Food resources and kitchen skills plus aerobic training (FoRKS+) for black adults with hypertension: A pilot trial protocol.

BACKGROUND: Midlife hypertension is associated with cognitive decline and Alzheimer's disease and related dementia (ADRD), suggesting that blood pressure control may be a therapeutic target for dementia prevention. Given excess hypertension in non-Hispanic Black (NHB) adults, blood pressure control may also reduce ADRD disparities. We describe a pilot randomized controlled trial (RCT) to evaluate the feasibility and preliminary efficacy of a multicomponent lifestyle-based intervention versus enhanced usual care on cognition among middle-aged NHB adults. METHODS AND STUDY DESIGN: The Food Resources and Kitchen Skills plus Aerobic Training (FoRKS+) study is a 2-arm, single-blinded trial that compares those receiving the FoRKS+ program (target N = 64) versus those receiving enhanced usual care (target N = 64) in local federally-qualified health centers. Key eligibility criteria include self-identified NHB adults between ages 35-75 with a mean systolic blood pressure ≥ 130 mm/Hg obtained from 24-h ambulatory blood pressure monitoring. The FoRKS+ program includes 5 weeks of hypertension self-management courses, 11 weeks of nutrition courses, and 12 weeks of aerobic training in dietitian and health coach-led virtual groups. We will collect data on primary cognitive outcomes, feasibility, hypothesized intervention mediators and moderators, and demographic and health covariates at baseline, near intervention weeks 16-, and 28 (primary outcome assessment), and week 52 follow-up. We will use mixed-effects modeling to examine intervention effects on cognition. DISCUSSION: This pilot RCT will examine the feasibility and preliminary effects of a multicomponent lifestyle intervention on cognitive function in NHB adults, which may have implications for reducing health disparities in ADRD.

Building the Infrastructure to Integrate Social Care in a Safety Net Health System.

A recent National Academies report recommended that health systems invest in new infrastructure to integrate social and medical care. Although many health systems routinely screen patients for social concerns, few health systems achieve the recommended model of integration. In this critical case study in an urban safety net health system, we describe the human capital, operational redesign, and financial investment needed to implement the National Academy recommendations. Using data from this case study, we estimate that other health systems seeking to build and maintain this infrastructure would need to invest $1 million to $3 million per year. While health systems with robust existing resources may be able to bootstrap short-term funding to initiate this work, we conclude that long-term investments by insurers and other payers will be necessary for most health systems to achieve the recommended integration of medical and social care. Researchers seeking to test whether integrating social and medical care leads to better patient and population outcomes require access to health systems and communities who have already invested in this model infrastructure. (Am J Public Health. 2024;114(6):619-625. https://doi.org/10.2105/AJPH.2024.307602).

Design and baseline characteristics of the Cognitive and Aerobic Resilience for the Brain (CARB) study.

BACKGROUND: Treatments that delay progression of cognitive impairment in older adults are of great public health significance. This manuscript outlines the protocol, recruitment, baseline characteristics, and retention for a randomized controlled trial of cognitive and aerobic physical training to improve cognition in individuals with subjective cognitive dysfunction, the "Cognitive and Aerobic Resilience for the Brain" (CARB) study. METHODS: Community-dwelling, older adults with self-reported memory loss were randomly assigned to receive either computer-based cognitive training, aerobic physical training, combined cognitive and physical training, or education control. Treatment was delivered 2- to 3-times per week in 45- to 90-min sessions for 12 weeks by trained facilitators videoconferencing into subject's home. Outcome assessments of were taken at the baseline, immediately following training, and 3-months after training. RESULTS: 191 subjects were randomized into the trial (mean age, 75.5 years; 68% female; 20% non-white; mean education, 15.1 years; 30% with 1+ APOE e4 allele). The sample was generally obese, hypertensive, and many were diabetic, while cognition, self-reported mood, and activities of daily living were in the normal range. There was excellent retention throughout the trial. Interventions were completed at high rates, participants found the treatments acceptable and enjoyable, and outcome assessments were completed at high rates. CONCLUSIONS: This study was designed to determine the feasibility of recruiting, intervening, and documenting response to treatment in a population at risk for progressive cognitive decline. Older adults with self-reported memory loss were enrolled in high numbers and were well engaged with the intervention and outcome assessments.

Delivering Food Resources and Kitchen Skills (FoRKS) to Adults with Food Insecurity and Hypertension: A Pilot Study.

Food insecurity affects nearly 50 million Americans and is linked to cardiovascular disease risk factors and health disparities. The purpose of this single-arm pilot study was to determine the feasibility of a 16-week dietitian-led lifestyle intervention to concurrently address food access, nutrition literacy, cooking skills, and hypertension among safety-net primary care adult patients. The Food Resources and Kitchen Skills (FoRKS) intervention provided nutrition education and support for hypertension self-management, group kitchen skills and cooking classes from a health center teaching kitchen, medically tailored home-delivered meals and meal kits, and a kitchen toolkit. Feasibility and process measures included class attendance rates and satisfaction and social support and self-efficacy toward healthy food behaviors. Outcome measures included food security, blood pressure, diet quality, and weight. Participants (n = 13) were on average {mean (SD)} aged 58.9 ± 4.5 years, 10 were female, and 12 were Black or African American. Attendance averaged 19 of 22 (87.1%) classes and satisfaction was rated as high. Food self-efficacy and food security improved, and blood pressure and weight declined. FoRKS is a promising intervention that warrants further evaluation for its potential to reduce cardiovascular disease risk factors among adults with food insecurity and hypertension.

Continuous Glucose Monitoring and Other Wearable Devices to Assess Hypoglycemia among Older Adult Outpatients with Diabetes Mellitus.

BACKGROUND: Hypoglycemia (HG) causes symptoms that can be fatal, and confers risk of dementia. Wearable devices can improve measurement and feedback to patients and clinicians about HG events and risk. OBJECTIVES: The aim of the study is to determine whether vulnerable older adults could use wearables, and explore HG frequency over 2 weeks. METHODS: First, 10 participants with diabetes mellitus piloted a continuous glucometer, physical activity monitor, electronic medication bottles, and smartphones facilitating prompts about medications, behaviors, and symptoms. They reviewed graphs of glucose values, and were asked about the monitoring experience. Next, a larger sample (N = 70) wore glucometers and activity monitors, and used the smartphone and bottles, for 2 weeks. Participants provided feedback about the devices. Descriptive statistics summarized demographics, baseline experiences, behaviors, and HG. RESULTS: In the initial pilot, 10 patients aged 50 to 85 participated. Problems addressed included failure of the glucometer adhesive. Patients sought understanding of graphs, often requiring some assistance with interpretation. Among 70 patients in subsequent testing, 67% were African-American, 59% were women. Nearly one-fourth (23%) indicated that they never check their blood sugars. Previous HG was reported by 67%. In 2 weeks of monitoring, 73% had HG (glucose ≤70 mg/dL), and 42% had serious, clinically significant HG (glucose under 54 mg/dL). Eight patients with HG also had HG by home-based blood glucometry. Nearly a third of daytime prompts were unanswered. In 24% of participants, continuous glucometers became detached. CONCLUSION: Continuous glucometry occurred for 2 weeks in an older vulnerable population, but devices posed wearability challenges. Most patients experienced HG, often serious in magnitude. This suggests important opportunities to improve wearability and decrease HG frequency among this population.

Improving Care for People Living With Dementia and Diabetes: Applying the Human-Centered Design Process to Continuous Glucose Monitoring.

People with Alzheimer's disease or related dementias and diabetes mellitus (ADRD-DM) are at high risk for hypoglycemic events. Their cognitive impairment and psychosocial situation often hinder detection of hypoglycemia. Extending use and benefits of continuous glucose monitoring (CGM) to people with ADRD-DM could improve hypoglycemia detection, inform care, and reduce adverse events. However, cognitive impairment associated with ADRD presents unique challenges for CGM use. This commentary proposes applying the human-centered design process to CGM, investigating design solutions or interventions needed to integrate CGM into the health care of patients with ADRD-DM. With this process, we can identify and inform CGM designs for people with ADRD-DM, broadening CGM access, increasing detection and treatment of the silent threat posed by hypoglycemia.

Environments and situations as correlates of eating and drinking among women living with obesity and urban poverty.

Objective: One path to improving weight management may be to lessen the self-control burden of physical activity and healthier food choices. Opportunities to lessen the self-control burden might be uncovered by assessing the spatiotemporal experiences of individuals in daily context. This report aims to describe the time, place, and social context of eating and drinking and 6-month weight change among 209 midlife women (n = 113 African-American) with obesity receiving safety-net primary care. Methods: Participants completed baseline and 6-month weight measures, observations and interviews regarding obesogenic cues in the home environment, and up to 12 ecological momentary assessments (EMA) per day for 30 days inquiring about location, social context, and eating and drinking. Results: Home was the most common location (62%) at times of EMA notifications. Participants reported "yes" to eating or drinking at the time of nearly one in three (31.1% ± 13.2%) EMA notifications. Regarding social situations, being alone was significantly associated with less frequent eating and drinking (OR = 0.75) unless at work in which case being alone was significantly associated with a greater frequency of eating or drinking (OR = 1.43). At work, eating was most common late at night, whereas at home eating was most frequent in the afternoon and evening hours. However, eating and drinking frequency was not associated with 6-month weight change. Conclusions: Home and work locations, time of day, and whether alone may be important dimensions to consider in the pursuit of more effective weight loss interventions. Opportunities to personalize weight management interventions, whether digital or human, and lessen in-the-moment self-control burden might lie in identifying times and locations most associated with caloric consumption.Clinical trial registration: NCT03083964 in clinicaltrials.gov.

Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial.

INTRODUCTION: A growing body of scientific evidence points to the potentially harmful cognitive effects of anticholinergic medications among older adults. Most interventions designed to promote deprescribing of anticholinergics have directly targeted healthcare professionals and have had mixed results. Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts. METHODS: We initiated a randomized clinical trial to evaluate the effectiveness of a patient-facing mobile application (Brain Safe app) compared to an attention control medication list app in reducing anticholinergic exposure among community-dwelling older adults. Study participants are adults aged 60 years and above, currently using at least one prescribed strong anticholinergic, and receiving primary care. The trial plans to enroll a total of 700 participants, randomly allocated in 1:1 proportion to the two study arms. Participants will have the Brain Safe app (intervention arm) or attention control medication list app (control arm) loaded onto a smartphone (study provided or personal device). All participants will be followed for 12 months and will have data collected at baseline, at 6 months, and 12 months by blinded outcome assessors. The primary outcome of the study is anticholinergic exposure measured as total standard daily dose (TSDD) computed from medication prescription electronic records. Secondary outcomes of the study are cognitive function and health-related quality of life. DISCUSSION: A consumer-facing intervention to promote deprescribing of potentially high-risk medications can be part of a multi-pronged approach to reduce inappropriate medication use among older adult patients. Delivering a deprescribing intervention via a mobile app is a novel approach and may hold great promise to accelerate deployment of medication safety initiatives across diverse patient populations. CLINICAL TRIAL REGISTRATION: Registered at ClinicalTrials.gov on October 10, 2019. Identifier number: NCT04121858.

Multicomponent behavioral intervention to reduce exposure to anticholinergics in primary care older adults.

OBJECTIVE: To test the impact of a multicomponent behavioral intervention to reduce the use of high-risk anticholinergic medications in primary care older adults. DESIGN: Cluster-randomized controlled trial. SETTING AND PARTICIPANTS: Ten primary care clinics within Eskenazi Health in Indianapolis. INTERVENTION: The multicomponent intervention included provider- and patient-focused components. The provider-focused component was computerized decision support alerting of the presence of a high-risk anticholinergic and offering dose- and indication-specific alternatives. The patient-focused component was a story-based video providing education and modeling an interaction with a healthcare provider resulting in a medication change. Alerts within the medical record triggered staff to play the video for a patient. Our design intended for parallel, independent priming of both providers and patients immediately before an outpatient face-to-face interaction. MEASUREMENT: Medication orders were extracted from the electronic medical record system to evaluate the prescribing behavior and population prevalence of anticholinergic users. The intervention was introduced April 1, 2019, through March 31, 2020, and a preintervention observational period of April 1, 2018, through March 31, 2019, facilitated difference in difference comparisons. RESULTS: A total of 552 older adults had visits at primary care sites during the study period, with mean age of 72.1 (SD 6.4) years and 45.3% African American. Of the 259 provider-focused alerts, only three (1.2%) led to a medication change. Of the 276 staff alerts, 4.7% were confirmed to activate the patient-focused intervention. The intervention resulted in no significant differences in either the number of discontinue orders for anticholinergics (intervention: two additional orders; control: five fewer orders, p = 0.7334) or proportion of the population using anticholinergics following the intervention (preintervention: 6.2% and postintervention: 5.1%, p = 0.6326). CONCLUSION: This multicomponent intervention did not reduce the use of high-risk anticholinergics in older adults receiving primary care. Improving nudges or a policy-focused component may be necessary to reduce use of high-risk medications.

Complex Transitions from Skilled Nursing Facility to Home: Patient and Caregiver Perspectives.

BACKGROUND: Patients who undergo the complex series of transitions from the hospital to a skilled nursing facility (SNF) back to home represent a unique patient population with multiple comorbidities and impaired functional abilities. The needs and outcomes of patients who are discharged from the hospital to SNF before returning home are understudied in care transitions scholarship. OBJECTIVE: To study the patient and caregiver challenges and perspectives on transitions from the hospital to the SNF and back to home. DESIGN: Between 48 h and 1 week after discharge from the SNF, semi-structured interviews were performed with a convenience sample of patients and caregivers in their homes. Within 1 to 2 weeks after the baseline interview, follow-up interviews were performed over the phone. PARTICIPANTS: A total of 39 interviewees comprised older adults undergoing the series of transitions from hospital to skilled nursing facility to home and their informal caregivers. MAIN MEASURES: A constructionist, grounded-theory approach was used to code the interviews, identify major themes and subthemes, and develop a theoretical model explaining the outcomes of the SNF to home transition. KEY RESULTS: The mean age of the patients was 76.6 years and 64.8 years for the caregivers. Four major themes were identified: comforts of home, information needs, post-SNF care, and independence. Patients noted an extended time away from home and were motivated to return to and remain in the home. Information needs were variably met and affected post-SNF care, including medication management, appointments, and therapy gains and setbacks. Interviewees identified independent function at home as the most important outcome of the transition home. CONCLUSIONS: Post-SNF in home support is needed rapidly after discharge from the SNF to prevent adverse outcomes. In-home support needs to be highly individualized based on a patient's and caregiver's unique situation and needs.

Depressive symptom severity as a predictor of attendance in the HOME behavioral weight loss trial.

OBJECTIVE: We examined whether total depressive symptoms and symptom clusters predicted behavioral weight loss attendance among economically disadvantaged adults in a randomized controlled trial. METHODS: 150 adults with obesity were randomized to 12 months of in-person, video conference, or enhanced usual care weight loss groups. We categorized percent session attendance in the intervention arms into three levels: no attendance, poorer attendance, and better attendance. RESULTS: Higher baseline Patient Health Questionnaire-8 (PHQ-8) score was associated with a greater odds of being in the poorer versus better attendance group (OR = 1.94, 95% CI: 1.02-3.69, p = .04). A similar relationship between PHQ-8 score and odds of being in the no attendance versus better attendance group was observed but was not statistically significant (OR = 1.63, 95% CI: 0.94-2.81, p = .08). Both cognitive/affective and somatic clusters contributed to the depressive symptoms-attendance relationships. CONCLUSION: Greater depressive symptoms at the start of a behavioral weight loss program may predict poorer subsequent session attendance. Screening for and addressing depression may improve intervention uptake. ClinicalTrials.gov Identifier: NCT02057952.

Usability and feasibility of consumer-facing technology to reduce unsafe medication use by older adults.

BACKGROUND: Mobile health technology can improve medication safety for older adults, for instance, by educating patients about the risks associated with anticholinergic medication use. OBJECTIVE: This study's objective was to test the usability and feasibility of Brain Buddy, a consumer-facing mobile health technology designed to inform and empower older adults to consider the risks and benefits of anticholinergics. METHODS: Twenty-three primary care patients aged ≥60 years and using anticholinergic medications participated in summative, task-based usability testing of Brain Buddy. Self-report usability was assessed by the System Usability Scale and performance-based usability data were collected for each task through observation. A subset of 17 participants contributed data on feasibility, assessed by self-reported attitudes (feeling informed) and behaviors (speaking to a physician), with confirmation following a physician visit. RESULTS: Overall usability was acceptable or better, with 100% of participants completing each Brain Buddy task and a mean System Usability Scale score of 78.8, corresponding to "Good" to "Excellent" usability. Observed usability issues included higher rates of errors, hesitations, and need for assistance on three tasks, particularly those requiring data entry. Among participants contributing to feasibility data, 100% felt better informed after using Brain Buddy and 94% planned to speak to their physician about their anticholinergic related risk. On follow-up, 82% reported having spoken to their physician, a rate independently confirmed by physicians. CONCLUSION: Consumer-facing technology can be a low-cost, scalable intervention to improve older adults' medication safety, by informing and empowering patients. User-centered design and evaluation with demographically heterogeneous clinical samples uncovers correctable usability issues and confirms the value of interventions targeting consumers as agents in shared decision making and behavior change.

MIND food and speed of processing training in older adults with low education, the MINDSpeed Alzheimer's disease prevention pilot trial.

BACKGROUND: Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve. OBJECTIVES: Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed. DESIGN: MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games. METHODS: All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions. SUMMARY: MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations.

Context-Sensitive Ecological Momentary Assessment: Application of User-Centered Design for Improving User Satisfaction and Engagement During Self-Report.

BACKGROUND: Ecological momentary assessment (EMA) can be a useful tool for collecting real-time behavioral data in studies of health and health behavior. However, EMA administered through mobile technology can be burdensome, and it tends to suffer from suboptimal user engagement, particularly in low health-literacy populations. OBJECTIVE: This study aimed to report a case study involving the design and evaluation of a mobile EMA tool that supports context-sensitive EMA-reporting of location and social situations accompanying eating and sedentary behavior. METHODS: An iterative, user-centered design process with obese, middle-aged women seeking care in a safety-net health system was used to identify the preferred format of self-report measures and the look, feel, and interaction of the mobile EMA tool. A single-arm feasibility field trial with 21 participants receiving 12 prompts each day for momentary self-reports over a 4-week period (336 total prompts per participant) was used to determine user satisfaction with interface quality and user engagement, operationalized as response rate. A second trial among 38 different participants randomized to receive or not to receive a feature designed to improve engagement was conducted. RESULTS: The feasibility trial results showed high interface satisfaction and engagement, with an average response rate of 50% over 4 weeks. Qualitative feedback pointed to the need for auditory alerts. We settled on 3 alerts at 10-min intervals to accompany each EMA-reporting prompt. The second trial testing this feature showed a statistically significant increase in the response rate between participants randomized to receive repeat auditory alerts versus those who were not (60% vs 40%). CONCLUSIONS: This paper reviews the design research and a set of design constraints that may be considered in the creation of mobile EMA interfaces personalized to users' preferences. Novel aspects of the study include the involvement of low health-literacy adults in design research, the capture of data on time, place, and social context of eating and sedentary behavior, and reporting prompts tailored to an individual's location and schedule. TRIAL REGISTRATION: ClinicalTrials.gov NCT03083964; https://clinicaltrials.gov/ct2/show/NCT03083964.

Understanding older adults' medication decision making and behavior: A study on over-the-counter (OTC) anticholinergic medications.

BACKGROUND: Older adults purchase and use over-the-counter (OTC) medications with potentially significant adverse effects. Some OTC medications, such as those with anticholinergic effects, are relatively contraindicated for use by older adults due to evidence of impaired cognition and other adverse effects. OBJECTIVE: To inform the design of future OTC medication safety interventions for older adults, this study investigated consumers' decision making and behavior related to OTC medication purchasing and use, with a focus on OTC anticholinergic medications. METHODS: The study had a cross-sectional design with multiple methods. A total of 84 adults participated in qualitative research interviews (n = 24), in-store shopper observations (n = 39), and laboratory-based simulated OTC shopping tasks (n = 21). Simulated shopping participants also rank-ordered eight factors on their importance for OTC decision making. RESULTS: Findings revealed that many participants had concerns about medication adverse effects, generally, but were not aware of age-related risk associated with the use of anticholinergic medications. Analyses produced a map of the workflow of OTC-related behavior and decision making as well as related barriers such as difficulty locating medications or comparing them to an alternative. Participants reported effectiveness, adverse effects or health risks, and price as most important to their OTC medication purchase and use decisions. A persona analysis identified two types of consumers: the habit follower, who frequently purchased OTC medications and considered them safe; and the deliberator, who was more likely to weigh their options and consider alternatives to OTC medications. CONCLUSION: A conceptual model of OTC medication purchase and use is presented. Drawing on study findings and behavioral theories, the model depicts dual processes for OTC medication decision making - habit-based and deliberation-based - as well as the antecedents and consequences of decision making. This model suggests several design directions for consumer-oriented interventions to promote OTC medication safety.

The Association of Early Life Factors and Declining Incidence Rates of Dementia in an Elderly Population of African Americans.

Objectives: To explore the possible association of childhood residence, education levels, and occupation with declining incidence rates of dementia in 2 cohorts of elderly African Americans. Methods: African Americans residing in Indianapolis without dementia were enrolled in 1992 and 2001 and evaluated every 2-3 years. The cohorts consist of 1,440 participants in 1992 and 1,835 participants in 2001 aged 70 years and older. Cox proportional hazard regression models were used to compare cohort differences in dementia and Alzheimer's disease (AD) risk. Results: The 2001 cohort had significantly decreased risk of both incident dementia and AD (hazard ratio [HR]: 0.62/0.57 for dementia/AD). Years of education was associated with decreased risk of dementia (HR = 0.93; p = .0011). A significant interaction (p = .0477) between education and childhood rural residence was found for the risk of AD that higher education level is significantly associated with reduced AD risk (HR = 0.87) in participants with childhood rural residence, but no association in those with urban upbringing. The cohort difference for dementia rates were attenuated by adjusting for the 3 risk factors but remained significant (HR = 0.75; p = .04). Discussion: These results emphasize the importance of early life factors including rural residence and education for the risk for dementia later in life.

Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial.

BACKGROUND: Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. METHODS: IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. DISCUSSION: This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03095417 . Registered on 23 March 2017. Last updated on 15 May 2017.

Addressing people and place microenvironments in weight loss disparities (APP-Me): Design of a randomized controlled trial testing timely messages for weight loss behavior in low income Black and White Women.

BACKGROUND: Behavioral interventions for weight loss have been less effective in lower income and black women. These poorer outcomes may in part be related to these women having more frequent exposures to social and physical situations that are obesogenic, i.e., eating and sedentary cues or situations. OBJECTIVES: Working with obese, lower income Black and White Women, Addressing People and Place Microenvironments (APP-Me) was designed to create awareness of self-behavior at times and places of frequent eating and sedentary behavior. DESIGN: APP-Me is being evaluated in a randomized controlled trial with 240 participants recruited from federally qualified health centers located in a single Midwestern city. All participants complete four weeks of ecological momentary assessments (EMA) of situations and behavior. At the end of the four weeks, participants are randomized to enhanced usual care (UC) or UC plus APP-Me. METHODS: APP-Me is an automated short messaging system (SMS). Messages are text, image, audio, or a combination, and are delivered to participants' mobile devices with the intent of creating awareness at the times and places of frequent eating or sedentary behavior. The EMA data inform the timing of message deliveries. SUMMARY: This project aims to create and test timely awareness messages in a subpopulation that has not responded well to traditional behavioral interventions for weight loss. Novel aspects of the study include the involvement of a low income population, the use of data on time and place of obesogenic behavior, and message delivery time tailored to an individual's behavioral patterns.

Speed of processing training results in lower risk of dementia.

INTRODUCTION: Cognitive training improves cognitive performance and delays functional impairment, but its effects on dementia are not known. We examined whether three different types of cognitive training lowered the risk of dementia across 10 years of follow-up relative to control and if greater number of training sessions attended was associated with lower dementia risk. METHODS: The Advanced Cognitive Training in Vital Elderly (NCT00298558) study was a randomized controlled trial (N = 2802) among initially healthy older adults, which examined the efficacy of three cognitive training programs (memory, reasoning, or speed of processing) relative to a no-contact control condition. Up to 10 training sessions were delivered over 6 weeks with up to four sessions of booster training delivered at 11 months and a second set of up to four booster sessions at 35 months. Outcome assessments were taken immediately after intervention and at intervals over 10 years. Dementia was defined using a combination of interview- and performance-based methods. RESULTS: A total of 260 cases of dementia were identified during the follow-up. Speed training resulted in reduced risk of dementia (hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.50-0.998, P = .049) compared to control, but memory and reasoning training did not (HR 0.79, 95% CI 0.57-1.11, P = .177 and HR 0.79, 95% CI 0.56-1.10, P = .163, respectively). Each additional speed training session was associated with a 10% lower hazard for dementia (unadjusted HR, 0.90; 95% CI, 0.85-0.95, P < .001). DISCUSSION: Initially, healthy older adults randomized to speed of processing cognitive training had a 29% reduction in their risk of dementia after 10 years of follow-up compared to the untreated control group.

Promoting ADL independence in vulnerable, community-dwelling older adults: a pilot RCT comparing 3-Step Workout for Life versus resistance exercise.

BACKGROUND: Resistance exercise is effective to increase muscle strength for older adults; however, its effect on the outcome of activities of daily living is often limited. The purpose of this study was to examine whether 3-Step Workout for Life (which combines resistance exercise, functional exercise, and activities of daily living exercise) would be more beneficial than resistance exercise alone. METHODS: A single-blind randomized controlled trial was conducted. Fifty-two inactive, community-dwelling older adults (mean age =73 years) with muscle weakness and difficulty in activities of daily living were randomized to receive 3-Step Workout for Life or resistance exercise only. Participants in the 3-Step Workout for Life Group performed functional movements and selected activities of daily living at home in addition to resistance exercise. Participants in the Resistance Exercise Only Group performed resistance exercise only. Both groups were comparable in exercise intensity (moderate), duration (50-60 minutes each time for 10 weeks), and frequency (three times a week). Assessment of Motor and Process Skills, a standard performance test on activities of daily living, was administered at baseline, postintervention, and 6 months after intervention completion. RESULTS: At postintervention, the 3-Step Workout for Life Group showed improvement on the outcome measure (mean change from baseline =0.29, P=0.02), but the improvement was not greater than the Resistance Exercise Only Group (group mean difference =0.24, P=0.13). However, the Resistance Exercise Only Group showed a significant decline (mean change from baseline =-0.25, P=0.01) 6 months after the intervention completion. Meanwhile, the superior effect of 3-Step Workout for Life was observed (group mean difference =0.37, P<0.01). CONCLUSION: Compared to resistance exercise alone, 3-Step Workout for Life improves the performance of activities of daily living and attenuates the disablement process in older adults.