Identifying new interventions to slow and prevent cognitive decline associated with dementia is critical. Nonpharmacological interventions targeting modifiable risk factors are promising, relatively low-cost, accessible, and safe approaches. To compare the effects of two 2-year lifestyle interventions on cognitive trajectory in older adults at risk of cognitive decline and dementia. Single-blind, multicenter randomized clinical trial enrolling 2111 participants from May 2019 to March 2023 (final follow-up, May 14, 2025) at 5 clinical sites in the US. Participant inclusion criteria enriched risk of cognitive decline and included age 60 to 79 years, sedentary lifestyle, and suboptimal diet plus at least 2 additional criteria related to family history of memory impairment, cardiometabolic risk, race and ethnicity, older age, and sex. Participants were randomly assigned with equal probability to structured (n = 1056) or self-guided (n = 1055) interventions. Both interventions encouraged increased physical and cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, but differed in structure, intensity, and accountability. The primary comparison was difference between intervention groups in annual rate of change in global cognitive function, assessed by a composite measure of executive function, episodic memory, and processing speed, over 2 years. Among the 2111 individuals enrolled (mean age, 68.2 [SD, 5.2] years; 1455 [68.9%] female), 89% completed the year 2 assessment. The mean global cognitive composite z score increased from baseline over time in both groups, with a mean rate of increase per year of 0.243 SD (95% CI, 0.227-0.258) for the structured intervention and 0.213 SD (95% CI, 0.198-0.229) for the self-guided intervention. The mean rate of increase per year was statistically significantly greater for the structured group than the self-guided group by 0.029 SD (95% CI, 0.008-0.050; P = .008). Based on prespecified secondary subgroup comparisons, the structured intervention benefit was consistent for APOE ε4 carriers and noncarriers (P = .95 for interaction) but appeared greater for adults with lower vs higher baseline cognition (P = .02 for interaction). Fewer ascertained adverse events were reported in the structured group (serious: 151; nonserious: 1091) vs the self-guided group (serious: 190; nonserious: 1225), with a positive COVID-19 test result being the most common adverse event overall and more frequent in the structured group. Among older adults at risk of cognitive decline and dementia, a structured, higher-intensity intervention had a statistically significant greater benefit on global cognition compared with an unstructured, self-guided intervention. Further investigation of functional outcomes, biomarkers, and ongoing extended follow-up will help address clinical relevance and sustainability of the observed cognitive benefits. ClinicalTrials.gov Identifier: NCT03688126
The Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet, featuring emphasis on green leafy and other colorful vegetables, berries, unsaturated fats, fish, and whole grains is a major component of the U.S. POINTER multi-domain lifestyle intervention. The purpose of this study is to examine the associations among MIND diet screener scores, and measures of cognitive function, and physical and mental health at baseline. U.S. POINTER is a randomized controlled trial of two multidomain lifestyle interventions. (n = 2112; mean age = 68.18±5.15y). Cognitive function measures included global, episodic memory, executive function, and processing speed, derived from the U.S. POINTER modified Neuropsychological Test Battery. Physical and mental health were assessed using measures of BMI, hypertension, diabetes, dyslipidemia, physical activity, the Geriatric Depression Scale, the Pittsburgh Sleep Quality Index (PSQI) and symptoms of psychological distress. Pearson correlations were used to estimate bivariate associations among variables. Generalized linear regression models were used to examine associations while controlling for demographic variables. Baseline MIND diet screener scores were inversely associated with BMI (r = -0.09, p<.0001), diastolic blood pressure (DBP) (r = -0.10, p<.0001), depression (r = -0.12, p<.0001), and PSQI (r = -0.09, p<0.0001). MIND diet scores were positively associated with frequency of moderate-intensity exercise (r = 0.10, p<.000) and total health score (r = 0.09, p<.0001). Linear models revealed that after controlling for demographics, MIND diet scores remained associated with BMI, DBP, frequency of exercise, depression, and sleep quality and total health (See Table 1). MIND diet scores were not associated with measures of cognition. In U.S. POINTER, MIND diet scores were not associated with cognition; however, those with higher MIND diet scores had lower BMI, DBP depression and PSQI scores, as well as higher frequency of moderate-intensity exercise, higher self-reported health.
The majority of the 18 million US adults with cancer history (“survivors”) do not meet recommendations for obtaining regular physical activity (PA) or limiting sedentary behavior in their daily lives. Breast cancer survivors (BCS) and colon cancer survivors (CCS) are particularly at risk of insufficient PA and excessive sedentary behavior (i.e., sitting) that may increase physical impairments, worsen cancer treatment symptoms, limit optimal cancer recovery, and limit opportunities to potentially reduce cancer risk. Research has shown that completion of clinical cancer treatment may serve as a ‘teachable moment’ for patients as they transition to recovery at home. Many of these survivors are uncertain about building a healthier lifestyle without guidance from the medical team, but few validated clinical tools exist to assess and counsel survivors on their behavioral choices relative to PA and sedentary behavior.Based on our recent findings, a simple screener that collects measures on PA, strength training, and sedentary behavior, the Physical Activity Index (PAI), may be effective for clinical use to monitor patient behaviors and provide specific, tailored recommendations on how to achieve and maintain behavioral goals. We propose a multicomponent, two-arm pilot 1:1 randomized controlled trial with waitlist control in which we will recruit (n = 20) BCS and CCS within three years of diagnosis to leverage the ‘teachable moment’ in early recovery. The PAI intervention will include standard survivorship follow-up care plus a PA assessment using the PAI screener that is supplied to the provider plus five remote coaching consultations with a certified exercise physiologist. All participants will also receive resistance bands to keep and an activity tracker to self-monitor their behaviors at home.We will determine feasibility by examining recruitment, retention, acceptability, and PAI intervention adherence goals. Secondarily, we will measure changes/variability in achievement of behavioral outcomes for PA and sedentary behaviors to inform future trial planning.
INTRODUCTION:EXERT was a multisite randomized controlled trial (RCT) examining the effects of moderate-high intensity aerobic training (AX) versus lower-intensity stretching/balance/range of motion (SBR) on cognitive trajectories in older adults with amnestic mild cognitive impairment (aMCI). METHODS:Preplanned post-hoc analyses were conducted to compare each arm to a propensity-matched usual care (no intervention) group from Alzheimer's Disease Neuroimaging Initiative 1 (ADNI-1) selected for similarity across key characteristics. Differences in 12-month trajectories in the primary endpoint (ADAS-Cog-Exec) and magnetic resonance imaging (MRI) volumes in prespecified brain regions were compared. RESULTS:AX and SBR showed significantly less 12-month cognitive decline than ADNI-1 (AX:n = 109, β = 0.169, 95% confidence interval [CI] 0.011-0.328; SBR:n = 105, β = 0.181, 95% CI 0.007-0.354). There were trends of less prefrontal cortex volume loss for both EXERT groups and less AD signature region volume loss for SBR relative to ADNI-1 over 12 months. DISCUSSION:Moderate-high intensity aerobic or low-intensity flexibility exercise for 12 months in participants with aMCI may provide protection against decline relative to usual care. CLINICAL TRIAL REGISTRATION:The EXERT clinical trial is registered at clinicaltrials.gov (NCT02814526). HIGHLIGHTS:EXERT was a randomized controlled trial in sedentary older adults with aMCI. EXERT arms were propensity-matched to a usual care (no intervention) group (Alzheimer's Disease Neuroimaging Initiative 1 [ADNI-1]). High and low-intensity exercise arms had less 12-mo cognitive decline than ADNI-1. There were trends of less prefrontal cortex volume loss for each arm versus ADNI-1.
Importance Identifying new interventions to slow and prevent cognitive decline associated with dementia is critical. Nonpharmacological interventions targeting modifiable risk factors are promising, relatively low-cost, accessible, and safe approaches. Objective To compare the effects of two 2-year lifestyle interventions on cognitive trajectory in older adults at risk of cognitive decline and dementia. Design, Setting, and Participants Single-blind, multicenter randomized clinical trial enrolling 2111 participants from May 2019 to March 2023 (final follow-up, May 14, 2025) at 5 clinical sites in the US. Participant inclusion criteria enriched risk of cognitive decline and included age 60 to 79 years, sedentary lifestyle, and suboptimal diet plus at least 2 additional criteria related to family history of memory impairment, cardiometabolic risk, race and ethnicity, older age, and sex. Interventions Participants were randomly assigned with equal probability to structured (n = 1056) or self-guided (n = 1055) interventions. Both interventions encouraged increased physical and cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, but differed in structure, intensity, and accountability. Main Outcomes and Measures The primary comparison was difference between intervention groups in annual rate of change in global cognitive function, assessed by a composite measure of executive function, episodic memory, and processing speed, over 2 years. Results Among the 2111 individuals enrolled (mean age, 68.2 [SD, 5.2] years; 1455 [68.9%] female), 89% completed the year 2 assessment. The mean global cognitive composite z score increased from baseline over time in both groups, with a mean rate of increase per year of 0.243 SD (95% CI, 0.227-0.258) for the structured intervention and 0.213 SD (95% CI, 0.198-0.229) for the self-guided intervention. The mean rate of increase per year was statistically significantly greater for the structured group than the self-guided group by 0.029 SD (95% CI, 0.008-0.050; P = .008). Based on prespecified secondary subgroup comparisons, the structured intervention benefit was consistent for APOE epsilon 4 carriers and noncarriers (P = .95 for interaction) but appeared greater for adults with lower vs higher baseline cognition (P = .02 for interaction). Fewer ascertained adverse events were reported in the structured group (serious: 151; nonserious: 1091) vs the self-guided group (serious: 190; nonserious: 1225), with a positive COVID-19 test result being the most common adverse event overall and more frequent in the structured group. Conclusions and Relevance Among older adults at risk of cognitive decline and dementia, a structured, higher-intensity intervention had a statistically significant greater benefit on global cognition compared with an unstructured, self-guided intervention. Further investigation of functional outcomes, biomarkers, and ongoing extended follow-up will help address clinical relevance and sustainability of the observed cognitive benefits.
Multidomain lifestyle interventions have shown promise to slow cognitive decline and possibly prevent dementia. However, challenges arise in analyzing and interpreting treatment response when participants vary in their adherence to intervention components. The U.S. POINTER trial, a phase 3, multicenter, randomized 2-year clinical trial, is investigating the impact of lifestyle interventions on cognition in older adults at risk of cognitive decline. Four composite scores are proposed to assess engagement in the POINTER multidomain intervention. Composite score one was based on the U.S. POINTER Prescription adherence goals for three intervention domains (physical activity, diet, brain training). For this composite score, values range from 0 to 1.25, where “1” signifies the adherence goal was met, and “1.25” indicates the goal was exceeded (Table 1). The composite score is the sum of values across domains. Composite score two was constructed using Consistent Intervals , maintaining consistent scaling between the measurement of intervention domains and the values. The composite score is the sum of the values across the three domains, each ranging 0 to 1 (Table 1). Composite score three employed a Proportional Approach , measuring engagement in the three intervention domains as a proportion of achieved U.S. POINTER prescription goals. The composite score is the sum of values across domains. Composite score four utilized Exploratory Factor Analysis to identify optimal weighting for each domain’s adherence scores, aiming for a comprehensive assessment of participants' behavior. Missing data are examined in two ways: (a) assume missing data indicates no adherence and assign zero, and (b) multiple imputation to predict missing values before composite calculation. Properties of the four composites are examined using simulated datasets in preparation for later use in U.S. POINTER. Distributions, central tendency, and variability of adherence values for each composite score will be presented. Four possible multidomain adherence composite scores are proposed, reflecting intervention engagement in U.S. POINTER. In the future, we will explore sensitivity of each composite score to detect treatment-related change in cognition. This study will lay the foundation for broader applications in other multidomain trials with quantifiable adherence metrics, such as FINGER and LatAm-FINGERS.
INTRODUCTION:The EXERT study (Exercise in Adults with Mild Memory Problems) was a Phase 3, multicenter, randomized controlled trial that examined effects of exercise on cognition and other measures of brain health in sedentary older adults with amnestic mild cognitive impairment (MCI). METHODS:Participants were randomized to moderate-high intensity aerobic training (AX) or low-intensity stretching/balance/range of motion (SBR) for 18 months. Exercise was supervised for the first 12 months. Assessments were administered at baseline and every 6 months. The primary outcome was a global cognitive composite. RESULTS:A total of 296 participants were enrolled, and intervention adherence was high (supervised session attendance: AX = 81%, SBR = 87%). Intervention effects on cognition did not differ for AX and SBR (regression = -0.078, standard error [SE] = 0.074; p = 0.3). Notably, there was no 12 month cognition decline for either group, and mean 12 month hippocampal volume loss for both groups was low at 0.51%. DISCUSSION:Exercise intensity did not differentially affect cognitive trajectory. Intervention delivery was successful (high adherence) and cognition remained stable over 12 months for both MCI groups, an association that warrants further study. HIGHLIGHTS:Exercise in Adults with Mild Memory Problems (EXERT) was a large multisite randomized controlled trial of moderate-high intensity aerobic training versus lower-intensity flexibility and balance exercise in sedentary older adults with amnestic mild cognitive impairment (MCI). A sensitive and validated measure of global cognitive function, the Alzheimer's Disease Assessment Scale-Cognition supplemented with tests of executive function (ADAS-Cog-Exec), was used to assess intervention efficacy with 12 months of supervised exercise. There was no intervention group difference on the 12-month cognitive trajectory of the ADAS-Cog-Exec. Intervention delivery was successful (high adherence), and cognition remained stable over 12 months for both exercise groups. Regular supported moderate-high or lower-intensity exercise may stall decline in adults with amnestic MCI, but further investigation is needed.
Although technology-assisted diabetes prevention programs (DPPs) have been shown to improve glycemic control and weight loss, information are limited regarding relevant costs and their cost-effectiveness. To describe a retrospective within-trial cost and cost-effectiveness analysis (CEA) to compare a digital-based DPP (d-DPP) with small group education (SGE), over a 1-year study period. The costs were summarized into direct medical costs, direct nonmedical costs (i.e., times that participants spent engaging with the interventions), and indirect costs (i.e., lost work productivity costs). The CEA was measured by the incremental cost-effectiveness ratio (ICER). Sensitivity analysis was performed using nonparametric bootstrap analysis. Over 1 year, the direct medical costs, direct nonmedical costs, and indirect costs per participant were $4,556, $1,595, and $6,942 in the d-DPP group versus $4,177, $1,350, and $9,204 in the SGE group. The CEA results showed cost savings from d-DPP relative to SGE based on a societal perspective. Using a private payer perspective for d-DPP, ICERs were $4,739 and $114 to obtain an additional unit reduction in HbA1c (%) and weight (kg), and were $19,955 for an additional unit gain of quality-adjusted life years (QALYs) compared to SGE, respectively. From a societal perspective, bootstrapping results indicated that d-DPP has a 39% and a 69% probability, at a willingness-to-pay of $50,000/QALY and $100,000/QALY, respectively, of being cost-effective. The d-DPP was cost-effective and offers the prospect of high scalability and sustainability due to its program features and delivery modes, which can be easily translated to other settings.
INTRODUCTION:The U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER) is conducted to confirm and expand the results of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) in Americans. METHODS:U.S. POINTER was planned as a 2-year randomized controlled trial of two lifestyle interventions in 2000 older adults at risk for dementia due to well-established factors. The primary outcome is a global cognition composite that permits harmonization with FINGER. RESULTS:U.S. POINTER is centrally coordinated and conducted at five clinical sites (ClinicalTrials.gov: NCT03688126). Outcomes assessments are completed at baseline and every 6 months. Both interventions focus on exercise, diet, cognitive/social stimulation, and cardiovascular health, but differ in intensity and accountability. The study partners with a worldwide network of similar trials for harmonization of methods and data sharing. DISCUSSION:U.S. POINTER is testing a potentially sustainable intervention to support brain health and Alzheimer's prevention for Americans. Impact is strengthened by the targeted participant diversity and expanded scientific scope through ancillary studies.
Mid- and late-life exercise has been associated with lower dementia risk. The EXERT trial tested whether aerobic training (AX), compared to stretching/balance/range-of-motion training (SBR), could slow cognitive decline in MCI. While no difference was detected between exercise arms, EXERT participants overall showed little cognitive change over 12 months. It is possible that the amount of exercise, rather than the type, may be protective against decline. In this exploratory, post-hoc analysis of EXERT data, we assessed whether intervention adherence, operationalized as the number of supervised exercise sessions completed, was associated with slower brain atrophy over 12 months. 194 EXERT participants with baseline and follow-up MRI were included in this analysis. For each participant, the number of supervised exercise sessions of at least 40 minutes in duration completed during the first 12 months was determined. MRI data were processed using FreeSurfer. Repeated measures ANOVAs were conducted using regional volume or thickness as the dependent variable, and the interaction between number of sessions (continuous scale) and study visit as the independent variable. Baseline age and sex, as well as their interactions with time were included in the model. FDR-adjusted p-values <0.05 were considered significant. Greater number of sessions completed was associated with less brain atrophy over 12 months in the hippocampus and parahippocampus, and less ventricular expansion in the lateral and inferior lateral ventricles (Table 1, Figure 1; FDR-corrected p<0.05 for interaction term). Results remained unchanged when including exercise type (AX vs. SBR), baseline CDR-SB, or baseline plasma Aβ42/40 in the model. Findings were similar when analyses were restricted to participants who completed the study prior to the onset of the COVID-19 pandemic. Our results show that higher adherence to a supervised exercise intervention over 12 months was associated with reduced brain atrophy in adults with amnestic MCI. These findings were obtained in post-hoc, exploratory analyses, so causality should be interpreted with caution. EXERT was supported by the Alzheimer’s Disease Cooperative Study and funded by the National Institutes of Health grant U19-AG010483.
Objective: To examine changes in cardiovascular disease (CVD) risk outcomes of overweight/obese adults with prediabetes.Methods: Using data from a randomized control trial of digital diabetes prevention program (d-DPP) with 599 participants. We applied the atherosclerotic CVD (ASCVD) risk calculator to predict 10-year CVD risk for d-DPP and small education (comparison) groups. Between-group risk changes at 4 and 12 months were compared using a repeated measures linear mixed-effect model. We examined within-group differences in proportion of partic-ipants over time for specific CVD risk factors using generalized estimating equations.Results: We found no differences between baseline 10-year ASCVD risk. Relative to the comparison group, the d -DPP group experienced greater reductions in predicted 10-year ASCVD risk at each follow-up visit and a sig-nificant group difference at 4 months (-0.96%; 95% confidence interval:-1.58%,-0.34%) (but not at 12 months). Additionally, we observed that the d-DPP group experienced a decreased proportion of individuals with hyperlipidemia (18% and 16% from baseline to 4 and 12 months), high-risk total cholesterol (8% from baseline to 12 months), and being insufficiently active (26% and 22% from baseline to 4 and 12 months at follow-up time points.Conclusions: Our findings suggest that a digitally adapted DPP may promote the prevention of cardiometabolic disease among overweight/obese individuals with prediabetes. However, given the lack of maintenance of effect on ASCVD risk at 12 months, there may also be a need for additional interventions to sustain the effect detected at 4 months.
Abstract Background: The relevance of social support for weight management is not well documented in people with prediabetes. An important consideration is the adequate assessment of social provisions related to weight management in this population. Purpose: To assess the factor structure and measurement invariance of an adapted Social Provisions Scale specific to weight management (SPS-WM). Methods: Participants of a diabetes prevention trial (n=599) completed a demographic survey, and the SPS-WM. Confirmatory analyses tested the factor structure of the SPS-WM, and measurement invariance was assessed for gender, weight status, education level, and age. Results: Removal of two collinear items resulted in acceptable model fit, supporting six correlated factors for social provisions specific to weight management. Measurement invariance was supported across all subgroups. Conclusion: Results support score interpretations for these scales reflecting distinct components of social support specific to weight management in alignment with those of the original survey.
Mihalko, Shannon L. PhD; Katula, Jeffrey A. PhD; Brubaker, Peter H. PhD Author Information
There has been little investigation into the relationship between physical, cognitive, and social activity and subjective concern about cognition (SCD) in the absence of objective cognitive decline. This concern about subjective change is an important concept in the field of Alzheimer’s disease as it independently confers risk for developing MCI/AD. However, the exact relationship between SCD and engagement in positive daily activities is poorly understood. This project examines the relationship between SCD and self-reported engagement in these activities. U.S. POINTER is a phase 3, multicenter, 2-year randomized controlled trial of two lifestyle interventions varying in intensity and format, conducted in older adults living in the U.S. who do not have objective cognitive impairment at study entry, but have increased risk of cognitive decline and dementia. Participants completed myriad measures at baseline, including the Cognitive Function Inventory (CFI) assessing subjective cognitive decline, and the Community Healthy Activities Model Program for Seniors (CHAMPS) which assesses self-reported engagement in social, cognitive, and physical activities over the past 4 weeks. Baseline study characteristics of the current sample (N = 1823) are: Mean age = 68.2y (5.2), 73.5% female, 29.8% with less than 18+ years education, and 29.3% from underrepresented groups (URG). In separate multivariate linear models, CFI was associated with weekly caloric expenditure in exercise ( p < .001) and cognitive activity ( p <.001), such that CFI scores were higher for participants with lower exercise-related caloric expenditure and lower cognitive activity levels. Higher CFI scores also tended to predict social activity levels ( p = .06). The inverse relationship between CFI and all three variables is significant in women ( p = .04; .0001; .05, respectively) but not in men, and the CFI-cognitive activity relationship is significant for URG ( p = .005) but not White participants. In sum, SCD and engagement in physical, cognitive, and social activities are inversely related to varying degrees, such that individuals who report lower levels of engagement in these activities report more subjective cognitive concerns. However, different patterns emerged for some subgroups. Additional modeling is needed to demonstrate the directionality of the relationships between these activities and CFI, and the relationship with demographic variables of interest.
Introduction: In light of the need to expand the reach and access of clinically proven digital Diabetes Prevention Programs (d-DPPs) and the need for rigorous evidence of effectiveness, the purpose of this study was to determine the effectiveness of a digital Diabetes Prevention Program for improving weight, HbA1c, and cardiovascular risk factors among people with prediabetes compared to enhanced standard care plus waitlist control. Study Design: This was a single-blind RCT among participants at risk of developing type 2 diabetes and included 12 months of follow-up. Setting/Participants: A total of 599 volunteer patients with prediabetes were recruited primarily through electronic medical records and primary care practices. Intervention: Participants were randomized to either a d-DPP (n=299) or a single-session small-group diabetes-prevention education class (n=300) focused on action planning for weight loss. The d-DPPs consisted of 52 weekly sessions, lifestyle coaching, virtual peer support, and behavior tracking tools. Main Outcome Measures: The primary outcome was a change in HbA1c from baseline to 12 months using intent-to-treat analyses. On the basis of multiple comparisons of endpoints, 95% CIs are presented and 2-sided p<0.025 was required for statistical significance. Secondary outcomes included body weight and cardiovascular disease risk factors. Results: Among 599 randomized participants (mean age=55.4 years, 61.4% women), 483 (80%) completed the study. The d-DPPs produced significantly greater reductions in HbA1c (0.08%, 95% CI= -0.12, -0.03) and percentage change in body weight (-5.5% vs -2.1%, p<0.001) at 12 months. A greater proportion of the d-DPPs group achieved a clinically significant weight loss >= 5% (43% vs 21%, p<0.001), and more participants shifted from prediabetes to normal HbA1c range (58% vs 48%, p=0.04). Engagement in d-DPPs was significantly related to improved HbA1c and weight loss. Conclusions: This d-DPPs demonstrated clinical effectiveness and has significant potential for widespread dissemination and impact, particularly considering the growing demand for telemedicine in preventive healthcare services. (C) 2021 American Journal of Preventive Medicine. Published by Elsevier Inc.
In response to the global pandemic, U.S. POINTER procedures were adapted to include virtual intervention delivery. Here we describe the impact of this adaptation on adherence in a large community-based lifestyle intervention trial. U.S. POINTER is conducted through a partnership between the Alzheimer’s Association (AA) and five clinical sites. A total of 2000 older adults at risk for cognitive decline are assigned to one of two 24-month multi-domain lifestyle interventions. The Self-Guided (SG) group works toward lifestyle goals that best meet their individual needs and schedules. The Structured (STR) group follows a coordinated program with specific goals for physical activity, diet, cognitive/social challenge, and health monitoring. Both groups meet in teams of 12-15 participants throughout the study for support and guidance, which are led by trained staff. SG teams meet six times over 24 months, and STR teams meet weekly for the first 4 months, then 2x/month for 2 months, and then monthly. Although Team Meetings for both intervention groups were planned as in-person events, the global pandemic necessitated a pivot to virtual delivery. From January through December 2021, N = 2103 Team Meetings were conducted in-person and N = 4663 Team Meetings were conducted virtually for 824 participants. For both intervention groups, in-person and virtual Team Meeting attendance was the same, at 90%. When Team Meetings were held in-person, STR participants completed a median of 93 very active Fitbit minutes/week (IQR = 38,185) and reported a median MIND Diet score of 11.0 (IQR = 9.5,12.0). When Team Meetings were virtual, adherence metrics were comparable with median values of 101 very active Fitbit minutes/week (IQR = 43,192) and a MIND Diet score of 11.0 (IQR = 9.8,12.0). Blood pressure monitoring and cognitive training metrics were also comparable without regard to Team Meeting delivery format. Our findings demonstrate that a shift to virtual participant contact during the pandemic did not compromise adherence to a complex multi-domain lifestyle intervention in older adults. These findings have high relevance for other ongoing lifestyle intervention studies within and outside of WW-FINGERS, and highlight the importance of adaptability in clinical trial design and implementation to foster sustainability under challenging life circumstances.
Observational evidence suggests that higher physical activity is associated with slower kidney function decline; however, to our knowledge, no large trial has evaluated whether activity and exercise can ameliorate kidney function decline in older adults.To evaluate whether a moderate-intensity exercise intervention can affect the rate of estimated glomerular filtration rate per cystatin C (eGFRCysC) change in older adults.This ancillary analysis of the Lifestyle Interventions and Independence For Elders randomized clinical trial enrolled 1199 community-dwelling, sedentary adults aged 70 to 89 years with mobility limitations and available blood specimens. The original trial was conducted across 8 academic centers in the US from February 2010 through December 2013. Data for this study were analyzed from March 29, 2021, to February 28, 2022.Structured, 2-year, partially supervised, moderate-intensity physical activity and exercise (strength, flexibility) intervention compared with a health education control intervention with 2-year follow-up. Physical activity was measured by step count and minutes of moderate-intensity activity using accelerometers.The primary outcome was change in eGFRCysC. Rapid eGFRCysC decline was defined by the high tertile threshold of 6.7%/y.Among the 1199 participants in the analysis, the mean (SD) age was 78.9 (5.2) years, and 800 (66.7%) were women. At baseline, the 2 groups were well balanced by age, comorbidity, and baseline eGFRCysC. The physical activity and exercise intervention resulted in statistically significantly lower decline in eGFRCysC over 2 years compared with the health education arm (mean difference, 0.96 mL/min/1.73 m2; 95% CI, 0.02-1.91 mL/min/1.73 m2) and lower odds of rapid eGFRCysC decline (odds ratio, 0.79; 95% CI, 0.65-0.97).Results of this ancillary analysis of a randomized clinical trial showed that when compared with health education, a physical activity and exercise intervention slowed the rate of decline in eGFRCysC among community-dwelling sedentary older adults. Clinicians should consider targeted recommendation of physical activity and moderate-intensity exercise for older adults as a treatment to slow decline in eGFRCysC.ClinicalTrials.gov Identifier: NCT01072500.
U.S. POINTER is testing whether multidomain lifestyle interventions focused on physical exercise, nutrition, cognitive challenge, and risk factor management reduces risk of cognitive decline in a heterogeneous population of at‐risk older adults in America. The study adapts the FINGER (Finnish Intervention Geriatric Study to Prevent Cognitive Impairment and Disability) interventions to fit the United States culture and delivers the intervention within the community at 5 sites across the country.