Post-intervention Changes Research Articles

Feasibility of using an app-based coaching intervention to improve provider communication about HPV vaccination.

Provider communication training is effective for increasing HPV vaccination rates among U.S. adolescents. However, such trainings often rely on in-person meetings, which can be burdensome for providers and costly to implement. To evaluate the feasibility of Checkup Coach, an app-based coaching intervention, to improve provider communication about HPV vaccination. In 2021, we offered Checkup Coach to providers in 7 primary care clinics in a large integrated delivery system. Participating providers (n = 19) attended a 1-h interactive virtual workshop that taught 5 high-quality practices for recommending HPV vaccination. Providers then had 3 months of access to our mobile app, which offered ongoing communication assessments, tailored tips for addressing parents' concerns, and a dashboard of their clinic's HPV vaccination coverage. Online surveys assessed pre-/post-intervention changes in providers' perceptions and communication behaviors. Compared to baseline, more providers reported high-quality HPV vaccine recommendation practices at 3-month follow-up (47% vs. 74%, p < .05). Providers' knowledge, self-efficacy, and shared commitment to improving HPV vaccination also improved (all p < .05). Although we found improvements in several other cognitions after the workshop, these changes did not retain statistical significance at 3 months. About three-quarters (78%) of providers used the mobile app, logging 2.3 sessions on average. Most providers agreed the app was easy to use (mean = 4.7/5.0), a convenient way to get vaccination data (mean = 4.6/5.0), and a tool they would recommend (mean = 4.3/5.0). Our app-based coaching intervention demonstrated feasibility and warrants additional evaluation as a novel mode for training providers to improve their HPV vaccine communication.

Impact of ¡Míranos! on parent-reported home-based healthy energy balance-related behaviors in low-income Latino preschool children: a clustered randomized controlled trial

BackgroundWidespread establishment of home-based healthy energy balance-related behaviors (EBRBs), like diet, physical activity, sedentary behavior, screen time, and sleep, among low-income preschool-aged children could curb the childhood obesity epidemic. We examined the effect of an 8-month multicomponent intervention on changes in EBRBs among preschool children enrolled in 12 Head Start centers.MethodsThe Head Start (HS) centers were randomly assigned to one of three treatment arms: center-based intervention group (CBI), center-based plus home-based intervention group (CBI + HBI), or control. Before and following the intervention, parents of 3-year-olds enrolled in participating HS centers completed questionnaires about their child’s at-home EBRBs. Adult-facilitated physical activity (PA) was measured by an index based on questions assessing the child’s level of PA participation at home, with or facilitated by an adult. Fruit, vegetable, and added sugar intake were measured via a short food frequency questionnaire, and sleep time and screen time were measured using 7-day logs. A linear mixed effects model examined the intervention’s effect on post-intervention changes in PA, intake of fruit, vegetable, and added sugar, sleep time, and screen time from baseline to post-intervention.ResultsA total of 325 parents participated in the study (CBI n = 101; CBI + HBI n = 101; and control n = 123). Compared to control children, CBI and CBI + HBI parents reported decreases in children’s intake of added sugar from sugar-sweetened beverages. Both CBI and CBI + HBI parents also reported smaller increases in children’s average weekday screen time relative to controls. In addition, CBI + HBI parents reported CBI + HBI parents reported increases in children’s adult-facilitated PA, fruit and vegetable intake, and daily sleep time during weekdays (excluding weekends) and the total week from baseline to post-intervention, while children in the CBI increased sleep time over the total week compared to the children in the control group.ConclusionsParent engagement strengthened the improvement in parent-reported EBRBs at home in young children participating in an evidence-based obesity prevention program in a childcare setting. Future studies should investigate equity-related contextual factors that influence the impact of obesity prevention in health-disparity populations.Trial registrationClinicalTrials.gov, NCT03590834. Registered July 18, 2018, https://clinicaltrials.gov/ct2/show/NCT03590834

Repeat Ivermectin Mass Drug Administrations for Malaria Control II: Protocol for a Double-blind, Cluster-Randomized, Placebo-Controlled Trial for the Integrated Control of Malaria

The gains made against malaria have stagnated since 2015, threatened further by increasing resistance to insecticides and antimalarials. Improvement in malaria control necessitates a multipronged strategy, which includes the development of novel tools. One such tool is mass drug administration (MDA) with endectocides, primarily ivermectin, which has shown promise in reducing malaria transmission through lethal and sublethal impacts on the mosquito vector. The primary objective of the study is to assess the impact of repeated ivermectin MDA on malaria incidence in children aged ≤10 years. Repeat Ivermectin MDA for Malaria Control II is a double-blind, placebo-controlled, cluster-randomized, and parallel-group trial conducted in a setting with intense seasonal malaria transmission in Southwest Burkina Faso. The study included 14 discrete villages: 7 (50%) randomized to receive standard measures (seasonal malaria chemoprevention [SMC] and bed net use for children aged 3 to 59 months) and placebo, and 7 (50%) randomized to receive standard measures and monthly ivermectin MDA at 300 μg/kg for 3 consecutive days, provided under supervision to all eligible village inhabitants, over 2 successive rainy seasons. Nonpregnant individuals >90 cm in height were eligible for ivermectin MDA, and cotreatment with ivermectin and SMC was not permitted. The primary outcome is malaria incidence in children aged ≤10 years, as assessed by active case surveillance. The secondary safety outcome of repeated ivermectin MDA was assessed through active and passive adverse event monitoring. The trial intervention was conducted from July to November in 2019 and 2020, with additional sampling of humans and mosquitoes occurring through February 2022 to assess postintervention changes in transmission patterns. Additional human and entomological assessments were performed over the 2 years in a subset of households from 6 cross-sectional villages. A subset of individuals underwent additional sampling in 2020 to characterize ivermectin pharmacokinetics and pharmacodynamics. Analysis and unblinding will commence once the database has been completed, cleaned, and locked. Our trial represents the first study to directly assess the impact of a novel approach for malaria control, ivermectin MDA as a mosquitocidal agent, layered into existing standard-of-care interventions. The study was designed to leverage the current SMC deployment infrastructure and will provide evidence regarding the additional benefit of ivermectin MDA in reducing malaria incidence in children. ClinicalTrials.gov NCT03967054; https://clinicaltrials.gov/ct2/show/NCT03967054 and Pan African Clinical Trials Registry PACT201907479787308; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=8219. DERR1-10.2196/41197.

A randomized controlled trial of gamification, financial incentives, or both to increase physical activity among patients with elevated risk for cardiovascular disease: rationale and design of the be active study

Higher levels of physical activity are associated with improvements in cardiovascular health, and consensus guidelines recommend that individuals with or at risk for atherosclerotic cardiovascular disease (ASCVD) participate in regular physical activity. However, most adults do not achieve recommended levels of physical activity. Concepts from behavioral economics have been used to design scalable interventions that increase physical activity over short time periods, but the longer-term efficacy of these strategies is uncertain. BE ACTIVE (NCT03911141) is a pragmatic, virtual, randomized controlled trial designed to evaluate the effectiveness of 3 strategies informed by behavioral economic concepts to increase daily physical activity in patients with established ASCVD or 10-year ASCVD risk > 7.5% who are seen in primary care and cardiology clinics affiliated with the University of Pennsylvania Health System. Patients are contacted by email or text message, and complete enrollment and informed consent on the Penn Way to Health online platform. Patients are then provided with a wearable fitness tracker, establish a baseline daily step count, set a goal to increase daily step count by 33% to 50%, and are randomized 1:2:2:2 to control, gamification, financial incentives, or both gamification and financial incentives. Interventions continue for 12 months, with follow-up for an additional 6 months to evaluate the durability of behavior change. The trial has met its enrollment goal of 1050 participants, with a primary endpoint of change from baseline in daily steps over the 12-month intervention period. Key secondary endpoints include change from baseline in daily steps over the 6-month post-intervention follow-up period and change in moderate to vigorous physical activity over the intervention and follow-up periods. If the interventions prove effective, their effects on life expectancy will be compared with their costs in cost-effectiveness analysis. BE ACTIVE is a virtual, pragmatic randomized clinical trial powered to demonstrate whether gamification, financial incentives, or both are superior to attention control in increasing physical activity. Its results will have important implications for strategies to promote physical activity in patients with or at risk for ASCVD, as well as for the design and implementation of pragmatic virtual clinical trials within health systems.

Effect of disturbance stimulation using a split-belt treadmill on a patient with cerebellar ataxia: a case report

PurposeWe present the case of a patient with cerebellar ataxia who was treated with walking practice using a split-belt treadmill with disturbance stimulation. The treatment effects were evaluated for improvements in standing postural balance and walking ability.Case presentationThe patient was a 60-year-old Japanese male who developed ataxia after cerebellar hemorrhage. Assessment was performed using the Scale for the Assessment and Rating of Ataxia, Berg Balance Scale, and Timed Up-and-Go tests. A 10 m walking speed and walking rate were also assessed longitudinally. The obtained values were fit into a linear equation (y = ax + b), and the slope was calculated. This slope was then used as the predicted value for each period relative to the pre-intervention value. After removing the trend of the value for each period relative to the pre-intervention value, the amount of pre- to post-intervention change for each period was calculated to verify the intervention effect. Furthermore, to verify the changes in gait over time, a three-dimensional motion analyzer was used to analyze the pre- and post-intervention gait five times, and the results were kinematically compared.ResultsNo significant pre- to post-intervention changes were observed in the Scale for the Assessment and Rating of Ataxia scores. Conversely, the Berg Balance Scale score, walking rate, and 10 m walking speed increased, and the Timed Up-and-Go score decreased in the B1 period, indicating a marked improvement from the predicted results based on the linear equation. For changes in gait determined using three-dimensional motion analysis, an increase in stride length was observed in each period.ConclusionThe present case findings suggest that walking practice with disturbance stimulation using a split-belt treadmill does not improve inter-limb coordination, but contributes to improving standing posture balance, 10 m walking speed, and walking rate.

Building Emotional Awareness and Mental Health (BEAM): an open-pilot and feasibility study of a digital mental health and parenting intervention for mothers of infants

BackgroundMaternal mental health concerns and parenting stress in the first few years following childbirth are common and pose significant risks to maternal and child well-being. The COVID-19 pandemic has led to increases in maternal depression and anxiety and has presented unique parenting stressors. Although early intervention is crucial, there are significant barriers to accessing care.MethodsTo inform a larger randomized controlled trial, the current open-pilot trial investigated initial evidence for the feasibility, acceptability, and efficacy of a newly developed online group therapy and app-based mental health and parenting program (BEAM) for mothers of infants. Forty-six mothers 18 years or older with clinically elevated depression scores, with an infant aged 6–17 months old, and who lived in Manitoba or Alberta were enrolled in the 10-week program (starting in July 2021) and completed self-report surveys.ResultsThe majority of participants engaged in each of the program components at least once and participants indicated relatively high levels of app satisfaction, ease of use, and usefulness. However, there was a high level of attrition (46%). Paired-sample t-tests indicated significant pre- to post-intervention change in maternal depression, anxiety, and parenting stress, and in child internalizing, but not externalizing symptoms. Effect sizes were in the medium to high range, with the largest effect size observed for depressive symptoms (Cohen’s d = .93).DiscussionThis study shows moderate levels of feasibility and strong preliminary efficacy of the BEAM program. Limitations to program design and delivery are being addressed for testing in adequately powered follow-up trials of the BEAM program for mothers of infants.Trial registrationNCT04772677. Registered on February 26 2021.

Centering Historical Oppression in Prevention Research with Indigenous Peoples: Differentiating Substance Use, Mental Health, Family, and Community Outcomes

The purpose of this pilot study was to understand how historical oppression relates to changes in outcomes for people who participate in the culturally grounded Weaving Healthy Families (WHF) program (i.e., alcohol and drug use, symptoms of anxiety, parenting practices, and communal mastery [CM]). This nonexperimental and longitudinal design used repeated measures regression analysis and generalized estimating equations (GEE) to examine postintervention changes according to reported levels of historical oppression among 24 participants in eight families. How do postintervention changes differ for WHF participants reporting lower and higher levels of historical oppression? Results indicated that participants reporting lower historic oppression reported greater postintervention improvements as indicated by declines in alcohol use, anxiety, and poor parental monitoring. All participants reported increases in CM, regardless of the level of historical oppression. Given historical oppression drives psychosocial conditions, such as substance abuse, mental health, and family challenges, settler colonial oppression must be addressed within social service interventions. Social service providers must work redress historical oppression rather than replicate them. The WHF program holds promise to center structural determinants in social service programs. Future inquiries assessing longitudinal changes in perceptions of historical oppression change and how they are associated with psychosocial outcomes are needed.

Roles and effectiveness of knowledge brokers for translating clinical practice guidelines in health-related settings: a systematic review

BackgroundPoor translation of clinical practice guidelines (CPGs) into clinical practice is a barrier to the provision of consistent and high-quality evidence-based care. The objective was to systematically review the roles...

Participant-Level Analysis of the Effects of Interventions on Patient-Reported Outcomes in Patients With Chronic Ankle Instability.

Intervention studies for chronic ankle instability (CAI) often focus on improving physical impairments of the ankle complex. However, using an impairments-focused approach may miss psychological factors that may mediate function and recovery. Patient-reported outcome (PRO) measures can be used to assess several dimensions of the health-related quality of life (HRQoL) and deliver enhanced patient-centered care. Therefore, the purpose of this investigation was to evaluate group-level improvements in HRQoL and treatment response rates following various interventions in patients with CAI. Cross-sectional. Data from 7 previous studies were pooled by the chronic ankle instability outcomes network for participant-level analysis, resulting in 136 patients with CAI. Several interventions were assessed including balance training, gait biofeedback, joint mobilizations, stretching, and strengthening, with treatment volume ranging from 1 to 4weeks. Outcome measures were PROs that assessed ankle-specific function (Foot and Ankle Ability Measure), injury-related fear (Tampa Scale of Kinesiophobia and Fear Avoidance Belief Questionnaire), and global well-being (Disablement in the Physically Active); the PROs assessed varied between studies. Preintervention to postintervention changes were evaluated using separate Wilcoxon signed-rank tests and effect sizes, and a responder analysis was conducted for each PRO. Significant, moderate to large improvements were observed in PROs that assessed ankle-specific function, injury-related fear, and global well-being following intervention (P < .001). Responder rates ranged from 39.0% to 53.3%, 12.8% to 51.4%, and 37.8% for ankle specific function, injury-related fear, and global well-being, respectively. Various interventions can lead to positive improvements in HRQoL in patients with CAI. Treatment response rates at improving HRQoL are similar to response rates at improving impairments such as balance, further reinforcing the need for individualized treatment approaches when treating a patient with CAI.

Prospective evaluation of digital therapeutic intervention on blood pressure control in Indian patients with uncontrolled primary hypertension

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Terrals Technologies Private Limited Background Digital therapeutics (DTx) has emerged as a new approach in recent years making use of connected devices, smartphone software and electronic communication tools to help manage chronic cardiovascular diseases such as hypertension. Considering its nascent stage, many questions still remain with respect to its applicability, effectiveness and limitations. Purpose Assess the effectiveness of digital therapeutic intervention in controlling blood pressure in Indian patients with primary hypertension Methods We conducted a prospective, 12 week, single arm, interventional study, including 125 subjects at multiple sites in India. Subjects with uncontrolled primary hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic) in the age group of 30-65 years who were under routine antihypertensive treatment were enrolled. They were provided supplementary DTx intervention comprising of smartphone application based personalized management of diet, exercise, self monitoring and health education by nutritionists and health coaches. Efficacy endpoints such as blood pressure (BP), body mass index (BMI), lipids, etc. were measured before and after the intervention. Results A total of 122 subjects who completed the trial had mean age of 47.44 ± 9.43 years, comprising 58 (48%) male and 64 (52%) female patients and mean BMI of 27.21 ±4.7 kg/m². Post-intervention change in mean systolic BP (SBP) was -25.61 mmHg (95% CI 22.55 - 28.66, 154.98 mmHg vs 129.37 mmHg, P&amp;lt;.001). The post-intervention change in mean diastolic BP (DBP) was -18.62 mmHg (95% CI 16.29 - 20.96, 100.04 mmHg vs 81.42 mmHg, P&amp;lt;.001). Patients with stage 1 hypertension (69.6%) achieved mean systolic reduction of 20.87 ± 13.9 mmHg, (148.54 mmHg vs 127.67 mmHg, P&amp;lt;.001). The patients with stage 2 (27.04%) and stage 3 (3.27%) hypertension achieved a higher mean SBP reduction of 34.67 ± 15.19 mmHg (167.24 mmHg vs 132.58 mmHg, P&amp;lt;.001) and 51.5 ± 40.45 mmHg (190.75 mmHg vs 139.25 mmHg, P=.084), respectively. Male and female patients showed almost similar reduction in systolic BP of 25.47 ± 14.72 and 25.73 ± 19.39 mmHg, respectively. Also, the subjects with other chronic comorbidities (23.9%) achieved a mean systolic BP reduction of 29.51 ± 15.25 mmHg. A total of 79.51% (n=97) patients achieved the SBP &amp;lt;140 mmHg, while 59.84% (n=73) patients achieved SBP &amp;lt;130 mmHg. Combining both the systolic and diastolic targets together, 65.57% (n=80) patients achieved the target of &amp;lt;140/90 mmHg, while ESC/ESH 2018 recommended BP target of &amp;lt;130/80 mmHg was achieved by 31.15% (n=38) patients. Conclusion The implementation of Digital therapeutic application integrated with primary healthcare resulted in significant reduction in blood pressure in participants with uncontrolled hypertension. Greater improvement was observed in participants with higher baseline blood pressure.

Predictors of Adolescents' Response to a Web-Based Intervention to Improve Psychosocial Adjustment to Having an Appearance-Affecting Condition (Young Person's Face IT): Prospective Study.

Adolescents with a condition affecting their appearance that results in a visible difference can be at risk of psychosocial distress and impaired adjustment. Evidence for the effectiveness of existing interventions in improving psychosocial outcomes is limited, and relevant treatment can be difficult to access. Young Person's Face IT (YPF), a self-guided web-based intervention, has demonstrated potential in reducing social anxiety in adolescents with a visible difference. However, more knowledge is needed about the variables that contribute to variations in intervention effects to identify those who may benefit most from YPF. This study aimed to investigate demographic, psychosocial, and intervention-related variables as predictors of overall intervention effects after adolescents' use of YPF. We used longitudinal data collected as part of a larger, ongoing mixed methods project and randomized controlled trial (ClinicalTrials.gov NCT03165331) investigating the effectiveness of the Norwegian version of YPF. Participants were 71 adolescents (mean age 13.98, SD 1.74 years; range 11-18 years; 43/71, 61% girls) with a wide range of visible differences. The adolescents completed primary (body esteem and social anxiety symptoms) and secondary (perceived stigmatization, life disengagement, and self-rated health satisfaction) outcome measures at baseline and postintervention measurement. The predictor variables were demographic (age and gender), psychosocial (frequency of teasing experiences related to aspects of the body and appearance as well as depressive and anxiety symptoms), and intervention-related (time spent on YPF) variables. Two-thirds (47/71, 66%) of the adolescents completed all YPF sessions and spent an average of 265 (SD 125) minutes on the intervention. Backward multiple regression analyses with a 2-tailed P-value threshold of .20 revealed that several variables were retained in the final models and predicted postintervention outcome changes. Body esteem was predicted by age (P=.14) and frequency of teasing experiences (P=.09). Social anxiety symptoms were predicted by gender (P=.12), frequency of teasing experiences (P=.03), depressive and anxiety symptoms (P=.08), and time spent on YPF (P=.06). Perceived stigmatization was predicted by age (P=.09), gender (P=.09), frequency of teasing experiences (P=.19), and depressive and anxiety symptoms (P=.06). Life disengagement was predicted by gender (P=.03), depressive and anxiety symptoms (P=.001), and time spent on YPF (P=.14). Self-rated health satisfaction was predicted by age (P=.008). However, the results were limited by relatively low explained postintervention variance, ranging from 1.6% to 24.1%. This study suggests that adolescent boys, adolescents who experience higher levels of psychosocial distress related to their visible difference, and adolescents who spend sufficient time on YPF may obtain better overall intervention effects.

The Development and Initial Feasibility of a Cognitive-Behavioural Group Intervention for COVID-19-Related Anxiety and Depression

Background: The COVID-19 pandemic resulted in adverse psychological outcomes for many people in the general public globally. Aim: This paper discusses the development and initial feasibility testing of a novel manualised online group cognitive behavioural therapy intervention targeting the maintenance factors of COVID-19-related anxiety and depression. The paper is in two sections describing: (i) the development of the intervention and (ii) a pilot study examined initial acceptability and feasibility of the intervention. Methods: Section 1 used the Six Steps in Quality Intervention Development methodology to systematically develop the intervention. Section 2 used a mixed-method design to assess feasibility and acceptability. The quantitative assessment examined uptake, completion, and pre–post intervention changes in psychological distress (N=8). A thematic analysis of qualitative interviews measured subjective acceptability. Results: A theoretically coherent, novel intervention that did not replicate existing treatment designs was developed. Low levels of engagement in online data-gathering did not allow for an assessment of effectiveness. However, there was a high level of participant retention, and qualitative data highlighted a high level of treatment appropriateness, positive post-intervention change and acceptability for those who took part. Conclusion: This initial feasibility study indicated that the intervention was feasible and acceptable and warranted further investigation.

Abstract B029: Partnering with an urban public recreation system to implement Total Wellness, a cancer prevention intervention

Abstract Introduction Cancer is a leading cause of death in Wisconsin, with higher mortality rates in African American (AA) and Hispanic (Hisp) populations. Focus groups with community members highlighted interest in programming to increase cancer awareness and support healthy behaviors. With this goal in mind and in partnership with the Milwaukee Recreation System (MKE Rec), Total Wellness (TW) was created to provide programming to Milwaukee communities. We present a program description and preliminary results for implementation of TW. Methods TW program content was informed by the American Cancer Society Guidelines and community feedback through surveys and discussion sessions. TW is a 16-week program implemented over two 8-week sessions (TW 1.0, 2.0) led by instructors trained in cancer prevention and lifestyle change. The program meets 2x weekly: Class 1 is a 30-min cancer and lifestyle education session targeting a weekly topic (wks 6, 10 include cooking demo), followed by a 60-min exercise class; Class 2 is a 60-min exercise class. TW is listed as a wellness class in the MKE Rec program guide. To promote enrollment, TW was advertised on MKE Rec’s website and social media, and program ads were distributed to zip codes of predominantly AA and Hisp neighborhoods. Once registered, participants were invited to complete an evaluation to assess program impact. Evaluation completion was not required to enroll in the class. TW is being evaluated at a systems level (i.e., # of registrants and # of instructors trained) and at an individual level (i.e., cancer awareness, health behaviors, fitness). Results At the systems level, 3 instructors were trained (2 are bilingual English/Spanish, 1 English only). The first TW 1.0 class began in January 2022 at a MKE Rec facility within a predominantly AA neighborhood and enrolled to capacity. In March 2022, a new TW 1.0 session at the same site enrolled to capacity, and 66% from the premiere TW 1.0 class re-enrolled for TW 2.0. Going forward, MKE Rec will offer TW 1.0 and 2.0 each season at the first site. In June 2022, MKE Rec began a TW 1.0 Spanish language class, the first of its kind, at a new site in a predominantly Hispanic neighborhood. At the individual level, 22 of 30 enrollees consented to participate in the evaluation. Participants are a mean age of 45.81 yrs; 72.7% are Black/African American, 22.7% White, 10.5% Hispanic/Latino, and 4.5% American Indian/Alaska Native (&amp;gt;100% ethnicity includes mixed-race participants). Most participants are employed full-time with varied education, marital status, and incomes. 57.1% of participants report HTN, 28.6% hyperlipidemia, and 54.5% obesity (mean BMI 35.25). 28.5% were current/former tobacco users, and 57.2% were insufficiently physically active. Given ongoing data collection, pre- and post-intervention changes have not yet been analyzed. Conclusion Though still in its early stages, TW has shown success in being integrated into MKE Rec and reaching AA and Hisp communities. Future reports will demonstrate program efficacy and sustainability. Citation Format: Devon C. Riegel, Jamila L. Kwarteng, Laura Pinsoneault, AnaKaren Manriquez Prado, Sandra Contreras, Sophia Aboagye, Erica Wasserman, Derek Donlevy, Alexis Visotcky, Patricia Sheean, Margaret Tovar, Kathleen Jensik, Regina Vidaver, Melinda R. Stolley. Partnering with an urban public recreation system to implement Total Wellness, a cancer prevention intervention [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B029.

Efficacy of Combined Visual-Olfactory Training With Patient-Preferred Scents as Treatment for Patients With COVID-19 Resultant Olfactory Loss

The number of olfactory dysfunction cases has increased dramatically because of the COVID-19 pandemic. Identifying therapies that aid and accelerate recovery is essential. To determine the efficacy of bimodal visual-olfactory training and patient-preferred scents vs unimodal olfactory training and physician-assigned scents in COVID-19 olfactory loss. This was a randomized, single-blinded trial with a 2-by-2 factorial design (bimodal, patient preferred; unimodal, physician assigned; bimodal, physician assigned; unimodal, patient preferred) and an independent control group. Enrollment occurred from February 1 to May 27, 2021. Participants were adults 18 to 71 years old with current olfactory loss defined as University of Pennsylvania Smell Identification Test (UPSIT) score less than 34 for men and less than 35 for women and duration of 3 months or longer. Olfactory loss was initially diagnosed within 2 weeks of COVID-19 infection. Participants sniffed 4 essential oils for 15 seconds with a 30-second rest in between odors for 3 months. Participants in the physician-assigned odor arms trained with rose, lemon, eucalyptus, and clove. Participants randomized to the patient-preferred arms chose 4 of 24 available scents. If assigned to the bimodal arm, participants were shown digital images of the essential oil they were smelling. The primary end point was postintervention change in UPSIT score from baseline; measures used were the UPSIT (validated, objective psychometric test of olfaction), Clinical Global Impressions Impression-Improvement (CGI-I; self-report improvement scale), and Olfactory Dysfunction Outcomes Rating (ODOR; olfaction-related quality-of-life questionnaire). Among the 275 enrolled participants, the mean (SD) age was 41 (12) years, and 236 (86%) were female. The change in UPSIT scores preintervention to postintervention was similar between the study arms. The marginal mean difference for change in UPSIT scores preintervention to postintervention between participants randomized to patient-preferred vs physician-assigned olfactory training was 0.73 (95% CI, -1.10 to 2.56), and between participants randomized to bimodal vs unimodal olfactory training was 1.10 (95% CI, -2.92 to 0.74). Five (24%) participants in the control arm had clinically important improvement on UPSIT compared with 18 (53%) in the bimodal, patient-preferred arm for a difference of 29% (95% CI, 4%-54%). Four (19%) participants in the control group self-reported improvement on CGI-I compared with 12 (35%) in the bimodal, patient-preferred arm for a difference of 16% (95% CI, -7% to 39%). The mean change in ODOR score preintervention to postintervention was 11.6 points (95% CI, 9.2-13.9), which was not deemed clinically important nor significantly different between arms. Based on the change in UPSIT scores, this randomized clinical trial did not show any difference between intervention arms, but when exploring within-patient change in UPSIT as well as self-reported impression of improvement, active interventions were associated with larger improvement than controls with a potential advantage of bimodal intervention. While not definitive, these results suggest that patients with COVID-19 olfactory loss may benefit from bimodal visual-olfactory training with patient-preferred scents. ClinicalTrials.gov Identifier: NCT04710394.

The effectiveness of a “EspaiJove.net”- a school-based intervention programme in increasing mental health knowledge, help seeking and reducing stigma attitudes in the adolescent population: a cluster randomised controlled trial

BackgroundThe aim of this study is to evaluate the short- and long-term effects of the universal mental health literacy intervention “EspaiJove.net” in increasing mental health knowledge, help seeking and reducing stigma attitudes in the adolescent population. We also examine whether these effects depend on the intervention intensity. MethodsA clustered school-based randomised controlled trial (cRCT) design. Subjects: 1,298 secondary pupils aged 13 and 14 were recruited from 18 schools in Barcelona (Spain) between September 2016 and January 2018. Intervention: Three programmes were assessed: 1) Sensitivity Programme (SP; 1 h); 2) Mental Health Literacy (MHL; 6 h); 3) MHL plus a first-person Stigma Reduction Programme (MHL + SR; 7 h); 4) Control group (CG): waiting list. Outcome measures: 1) MHL: EspaiJove.net EMHL Test (First part and Second Part); 2) Stigma: RIBS and CAMI; 3) Help-seeking and use of treatment: GHSQ. Analysis: The data was collected at baseline, post-intervention and 6 and 12 months later. An intention-to-treat analysis and imputation method was used to analyse the missing data. Intervention effects were analysed using multilevel modelling.ResultsOne thousand thirty-two students were included (SP = 225; MHL = 261; MHL + SR = 295 and CG = 251). The MHL and MHL + SR interventions showed short- and long-term an increase in knowledge compared to SP and CG, but no significant change post-intervention or over time (First part p = 0.52 and Second part p = 0.62) between intervention groups and CG. No significant changes were found in stigma scores post-intervention or over time (CAMI p = 0.61 and RIBS p = 0.98) or in help-seeking scores (parent p = 0.69; teacher p = 0.23 and healthcare professional p = 0.75). The MHL + SR intervention was the best valued and recommended (p < 0.005).ConclusionsThe three interventions of the EspaiJove.net programme (SP, MHL and MHL + SR) seem not to be effective in terms MHL, Stigma and help-seeking behaviours. The contact with a person who has experimented mental illness first-hand did not reduce stigma attitudes. Further research should deal with the heterogeneity of MHL interventions (concept, duration and measures) and identify which components of stigma interventions are effective.Trial registrationClinicalTrials.gov identifier: NCT03215654 (registration date 12 July 2017).

An Analysis of Equity in Service Provided by the SNAP-Ed Program: A Comparison of Dietary Outcomes among African American and White Participants in Louisiana

Structural racism has contributed to increased poverty, food insecurity, and obesity rates among African Americans relative to Whites. Nutrition education programs should therefore consider how well they serve this population. The objective of this investigation was to assess whether African American and White Supplemental Nutrition Assistance Program Education (SNAP-Ed) participants in Louisiana had comparable dietary behavior outcomes by conducting secondary data analysis of previous program evaluations from 2017-2018 and 2018-2019 among African American and White SNAP-Ed participants (n = 434). Variables measured included pre- to post-intervention changes in dietary behaviors (e.g., self-reported consumption frequency of fruit, vegetables, whole grains, low-fat dairy, sugar-sweetened beverages, and juice). Statistical analyses included t-tests stratified by race and Pearson’s chi-square test for categories of change in dietary behaviors. In categorical analyses, Whites had increased consumption, and African Americans had decreased consumption of whole grain pasta following SNAP-Ed participation. Among those who did not change consumption patterns following SNAP-Ed participation, African Americans were more likely to consume fruit juice and juice-flavored sugary drinks at a rate above median consumption compared to White participants. Future research should identify how program participation is followed by different dietary behavior outcomes in different races and explore how SNAP-Ed could specifically address barriers to equity.

The impact of Illinois’ comprehensive handheld phone ban on talking on handheld and handsfree cellphones while driving

Introduction: Distracted driving has been linked to multiple driving decrements and is responsible for thousands of motor-vehicle fatalities annually. Most U.S. states have enacted restrictions on cellphone use while driving, the strictest of which prohibit any manual operation of a cellphone while driving. Illinois enacted such a law in 2014. To better understand how this law affected cellphone behaviors while driving, associations between Illinois’ handheld phone ban and self-reported talking on handheld, handsfree, and any cellphone (handheld or handsfree) while driving were estimated. Methods: Data from annual administrations of the Traffic Safety Culture Index from 2012–2017 in Illinois and a set of control states were leveraged. The data were cast into a difference-in-differences (DID) modeling framework, which compared Illinois to control states in terms of pre- to post-intervention changes in the proportion of drivers who self-reported the three outcomes. Separate models for each outcome were fit, and additional models were fit to the subset of drivers who talk on cellphones while driving. Results: In Illinois, the pre- to post-intervention decrease in the drivers’ probability of self-reporting talking on a handheld phone was significantly more extreme than that of drivers in control states (DID estimate −0.22; 95% CI −0.31, −0.13). Among drivers who talk on cellphones while driving, those in Illinois exhibited a more extreme increase in the probability of talking on a handsfree phone while driving than those control states (DID estimate 0.13; 95% CI 0.03, 0.23). Conclusions: These results suggest that Illinois’ handheld phone ban reduced talking on handheld phones while driving among study participants. They also corroborate the hypothesis that the ban promoted substitution from handheld to handsfree phones among drivers who talk on the phone while driving. Practical Applications: These findings should encourage other states to enact comprehensive handheld phone bans to improve traffic safety.

P016 Evaluating the effectiveness of an interactive educational intervention on sleep health for second-year pharmacy students

Abstract Background Pharmacists are usually the most frequently consulted professionals in primary care for health concerns, such as sleep disturbances. However, conventionally, curricular space devoted to sleep health has been insufficient and this eventuates in suboptimal care provision. For example, pharmacists often provide over the counter/complementary medicines rather than the recommended behavioural counselling for insomnia management. Clearly, pedagogically informed learning experiences about sleep health/insomnia management are important to improve practice. Objectives To develop, implement and evaluate an interactive sleep health educational intervention for 2nd year pharmacy students. Methods An educational intervention utilising a flipped classroom approach, with interactive lectures, self-reflection around personal sleep habits, and role-playing behavioural treatment provision was designed and implemented. A questionnaire assessing pre- and post-intervention changes in knowledge about and attitudes towards sleep as well as post-intervention learning satisfaction, was administered to students. Results Mean total knowledge scores for participating students (n=125, 70.4% females) improved significantly post-intervention from a baseline of 11.1 ± 3.8 to 17.1 ± 3.5 post-intervention, p &amp;lt;0.05 (Score range= 0-25). The mean total attitudes scores also improved from 28.8 ± 3.2 at baseline to 29.4 ± 3.8 (Score range= 10-50), p=0.07; however, this change was insignificant. Conclusion Carefully crafted educational interventions for pharmacy students can help improve sleep health knowledge. Whilst a trend to improved sleep health attitudes was evident, it was not significant, possibly because of positive sleep health attitudes even at baseline. Such programs should be incorporated into pharmacy pre-registration curricula to potentially enhance future pharmacists’ skills in sleep health provision.

Increased insula response to interoceptive attention following mindfulness training is associated with increased body trusting among patients with depression

Interoceptive dysfunction is often present in anxiety and depression. We investigated the effects of an 8-week intervention, Mindfulness Training for Primary Care (MTPC), on brain mechanisms of interoceptive attention among patients with anxiety and/or depression. We hypothesized that fMRI brain response to interoception in the insula, a region known for interoceptive processing, would increase following the MTPC intervention, and that such increases would be associated with post-intervention changes in self-reported measures of interoceptive awareness. Adults (n = 28) with anxiety and/or depression completed baseline and post-intervention fMRI visits, including a task in which they alternated between focusing on their heartbeat (interoception (INT)) and a control visual attention task (exteroception (EXT)). Following MTPC, we observed increased evoked fMRI response (relative to baseline) in left anterior insula during the INT-EXT task contrast (z > 3.1, p < 0.001 corrected). In patients with moderate-to-severe depression as defined by the Patient Reported Outcomes Measurement Information System (PROMIS), increased post-intervention insula response was associated with increased Body Trusting, a subscale of the Multidimensional Assessment of Interoceptive Awareness (z > 3.1, p = 0.007 corrected). This study demonstrates that patients with mood disorders may respond differentially to mindfulness-based treatment depending on depression severity, and that among those who are more depressed, increased trusting in one's own body sensations and experiencing the body as a safe place to attend to may be necessary components of positive responses to mindfulness-based interventions.

A Non-Randomized Combined Program of Walking and Low-Load Resistance Exercise Improves Cognitive Function and Cardiometabolic Risk Factors in Community-Dwelling Elderly Women.

Background: This study examines whether changes in cardiometabolic risk factors, functional fitness, and depressive symptoms following a six-month exercise intervention were associated with cognitive function in Korean women aged 65 years and older. Methods: A non-randomized study design was used to compare post-intervention changes in measured variables between control (n = 30) and exercise (n = 30) groups. The exercise intervention consisted of three days of low-load resistance exercise and two days of walking. Cognitive function and depressive symptoms were assessed with the Korean version of the Mini–Mental State Examination and the Korean version of the Geriatric Depression Scale, respectively. Functional fitness was measured using a senior fitness test battery. Results: The exercise group showed a significant improvement in cognitive function (p < 0.001) in conjunction with significant decreases in blood glucose (p = 0.052), triglycerides (p = 0.011), insulin (p = 0.002), tumor necrosis factor-α (p = 0.043), and depressive symptoms (p = 0.006) and an increase in interleukin-10 (p = 0.037), compared with the control group. Multivariate stepwise regression showed that changes in depressive symptoms (p < 0.001), insulin resistance (p < 0.001), and upper body muscle strength (p = 0.003) were positively associated with cognitive function. Conclusion: A six-month exercise intervention consisting of walking and low-load/high-repetition elastic band resistance exercise has the potential to improve cognitive function, as well as physical function and cardiometabolic risk factors, and to decrease depressive symptoms in older women.