Background:Multi-component interventions may be critical for reducing Alzheimer's disease (AD) risk since AD pathogenesis is multi-factorial. Combined Aerobic exercise and Cognitive Training (ACT) may have synergistic effects, but studies are limited with mixed findings. Methods:A 3-site, single-blinded Stage II 2 × 2 factorial trial aimed to test the effects of 6-month ACT on cognition in older adults with amnestic mild cognitive impairment in academic research facilities and gyms. Among 325 participants consented, 146 were enrolled and randomized equally to 6-month ACT, cycling only, speed of processing (SOP) cognitive training only, or control. Primary outcomes, executive function and episodic memory, were measured with alternating EXAMINER and Brief Visuospatial Memory Test-Revised (BVMT-R) forms at baseline, 3, 6, 12, and 18 months, and global cognition with the Montreal Cognitive Assessment (MoCA) and EXAMINER/BVMT-R composite. Results:Executive function improved significantly from baseline to 6 months (ds = 0.58-1.18, adjusted Ps < 0.001-0.026) in all groups except SOP. Global cognition composite increased in cycling only (d = 0.73; adjusted P = 0.012). MoCA decreased over 18 months (adjusted P = 0.030) in the control group only. Between-group comparison was significant between ACT and SOP groups at 6 months (adjusted P = 0.029), but sensitivity analyses showed ACT being superior to both cycling- and SOP-only groups (Ps = 0.030 and 0.002, respectively) among in-person interventions (48.6% of all sessions were delivered in person as designed due to COVID-19). Conclusions:ACT's synergistic effects remain to be determined. All interventions are feasible for clinical practice. Trial Registration:www.clinicaltrials.gov (NCT03313895; date of registration: 10/18/2017).

OBJECTIVE:Research examining associations between intraindividual variability in affective experiences and health stems largely from non-clinical samples and individuals versus within a dyadic context. We sought to examine this linkage in couples coping with cancer. METHODS:233 patients with cancer and their spouses/partners (mean age = 52.5) completed twice-daily ecological momentary assessments for 14 days. Nine negative affect items were used to compute intraindividual negative affect means, standard deviations (SDs, capturing overall dispersion), and mean square successive differences (MSSDs, capturing occasion-to-occasion shifts). Upon study entry and 12 months later, participants completed a measure of physical well-being. Within- and across-partner associations between negative affect dynamics and 12-month change in physical well-being were examined using an Actor-Partner Interdependence Model framework. RESULTS:When SD was used as the indicator of negative affect intraindividual variability, higher mean negative affect predicted declines in physical well-being for caregivers (actor effect, P=.035), and greater patient variability predicted declines in caregiver physical well-being (partner effect, P=.036). When MSSD was used as the indicator of intraindividual variability, greater patient variability predicted declines in their own physical well-being more strongly among those with lower average negative affect (patient mean x patient MSSD interaction, P=.021) and for patients whose partners had greater negative affect variability (patient MSSD x caregiver MSSD interaction, P=.013). CONCLUSIONS:Future work could examine intervention strategies to minimize negative affect and foster equanimity in this population, potentially tailoring based on participants' own mean levels and their partner's variability.

Introduction Few randomized controlled trials (RCTs) have investigated the effects of choral singing (CS) on older adults at-risk of cognitive decline and dementia. Extant RCTs on CS also lack an active control arm controlling for non-intervention-specific active components. Methods In this parallel-arm, open-label RCT, 200 community-dwelling older adults at-risk of cognitive decline were randomized to the treatment arm, i.e., CS, or the active control arm (i.e., health education program, i.e., HEP, matched with non-intervention-specific components). Both arms involved weekly 1-h group sessions held continuously for two years. We examined the a priori registered secondary outcomes, positive screens for depressive and anxiety disorders, at baseline, 1-year, and 2-year time-points, using linear-mixed models with intention-to-treat. Results Compared to the HEP, CS participants experienced similar decreased odds of positive screens for depressive and anxiety disorders throughout all the time-points, though different trajectories. Discussion In contrary to previous studies using passive controls reporting positive outcomes, compared to HEP as an active comparator, CS is as effective as HEP in delaying progression to clinically significant depressive and anxiety disorders in at-risk community-dwelling older adults. Our findings highlight the critical importance of incorporating an intervention-components-matched comparison arm in non-pharmacological interventions. Trial registration Choral Singing For the Prevention of Dementia, https://clinicaltrials.gov/study/NCT02919748; Trial Registration: NCT02919748.

Aerobic exercise is promising for preventing Alzheimer’s disease (AD) and AD-related dementia (ADRD), but exercise trials have shown mixed results. An important, understudied factor potentially contributing to mixed results is individual differences in aerobic fitness responses to moderate-intensity continuous training (MICT). This trial will test the effects and mechanisms of 6 months of aerobic exercise tailored on aerobic fitness response to MICT in community-dwelling older adults with early symptomatic AD. We aim to (I) test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity volume (WMHv), and patient-centered outcomes in older adults with early symptomatic AD; (II) determine the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and (III) examine the mechanisms of aerobic exercise’s action on cognition. This stage II trial is a Sequential, Multiple Assignment, Randomized Trial (SMART). The hypothesis is that MICT augmented with high-intensity interval training (HIIT) or combined aerobic and resistance exercise (CARE) will improve aerobic fitness, WMHv, and AD/ADRD plasma biomarkers. This trial will enroll 108 dyads (participants and their study partners). Participants (n = 108) are randomized using a 2:1 allocation ratio to 3-month MICT or 6-month stretching control. After the initial 3-month intervention period for participants assigned to MICT, aerobic fitness is measured with peak oxygen consumption (VO2peak) from a cycle-ergometer exercise testing and the shuttle walk test to identify non-response (< 5

Combined Aerobic exercise and Cognitive Training (ACT) may have synergistic effects on cognition, capitalizing on their different mechanisms of action. However, combined physical and cognitive activities showed mixed effects due to widely differing intervention components. To this end, the ACT Trial tested the efficacy of a 6-month combined cycling and speed of processing (SOP) cognitive training on cognition in community-dwelling older adults with amnestic mild cognitive impairment. The ACT Trial used a 2x2 factorial design to randomize participants equally to four arms: control, cycling only, SOP only, and ACT (cycling+SOP). Executive function and episodic memory were measured with EXAMINER and Brief Visuospatial Memory Test-Revised (BVMT-R) at baseline, 3, 6, 12, and 18 months by trained data collectors blinded to group allocation. The mean of z-transformed scores of EXAMINER and BVMT-R was used to assess global cognition. Data were analyzed under intention-to-treat using linear mixed models with multiple imputed datasets in R. The sample ( n  = 146; 48% women; 91.8% White) was on average 73.72±5.73 years old, had 16.87±2.88 years of education, and scored 23.45±2.16 on Montreal Cognitive Assessment. All groups showed modest declines in outcomes from 3 months to 18 months (Cohen's ds=0.03–0.04 for executive function; ds=0.18–0.25 for delayed recall; ds=0.07–0.18 for global cognition). Baseline-adjusted ACT group means on outcomes (0.18 for executive function, 41.7 for memory, and 0.00 for global cognition at 6 months; 0.02, 42.5, 0.20, respectively at 18 months) did not differ significantly from those for cycling only (ps = .19, .56, and .90, respectively at 6 months; p s = .66, .81, and .65, respectively at 18 months) or SOP only (ps=.59, .13, and .56, respectively at 6 months; p s = .72, .43, and .48, respectively at 18 months). There were 10 possibly study-related, mild-to-moderate adverse events that did not differ between groups. ACT did not show statistically significant superior effects on cognition relative to its components among older adults with aMCI, although observed values trended in the desired directions. The COVID-19 pandemic contributed to higher attrition and lower dose delivery, especially in the ACT group, leading to smaller effect sizes than expected.

Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), are efficacious mind–body treatments for chronic pain, though their modest effect sizes suggest room for improvement. Notably, recent studies indicate that mindfulness meditation does not engage the endogenous opioid system, which plays an important role in analgesia. Therefore, exploring the combination of a mindfulness-based intervention with a non-opioid treatment that activates this system is warranted. Open-label placebo (OLP), a placebo that is given to a participant without deception, has shown significant promise as a safe and potentially effective analgesic, with studies indicating its effects are mediated by the release of endogenous opioids. This study aims to evaluate the feasibility and acceptability of combining MBSR and OLP treatment compared to each intervention alone for chronic pain in a three-arm randomized controlled trial (RCT). This study will include an 8-week exposure to one of three treatments for individuals with chronic pain: MBSR-only, OLP-only, or a combined MBSR + OLP intervention. Participants will attend four in-person sessions (baseline assessment, randomization session, mid-treatment assessment, and posttreatment assessment), followed by an online assessment at a 3-month follow-up. MBSR sessions will be conducted live via Zoom. Participants in OLP groups will take placebo pills twice daily, with adherence monitored using an electronic pill bottle cap and urine riboflavin tracer testing. Daily diary assessments will be completed over 7-day periods at baseline, mid-treatment, post-treatment, and 3-month follow-up. Findings from this single-site feasibility RCT will help refine and optimize study protocols needed for a future, fully powered multi-site efficacy trial. NCT06720909 . Registered 12/06/2024.

Background/Objectives: This study examines the relationship of eating in the absence of hunger (EAH) with child sex, food preference, and body mass index (BMI) percentiles in primarily Hispanic preschoolers, an understudied population. Methods: This was a secondary analysis of data from 211 children (79% Hispanic) aged 3 to 5 years from low-income families who completed a cluster randomized controlled trial from September 2017 to June 2020. Weight and height were used to calculate BMI percentiles. Sweet (animal crackers) and salty (pretzels) snacks were used to conduct a validated classroom-based EAH assessment. A generalized estimating equation (GEE) approach investigated associations between the grams of snacks consumed and BMI percentiles. A set of nested multivariable GEEs were estimated, while adjusting for potentially important covariates. Results: Boys significantly consumed more snacks than girls (13.34 ± 9.71 g vs. 8.13 ± 7.36 g; p < 0.001). Children who indicated greater preference for sweet snacks consumed more sweet snacks (r = 0.19; b = 2.05, p < 0.001) and total grams of total snacks (r = 0.18; b = 2.42, p = 0.004) but not salty snacks (pretzels). Consuming more sweet snacks was significantly associated with higher BMI percentiles (b = 0.55; p = 0.024). Conclusions: The findings suggest that a preference for sweet snacks is associated with EAH, and eating sweet snacks in the absence of hunger is related to higher BMI percentiles. Obesity prevention programs may focus on addressing eating sweet snacks in the absence of hunger starting in early childhood.

Improvements in cardiorespiratory fitness following moderate-intensity continuous aerobic training (MICT) are well-documented but show variability across individuals. This heterogeneity among older adults may contribute to inconsistent findings regarding the effects of MICT on cognition in individuals with Alzheimer's disease (AD). This presentation will examine the feasibility of using aerobic fitness, as measured by peak oxygen consumption (VO2peak) through a symptom-limited cycle-ergometer test, to identify non-responders to MICT and adapt exercises from the FIT-AD Sequential, Multiple Assignment, Randomized Trial (SMART). FIT-AD SMART aims to enroll 108 older adults with early AD, assigning 72 to MICT and 36 to stretching exercises for six months. After three months, VO2peak is reassessed to identify non-responses, defined as <5% improvement in VO2peak from baseline. Non-responders are re-randomized to either high-intensity interval training or a combined aerobic and resistance exercise program, while responders continue with MICT for another three months. As of January 2, 2025, 19 participants had passed the 3-month assessment period. They were 70.95±5.75 years of age, had 16.05±2.74 years of education, and scored 22.74±3.51 on the Montreal Cognitive Assessment (MoCA). About 57.1% of the participants were female, and 28.6% were Hispanic. Their VO2peak averaged 18.72±4.75 mL/kg/min at baseline and 21.73±6.91 mL/kg/min at three months, representing a mean improvement of 6.93%±10.43%. Among the 19 participants, 13 were randomized to MICT and 11 completed 3-month exercise testing. The 11 MICT participants’ VO2peak was 19.05 mL/kg/min at baseline and 20.40 mL/kg/min at 3 months, representing a 15.2% increase. Six of the MICT participants were classified as non-responders (VO2peak change: -2.96%±8.85%), and five were responders (VO2peak change: 36.9%±51.9%). In contrast, VO2peak of the stretching group ( n  = 6) decreased 6.2%. The findings indicate that VO2peak did not improve among half of participants assigned to MICT following 3-months of training, although the amount of improvement was considerable among responders. These findings underscore the importance of using VO2peak as a key physiological marker for identifying exercise non-response in older adults with AD early during exercise interventions. Subsequent tailoring of exercise interventions following non-response to MICT may help maximize the benefits of aerobic exercise on cognitive health.

Schools in the United States play a crucial role in promoting healthy eating habits. Despite numerous public health efforts, children’s consumption of fruits and vegetables (FVs) still fall short of recommended amounts. Advocates have promoted school lunch salad bars as an effective strategy to increase primary students’ FV consumption, but rigorous research has lagged behind their efforts. This study evaluated the effectiveness of introducing school lunch salad bars, FV marketing, and the combination of both on elementary students’ objectively measured fresh FV selection and consumption. A cluster-randomized factorial trial was conducted among 13 elementary schools from 12 public school districts participating in the U.S. National School Lunch Program with more than 50

Objectives Home blood pressure monitoring (HBPM) is crucial for managing hypertension, but there is a potential trade-off between measurement accuracy and health/economic outcomes due to asymmetric costs associated with misclassifying an individual as having hypertension or not. We assessed whether adjustments to device readings that increased overall accuracy produced net health and economic benefits. Methods We analyzed data from N = 89 Alaska Native individuals who used 2 HBPM devices and a standard aneroid sphygmomanometer. We modeled changes in expected costs associated with individuals being misclassified as hypertensive or not under 3 different models of adjusting HBPM device readings. Results The gains in accuracy produced by adjusting HBPM readings decreased the overall rate of hypertension misclassification but increased the rate of false-negative readings. Adjusting readings led to a net increase in expected health and economic costs. Discussion Ignoring asymmetric costs of misclassification can escalate overall costs and worsen uncontrolled hypertension. Home blood pressure monitoring algorithms must be cautiously designed, considering both false negatives and positives. Greater transparency in HBPM algorithms is needed for effective coordination among manufacturers, clinicians, and patients.

Objective: To evaluate a serious game-based intervention's feasibility, acceptability, and efficacy in encouraging coronavirus disease (COVID-19) vaccination among 11-14-year-olds in the United States and assess participant experiences.Materials and Methods: The study, grounded in social cognitive theory and health belief model, recruited and engaged 32 English-speaking parent-child dyads with unvaccinated youths via snowball sampling and social media outreach. These dyads were randomly assigned to either the COVID-19 serious game-based intervention group (n = 16) or a usual care group (n = 16). The study measured beliefs, self-efficacy, and intentions regarding vaccination using surveys before and after the intervention, with follow-up at 2 months to evaluate vaccine uptake. Semistructured interviews provided insights into the gaming experience and study process.Results: All 32 eligible parent-youth dyads (16 in each group) completed the study with full participation. Most participants were Black or African American fathers, making up 75% and 81.3% of the intervention and control groups, respectively. The intervention impacted vaccine uptake, with 75% of the intervention group vaccinating their children compared with 37.5% of the control group [chi 2(1, n = 32) = 4.57, P = 0.033]. Key factors for vaccine uptake included parents' motivation and youths' perceived susceptibility, with correlations of r(30) = 0.66, P = 0.006, and r(30) = 0.55, P = 0.029, respectively. The intervention reshaped youth perceptions about self and community protection. Participants expressed overall satisfaction with both the intervention and the study process.Conclusions: The intervention was found to be feasible and acceptable, with potential for integration into youth vaccination strategies to support COVID-19 vaccine decision-making.

Granular control over medical record sharing empowers patients to manage access to sensitive information, like substance use disorders (SUD), often withheld due to stigma. Although federal and state laws protect this data, manual segmentation processes remain error-prone, complicating care coordination. Integrating contextual EHR data into segmentation technologies could enhance accuracy, better aligning sensitivity classifications with providers’ assessments. This is the first study to examine the influence of context, specifically pertinent health data availability, on how physicians categorize potentially sensitive health data items. The goal is to increase the accuracy of automated sensitive data segmentation technologies. 1,000 data items from deidentified EHRs from patients receiving behavioral health care were distributed across 12 surveys. These data items were randomly assigned to 12 pairs of physicians to categorize into a sensitive data taxonomy. During a follow-up interview, participants categorized 120 survey data items and could use the medical record to support their answers. Survey and interview results were compared. Educational materials provided during surveys and interviews for the sensitive data taxonomy were helpful (75.0% and 70.8%, respectively), but the provided data sensitive taxonomy may require further revisions and validations. 62.5% of the participants used the provided patient EHR data to justify their categorizations during the interview. Some participants felt they needed access to more patient data (50%) or speak with the patient (8.3%) to best categorize a data item. When considering the 240 survey and interview responses, accessing additional patient health data led to multiple (72.1%) changes in categorizations. When comparing the survey and interview categorizations of data items, disagreements decreased by 20.1%, partial agreements increased by 26.4%, but agreements decreased by 6.4%. Incorporating context using additional data from a patient’s EHR impacted how physicians categorize potentially sensitive health data. As future work, this study's results will open new research discussions in physician-validated data segmentation methods.

OBJECTIVE To investigate the feasibility and acceptability of SleepWell24, a multicomponent, evidence-based smartphone application, to improve positive airway pressure therapy (PAP) adherence, among patients with obstructive sleep apnea (OSA) naive to PAP. METHODS In a single-blind randomized controlled trial, SleepWell24, with a companion activity monitor was compared to usual care plus the activity monitor and its associated app. SleepWell24 provides objective feedback on PAP usage and sleep/physical activity patterns, and chronic disease management. Patients were recruited from two sleep medicine centers and followed over the first 60 days of PAP. Feasibility and acceptability were measured by recruitment/retention rates, app usage, differences in post-trial Treatment Evaluation Questionnaire (TEQ) scores, and patient interviews. Exploratory, intent-to-treat logistic and linear mixed models estimated PAP adherence and clinical outcomes. RESULTS Of 103 eligible participants, 87 were enrolled (SleepWell24 n = 40, control n = 47; mean 57.6y [SD = 12.3], 44.8% female). Retention was ≥95% across arms. There were no significant differences in TEQ scores. SleepWell24 participants engaged with the app on 62.9% of trial days. PAP use was high across both arms (SleepWell24 vs. Control: mean hours 5.98 vs. 5.86). There were no differences in PAP adherence or clinical outcomes. CONCLUSIONS SleepWell24 was feasible and acceptable among PAP-naive patients with OSA. CLINICAL TRIAL REGISTRATION NCT03156283https://www.clinicaltrials.gov/study/NCT03156283.

COVID-19 vaccines, currently available to children over six months old, are a powerful method of reducing the risk of COVID-19-related hospitalizations and death. However, vaccination rates among Hispanic children remain suboptimal, primarily due to parental vaccine hesitancy. Health communication researchers have suggested using culturally aligned storytelling to reduce vaccine hesitancy; however, few studies have evaluated this approach for Hispanic parents of unvaccinated children. Working with community health workers, we will engage Hispanic parents who were previously hesitant to vaccinate their child(ren) against COVID-19 but currently support vaccination. We will ask them to share their stories of conversion in COVID-19 vaccine perspectives to help other parents overcome their mistrust of COVID-19 vaccines. We will then assess the feasibility and acceptability of a web-based pilot digital storytelling intervention based on these conversion stories vs. an information-only control among 80 parents and/or legal guardians of children who are not up-to-date with COVID-19 vaccines. We will also examine pre- to post-intervention changes in vaccine perceptions, hesitancy, intentions, and uptake of children’s COVID-19 vaccination at two months post-intervention. If our pilot study demonstrates feasibility and acceptability while reducing COVID-19 vaccine hesitancy and increasing vaccine uptake, we will conduct a full-scale randomized controlled trial to examine the effectiveness of the DST intervention to reduce vaccine hesitancy.