Attention Control Intervention Research Articles

Neurobiological and Anti-Inflammatory Effects of a DeepDiaphragmatic Breathing Technique Based on Neofunctional Psychotherapy: A Pilot RCT.

We examined the feasibility of using the neofunctional deep breathing (NDB) technique to reduce the allostatic load following the Trier Social Stress Test (TSST). Forty-four healthy subjects were randomised into experimental and control groups. Following the TSST procedure, participants underwent either a single session of NDB or an attention control intervention. The Procomp Infinity Biofeedback system measured breath per minute (BPM), respiratory amplitude, HRV linear domains, skin conductance, and trapezius muscle electromyographic activity. Cortisol and cytokine salivary concentrations, perceived stress, and anxiety levels were also assessed. These parameters were combined into an allostatic load index (ALI) to measure the intervention's effect. This pilot RCT demonstrated the feasibility of the study design and practicality of the intervention. The NDB group showed reduced ALI, increased respiratory abdominal amplitude, decreased BPM, increased HRV indicating parasympathetic activation, and decreased cortisol and inflammatory cytokines. This study highlighted the feasibility of testing the NDB technique in reducing allostatic load through a neurobiological and anti-inflammatory response after exposure to psychosocial stress. This protocol can represent a non-invasive therapeutic adjutant in disorders related to a dysregulation of the HPA axis or to an inflammatory state. Trial Registration: NCT04102813.

Disparities between rural and urban communities: Response to 18-months of diet and exercise versus control for knee osteoarthritis and overweight or obesity.

The study objective was to determine whether the clinical response of older adults with knee osteoarthritis and overweight or obesity to 18 months of diet and exercise or attention control interventions differed between participants from rural versus urban communities. Participants were 823 older adults (mean age, 64.6 years; 77% women) with knee osteoarthritis, overweight or obesity, who resided in rural (N = 410) and urban (N = 413) counties in North Carolina. All were enrolled in the WE-CAN clinical trial that randomly assigned participants to either 18-months of diet and exercise (D+E) or attention control (C) interventions. General linear models were used to examine differences in clinical outcomes between rural and urban groups after adjusting for covariates. The rural group had significant differences (P<.05) at baseline in clinical outcomes, education, comorbidities, medication use, and income compared to the urban dwellers. After adjusting for baseline differences, the group (rural, urban) by treatment (D+E, C) interactions for WOMAC pain (rural: D+E-C= -0.63,95%CI,-1.31 to 0.06; urban: D+E-C= -0.29,95%CI,-0.99 to 0.41;P=.50) and WOMAC function (rural: D+E-C = -4.60,95%CI,-6.89 to -2.31; urban: D+E-C = -1.38,95%CI,-3.73 to 0.94;P=.054) indicated that the groups responded similarly to the interventions. Among participants with knee osteoarthritis and overweight or obesity, diet and exercise compared to attention control led to similar pain outcomes in rural and urban dwellers that favored diet and exercise; the possibility there may be greater differential efficacy in functional outcomes among rural participants needs further study.

Equine-assisted service’s effect on cartilage and skeletal biomarkers for adults and older adults with arthritis: A pilot study

ObjectiveThe object of this study was to determine the effect of EAS (Equine-Assisted Services) on arthritis conditions, as measured by the sTnT (Skeletal troponin) and COMP (cartilage oligomeric matrix proteins) biomarkers, compared to an exercise attention control intervention. DesignThis was a secondary analysis of a randomized clinical trial comparing equine-assisted therapy to exercise education attention-control on cartilage and skeletal biomarkers in adults with arthritis. Twenty-one adults (Mage = 64 years) with arthritis who attended rheumatology clinics in the midwestern United States participated. ResultsNo changes were found in sTnT from baseline to week six within either intervention nor were there differences in changes between the two groups (p = 0.91). COMP increased from baseline to week six for both conditions, suggesting increased deterioration of cartilage and joints. Although the attention-control condition demonstrated larger increases in cartilage oligomeric matrix proteins level, compared to the EAS condition, these differences were not statistically (p = 0.58) or clinically significant (i.e., trivial effect, d = −0.16). When 3 outliers were removed, the differences in changes between EAT and attention-control group could be arguably of clinical significance (d = - 0.33), suggesting that the attention-control group demonstrated larger increases in levels of COMP than those in the EAS condition, though this difference was not statistically significant (p = 0.28). ConclusionAlthough equine-assisted therapy may reduce pain and improve quality of life for adults with arthritis, findings here are not fully corroborated with biomarkers.

Effectiveness of Exercise Interventions for Preventing Neck Pain: A Systematic Review With Meta-analysis of Randomized Controlled Trials.

OBJECTIVE: To update the evidence on the effectiveness of exercise interventions to prevent episodes of neck pain. DESIGN: Systematic review with meta-analysis. LITERATURE SEARCH: MEDLINE, Embase, CENTRAL, CINAHL, SPORTDiscus, PEDro, and trial registries from inception to December 2, 2022. Forward and backward citation searches. STUDY SELECTION CRITERIA: Randomized controlled trials (RCTs) that enrolled adults without neck pain at baseline and compared exercise interventions to no intervention, placebo/sham, attention control, or minimal intervention. Military populations and astronauts were excluded. DATA SYNTHESIS: Random-effects meta-analysis. Risk of bias was assessed using the Cochrane RoB 2 tool. The certainty of evidence was judged according to the GRADE approach. RESULTS: Of 4703 records screened, 5 trials (1722 participants at baseline) were included and eligible for meta-analysis. Most (80%) participants were office workers. Risk of bias was rated as some concerns for 2 trials and high for 3 trials. There was moderate-certainty evidence that exercise interventions probably reduce the risk of a new episode of neck pain (OR, 0.49; 95% confidence interval: 0.31, 0.76) compared to no or minimal intervention in the short-term (≤12 months). The results were not robust to sensitivity analyses for missing outcome data. CONCLUSION: There was moderate-certainty evidence supporting exercise interventions for reducing the risk for an episode of neck pain in the next 12 months. The clinical significance of the effect is unclear. J Orthop Sports Phys Ther 2023;53(10):1-16. Epub: 8 September 2023. doi:10.2519/jospt.2023.12063.

The use of mentalization-based techniques in online psychodynamic child psychotherapy

Objective: Psychodynamic child psychotherapy is an evidence-based approach for a range of child mental health difficulties and needs to constantly adapt to meet the needs of children. This study is the first to investigate whether the use of mentalization-based interventions (i.e., a focus on promoting attention control, emotion regulation, and explicit mentalization) predicted a good therapeutic outcome in online psychodynamic child therapy sessions conducted during the COVID-19 pandemic. Methods: The sample included 51 Turkish children (M age = 7.43, 49% girls) with mixed emotional and behavioral problems. Independent raters coded 203 sessions from different phases in each child’s treatment using the Mentalization-Based Treatment for Children Adherence Scale (MBT-CAS). Results: Multilevel modeling analyses showed children with higher emotional lability benefited more from attention control interventions compared to those with lower emotional lability. Discussion: Interventions that focus on developing the basic building blocks of mentalizing may be effective components of therapeutic action for online delivery of psychodynamic child psychotherapy, especially for children with greater emotional lability.

A positive parenting program to enhance positive affect in children of previously depressed mothers.

Children of mothers with a history of depression are at heightened risk for developing depression and other maladaptive outcomes. Deficits in parenting are one putative mechanism underlying this transmission of risk from mother to child. The present study evaluated whether a brief intervention with mothers with a history of depression produced greater use of positive parenting behaviors and an increase in observed positive affect in their 8- to 10-year-old children. Mothers with a history of depression (n = 65) were randomly assigned to either a positive parenting intervention or an attention control intervention condition. In addition, a comparison group of 66 mothers with no history of depression was evaluated one time. Results revealed significant increases in positive parenting behaviors (e.g., active listening, praise) immediately postintervention in mothers randomized to the positive parenting intervention as compared to those in the attention control condition. Children of mothers in the positive parenting intervention showed increases in positive affect as compared to children of mothers in the attention control intervention. Increases in mothers' active listening and smiling/laughing significantly predicted increases in children's positive affect. The intervention did not increase the rate of children's moment-by-moment positive affect contingent on mothers' positive parenting behaviors. This study showed the short-term effectiveness of a brief parenting intervention for enhancing interactions between mothers with a history of depression and their children by directly targeting mothers' positive parenting and, indirectly, children's expressions of positive affect. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Effectiveness of weight management interventions for adults delivered in primary care: systematic review and meta-analysis of randomised controlled trials

ObjectiveTo examine the effectiveness of behavioural weight management interventions for adults with obesity delivered in primary care.DesignSystematic review and meta-analysis of randomised controlled trials.Eligibility criteria for selection of studiesRandomised controlled...

Adding Physical Activity Coaching and an Activity Monitor Was No More Effective Than Adding an Attention Control Intervention to Group Exercise for Patients With Chronic Nonspecific Low Back Pain (PAyBACK Trial): A Randomized Trial.

To investigate whether adding physical activity coaching and an activity monitor enhanced the effects of a group exercise program on pain intensity and disability for people with chronic nonspecific low back pain. Randomized controlled trial with concealed allocation, intention-to-treat analysis, and blinding of participants and assessors. One hundred sixty participants with chronic nonspecific low back pain who were aged between 18 and 60 years and seeking care at an outpatient physiotherapy clinic participated. Both groups received supervised group exercise therapy. The intervention group also received physical activity coaching sessions aimed at improving physical activity, and physical activity electronic feedback delivered by an activity monitor. The attention control group received modified approaches of coaching sessions and an activity monitor. Disability was measured using the Roland Morris Disability Questionnaire (0-24), and pain intensity was measured using the 11-point Numerical Rating Scale (0-10). Linear mixed models were performed to test for differences between groups. There were no differences between groups for reductions in disability (mean difference [MD] = -0.5 out of 24 points; 95% confidence interval [CI]: -2.2, 1.1) and pain intensity (MD = -0.4 out of 10 points; 95% CI: -1.3, 0.5) at 3-month follow-up. There were no between-groups differences at 6- and 12-month follow-up assessments. Adding targeted physical activity coaching and an activity monitor did not reduce pain intensity or disability more than an attention control approach in participants with chronic low back pain who were undertaking a group exercise program. J Orthop Sports Phys Ther 2022;52(5):287-299. doi:10.2519/jospt.2022.10874.

Multilevel Intervention for Low-Income Maternal Smokers in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Objectives. To test the efficacy of Babies Living Safe and Smokefree (BLiSS), a multilevel intervention initiated in a citywide safety net health system to improve low-income maternal smokers' abstinence and reduce child tobacco smoke exposure. Methods. This randomized controlled trial in Philadelphia, Pennsylvania (2015-2020), recruited low-income maternal smokers who received a brief smoking intervention (Ask, Advise, Refer [AAR]) from nutrition professionals in the Special Supplemental Nutrition Program for Women, Infants, and Children before randomization to (1) a multilevel intervention (AAR + multimodal behavioral intervention [MBI]; n = 199) or (2) an attention control intervention (AAR + control; n = 197). Results. AAR + MBI mothers had significantly higher 12-month bioverified abstinence rates than did AAR + control mothers (odds ratio [OR] = 9.55; 95% confidence interval [CI] = 1.54, 59.30; P = .015). There were significant effects of time (b = -0.15; SE = 0.04; P < .001) and condition by time (b = -0.19; SE = 0.06; P < .001) on reported child exposure favoring AAR + MBI, but no group difference in child cotinine. Presence of other residential smokers was related to higher exposure. Higher baseline nicotine dependence was related to higher child exposure and lower abstinence likelihood at follow-up. Conclusions. The multilevel BLiSS intervention was acceptable and efficacious in a population that experiences elevated challenges with cessation. Public Health Implications. BLiSS is a translatable intervention model that can successfully improve efforts to address the persistent tobacco-related burdens in low-income communities. Trial Registration. ClinicalTrials.govidentifier: NCT02602288. (Am J Public Health. 2022;112(3):472-481. https://doi.org/10.2105/AJPH.2021.306601).

The Intersectionality of HIV-Related Stigma and Tobacco Smoking Stigma With Depressive and Anxiety Symptoms Among Women Living With HIV in the United States: A Cross-sectional Study

This study examined the intersectionality of HIV-related stigma, tobacco smoking stigma, and mental health among women living with HIV who were daily smokers. This secondary analysis used baseline data from 2 pilot smoking cessation studies. Participants received either an HIV-tailored or an attention-control intervention focused on smoking cessation as an outcome. There were significant positive relationships between HIV-related stigma and depressive and anxiety symptoms. In contrast, tobacco smoking stigma had no significant relationship with either of the symptoms when HIV-related stigma was controlled. However, there was a significant interaction effect (β = 1.37, p = .02) of tobacco smoking stigma with internalized HIV-related stigma on anxiety symptoms. Tobacco smoking stigma worsened anxiety symptoms for women who had high internalized HIV-related stigma. Health care providers should understand the effect of HIV-related stigma on mental health and address the intersectionality of HIV-related stigma with other socially disapproved behaviors, such as tobacco smoking.

HomeStyles-2: Randomized controlled trial protocol for a web-based obesity prevention program for families with children in middle childhood

BackgroundParents are children's primary role models, are food and physical activity gatekeepers, and create the home structure/lifestyle environment. Thus, parents strongly influence children's weight-related behaviors and have the opportunity to cultivate a “culture of health” within the home. Yet, there is a dearth of evidence-based obesity prevention intervention programs, especially for families with children aged 6–11 years, commonly called middle childhood. MethodsThe aim of the HomeStyles-2 online learning mode RCT is to determine whether this novel, age-appropriate, family intervention enables and motivates parents to shape home environments and weight-related lifestyle practices (i.e.,diet, exercise, sleep) to be more supportive of optimal health and reduced obesity risk in middle childhood youth more than those in the control condition. The RCT will include the experimental group and an attention control group. The participants will be parents with school-age children who are systematically randomly assigned by computer to study condition. The HomeStyles intervention is predicated on the social cognitive theory and a social ecological framework. The RCT will collect sociodemographic characteristics of the participant, child, and partner/spouse; child and parent health status; parent weight-related cognitions; weight-related behaviors of the parent and child; and weight-related characteristics of the home environment. Deliverables Enrollment for this study will begin in 2022. DiscussionThis paper describes these aspects of the HomeStyles-2 intervention: rationale; sample eligibility criteria and recruitment; study design; experimental group intervention theoretical and philosophical underpinnings, structure, content, and development process; attention control intervention; survey instrument development and components; outcome measures; and planned analyses. Trial registrationClinicalTrials.gov, Protocol #NCT04802291, Registered March 14, 2021.

Abstract 13456: Characterizing Changes in Quality of Life and in Older Patients With Acute Decompensated Heart Failure Enrolled in a Rehab Intervention Clinical Trial

Introduction: Older patients with acute decompensated heart failure (ADHF) have severely impaired QOL. We recently reported that a novel physical rehab intervention improves QOL. Here we report trajectories of improvement and relationship to participation in a rehab intervention. Methods: Patients with ADHF, regardless of EF and ≥ 60 years old were randomized to either attention control (AC) or rehab intervention (RI). Participants completed the KCCQ, a disease-specific QOL instrument, and 12-Item Short-Form Health Survey (SF-12), a general QOL instrument composed of a mental and physical composite score, at baseline (inpatient), 1 month and 3 months. Effects of the intervention were assessed using linear mixed effects models including the main effect of intervention, follow-up visit, and interaction term with adjustment for EF category, age, and sex. Results: The REHAB-HF trial enrolled 349 patients with a mean age of 72.7±8.1 years, 52% women and 49% non-white. Baseline KCCQ scores were low for both arms (Figure 1). There was a substantial increase in KCCQ score at 1 month in both arms. However, in contrast to the AC participants who showed no further improvement, RI participants continued to experience an increase in QOL at 3 months creating a significant difference between arms (p&lt; 0.01). Both SF-12 composite scores also increased in both arms at 1 month with continued improvement only in the RI arm; reaching significance for the mental composite at 1 month (50.8±1.1 vs. 46.9±1.1, p &lt; 0.01) and at 3 months (52.7±1.1 vs. 48.2±1.1, p&lt; 0.01). Conclusions: Older patients hospitalized with ADHF have severely impaired disease-specific and general QOL that improves soon after discharge. Patients receiving a novel physical rehabilitation intervention experienced an early benefit in terms of QOL that continued to improve throughout the 3 months trial period. Future studies will help determine if these benefits are sustained with longer term follow-up.

Supporting treatment adherence regimens in children with epilepsy: A randomized clinical trial.

This study was undertaken to examine the efficacy of a family-tailored education and problem-solving behavioral intervention, Supporting Treatment Adherence Regimens (STAR), in young children (2-12years old) with new onset epilepsy compared to an attention control (i.e., education only [EO]) intervention. Participants randomized to the STAR intervention were hypothesized to demonstrate significantly improved adherence at postintervention and 3-, 6-, and 12-month follow-up visits compared to the EO intervention. Seizure and health-related quality of life (HRQOL) outcomes were also examined. Two hundred children with new onset epilepsy and their caregivers were recruited during routine epilepsy clinic visits. Baseline questionnaires were completed, and electronic adherence monitors were provided. Participants with adherence less than 95% during the run-in period were randomized to either STAR or EO intervention. Active intervention was provided to both groups for 4months. Questionnaires were completed at conclusion of the active intervention phase and three follow-up time points (3, 6, and 12 months). Group differences in adherence, seizure outcomes, and HRQOL were examined using regression-based analyses of covariance and longitudinal mixed effect linear or logistical models. Adherence at 12-month follow-up was significantly different between the STAR (mean=82.34, SD=21.29) and EO intervention groups (mean=61.77, SD=28.29), with the STAR group demonstrating 20.6% greater adherence (b=19.11, p=.04, 95% confidence interval=1.00-37.22, d=.83). No significant differences were found between groups in seizure and HRQOL outcomes. A family-based behavioral adherence intervention demonstrated sustained adherence improvements 1year following epilepsy diagnosis compared to an epilepsy-specific education intervention. STAR is an efficacious adherence intervention that can easily be implemented into routine epilepsy care.

Group-randomized trial of tailored brief shared decision-making to improve asthma control in urban black adults.

To assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision-making intervention and evaluate feasibility and acceptability of intervention procedures. Group-randomized longitudinal pilot study. In total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N=40) to a dose-matched attention control intervention (N=40). BREATHE is a one-time shared decision-making intervention delivered by clinicians during routine office visits. Ten clinicians were randomized and trained on BREATHE or the control condition. Participants were followed monthly for 3months post-intervention. Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews. Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45). BREATHE clinicians delivered BREATHE to all 40 participants with fidelity based on expert review of audiorecordings. While the control group reported improvements in asthma control at 1-month and 3-month follow-up, only BREATHE participants had better asthma control at each timepoint (β=0.77; standard error (SE)[0.17]; p≤0.0001; β=0.71; SE[0.16]; p≤0.0001; β=0.54; SE[0.15]; p=.0004), exceeding the minimally important difference. BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β=7.39; SE[3.51]; p=.03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls. Both groups reported improved adherence and fewer erroneous medication beliefs. BREATHE is a promising brief tailored intervention that can be integrated into office visits using clinicians as interventionists. Thus, BREATHE offers a pragmatic approach to improving asthma outcomes and shared decision-making in a health disparity population. The study addressed the important problem of uncontrolled asthma in a high-risk vulnerable population. Compared with the dose-matched attention control condition, participants receiving the novel brief tailored shared decision-making intervention had significant improvements in asthma outcomes and greater perceived engagement in shared decision-making. Brief interventions integrated into office visits and delivered by clinicians may offer a pragmatic approach to narrowing health disparity gaps. Future studies where other team members (e.g., office nurses, social workers) are trained in shared decision-making may address important implementation science challenges as it relates to adoption, maintenance, and dissemination. TRAIL REGISTRATION: clinicaltrials.gov # NCT03300752.

Rates and Predictors of Deterioration in a Trial of Internet-Delivered Cognitive Behavioral Therapy for Reducing Suicidal Thoughts

Objective It is necessary for suicide prevention interventions to demonstrate safety. One important aspect of safety is evidence that deterioration rates are low. No studies have examined deterioration of suicidal ideation in the context of an internet-based cognitive behavioral therapy (CBT) intervention to reduce suicidal ideation. A secondary analysis of the outcomes of an online trial was conducted to determine rates of deterioration in a CBT intervention called Living with Deadly Thoughts, relative to an attention control condition, and to identify factors associated with deterioration. Method The randomized controlled trial included 418 adults with suicidal ideation at baseline (77% females, mean age 40.6 years). Deterioration was defined in two ways: a reliable increase in Suicidal Ideation Attributes Scale (SIDAS score) of ≥6.0 units; or triggering the safety protocol during the trial as determined by high levels of suicidality. Analyses were repeated with multiply imputed data. Predictors of deterioration were identified using logistic regression analysis. Results 30 (14%) participants in the control group and 15 (7%) in the intervention group met criteria for reliable deterioration (Fisher’s exact p = 0.027). In a fully adjusted logistic regression model, greater initial severity of suicidal thinking was associated with lower odds of deterioration, while intervention condition, demographics, psychological factors and mental health factors had no significant association with deterioration. Conclusions Participation in an online suicide prevention intervention was associated with lower prevalence of reliable deterioration than participation in an attention-control intervention, providing further evidence that internet-based CBT interventions do not cause harm. Highlights First study to assess deterioration in an internet suicide prevention intervention Rates of reliable deterioration were higher in control (14%) than intervention (7%) No psychological or demographic factors were robustly associated with deterioration Findings provide further evidence that internet based CBT programs are not harmful

Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review.

Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review.

Building a Healthy Temple diabetes self-management education support program in Hispanic faith community settings: A cluster randomized controlled trial

Diabetes self-management is key to preventing diabetes complications disproportionately affecting Hispanics. Church appears a promising setting for delivering a diabetes self-management education support (DSMES) program. “Faith-placed” (FP) programing refers to health interventions implemented in the church setting; while “faith-based” (FB) signifies integrating spirituality with health interventions. The Building a Health Temple (BHT) DSMES program integrates spirituality with DSMES to improve diabetic outcomes.This cluster-randomized trial tests the effectiveness of BHT DSMES by adapting an existing DSMES program into faith-based context. A total of 360 participants will be recruited from 18 churches (~20 participants/church). Churches will be randomly assigned to either the FB or FP intervention arm. Intervention activities will be implemented over 14 consecutive weeks. Participants in the FB arm will participate in BHT DSMES including a Health Sermon, the Self-Management Resource Center (SMRC) Diabetes Self-Management Program (DSMP), and a 7-session Healthy Bible Study, delivered by two trained church lay health leaders. Participants in the FP arm will attend the same SMRC DSMP facilitated by outside health professional, followed by a 7-session community health and safety curriculum as a partial attention control intervention. The primary outcome will be a change in Hemoglobin A1c (HbA1c) level. Secondary outcomes include: changes in body mass index, waist circumference, diabetes distress score, diabetes self-care behaviors, eating behavior, and physical activity level. Data will be collected at baseline, 6, 9, and 12 months during the study period.The proposed study will lead to innovative DSMES program delivery through faith settings for Hispanic persons with diabetes.

CITY Health II - using entertainment education and social media to reduce HIV among emerging adults: A protocol paper for the Beat HIVe project

BackgroundDespite multiple efforts to reduce HIV rates among African American young adults, a significant racial disparity persists and continues to grow among this population. New approaches are needed to reach this at-risk group and engage them in prevention efforts. The Community Influences Transitions of Youth Health (CITY Health II) study aims to increase HIV preventive behaviors to decrease HIV rates among 18–25 year old African American emerging adults living in resource-poor southern urban communities. MethodsCITY Health II is a 5-year HIV prevention study that evaluates the efficacy of a peer-driven entertainment education intervention compared to an attention-control intervention using a cluster randomized trial design. Participants were recruited through respondent-driven sampling (RDS) to participate in a social media intervention. We enlisted eight musicians and groups to help us create an entertaining and educational web-based video series, “The Beat HIVe”, for study participants to view on smartphones and share with peers on social media. Data collection interviews at baseline, 3-month, and 6-month follow-up assessed socio-demographics, risk and protective behaviors, social networks, and peer norms.Analyses will determine if participation is associated with improved HIV-related outcomes; examine whether intervention changes are mediated by perceived social norms and outcome expectations; determine whether intervention benefits vary by sociodemographic characteristics related to mediators, intervention outcome, or level of engagement; and examine the relationship between participant dose of intervention and outcomes. DiscussionOutcomes will inform ways to engage African American emerging adults through entertainment education and other strategies for increasing optimal sexual health behaviors.Trial Registration: NCT04320186

Initial Testing of a Web-Based Intervention to Reduce Adolescent Driver Inattention: A Randomized Controlled Trial

IntroductionMotor vehicle crashes are the leading cause of adolescent death. Inattention to the roadway contributes to crash risk. The objective of this study was to deploy an initial study of a web-based intervention (Let’s Choose Ourselves) designed to improve adolescent driver attention to the roadway. MethodsWe used a randomized controlled trial design in a sample of adolescent drivers to test if a web-based intervention decreased cell phone engagement in driving simulation at 3 months as compared with controls. As secondary hypotheses, we tested if the intervention increased the use of peer passengers to manage distractions and decreased eyes off the forward roadway in driving simulation and decreased self-reported risky driving behaviors. Adolescents, aged 16-17 years, licensed for ≤90 days were randomized to Let’s Choose Ourselves with distractions in the simulator protocol at baseline, Let’s Choose Ourselves with no distractions, an attention control intervention on healthy eating with distractions, or attention control with no distractions. We used Poisson regression modeling to test the primary and secondary hypotheses. ResultsThe trial included 60 adolescents (66.7% female, 78.3% non-Hispanic white subjects, mean age 16.8 years, licensed 50.8 days). In Poisson regression, controlling for sex, we found no significant effects of Let’s Choose Ourselves on primary or secondary outcomes. However, there was a significant effect of visit on self-report outcomes, with self-reported distracted driving behaviors increasing over time. DiscussionAlthough there were no significant effects of Let’s Choose Ourselves, self-reported risky driving behaviors increased over time. Further investigation of the relationship between driving experience and increasing inattention to the road in adolescents is warranted.

Promoting Physical Activity in Older Adults With Knee Osteoarthritis and Hypertension: A Randomized Controlled Trial.

A 6-month self-efficacy intervention was compared with attention-control intervention on physical activity, clinical outcomes, and mediators immediate postintervention and 6-month postintervention in 182 older adults with knee osteoarthritis and hypertension using a randomized controlled trial design. The intervention group received six weekly individual physical therapy sessions for lower-extremity exercise and fitness walking and nine biweekly nurse telephone counseling sessions. The attention-control group received six weekly and nine biweekly nurse telephone sessions on health topics. Lower-extremity exercise was assessed by e-diary; fitness walking was assessed by accelerometer and e-diary; blood pressure was assessed by automated monitor; function was assessed by performance-based tests and questionnaires; and pain, self-efficacy, and outcome expectancy were assessed by questionnaires. Self-reported lower-extremity exercise and fitness walking, function, pain, self-efficacy, and outcome expectancy showed significant group or group by time effects favoring intervention. The intervention did not improve physical activity by accelerometer and blood pressure. Mean minutes of fitness walking fell short of the 150min/week goal.