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.

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.

Predictors of Clinically Meaningful Gait Speed Response to Caloric Restriction Among Older Adults Participating in Weight Loss Interventions.

BACKGROUND: The purpose of this study was to examine whether select baseline characteristics influenced the likelihood of an overweight/obese, older adult experiencing a clinically meaningful gait speed response (±0.05 m/s) to caloric restriction (CR). METHODS: Individual level data from 1 188 older adults participating in 8, 5/6-month, weight loss interventions were pooled, with treatment arms collapsed into CR (n = 667) or no CR (NoCR; n = 521) categories. Exercise assignment was equally distributed across groups (CR: 65.3% vs NoCR: 65.4%) and did not interact with CR (p = .88). Poisson risk ratios (95% confidence interval [CI]) were used to examine whether CR assignment interacted with select baseline characteristic subgroups: age (≥65 years), sex (female/male), race (Black/White), body mass index (BMI; ≥35 kg/m2), comorbidity (diabetes, hypertension, cardiovascular disease) status (yes/no), gait speed (<1.0 m/s), or inflammatory burden (C-reactive protein ≥3 mg/L, interleukin-6 ≥2.5 pg/mL) to influence achievement of ±0.05 m/s fast-paced gait speed change. Main effects were also examined. RESULTS: The study sample (69.5% female, 80.1% White) was 67.6 ± 5.3 years old with a BMI of 33.8 ± 4.4 kg/m2. Average weight loss achieved in the CR versus NoCR group was -8.3 ± 5.9% versus -1.1 ± 3.8%; p < .01. No main effect of CR was observed on the likelihood of achieving a clinically meaningful gait speed improvement (risk ratio [RR]: 1.09 [95% CI: 0.93, 1.27]) or gait speed decrement (RR: 0.77 [95% CI: 0.57, 1.04]). Interaction effects were nonsignificant across all subgroups. CONCLUSION: The proportion of individuals experiencing a clinically meaningful gait speed change was similar for CR and NoCR conditions. This finding is consistent across several baseline subgroupings.

Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial.

Importance: Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. Objective: To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control. Design, Setting, and Participants: Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020. Interventions: Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months. Main Outcomes and Measures: The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m). Results: Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, -6.4 m [95% CI, -21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P < .001) and the mean change for the between-group comparison was -40.9 m (97.5% CI, -61.7 to -20.0 m; P < .001). The 6-minute walk distance changed from 328.1 m at baseline to 317.5 m at 12-month follow-up in the nonexercise control group (within-group mean change, -15.1 m [95% CI, -35.8 to 5.7 m]; P = .10), which was not significantly different from the change in the low-intensity exercise group (between-group mean change, 8.7 m [97.5% CI, -17.0 to 34.4 m]; P = .44). Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group. One serious adverse event in each exercise group was related to study participation. Conclusions and Relevance: Among patients with PAD, low-intensity home-based exercise was significantly less effective than high-intensity home-based exercise and was not significantly different from the nonexercise control for improving 6-minute walk distance. These results do not support the use of low-intensity home-based walking exercise for improving objectively measured walking performance in patients with PAD. Trial Registration: ClinicalTrials.gov Identifier: NCT02538900.

Elevated IL-6 and CRP Levels Are Associated With Incident Self-Reported Major Mobility Disability: A Pooled Analysis of Older Adults With Slow Gait Speed.

BACKGROUND: Elevated interleukine-6 (IL-6) and C-reactive protein (CRP) are associated with aging-related reductions in physical function, but little is known about their independent and combined relationships with major mobility disability (MMD), defined as the self-reported inability to walk a quarter mile. METHODS: We estimated the absolute and relative effect of elevated baseline IL-6, CRP, and their combination on self-reported MMD risk among older adults (≥68 years; 59% female) with slow gait speed (<1.0 m/s). Participants were MMD-free at baseline. IL-6 and CRP were assessed using a central laboratory. The study combined a cohort of community-dwelling high-functioning older adults (Health ABC) with 2 trials of low-functioning adults at risk of MMD (LIFE-P, LIFE). Analyses utilized Poisson regression for absolute MMD incidence and proportional hazards models for relative risk. RESULTS: We found higher MMD risk per unit increase in log IL-6 (hazard ratio [HR] = 1.26; 95% confidence interval [95% CI] 1.13-1.41). IL-6 meeting predetermined threshold considered to be high (>2.5 pg/mL) was similarly associated with higher risk of MMD (HR = 1.31; 95% CI 1.12-1.54). Elevated CRP (CRP >3.0 mg/L) was also associated with increased MMD risk (HR = 1.38; 95% CI 1.10-1.74). The CRP effect was more pronounced among participants with elevated IL-6 (HR = 1.62; 95% CI 1.12-2.33) compared to lower IL-6 levels (HR = 1.19; 95% CI 0.85-1.66). CONCLUSIONS: High baseline IL-6 and CRP were associated with an increased risk of MMD among older adults with slow gait speed. A combined biomarker model suggests CRP was associated with MMD when IL-6 was elevated.

Trajectories in muscular strength and physical function among men with and without prostate cancer in the health aging and body composition study.

OBJECTIVES: To examine and compare changes in strength and physical function from pre- to post-diagnosis among men with prostate cancer (PC, [cases]) and matched non-cancer controls identified from the Health, Aging and Body Composition (Health ABC) study. MATERIALS AND METHODS: We conducted a longitudinal analysis of 2 strength and 3 physical function-based measures among both cases and controls, identified from a large cohort of community living older adults enrolled in the Health ABC study. We plotted trajectories for each measure and compared cases vs. controls from the point of diagnosis onwards using mixed-effects regression models. For cases only, we examined predictors of poor strength or physical function. RESULTS: We identified 117 PC cases and 453 matched non-cancer controls (50% African Americans). At baseline, there were no differences between cases and controls in demographic factors, comorbidities or self-reported physical function; however, cases had slightly better grip strength (44.6 kg vs. 41.0 kg, p<0.01), quadriceps strength (360.5 Nm vs. 338.7 Nm, p = 0.02) and Health ABC physical performance battery scores (2.4 vs. 2.3, p = 0.01). All men experienced similar declines in strength and physical function over an equivalent amount of time. The loss of quad strength was most notable, with losses of nearly two-thirds of baseline strength over approximately 7 years of follow up. CONCLUSIONS: Among both cases and controls, strength and physical function decline with increasing age. The largest declines were seen in lower body strength. Regular assessments should guide lifestyle interventions that can offset age- and treatment-related declines among men with PC.

Self-reported mobility as a preoperative risk assessment tool in older surgical patients compared to the American College of Surgeons National Surgical Quality Improvement Program.

BACKGROUND: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP®) developed a surgical risk calculator using data from 1.4 million patients and including 1557 unique Current Procedural Terminology (CPT) codes. Although this calculator demonstrated excellent performance in predicting postoperative mortality, morbidity, and six surgical complications, it was not developed specifically for use in older surgical patients who have worse surgical outcomes and additional unique risk factors compared to younger adults. We aimed to test the ability of a simple self-reported mobility tool to predict postoperative outcomes in the older surgical population compared to the NSQIP. METHODS: We used data from a prospective cohort study that enrolled 197 older surgical patients (≥ 69 years) undergoing various elective surgeries and assessed 30-day surgical outcomes. Statistical models included data from the Mobility Assessment Tool-short form (MAT-sf) alone, covariates alone, and MAT-sf data and covariates. We used leave-one-out (LOO) cross-validation of the models within our cohort and compared their performance for predicting postoperative outcomes against the NSQIP calculator based on receiver operating characteristic area under the curve (ROC AUC). RESULTS: Patients with poor self-reported mobility experienced higher rates of postoperative complications and nursing home placement. There was no difference in performance between any of our models and the NSQIP calculator (p > 0.1), with AUC between 0.604 and 0.697 for predicting postoperative complications and 0.653 and 0.760 for predicting nursing home placement. All models also predicted a length of stay (LOS) similar to the actual LOS. CONCLUSION: Mobility assessment alone using MAT-sf can predict postoperative complications, nursing home placement, and LOS for older surgical patients, with accuracy comparable to that of the NSQIP calculator. The simplicity of this noninvasive risk assessment tool makes it an attractive alternative to the NSQIP calculator that requires 20 patient predictors and the planned procedure, or CPT code to predict the chance that patients will have 15 different adverse outcomes following surgery.

Mindfulness-Based Movement: A Polyvagal Perspective.

Compelling evidence suggests that physical activity is an effective intervention for cancer survivors, including for those undergoing active cancer treatments. However, to date most evidence has emerged from interventions that have promoted moderate to vigorous physical activity. In this conceptual review, we argue that attention should be given to the entire continuum of physical activity from reducing sedentary behavior to increasing higher levels of physical activity when possible. In addition, considerable evidence in the cancer literature supports the value of mindfulness-based interventions as a means of helping patients and survivors cope with the variety of threats that accompany this disease. Based on the success of these two areas of research, we argue for conceptualizing and promoting physical activity as Mindfulness-Based Movement, using Polyvagal Theory as a theoretical framework to understand the role and value of Mindfulness-Based Movement as a potential intervention for cancer care and control.

Change in health-related quality of life and social cognitive outcomes in obese, older adults in a randomized controlled weight loss trial: Does physical activity behavior matter?

This article compared the effect of dietary weight loss administered alone (WL) or in combination with aerobic training (WL + AT) or resistance training (WL + RT) on health related quality of life, walking self-efficacy, stair climb self-efficacy, and satisfaction with physical function in older adults with cardiovascular disease or the metabolic syndrome. Participants (N = 249; M age = 66.9) engaged in baseline assessments and were randomly assigned to one of three interventions, each including a 6-month intensive phase and a 12-month follow-up. Those in WL + AT and WL + RT engaged in 4 days of exercise training weekly. All participants engaged in weekly group behavioral weight loss sessions with a goal of 7-10% reduction in body weight. Participants in WL + AT and WL + RT reported better quality of life and satisfaction with physical function at 6- and 18-months relative to WL. At month 6, WL + AT reported greater walking self-efficacy relative to WL + RT and WL, and maintained higher scores compared to WL at month 18. WL + AT and WL + RT reported greater stair climbing efficacy at month 6, and WL + RT remained significantly greater than WL at month 18. The addition of either AT or RT to WL differentially improved HRQOL and key psychosocial outcomes associated with maintenance of physical activity and weight loss. This underscores the important role of exercise in WL for older adults, and suggests health care providers should give careful consideration to exercise mode when designing interventions.

Physical Function Following a Long-Term Lifestyle Intervention Among Middle Aged and Older Adults With Type 2 Diabetes: The Look AHEAD Study.

Background: Lifestyle interventions have been shown to improve physical function over the short term; however, whether these benefits are sustainable is unknown. The long-term effects of an intensive lifestyle intervention (ILI) on physical function were assessed using a randomized post-test design in the Look AHEAD trial. Methods: Overweight and obese (body mass index ≥ 25 kg/m2) middle-aged and older adults (aged 45-76 years at enrollment) with type 2 diabetes enrolled in Look AHEAD, a trial evaluating an ILI designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including a 4- and 400-m walk, lower extremity physical performance (expanded Short Physical Performance Battery, SPPBexp), and grip strength approximately 11 years postrandomization and 1.5 years after the intervention was stopped (n = 3,783). Results: Individuals randomized to ILI had lower odds of slow gait speed (<0.8 m/s) compared to those randomized to DSE (adjusted OR [95% CI]: 0.84 [0.71 to 0.99]). Individuals randomized to ILI also had faster gait speed over 4- and 400-m (adjusted mean difference [95% CI]: 0.019 [0.007 to 0.031] m/s, p = .002, and 0.023 [0.012 to 0.034] m/sec, p < .0001, respectively) and higher SPPBexp scores (0.037 [0.011 to 0.063], p = .005) compared to those randomized to DSE. The intervention effect was slightly larger for SPPBexp scores among older versus younger participants (0.081 [0.038 to 0.124] vs 0.013 [-0.021 to 0.047], p = .01). Conclusions: An intensive lifestyle intervention has modest but significant long-term benefits on physical function in overweight and obese middle-aged and older adults with type 2 diabetes. ClinicalTrials.gov Identifier: NCT00017953.

Self-reported Mobility in Older Patients Predicts Early Postoperative Outcomes after Elective Noncardiac Surgery.

BACKGROUND: Specific geriatric assessment tools may complement traditional perioperative risk stratification. The aim of this study was to evaluate whether self-reported mobility is predictive of postoperative outcomes in older patients undergoing elective noncardiac surgery. METHODS: Patients aged 69 yr or older (n = 197) underwent (1) traditional risk assessments (American Society of Anesthesiologists physical status classification and Revised Cardiac Risk Index), (2) five-point frailty evaluation, (3) self-reported mobility assessment using the Mobility Assessment Tool-short form (range, 30.21 [poor] to 69.76 [excellent]), and (4) measurements of high-sensitivity C-reactive protein. Outcomes were postoperative complications, time to discharge, and nursing home placement (NHP). RESULTS: In the sample of this study (mean age, 75 ± 5 yr; 51% women), 72% had intermediate- or high-risk surgery. Median time to discharge was 3 days (interquartile range, 1 to 4 days). Thirty patients (15%) developed postoperative complications, and 27 (13%) required NHP. After controlling for age, sex, body mass index, pain score, Revised Cardiac Risk Index, American Society of Anesthesiologist physical status, surgical risk, and high-sensitivity C-reactive protein, worse self-reported mobility (per 10-point decrease in Mobility Assessment Tool, which is equivalent to 1 SD) was associated with more postoperative complications (odds ratio [OR], 1.69; 95% CI, 1.05 to 2.73), later time to discharge (hazards ratio, 0.81; 95% CI, 0.68 to 0.96), and increased NHP (OR, 2.01; 95% CI, 1.13 to 3.56). By using the same model, intermediate frailty or frailty increased NHP (OR, 3.11; 95% CI, 1.02 to 9.54) but was not related to either postoperative complications or time to discharge. CONCLUSIONS: Preoperative self-reported mobility using a novel and brief assessment may help identify elderly patients at risk for adverse postoperative events.

Effect of an 18-month physical activity and weight loss intervention on body composition in overweight and obese older adults.

OBJECTIVE: Our primary objective was to determine the long-term effects of physical activity (PA) and weight loss (WL) on body composition in overweight/obese older adults. Secondarily, the association between change in body mass and composition on change in several cardiometabolic risk factors and mobility was evaluated. DESIGN AND METHODS: 288 older (X ± SD: 67.0 ± 4.8 years), overweight/obese (BMI 32.8 ± 3.8 kg/m² ) men and women participated in this 18-month randomized, controlled trial. Treatment groups included PA + WL (n = 98), PA-only (n = 97), and a successful aging (SA) health education control (n = 93). DXA-acquired body composition measures (total body fat and lean mass), conventional biomarkers of cardiometabolic risk, and 400-m walk time were obtained at baseline and 18 months. RESULTS: Fat mass was significantly reduced from (X ± SE) 36.5 ± 8.9 kg to 31.7 ± 9.0 kg in the PA + WL group (p < 0.01), but remained unchanged from baseline in the PA-only (-0.8 ± 3.8 kg) and SA (-0.0 ± 3.9 kg) group. Lean mass losses were three times greater in the PA + WL groups compared to PA-only or SA groups (-2.5 ± 2.8 kg vs. -0.7 ± 2.2 kg or -0.8 ± 2.4 kg, respectively; p < 0.01); yet due to a larger decrease in fat mass, percent lean mass was significantly increased over baseline in the PA + WL groups (2.1% ± 2.6%; p < 0.01). Fat mass loss was primarily responsible for WL-associated improvements in cardiometabolic risk factors, while reduction in body weight, regardless of compartment, was significantly associated with improved mobility. CONCLUSION: This 18-month PA + WL program resulted in a significant reduction in percent body fat with a concomitant increase in percent body lean mass. Shifts in body weight and composition were associated with favorable changes in clinical parameters of cardiometabolic risk and mobility. Moderate PA without WL had no effect on body composition.

Independent and combined effects of physical activity and weight loss on inflammatory biomarkers in overweight and obese older adults.

OBJECTIVES: To determine the independent effect of long-term physical activity (PA) and the combined effects of long-term PA and weight loss (WL) on inflammation in overweight and obese older adults. DESIGN: Eighteen-month randomized, controlled trial. SETTING: The community infrastructure of cooperative extension centers. PARTICIPANTS: Overweight and obese (body mass index >28.0 kg/m(2) ) community-dwelling men and women aged 60 to 79 at risk for cardiovascular disease (CVD). INTERVENTION: Physical activity + weight loss (PA + WL) (n = 98), PA only (n = 97), or successful aging (SA) health education (n = 93) intervention. MEASUREMENTS: Biomarkers of inflammation (adiponectin, leptin, high-sensitivity interleukin (hsIL)-6, IL-6sR, IL-8, and soluble tumor necrosis factor receptor 1) were measured at baseline and 6 and 18 months. RESULTS: After adjustment for baseline biomarker, wave, sex, and visit, leptin and hsIL-6 showed a significant intervention effect. Specifically, leptin was significantly lower in the PA + WL group (21.3 ng/mL, 95% confidence interval (CI) = 19.7-22.9 ng/mL) than in the PA (29.3 ng/mL, 95% CI = 26.9-31.8 ng/mL) or SA (30.3 ng/mL, 95% CI = 27.9-32.8 ng/mL) group (both P < .001), and hsIL-6 was significantly lower in the PA + WL group (2.1 pg/mL, 95% CI = 1.9-2.3 pg/mL) than in the PA (2.5 pg/mL, 95% CI = 2.3-2.7 pg/mL) or SA (2.4 pg/mL, 95% CI = 2.2-2.6 pg/mL) group (P = .02). CONCLUSION: Addition of dietary-induced WL to PA reduced leptin and hsIL-6 more than PA alone and more than a SA intervention in older adults at risk for CVD. Results suggest that WL, rather than increased PA, is the lifestyle factor primarily responsible for improvement in the inflammatory profile.

Intensive weight loss intervention in older individuals: results from the Action for Health in Diabetes Type 2 diabetes mellitus trial.

OBJECTIVES: To compare the effects of 4 years of intensive lifestyle intervention on weight, fitness, and cardiovascular disease risk factors in older and younger individuals. DESIGN: Randomized controlled clinical trial. SETTING: Sixteen U.S. clinical sites. PARTICIPANTS: Individuals with type 2 diabetes mellitus: 1,053 aged 65 to 76 and 4,092 aged 45 to 64. INTERVENTIONS: An intensive behavioral intervention designed to promote and maintain weight loss through caloric restriction and increased physical activity was compared with diabetes mellitus support and education. MEASUREMENTS: Standardized assessments of weight, fitness (based on graded exercise testing), and cardiovascular disease risk factors. RESULTS: Over 4 years, older individuals had greater intervention-related mean weight losses (6.2%) than younger participants (5.1%; interaction P = .006) and comparable relative mean increases in fitness (0.56 vs 0.53 metabolic equivalents; interaction P = .72). These benefits were seen consistently across subgroups of older adults formed according to many demographic and health factors. Of a panel of age-related health conditions, only self-reported worsening vision was associated with poorer intervention-related weight loss in older individuals. The intensive lifestyle intervention produced mean increases in high-density lipoprotein cholesterol (2.03 mg/dL; P < .001) and decreases in glycated hemoglobin (0.21%; P < .001) and waist circumference (3.52 cm; P < .001) over 4 years that were at least as large in older as in younger individuals. CONCLUSION: Intensive lifestyle intervention targeting weight loss and increased physical activity is effective in overweight and obese older individuals to produce sustained weight loss and improvements in fitness and cardiovascular risk factors.

Weight loss and self-regulatory eating efficacy in older adults: the cooperative lifestyle intervention program.

OBJECTIVES: Using the weight efficacy lifestyle questionnaire (WEL), we examined whether a group-mediated intervention for weight loss among older, obese adults resulted in changes in self-regulatory self-efficacy for eating behavior and whether these changes mediated weight loss. METHODS: This was a randomized controlled design, and 288 older adults received 1 of 3 treatments for 6 months: physical activity only (PA), weight loss + physical activity (WL + PA), or a successful aging (SA) health education program. The WEL was administered prior to randomization and again at the 6-month follow-up visit. RESULTS: A significant treatment effect was observed for the WEL, F (2249) = 15.11, p < .0001, partial eta2 = .11, showing that improvement occurred only in the WL + PA group as compared with PA and SA. Changes in WEL scores partially mediated the effects of the WL + PA intervention on weight loss. DISCUSSION: These results illustrate that WL + PA can be effective in improving older adults' self-efficacy for the self-regulation of eating behavior and that these changes are prospectively related to the amount of weight loss. Further research is warranted on an expanded concept of self-efficacy as well as controlled experimental studies on eating behavior in older adults.

Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods.

Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to translate the DPP approach for use in community settings as a cost-effective intervention led by Community Health Workers (CHW's) and administered through a Diabetes Care Center (DCC). Approximately 300 overweight and obese (BMI 25-40 kg/m(2)) individuals with prediabetes (fasting blood glucose 95-124 mg/dl) were randomly assigned to either a lifestyle weight loss intervention (LW) or an enhanced usual care comparison condition (UC). The goal of LW is >or=7% weight loss achieved through increases in physical activity (180 min/wk) and decreases in caloric intake (approximately 1500 kcal/day). The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6 months and monthly thereafter for 18 months. UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter. The primary outcome is change in fasting blood glucose. Secondary outcomes include cardiovascular risk factors, health-related quality of life, and social cognitive variables. Outcomes are masked and are collected every 6 months. The cost-effectiveness of the program will also be assessed. A community-based program that is administered through local DCC's and that harnesses the experience of community members (CHW's) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals.

Weight regain is related to decreases in physical activity during weight loss.

PURPOSE: To examine whether adaptations in physical activity energy expenditure (PAEE) and resting metabolic rate (RMR) during weight loss were associated with future weight regain in overweight/obese, older women. RESEARCH METHODS AND PROCEDURES: Thirty-four overweight/obese (BMI = 25-40 kg x m(-2)), postmenopausal women underwent a 20-wk weight loss intervention of hypocaloric diet with (low- or high-intensity) or without treadmill walking (weekly caloric deficit was approximately 11,760 kJ), with a subsequent 12-month follow-up. RMR (via indirect calorimetry), PAEE (by RT3 accelerometer), and body composition (by dual-energy x-ray absorptiometry) were measured before and after intervention. Body weight and self-reported information on physical activity were collected after intervention and at 6 and 12 months after intervention. RESULTS: The intervention resulted in decreases in body weight, lean mass, fat mass, percent body fat, RMR, and PAEE (P < 0.001 for all). Weight regain was 2.9 +/- 3.3 kg (-3.1 to +9.2 kg) at 6 months and 5.2 +/- 5.0 kg (-2.3 to +21.7 kg) at 12 months after intervention. The amount of weight regained after 6 and 12 months was inversely associated with decreases in PAEE during the weight loss intervention (r = -0.521, P = 0.002 and r = -0.404, P = 0.018, respectively), such that women with larger declines in PAEE during weight loss experienced greater weight regain during follow-up. Weight regain was not associated with changes in RMR during intervention or with self-reported physical activity during follow-up. CONCLUSION: This study demonstrates that although both RMR and PAEE decreased during weight loss in postmenopausal women, maintaining high levels of daily physical activity during weight loss may be important to mitigate weight regain after weight loss.

The Arthritis, Diet and Activity Promotion Trial (ADAPT): design, rationale, and baseline results.

Osteoarthritis (OA) of the knee leads to restrictions of physical activity and ability to perform activities of daily living. Obesity is a risk factor for knee OA and it appears to exacerbate knee pain and disability. The Arthritis, Diet, and Activity Promotion Trial (ADAPT) was developed to test the efficacy of lifestyle behavioral changes on physical function, pain, and disability in obese, sedentary older adults with knee OA. This controlled trial randomized 316 sedentary overweight and obese older adults in a two-by-two factorial design into one of four 18-month duration intervention groups: Healthy Lifestyle Control; Dietary Weight Loss; Structured Exercise; or Combined Exercise and Dietary Weight Loss. The weight-loss goal for the diet groups was a 5% loss at 18 months. The intervention was modeled from principles derived from the group dynamics literature and social cognitive theory. Exercise training consisted of aerobic and strength training for 60 minutes, three times per week in a group and home-based setting. The primary outcome measure was self-report of physical function using the Western Ontario and McMaster University Osteoarthritis Index. Other measurements included timed stair climb, distance walked in 6 minutes, strength, gait, knee pain, health-related quality of life, knee radiographs, body weight, dietary intake, and cost-effectiveness of the interventions. We report baseline data stratified by level of overweight and obesity focusing on self-reported physical function and physical performance tasks. The results from ADAPT will provide approaches clinicians should recommend for behavioral therapies that effectively reduce the incidence of disability associated with knee OA.