education control condition (n=15). Blood samples were collected at baseline, post-intervention, and at a 3-month follow-up for genome-wide transcriptional profiling and bioinformatic analyses. Plasma inflammatory markers and salivary cortisol were also assessed. In promoter-based bioinformatics analyses, the yoga group showed reduced activity of the pro-inflammatory transcription factor nuclear factor kappa B (NF-κB), increased activity of the anti-inflammatory glucocorticoid receptor, and reduced activity of cAMP response element-binding protein (CREB) family transcription factors relative to controls (all ps<.05). There was also a significant intervention effect on the soluble tumor necrosis factor receptor type II (sTNF-RII), a marker of TNF activity; plasma levels of sTNF-RII remained stable in the yoga group, whereas levels of this marker increased in the health education group (p=.028). A similar, non-significant trend was observed for the interleukin 1 receptor antagonist (p=.16). No significant changes in C reactive protein (CRP), interleukin 6 (IL-6), or diurnal cortisol measures were observed. A 12-week restorative Iyengar yoga intervention reduced inflammation-related gene expression in breast cancer survivors with persistent fatigue. These findings suggest that a targeted yoga program may have beneficial effects on inflammatory activity in this patient population, with potential relevance for behavioral and physical health.

The Group Oriented Arterial Leg Study (GOALS) to improve walking performance in patients with peripheral arterial disease

People with lower extremity peripheral artery disease (PAD) have greater functional impairment and faster functional decline than those without PAD. We describe methods for the Group Oriented Arterial Leg Study (GOALS), an ongoing randomized controlled clinical trial designed to determine whether a Group-Mediated Cognitive Behavioral (GMCB) intervention improves functional performance in PAD participants, compared to a health education control condition.In GOALS, PAD participants were randomized to either an intervention or a health education control condition in a parallel design. Both conditions consist of weekly group sessions with other PAD participants. In the intervention, cognitive behavioral techniques are used to assist participants in setting and adhering to home-based walking exercise goals. Participants are encouraged to walk for exercise at home at least 5days/week. In the control condition, participants receive lectures on health-related topics. After 6months of on-site weekly sessions, participants are transitioned to telephone follow-up for another 6months. Participants in the intervention are asked to continue home walking exercise. The primary outcome is change in six-minute walk performance between baseline and six-month follow-up. Secondary outcomes include change in six-minute walk performance at 12-month follow-up, and change in treadmill walking performance, the Walking Impairment Questionnaire, quality of life, and physical activity at six and 12-month follow-up. In conclusion, if our group-mediated cognitive behavioral intervention is associated with improved walking performance in individuals with PAD, results will have major public health implications for the large and growing number of people with PAD.

Attendance and substance use outcomes for the Seeking Safety program: sometimes less is more.

This study uses data from the largest effectiveness trial to date on treatment of co-occurring posttraumatic stress and substance use disorders, using advances in statistical methodology for modeling treatment attendance and membership turnover in rolling groups. Women receiving outpatient substance abuse treatment (N = 353) were randomized to 12 sessions of Seeking Safety or a health education control condition. Assessments were completed at baseline and at 1 week, 3, 6, and 12 months posttreatment. Outcome measures were alcohol and cocaine use in the prior 30 days captured using the Addiction Severity Index. Latent class pattern mixture modeling (LCPMM) was used to estimate attendance patterns and to test for treatment effects within and across latent attendance patterns and group membership turnover. Across LCPMM analyses for alcohol and cocaine use, similar treatment attendance patterns emerged: Completers never decreased below an 80% probability of attendance, droppers never exceeded a 41% probability of attendance, and titrators demonstrated a 50% to 80% probability of attendance. Among completers, there were significant decreases in alcohol use from baseline to 1-week posttreatment, followed by nonsignificant increases in alcohol during follow-up. No differences between treatment conditions were detected. Titrators in Seeking Safety had lower rates of alcohol use from 1-week through 12-month follow-up compared with control participants. Droppers had nonsignificant increases in alcohol during both study phases. Cocaine use findings were similar but did not reach significance levels. The impact of client self-modulation of treatment dosage and group membership composition may influence behavioral treatment outcomes among this population.

Tobacco Use Harm Reduction, Elimination, and Escalation in a Large Military Cohort

We evaluated changing patterns of tobacco use following a period of forced tobacco abstinence in a US military cohort to determine rates of harm elimination (e.g., tobacco cessation), harm reduction (e.g., from smoking to smokeless tobacco use), and harm escalation (e.g., from smoking to dual use or from smokeless tobacco use to smoking or dual use). Participants were 5225 Air Force airmen assigned to the health education control condition in a smoking cessation and prevention trial. Tobacco use was assessed by self-report at baseline and 12 months. Among 114 baseline smokers initiating smokeless tobacco use after basic military training, most demonstrated harm escalation (87%), which was 5.4 times more likely to occur than was harm reduction (e.g., smoking to smokeless tobacco use). Harm reduction was predicted, in part, by higher family income and belief that switching from cigarettes to smokeless tobacco is beneficial to health. Harm escalation predictors included younger age, alcohol use, longer smoking history, and risk-taking. When considering a harm reduction strategy with smokeless tobacco, the tobacco control community should balance anticipated benefits of harm reduction with the risk of harm escalation and the potential for adversely affecting public health.

Move to Improve: A Randomized Workplace Trial to Increase Physical Activity

Workplaces are important settings for interventions to increase physical activity, but effects have been modest. To evaluate the efficacy of Move to Improve, a social-ecologic intervention delivered at the workplace to increase leisure-time physical activity. A group-randomized 12-week intervention consisting of organizational action and personal and team goal-setting was implemented in Fall 2005, with a multi-racial/ethnic sample of 1442 employees at 16 worksites of The Home Depot, Inc. Change in physical activity was analyzed in Fall 2007 using latent growth modeling and latent transition analysis. Participants in the intervention had greater increases in moderate and vigorous physical activity and walking compared to participants in a health education control condition. The proportion of participants that met the Healthy People 2010 recommendation for regular participation in either moderate or vigorous physical activity remained near 25% at control sites during the study but increased to 51% at intervention sites. During the last 6 weeks of the study, intervention participants exceeded 300 weekly minutes of self-reported moderate-to-vigorous physical activity and 9000 daily pedometer steps. The results support the feasibility and efficacy of the Move to Improve intervention and the role of goal-setting for attaining increased physical activity levels.