Successes and lessons learned from a mobile health behavior intervention to reduce pain and improve health in older adults with obesity and chronic pain: a qualitative study.

Introduction: Chronic pain is a prevalent issue among older adults in the United States that impairs quality of life. Physical activity has emerged as a cost-effective and non-pharmacological treatment for chronic pain, offering benefits such as improved physical functioning, weight loss, and enhanced mood. However, promoting physical activity in older individuals with chronic pain is challenging, given the cyclical relationship between pain and sedentary behavior. The Mobile Intervention to Reduce Pain and Improve Health (MORPH) trial was designed as an innovative, mobile health (mHealth) supported intervention to address this issue by targeting daylong movement, weight loss, and mindfulness to manage pain in older adults with chronic multisite pain. The objective of this paper is to provide the result of a qualitative analysis conducted on post-intervention interviews with MORPH participants. Methods: At the conclusion of the MORPH study, 14 participants were interviewed regarding their experience with the program. All interviews were conducted by phone before being transcribed and verified. A codebook of significant takeaways was created based on these accounts. Summaries were further synthesized into themes using the principles of thematic analysis. Results: Three key themes of the MORPH intervention emerged from the qualitative interviews: MORPH technology (smart scales, Fitbit, MORPH Companion App) facilitated program adherence and accountability; MORPH intervention components (food tracking and mindfulness activities) facilitated program adherence and awareness, respectively; and, group meetings provided motivational support and accountability. Mobile health technologies, including a dedicated MORPH app, facilitated self-monitoring strategies, helped to break the cycle of old habits, and provided participants with immediate feedback on successes; however, technical issues required timely support to maintain engagement. Food tracking contributed to adherence and accountability for weight loss. Mindfulness activities increased participants' awareness of anxiety provoking thoughts and pain triggers. Finally, social support via group meetings and connection, played a crucial role in behavior change, but participants noted consistency in the delivery medium was essential to fostering genuine connections. Conclusion: Overall, the study results highlight the key considerations related to program technology, intervention components, and the value of social support that can help to guide the development of future interventions similar to MORPH.

Associations Between Patterns of Daily Stepping Behavior, Health-Related Quality of Life, and Pain Symptoms Among Older Adults with Chronic Pain: A Secondary Analysis of Two Randomized Controlled Trials.

Purpose: One's amount, intensity, and distribution of physical activity may have implications for whether it has positive or negative effects on pain and quality of life for older adults living with chronic pain. Thus, we investigated baseline patterns of stepping related to pain symptoms and health-related quality of life at baseline and over a 12-week follow-up period. Patients and Methods: Participants were low-active older adults (69.54±6.74 years) with obesity and chronic pain who enrolled in one of two randomized controlled trials. Participants completed measures of pain intensity, interference, and health-related quality of life and wore an accelerometer for 7 days at baseline and week 12. Functional principal components analysis identified patterns of within-day stepping behavior at baseline, and linear regressions were used to investigate how these component scores related to pain and health-related quality of life at baseline and over 12 weeks. Results: Two patterns were extracted; one describing more vs less stepping and the second capturing movement later vs earlier in the day. More baseline stepping was associated with better physical functioning (B=0.148, p<0.001) and energy (B=0.073, p=0.033), while a later start in the day was associated with worse social functioning (B=-0.193, p=0.031). More stepping at baseline predicted positive changes in physical functioning (B=0.094, p=0.019), emotional role limitations (B=0.132, p=0.049), energy (B=0.112, p<0.001), social functioning (B=0.086, p=0.043), pain (B=0.086, p=0.009), general health (B=0.081, p=0.003) and pain intensity (B=-0.039, p=0.003). A later start to the day was associated with worsening physical functioning (B=-0.229, p<0.001), physical (B=-0.282, p=0.047) and emotional role limitations (B=-0.254, p=0.048), general health (B=-0.108, p=0.041), and pain interference (B=0.055, p=0.043). Conclusion: Findings suggest there is value in activity patterns as an indicator for additional behavioral intervention, as those who move little and/or delay daily movement are likely to experience subsequent decrements in quality of life and pain symptoms.

Home-Based Walking Exercise and Supervised Treadmill Exercise in Patients With Peripheral Artery Disease: An Individual Participant Data Meta-Analysis.

Importance: Few people with lower extremity peripheral artery disease (PAD) participate in supervised treadmill exercise covered by the Center for Medicare and Medicaid Services. In people with PAD, the benefits of home-based walking exercise, relative to supervised exercise, remain unclear. Objective: To study whether home-based walking exercise improves 6-minute walk (6MW) more than supervised treadmill exercise in people with PAD (defined as Ankle Brachial Index ≤0.90). Data Sources: Data were combined from 5 randomized clinical trials of exercise therapy for PAD using individual participant data meta-analyses, published from 2009 to 2022. Study Selection: Of the 5 clinical trials, 3 clinical trials compared supervised treadmill exercise to nonexercise control (N = 370) and 2 clinical trials compared an effective home-based walking exercise intervention to nonexercise control (N = 349). Data Extraction and Synthesis: Individual participant-level data from 5 randomized clinical trials led by 1 investigative team were combined. The 5 randomized clinical trials included 3 clinical trials of supervised treadmill exercise and 2 effective home-based walking exercise interventions. Main Outcomes and Measures: Change in 6MW distance, maximum treadmill walking distance, and Walking Impairment Questionnaire at 6-month follow-up. The supervised treadmill exercise intervention consisted of treadmill exercise in the presence of an exercise physiologist, conducted 3 days weekly for up to 50 minutes per session. Home-based walking exercise consisted of a behavioral intervention in which a coach helped participants walk for exercise in or around home for up to 5 days per week for 50 minutes per session. Results: A total of 719 participants with PAD (mean [SD] age, 68.8 [9.5] years; 46.5% female) were included (349 in a home-based exercise clinical trial and 370 in a supervised exercise trial). Compared with nonexercise control, supervised treadmill exercise was associated with significantly improved 6MW by 32.9 m (95% CI, 20.6-45.6; P < .001) and home-based walking exercise was associated with significantly improved 6MW by 50.7 m (95% CI, 34.8-66.7; P < .001). Compared with supervised treadmill exercise, home-based walking exercise was associated with significantly greater improvement in 6MW distance (between-group difference: 23.8 m [95% CI, 3.6, 44.0; P = .02]) but significantly less improvement in maximum treadmill walking distance (between-group difference:-132.5 m [95% CI, -192.9 to -72.1; P < .001]). Conclusions and Relevance: In this individual participant data meta-analyses, compared with supervised exercise, home-based walking exercise was associated with greater improvement in 6MW in people with PAD. These findings support home-based walking exercise as a first-line therapy for walking limitations in PAD.

Associations between patterns of physical activity, pain intensity, and interference among older adults with chronic pain: a secondary analysis of two randomized controlled trials.

Background: Clinical management of chronic pain often includes recommendations to engage in physical activity (PA), though there are little data on the interplay between pain symptoms and key aspects of PA participation (e.g., intensity and bout duration) among older adults. Herein we investigate the longitudinal relationships between changes in PA behavior and changes in pain intensity and interference among low-active older adults with obesity and chronic pain. Methods: Participants (N = 41) were enrolled in two randomized pilot trials wherein they were assigned to an intervention focused on participation in frequent PA across the day, or to a low-contact control. Participants completed the 3-item PROMIS pain intensity scale and 8-item PROMIS pain interference scale before and after the interventions. Participants also wore an ActivPAL accelerometer for 7 days before and during the final week of the interventions. Results: A series of linear regression analyses demonstrated that increased time spent stepping at a high-light intensity in very short bouts was associated with increased pain intensity scores. By contrast, increased time spent stepping at a high-light intensity in bouts of 5-20 min was associated with reductions in pain intensity and interference scores. Increased time spent stepping at a moderate intensity overall was associated with reduced pain intensity scores, and time spent stepping at a moderate intensity for 10-20 min associated with reduced pain interference. Conclusion: These findings suggest older adults with chronic pain may benefit by moving at high-light or moderate intensities in brief bouts of at least 5 min in duration.

Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial.

Background Overweight and obesity are associated with adverse functional outcomes in people with peripheral artery disease (PAD). The effects of weight loss in people with overweight/obesity and PAD are unknown. Methods The PROVE (Promote Weight Loss in Obese PAD Patients to Prevent Mobility Loss) Trial is a multicentered randomized clinical trial with the primary aim of testing whether a behavioral intervention designed to help participants with PAD lose weight and walk for exercise improves 6-minute walk distance at 12-month follow-up, compared with walking exercise alone. A total of 212 participants with PAD and body mass index ≥25 kg/m2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coaching. The primary outcome is 12-month change in 6-minute walk distance. Secondary outcomes include total minutes of walking exercise/wk at 12-month follow-up and 12-month change in accelerometer-measured physical activity, the Walking Impairment Questionnaire distance score, and the Patient-Reported Outcomes Measurement Information System mobility questionnaire. Tertiary outcomes include 12-month changes in perceived exertional effort at the end of the 6-minute walk, diet quality, and the Short Physical Performance Battery. Exploratory outcomes include changes in gastrocnemius muscle biopsy measures of mitochondrial cytochrome C oxidase activity, mitochondrial biogenesis, capillary density, and inflammatory markers. Conclusions The PROVE randomized clinical trial will evaluate the effects of exercise with an intervention of coaching and a smartphone application designed to achieve weight loss, compared with exercise alone, on walking performance in people with PAD and overweight/obesity. Results will inform optimal treatment for the growing number of patients with PAD who have overweight/obesity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04228978.

Associations of physical function and body mass index with functional brain networks in community-dwelling older adults.

Deficits in physical function that occur with aging contribute to declines in quality of life and increased mortality. There has been a growing interest in examining associations between physical function and neurobiology. Whereas high levels of white matter disease have been found in individuals with mobility impairments in structural brain studies, much less is known about the relationship between physical function and functional brain networks. Even less is known about the association between modifiable risk factors such as body mass index (BMI) and functional brain networks. The current study examined baseline functional brain networks in 192 individuals from the Brain Networks and mobility (B-NET) study, an ongoing longitudinal, observational study in community-dwelling adults aged 70 and older. Physical function and BMI were found to be associated with sensorimotor and dorsal attention network connectivity. There was a synergistic interaction such that high physical function and low BMI were associated with the highest network integrity. White matter disease did not modify these relationships. Future work is needed to understand the causal direction of these relationships.

Differential Momentary Reports of Stress and Affect Associated With Alcohol Consumption in Middle-Aged Versus Younger Adults.

Background: Stress is a motivator to consume alcohol, a well-documented relapse risk, and is known to differentially affect biological and psychological processes as people age.Objectives: Because alcohol consumption is known to acutely decrease stress and increase affect, this study examined differences in ratings of stress and affect in middle-aged versus younger adults who regularly consume alcohol.Methods: A sample of younger (n = 17) and middle-aged (n = 18) drinkers was studied during a 3-day period of typical alcohol consumption. Resting levels of respiratory sinus arrhythmia (RSA) were measured during a baseline study visit since RSA is a well-documented biomarker of stress and is known to decrease with age. Ecological momentary assessment (EMA) survey ratings (n = 1,598) were modeled using hierarchical regression to assess differences in stress and affect throughout the day between the two age groups.Results: As anticipated, middle-aged participants had lower RSA than those who were younger. Although the middle-aged adults showed overall lower stress, generally they also experienced higher affect than the younger adults. Middle-aged adults experienced a significant reduction in stress following drinking while no such effect was observed in the younger adults.Conclusions: To our knowledge, this is the first investigation using EMA methodology to examine stress and affect between younger and middle-aged adults who habitually consume alcohol. These cross-sectional data suggest potential momentary stress relief to engaging with moderate alcohol consumption in a middle-aged population. Future work must address this important motivational process in curtailing maintenance of alcohol consumption and preventing escalation of consumption.

Effect of exercise modality and weight loss on changes in muscle and bone quality in older adults with obesity.

BACKGROUND: Little is known about the effect of exercise modality during a dietary weight loss program on muscle size and quality, as measured by computed tomography (CT). Even less is known about how CT-derived changes in muscle track with changes in volumetric bone mineral density (vBMD) and bone strength. METHODS: Older adults (66 ± 5 years, 64 % women) were randomized to 18-months of diet-induced weight loss (WL), WL with aerobic training (WL + AT), or WL with resistance training (WL + RT). CT-derived muscle area, radio-attenuation and intermuscular fat percentage at the trunk and mid-thigh were determined at baseline (n = 55) and 18-month follow-up (n = 22-34), and changes were adjusted for sex, baseline value, and weight lost. Lumbar spine and hip vBMD and finite element-derived bone strength were also measured. RESULTS: After adjustment for the weight lost, muscle area losses at the trunk were -7.82 cm2 [-12.30, -3.35] for WL, -7.72 cm2 [-11.36, -4.07] for WL + AT, and -5.14 cm2 [-8.65, -1.63] for WL + RT (p < 0.001 for group differences). At the mid-thigh, decreases were -6.20 cm2 [-10.39, -2.02] for WL, -7.84 cm2 [-11.19, -4.48] for WL + AT, and -0.60 cm2 [-4.14, 2.94] for WL + RT; this difference between WL + AT and WL + RT was significant in post-hoc testing (p = 0.01). Change in trunk muscle radio-attenuation was positively associated with change in lumbar bone strength (r = 0.41, p = 0.04). CONCLUSIONS: WL + RT better preserved muscle area and improved muscle quality more consistently than WL + AT or WL alone. More research is needed to characterize the associations between muscle and bone quality in older adults undertaking weight loss interventions.

The impact of Dietary Weight loss, Aerobic Exercise, and Daylong Movement on Social Cognitive Mediators of Long-term Weight loss.

This report contrasts the impact of a dietary weight loss intervention (WL) paired with aerobic exercise (EX) and/or sitting less and moving throughout the day (SL) on self-efficacy for walking (hereafter walking self-efficacy) and satisfaction with physical functioning (hereafter satisfaction). Additional analyses examined dose-response associations between change in weight and changes in these key outcomes. Older adults (N = 112; age = 70.21[Formula: see text]4.43) were randomized to 6 months of WL+EX, WL+SL, or WL+EX+SL followed by a 12-month maintenance period. All groups reported increases in walking self-efficacy at month 6 with greater improvements in WL+EX and WL + EX+SL. Only WL+SL demonstrated improved walking self-efficacy at month 18. All conditions demonstrated improved satisfaction scores at both time points. Changes in walking self-efficacy and satisfaction were negatively associated with change in weight over the 6-month intervention and after the maintenance period. These results support the utility of WL + SL for improving key social cognitive outcomes in aging.

A remote group-mediated daylong physical activity intervention for older adults with chronic pain: Results of the MORPH-II randomized pilot trial.

Chronic pain is a debilitating condition that affects many older adults who often have limited access to non-pharmacological pain management strategies. One potentially effective and novel lifestyle medicine for chronic pain involves increasing physical activity through frequent movement across the day, thereby also decreasing the presence of extended sedentary bouts. The MORPH-II pilot randomized controlled refinement trial iterated on the MORPH trial, which was a first-of-its-kind group-mediated daylong physical activity (DPA) intervention for older adults with chronic pain rooted in social cognitive and self-determination theories and supported by an mHealth toolset designed to foster social connection and awareness of physical activity patterns. MORPH-II was delivered fully remotely via videoconference software and supported by a technology kit comprising an iPad, activity monitor, and wireless weight scale. It was also implemented a refined coaching model designed to help participants better understand their own patterns of activity. A total of 44 participants were randomized to receive the 12-week group-mediated DPA intervention or to a low-contact control. Qualitative interviews suggest the program was well-received by participants and that participants developed an understanding of how patterns of physical activity related to their pain symptoms. Participants also highlighted several additional areas for refinement related to the coaching model and feedback provided within the mHealth app. Analyses of covariance, controlling for baseline values, revealed a small effect (η 2 = 0.01) on pain intensity favoring the intervention condition, though both groups improved during the study period. There was a large effect favoring the intervention condition on ActivPAL-assessed average daily steps (η 2 = 0.23) and postural shifts (η 2 = 0.24). Control participants spent less time in short sedentary bouts (η 2 = 0.09), and there was a small effect (η 2 = 0.02) indicating intervention participants spent less time in extended sedentary bouts. Finally, relative to control, intervention participants demonstrated a moderate improvement in autonomy satisfaction (η 2 = 0.05), relatedness frustration (η 2 = 0.05), and competence frustration (η 2 = 0.06), and a large magnitude improvement in competence satisfaction (η 2 = 0.22). These findings indicate that the MORPH-II intervention was feasible and acceptable, and may positively impact steps, postural breaks, and several key domains of basic psychological needs detailed in self-determination theory.

Effects of Walking Exercise at a Pace With Versus Without Ischemic Leg Symptoms on Functional Performance Measures in People With Lower Extremity Peripheral Artery Disease: The LITE Randomized Clinical Trial.

Background In people with peripheral artery disease, post hoc analyses of the LITE (Low Intensity Exercise Intervention in Peripheral Artery Disease) randomized trial were conducted to evaluate the effects of walking exercise at a pace inducing ischemic leg symptoms on walking velocity and the Short Physical Performance Battery, compared with walking exercise without ischemic leg symptoms and compared with a nonexercising control group. Methods and Results Participants with peripheral artery disease were randomized to: home-based walking exercise that induced ischemic leg symptoms; home-based walking exercise conducted without ischemic leg symptoms; or a nonexercising control group for 12 months. Outcomes were change of walking velocity over 4 m and change of the Short Physical Performance Battery (0-12, with 12=best) at 6- and 12-month follow-up. A total of 264 participants (48% women, 61% Black race) were included. Compared with walking exercise without ischemic symptoms, walking exercise that induced ischemic symptoms improved change in usual-paced walking velocity over 4 m at 6-month (0.056 m/s [95% CI, 0.019-0.094 m/s]; P<0.01) and 12-month follow-up (0.084 m/s [95% CI, 0.049-0.120 m/s]; P<0.01), change in fast-paced of walking velocity over 4 m at 6-month follow-up (P=0.03), and change in the Short Physical Performance Battery at 12-month follow-up (0.821 [95% CI, 0.309-1.334]; P<0.01). Compared with control, walking exercise at a pace inducing ischemic symptoms improved change in usual-paced walking velocity over 4 m at 6-month follow-up (0.066 m/s [95% CI, 0.021-0.111 m/s]; P<0.01). Conclusions In people with peripheral artery disease, those who walked for exercise at a comfortable pace without ischemic leg symptoms slowed their walking speed during daily life and worsened the Short Physical Performance Battery score, a potentially harmful effect, compared with people who walked for exercise at a pace inducing ischemic leg symptoms. Compared with a control group who did not exercise, home-based walking exercise at a pace inducing ischemic leg symptoms significantly improved change of walking velocity over 4 m at 6-month follow-up, but this benefit did not persist at 12-month follow-up. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02538900.

Delivery fidelity of the REACT (REtirement in ACTion) physical activity and behaviour maintenance intervention for community dwelling older people with mobility limitations.

BACKGROUND: Fidelity assessment of behaviour change interventions is vital to understanding trial outcomes. This study assesses the delivery fidelity of behaviour change techniques used in the Retirement in ACTion (REACT) randomised controlled trial. REACT is a community-based physical activity (PA) and behaviour maintenance intervention to prevent decline of physical functioning in older adults (≥ 65 years) at high risk of mobility-related disability in the UK. METHODS: The delivery fidelity of intervention behaviour change techniques and delivery processes were assessed using multi-observer coding of purposively sampled in-vivo audio recordings (n = 25) of health behaviour maintenance sessions over 12-months. Delivery fidelity was scored using a modified Dreyfus scale (scores 0-5) to assess competence and completeness of delivery for each technique and delivery process. "Competent delivery" was defined as a score of 3 points or more for each item. Examples of competent intervention delivery were identified to inform recommendations for future programme delivery and training. RESULTS: The mean intervention fidelity score was 2.5 (SD 0.45) with delivery fidelity varying between techniques/processes and intervention groups. Person-centred delivery, Facilitating Enjoyment and Promoting Autonomy were delivered competently (scoring 3.0 or more). There was scope for improvement (score 2.0-2.9) in Monitoring Progress (Acknowledging and Reviewing), Self-Monitoring, Monitoring Progress (Eliciting Benefits of Physical Activity), Goal Setting and Action Planning, Modelling, Supporting Self-Efficacy for Physical Activity and Supporting Relatedness. Managing Setbacks and Problem Solving was delivered with low fidelity. Numerous examples of both good and sub-optimal practice were identified. CONCLUSIONS: This study highlights successes and improvements needed to enhance delivery fidelity in future implementation of the behavioural maintenance programme of the REACT intervention. Future training of REACT session leaders and assessment of delivery fidelity needs to focus on the delivery of Goal setting and Action Planning, Modelling, Supporting Relatedness, Supporting Self-Efficacy for Physical Activity, and Managing Setbacks/ Problem Solving.

Gradient and Acceleration of Decline in Physical and Cognitive Functions in Older Adults: A Disparity Analysis.

BACKGROUND: Substantive previous work has shown that both gait speed and global cognition decline as people age. Rates of their decline, as opposed to cross-sectional measurements, could be more informative of future functional status and other clinical outcomes because they more accurately represent deteriorating systems. Additionally, understanding the sex and racial disparity in the speed of deterioration, if any, is also important as ethnic minorities are at an increased risk of mobility disability and dementia. METHOD: Data from 2 large longitudinal intervention studies were integrated. Rates of decline were derived from individual-level measures of gait speed of 400-m walk and scores on the Modified Mini Mental State Examination (3MSE). We also assessed age-associated declines and accelerations in changes across the ages represented in the studies (age range 53-90). RESULTS: The mean rate of decline in 400-m gait speed across individuals was 0.03 m/s per year, and multivariable analysis showed a significant acceleration in decline of -0.0013 m/s/y2 (p < .001). Both race and sex moderated the rate of decline. For global cognition, the mean rate of decline was 0.05 of a point per year on the 3MSE scale, and acceleration in the rate of decline was significant (-0.017 point/y2, p < .001), but neither sex nor race moderated the decline. CONCLUSION: Rate of decline in physical but not cognitive function appears moderated by sex and race. This finding, as well as rates and accelerations of decline estimated herein, could inform future intervention studies. CLINICAL TRIALS REGISTRATION NUMBER: NCT00017953 (Look AHEAD); NCT01410097 (Look AHEAD ancillary); NCT00116194 (LIFE).

Estimating heterogeneity of physical function treatment response to caloric restriction among older adults with obesity.

Clinical trials conventionally test aggregate mean differences and assume homogeneous variances across treatment groups. However, significant response heterogeneity may exist. The purpose of this study was to model treatment response variability using gait speed change among older adults participating in caloric restriction (CR) trials. Eight randomized controlled trials (RCTs) with five- or six-month assessments were pooled, including 749 participants randomized to CR and 594 participants randomized to non-CR (NoCR). Statistical models compared means and variances by CR assignment and exercise assignment or select subgroups, testing for treatment differences and interactions for mean changes and standard deviations. Continuous equivalents of dichotomized variables were also fit. Models used a Bayesian framework, and posterior estimates were presented as means and 95% Bayesian credible intervals (BCI). At baseline, participants were 67.7 (SD = 5.4) years, 69.8% female, and 79.2% white, with a BMI of 33.9 (4.4) kg/m2. CR participants reduced body mass [CR: -7.7 (5.8) kg vs. NoCR: -0.9 (3.5) kg] and increased gait speed [CR: +0.10 (0.16) m/s vs. NoCR: +0.07 (0.15) m/s] more than NoCR participants. There were no treatment differences in gait speed change standard deviations [CR-NoCR: -0.002 m/s (95% BCI: -0.013, 0.009)]. Significant mean interactions between CR and exercise assignment [0.037 m/s (95% BCI: 0.004, 0.070)], BMI [0.034 m/s (95% BCI: 0.003, 0.066)], and IL-6 [0.041 m/s (95% BCI: 0.009, 0.073)] were observed, while variance interactions were observed between CR and exercise assignment [-0.458 m/s (95% BCI: -0.783, -0.138)], age [-0.557 m/s (95% BCI: -0.900, -0.221)], and gait speed [-0.530 m/s (95% BCI: -1.018, -0.062)] subgroups. Caloric restriction plus exercise yielded the greatest gait speed benefit among older adults with obesity. High BMI and IL-6 subgroups also improved gait speed in response to CR. Results provide a novel statistical framework for identifying treatment heterogeneity in RCTs.

Longitudinal relationship of baseline functional brain networks with intentional weight loss in older adults.

OBJECTIVE: The goal of this study was to determine whether the degree of weight loss after 6 months of a behavior-based intervention is related to baseline connectivity within two functional networks (FNs) of interest, FN1 and FN2, in a group of older adults with obesity. METHODS: Baseline functional magnetic resonance imaging data were collected following an overnight fast in 71 older adults with obesity involved in a weight-loss intervention. Functional brain networks in a resting state and during a food-cue task were analyzed using a mixed-regression framework to examine the relationships between baseline networks and 6-month change in weight. RESULTS: During the resting condition, the relationship of baseline brain functional connectivity and network clustering in FN1, which includes the visual cortex and sensorimotor areas, was significantly associated with 6-month weight loss. During the food-cue condition, 6-month weight loss was significantly associated with the relationship between baseline brain connectivity and network global efficiency in FN2, which includes executive control, attention, and limbic regions. CONCLUSION: These findings provide further insight into complex functional circuits in the brain related to successful weight loss and may ultimately aid in developing tailored behavior-based treatment regimens that target specific brain circuitry.

Cost-effectiveness of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: an economic evaluation of the REACT (Retirement in Action) trial.

BACKGROUND: Mobility limitations in older populations have a substantial impact on health outcomes, quality of life, and social care costs. The Retirement in Action (REACT) randomised controlled trial assessed a 12-month community-based group physical activity and behaviour maintenance intervention to help prevent decline in physical functioning in older adults at increased risk of mobility limitation. We aimed to do an economic evaluation of the REACT trial to investigate whether the intervention is cost-effective. METHODS: In this health economic evaluation, we did cost-effectiveness and cost-utility analyses of the REACT programme versus standard care on the basis of resource use, primary outcome, and health-related quality-of-life data measured in the REACT trial. We also developed a decision analytic Markov model that forecasts the mobility of recipients beyond the 24-month follow-up of the trial and translated this into future costs and potential benefit to health-related quality of life using the National Health Service and Personal Social Services perspective. Participants completed questionnaire booklets at baseline, and at 6, 12, and 24 months after randomisation, which included a resource use questionnaire and the EQ-5D-5L and 36-item short-form survey (SF-36) health-related quality-of-life instruments. The cost of delivering the intervention was estimated by identifying key resources, such as REACT session leader time, time of an individual to coordinate the programme, and venue hire. EQ-5D-5L and SF-36 responses were converted to preference-based utility values, which were used to estimate quality-adjusted life-years (QALYs) over the 24-month trial follow-up using the area-under-the-curve method. We used generalised linear models to examine the effect of the REACT programme on costs and QALYs and adjust for baseline covariates. Costs and QALYs beyond 12 months were discounted at 3·5% per year. This is a pre-planned analysis of the REACT trial; the trial itself is registered with ISRCTN (ISRCTN45627165). FINDINGS: The 12-month REACT programme was estimated to cost £622 per recipient to deliver. The most substantial cost components are the REACT session leader time (£309 per participant), venue hire (£109), and the REACT coordinator time (£80). The base-case analysis of the trial-based economic evaluation showed that reductions in health and social care usage due to the REACT programme could offset the REACT delivery costs (£3943 in the intervention group vs £4043 in the control group; difference: -£103 [95% CI -£695 to £489]) with a health benefit of 0·04 QALYs (0·009-0·071; 1·354 QALYs in the intervention group vs 1·314 QALYs in the control group) within the 24-month timeframe of the trial. INTERPRETATION: The REACT programme could be considered a cost-effective approach for improving the health-related quality of life of older adults at risk of mobility limitations. FUNDING: National Institute for Health Research Public Health Research Programme.

Effect of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: the REACT (Retirement in Action) randomised controlled trial.

BACKGROUND: Mobility limitations in old age can greatly reduce quality of life, generate substantial health and social care costs, and increase mortality. Through the Retirement in Action (REACT) trial, we aimed to establish whether a community-based active ageing intervention could prevent decline in lower limb physical functioning in older adults already at increased risk of mobility limitation. METHODS: In this pragmatic, multicentre, two-arm, single-blind, parallel-group, randomised, controlled trial, we recruited older adults (aged 65 years or older and who are not in full-time employment) with reduced lower limb physical functioning (Short Physical Performance Battery [SPPB] score 4-9) from 35 primary care practices across three sites (Bristol and Bath; Birmingham; and Devon) in England. Participants were randomly assigned to receive brief advice (three healthy ageing education sessions) or a 12-month, group-based, multimodal physical activity (64 1-h exercise sessions) and behavioural maintenance (21 45-min sessions) programme delivered by charity and community or leisure centre staff in local communities. Randomisation was stratified by site and adopted a minimisation approach to balance groups by age, sex, and SPPB score, using a centralised, online, randomisation algorithm. Researchers involved in data collection and analysis were masked but participants were not because of the nature of the intervention. The primary outcome was change in SPPB score at 24 months, analysed by intention to treat. This trial is registered with ISRCTN, ISRCTN45627165. FINDINGS: Between June 20, 2016, and Oct 30, 2017, 777 participants (mean age 77·6 [SD 6·8] years; 66% female; mean SPPB score 7·37 [1·56]) were randomly assigned to the intervention (n=410) and control (n=367) groups. Primary outcome data at 24 months were provided by 628 (81%) participants (294 in the control group and 334 in the intervention group). At the 24-month follow-up, the SPPB score (adjusted for baseline SPPB score, age, sex, study site, and exercise group) was significantly greater in the intervention group (mean 8·08 [SD 2·87]) than in the control group (mean 7·59 [2·61]), with an adjusted mean difference of 0·49 (95% CI 0·06-0·92; p=0·014), which is just below our predefined clinically meaningful difference of 0·50. One adverse event was related to the intervention; the most common unrelated adverse events were heart conditions, strokes, and falls. INTERPRETATION: For older adults at risk of mobility limitations, the REACT intervention showed that a 12-month physical activity and behavioural maintenance programme could help prevent decline in physical function over a 24-month period. FUNDING: National Institute for Health Research Public Health Research Programme (13/164/51).

The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA) trial: Design and methods.

Being overweight or obese is a primary modifiable risk factor that exacerbates disease progression and mobility disability in older knee osteoarthritis (OA) patients. Lifestyle interventions combining exercise with dietary weight loss (EX+DWL) yield meaningful improvements in mobility and weight loss that are superior to EX or DWL alone. Unfortunately, community access to practical, sustainable weight management interventions remains limited and places knee OA patients at increased risk of mobility disability. The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis patients (CLIP-OA), was a two-arm, 18 month randomized-controlled, comparative effectiveness trial designed to contrast the effects of an evidence-based, theory-driven EX+DWL intervention, personalized to patient needs and delivered by our community partners, with those of the Arthritis Foundation's Walk With Ease (WWE) standard of care self-management program in the treatment of knee OA patients with overweight or obesity. The primary outcome of the CLIP-OA trial was mobility performance assessed using the 400-m walk test (400MWT). Secondary outcomes included weight loss, pain, select quality of life and social cognitive variables, and cost-effectiveness of intervention delivery. Findings from the CLIP-OA trial will determine the comparative and cost-effectiveness of the EX+DWL and WWE interventions on key clinical outcomes and has the potential to offer a sustainable medium for intervention delivery that can promote widely accessible weight management among knee OA patients with overweight or obesity. Trial Registration: NCT02835326.