Within-Trial Cost-Effectiveness of a Structured Lifestyle Intervention in Adults With Overweight/Obesity and Type 2 Diabetes: Results From the Action for Health in Diabetes (Look AHEAD) Study.

OBJECTIVE: To assess the cost-effectiveness (CE) of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, as implemented in the Action for Health in Diabetes study. RESEARCH DESIGN AND METHODS: Data were from 4,827 participants during their first 9 years of study participation from 2001 to 2012. Information on Health Utilities Index Mark 2 (HUI-2) and HUI-3, Short-Form 6D (SF-6D), and Feeling Thermometer (FT), cost of delivering the interventions, and health expenditures was collected during the study. CE was measured by incremental CE ratios (ICERs) in costs per quality-adjusted life year (QALY). Future costs and QALYs were discounted at 3% annually. Costs were in 2012 U.S. dollars. RESULTS: Over the 9 years studied, the mean cumulative intervention costs and mean cumulative health care expenditures were $11,275 and $64,453 per person for ILI and $887 and $68,174 for DSE. Thus, ILI cost $6,666 more per person than DSE. Additional QALYs gained by ILI were not statistically significant measured by the HUIs and were 0.07 and 0.15, respectively, measured by SF-6D and FT. The ICERs ranged from no health benefit with a higher cost based on HUIs to $96,458/QALY and $43,169/QALY, respectively, based on SF-6D and FT. CONCLUSIONS: Whether ILI was cost-effective over the 9-year period is unclear because different health utility measures led to different conclusions.

Delivery of the research participant perception survey through the patient portal.

INTRODUCTION: The patient portal may be an effective method for administering surveys regarding participant research experiences but has not been systematically studied. METHODS: We evaluated 4 methods of delivering a research participant perception survey: mailing, phone, email, and patient portal. Participants of research studies were identified (n=4013) and 800 were randomly selected to receive a survey, 200 for each method. Outcomes included response rate, survey completeness, and cost. RESULTS: Among those aged <65 years, response rates did not differ between mail, phone, and patient portal (22%, 29%, 30%, p>0.07). Among these methods, the patient portal was the lowest-cost option. Response rates were significantly lower using email (10%, p<0.01), the lowest-cost option. In contrast, among those aged 65+ years, mail was superior to the electronic methods (p<0.02). CONCLUSIONS: The patient portal was among the most effective ways to reach research participants, and was less expensive than surveys administered by mail or telephone.

Effects of Religious Involvement on HIV Management Outcomes Among HIV-Positive Adults in Central North Carolina.

OBJECTIVES: The goals of this pilot cross-sectional study were to determine the feasibility of and begin measuring the effect of religious institution affiliation on human immunodeficiency virus (HIV) clinical outcomes in the southern United States, a region marked by later initiation of antiretroviral therapy, higher HIV-related morbidity, and higher mortality rates than people living with HIV (PLWH) elsewhere in the country. It also is a region with a high density of religious institutions, which may facilitate improved health outcomes through leveraged social capital. Because spirituality is a personal construct and PLWH constitute a vulnerable population, we wanted to determine whether it would be feasible to survey patients about the topic. We hypothesized that PLWH would be willing to participate and that PLWH who report involvement in religious institutions would be more likely to have suppressed HIV viral loads (VLs) and better engagement in care than PLWH not involved in a religious institution. METHODS: Eligible participants were enrolled from the Wake Forest Infectious Diseases Specialty Clinic to complete structured interviews using validated measures of religious institution affiliation, spiritual well-being, social support, and HIV-related stigma. HIV VL and engagement in care (clinic no-show rate) data were abstracted from the electronic medical record. Descriptive statistics calculated the prevalence of religious institution involvement, outcomes of interest, and potential confounders. t Tests compared continuous outcomes assuming normality, χ2 tests compared binary outcomes, and the Wilcoxon Mann-Whitney test compared outcomes for non-normal data. RESULTS: Fifty participants completed the study (55% participation rate); 72% identified as male and 28% identified as female. A total of 48% of participants identified as black/African American and 44% identified as white. Participants who identified as men who have sex with men made up 34%. More black/African American participants than white participants reported religious institution affiliation (23%; P = 0.15). There was no statistically significant relation between religious institution affiliation and CD4 or VL; however, higher levels of social support and spiritual well-being predicted a lower clinic no-show rate (P = 0.0077 and 0.0195, respectively). There was a trend toward greater perceived HIV-related stigma and CD4 (P = 0.0845) as well as more emergency department visits (P = 0.0976). CONCLUSION: PLWH in a southern US clinic were willing to answer questions about their spirituality. Religious institution affiliation was not significantly related to virologic suppression or CD4 in this sample. Higher levels of self-reported social support (P = 0.0077) and spiritual well-being (P = 0.0195) predict better clinic attendance. These results suggest that religious affiliation alone does not imply positive benefits for all. Social support and spiritual well-being, however obtained, predict engagement in care. The next steps should include a fully powered study to define the relations among social support, spiritual well-being, and relevant clinical outcomes. Our results also support further investigation of perceived HIV-related stigma and healthcare utilization, based on the trend toward significance between emergency department visits and stigma.

Clinical Characteristics and Health Outcomes of Neonates Reporting to the Emergency Department With Hypothermia.

OBJECTIVES: Although hypothermia has long been considered a sign of serious bacterial infection (SBI) in neonates, there is a lack of medical literature on this topic, and little is known about the prevalence of serious infection in these patients. Our primary objective was to assess the prevalence and type of serious infection in neonates with hypothermia. Our secondary objective was to describe the prevalence and type of significant pathology overall in this cohort. METHODS: We examined neonates (≤28 days old) evaluated in the emergency department and/or admitted to the hospital with hypothermia over a 3-year period. Demographics and relevant clinical data were extracted from the medical record. Fisher's exact test was used to determine differences in the prevalence of clinical and demographic characteristics in patients with and without a diagnosis of serious infection. RESULTS: Sixty-eight neonates met inclusion criteria, and 63 (93%) were admitted. Of those admitted to the hospital, 5 (7.9%) had a diagnosis of serious infection, including SBI (n = 4) and disseminated herpes simplex virus (n = 1). The types of SBI included urinary tract infection, septicemia, and meningitis. Eighty percent and 60% of neonates with hypothermia and diagnosed with serious infection had a temperature ≤34.4°C and ill appearance, respectively. Significant pathology was found in 9 (14.3%) patients and included both infectious and noninfectious diagnoses. CONCLUSIONS: Neonates presenting with hypothermia have a substantial risk for SBI or other significant pathology. This population merits further investigation; a multicenter prospective study should be conducted to better understand associations between risk factors and outcomes.

Influence of Prehospital Function and Strength on Outcomes of Critically Ill Older Adults.

OBJECTIVES: To understand the influence of prehospital physical function and strength on clinical outcomes of critically ill older adults. DESIGN: Secondary analysis of prospective cohort study. SETTING: Health, Aging and Body Composition (Health ABC) Study. PARTICIPANTS: Of 3,075 older adult Health ABC participants, we identified 575 (60% white, 61% male, mean age 79) with prehospital function or grip strength measurements within 2 years of an intensive care unit stay. MEASUREMENTS: The primary analysis evaluated the association between prehospital walk speed and mortality, and secondary analyses focused on associations between function or grip strength and mortality or hospital length of stay. Function and grip strength were analyzed as continuous and categorical predictors. RESULTS: Slower prehospital walk speed was associated with greater risk of 30-day mortality (for each 0.1 m/s slower, odds ratio = 1.13, 95% confidence interval (CI) = 1.04-1.23, P = .004). Grip strength, chair stands, and balance had weaker, non-statistically significant associations with 30-day mortality. Participants with slower prehospital walk speed (hazard ratio (HR) = 0.94, 95% CI = 0.90-0.98, P = .005) and weak grip strength (HR = 0.85, 95% CI = 0.73-0.99, P = .03) were less likely to be discharged from the hospital alive. All function and strength measures were significantly associated with 1-year mortality. CONCLUSION: Slow prehospital walk speed was strongly associated with greater 30-day mortality and longer hospital stay in critically ill older adults, and measures of function and strength were associated with 1-year mortality. These data add to the accumulating evidence on the relationship between physical function and critical care outcomes.

A survey of intracranial aneurysm treatment practices among United States physicians.

BACKGROUND: Recent surveys have failed to examine cerebrovascular aneurysm treatment practices among US physicians. OBJECTIVE: To survey physicians who are actively involved in the care of patients with cerebrovascular aneurysms to determine current aneurysm treatment preferences. METHODS: A 25-question SurveyMonkey online survey was designed and distributed electronically to members of the Society of NeuroInterventional Surgery, Society of Vascular and Interventional Neurology, and the American Association of Neurological Surgeons/Congress of Neurological Surgeons Combined Cerebrovascular Section. RESULTS: 211 physicians completed the survey. Most respondents recommend endovascular treatment as the first-line management strategy for most ruptured (78%) and unruptured (71%) aneurysms. Thirty-eight per cent of respondents indicate that they routinely treat all patients with subarachnoid hemorrhage regardless of grade. Most physicians use the International Study of Unruptured Intracranial Aneurysms data for counseling patients on natural history risk (80%); a small minority (11%) always or usually recommend treatment of anterior circulation aneurysms of <5 mm. Two-thirds of respondents continue to recommend clipping for most middle cerebral artery aneurysms, while most (51%) recommend flow diversion for wide-necked internal carotid artery aneurysms. Follow-up imaging schedules are highly variable. Neurosurgeons at academic institutions and those practicing longer were more likely to recommend clipping surgery for aneurysms (p<0.05). CONCLUSIONS: This survey demonstrates considerable variability in patient selection for intracranial aneurysm treatment, preferred treatment strategies, and follow-up imaging schedules among US physicians.

Characterizing the Functional Decline of Older Women With Incident Urinary Incontinence.

OBJECTIVE: To characterize change in physical performance and differential prevalence of low skeletal muscle mass and strength (sarcopenia) and lower 25-hydroxyvitamin D concentrations among older women who developed urinary incontinence (UI) symptoms. METHODS: This is a secondary analysis of the Health, Aging, and Body Composition Study. Urinary incontinence symptoms were assessed using validated questions. The Short Physical Performance Battery measured physical performance. Sarcopenia, defined by low muscle mass and strength, was determined using validated cutoffs for gait speed, grip strength, and appendicular skeletal muscle mass. All parameters were evaluated at baseline and year 4. Serum 25-hydroxyvitamin D concentrations were assessed at year 2. The primary outcome was change in Short Physical Performance Battery total scores. Sarcopenia and lower serum 25-hydroxyvitamin D concentrations have been independently associated with poor physical performance and UI and were therefore included as secondary outcomes. Univariate and multivariate analyses were used to characterize the associations of change in physical performance from baseline to year 4, incidence of sarcopenia, and lower serum 25-hydroxyvitamin D on the development of UI symptoms. RESULTS: Of the 1,583 women enrolled, 910 were excluded (730 had baseline UI; 180 with missing data). Six hundred seventy-three women were continent at baseline; 223 (33%) developed UI symptoms at year 4. SPPB total scores significantly declined in women with UI versus continent women (mean difference continent-incident UI 0.32, 95% CI 0.04-0.60, P=.02). Of subscale measures, standing balance showed the greatest decline at 0.20 (0.05-0.36; continent-incident UI, respectively; P=.009). Sarcopenia developed at a higher rate with incident UI (adjusted odds ratio [OR] 1.7, 95% CI 1.0-2.9). Low 25-hydroxyvitamin D was not associated with incident UI (adjusted OR 1.1, 95% CI 0.7-1.6 and 1.1, 95% CI 0.7-1.6 for deficient or insufficient versus sufficient status, respectively). CONCLUSION: We observed a significant decline in standing balance among older women who developed UI symptoms. This decline may be associated with coinciding development of sarcopenia.

Effects of Physical Activity Intervention on Physical and Cognitive Function in Sedentary Adults With and Without Diabetes.

BACKGROUND: Type 2 diabetes mellitus may alter the effect of physical activity on physical and cognitive function. METHODS: The Lifestyle Interventions and Independence for Elders (LIFE) trial randomized controlled clinical trial of physical activity intervention (walking, resistance training, and flexibility exercises) enrolled adults aged 70-89 years who were sedentary and non-demented and who had functional limitations. Standardized measures of physical and cognitive function were collected an average of 2 years post-randomization. Differences between the intervention and control groups from 415 individuals with diabetes and 1,061 individuals without diabetes were contrasted with analyses of covariance. RESULTS: At 24 months, assignment to the physical activity intervention resulted in 0.019 m/s relatively faster average 400-meter gait speeds (p = .007 overall) both for individuals with and without diabetes (intervention × diabetes interaction p = .99). No benefits were seen on scores from a physical performance battery. Performance on cognitive tests was better among participants assigned to the physical activity intervention compared with control only for those with diabetes, particularly for global cognitive function (p = .02) and delayed memory (p = .005), with mean [95% confidence intervals] for benefit from physical activity intervention of 0.114 [0.007,0.111] and 0.208 [0.030,0.387] standard deviations, respectively. CONCLUSIONS: Physical activity intervention improved the gait speed of older, sedentary individuals with and without diabetes. The cognitive function benefits occurred among participants with, but not without, diabetes. The mechanisms through which physical activity affects physical and cognitive function in older adults may differ for individuals by diabetes status.

Impact on weight and physical function of intensive medical weight loss in older adults with stage II and III obesity.

OBJECTIVE: A 6-month pilot trial compared two strategies for weight loss in older adults with body mass indexes (BMIs) ≥35 kg/m(2) to assess weight loss response, safety, and impact on physical function. METHODS: Twenty-eight volunteers were randomized to a balanced deficit diet (BDD) (500 kcal/day below estimated energy needs) or an intensive, low-calorie, meal replacement diet (ILCD, 960 kcal/day). Behavioral interventions and physical activity prescriptions were similar for both groups. Primary outcomes were changes in body weight and adverse event frequency; secondary outcomes included measures of physical function and body composition. RESULTS: ILCD average weight change was -19.1 ± 2.2 kg or 15.9 ± 4.6% of initial body weight compared with -9.1 ± 2.7 kg or 7.2 ± 1.9% for BDD. ILCD lost more fat mass (-7.7 kg, 95% CI [-11.9 to -3.5]) but had similar loss of lean mass (-1.7 kg, 95% CI [-4.1 to 0.6]) compared with BDD. There were no significant differences in change in physical function or adverse event frequency. CONCLUSIONS: Compared with a traditional BDD intervention, older adults who have severe obesity treated with intensive medical weight loss had greater weight loss and decreases in fat mass without a higher frequency of adverse events. In the short term, however, this did not translate into greater improvements in physical function.

Cost-effectiveness of the LIFE Physical Activity Intervention for Older Adults at Increased Risk for Mobility Disability.

BACKGROUND: Losing the ability to walk safely and independently is a major concern for many older adults. The Lifestyle Interventions and Independence for Elders study recently demonstrated that a physical activity (PA) intervention can delay the onset of major mobility disability. Our objective is to examine the resources required to deliver the PA intervention and calculate the incremental cost-effectiveness compared with a health education intervention. METHODS: The Lifestyle Interventions and Independence for Elders study enrolled 1,635 older adults at risk for mobility disability. They were recruited at eight field centers and randomly assigned to either PA or health education. The PA program consisted of 50-minute center-based exercise 2× weekly, augmented with home-based activity to achieve a goal of 150 min/wk of PA. Health education consisted of weekly workshops for 26 weeks, and monthly sessions thereafter. Analyses were conducted from a health system perspective, with a 2.6-year time horizon. RESULTS: The average cost per participant over 2.6 years was US$3,302 and US$1,001 for the PA and health education interventions, respectively. PA participants accrued 0.047 per person more Quality-Adjusted Life-Years (QALYs) than health education participants. PA interventions costs were slightly higher than other recent PA interventions. The incremental cost-effectiveness ratios were US$42,376/major mobility disability prevented and US$49,167/QALY. Sensitivity analyses indicated that results were relatively robust to varied assumptions. CONCLUSIONS: The PA intervention costs and QALYs gained are comparable to those found in other studies. The ICERS are less than many commonly recommended medical treatments. Implementing the intervention in non-research settings may reduce costs further.

Effect of a 24-Month Physical Activity Intervention vs Health Education on Cognitive Outcomes in Sedentary Older Adults: The LIFE Randomized Trial.

IMPORTANCE: Epidemiological evidence suggests that physical activity benefits cognition, but results from randomized trials are limited and mixed. OBJECTIVE: To determine whether a 24-month physical activity program results in better cognitive function, lower risk of mild cognitive impairment (MCI) or dementia, or both, compared with a health education program. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial, the Lifestyle Interventions and Independence for Elders (LIFE) study, enrolled 1635 community-living participants at 8 US centers from February 2010 until December 2011. Participants were sedentary adults aged 70 to 89 years who were at risk for mobility disability but able to walk 400 m. INTERVENTIONS: A structured, moderate-intensity physical activity program (n = 818) that included walking, resistance training, and flexibility exercises or a health education program (n = 817) of educational workshops and upper-extremity stretching. MAIN OUTCOMES AND MEASURES: Prespecified secondary outcomes of the LIFE study included cognitive function measured by the Digit Symbol Coding (DSC) task subtest of the Wechsler Adult Intelligence Scale (score range: 0-133; higher scores indicate better function) and the revised Hopkins Verbal Learning Test (HVLT-R; 12-item word list recall task) assessed in 1476 participants (90.3%). Tertiary outcomes included global and executive cognitive function and incident MCI or dementia at 24 months. RESULTS: At 24 months, DSC task and HVLT-R scores (adjusted for clinic site, sex, and baseline values) were not different between groups. The mean DSC task scores were 46.26 points for the physical activity group vs 46.28 for the health education group (mean difference, -0.01 points [95% CI, -0.80 to 0.77 points], P = .97). The mean HVLT-R delayed recall scores were 7.22 for the physical activity group vs 7.25 for the health education group (mean difference, -0.03 words [95% CI, -0.29 to 0.24 words], P = .84). No differences for any other cognitive or composite measures were observed. Participants in the physical activity group who were 80 years or older (n = 307) and those with poorer baseline physical performance (n = 328) had better changes in executive function composite scores compared with the health education group (P = .01 for interaction for both comparisons). Incident MCI or dementia occurred in 98 participants (13.2%) in the physical activity group and 91 participants (12.1%) in the health education group (odds ratio, 1.08 [95% CI, 0.80 to 1.46]). CONCLUSIONS AND RELEVANCE: Among sedentary older adults, a 24-month moderate-intensity physical activity program compared with a health education program did not result in improvements in global or domain-specific cognitive function. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01072500.

The MAT-sf: identifying risk for major mobility disability.

BACKGROUND: The assessment of mobility is essential to both aging research and clinical geriatric practice. A newly developed self-report measure of mobility, the mobility assessment tool-short form (MAT-sf), uses video animations as an innovative method to improve measurement accuracy/precision. The primary aim of the current study was to evaluate whether MAT-sf scores can be used to identify risk for major mobility disability (MMD). METHODS: This article is based on data collected from the Lifestyle Interventions and Independence for Elders study and involved 1,574 older adults between the ages of 70-89. The MAT-sf was administered at baseline; MMD, operationalized as failure to complete the 400-m walk ≤ 15 minutes, was evaluated at 6-month intervals across a period of 42 months. The outcome of interest was the first occurrence of MMD or incident MMD. RESULTS: After controlling for age, sex, clinic site, and treatment arm, baseline MAT-sf scores were found to be effective in identifying risk for MMD (p < .0001). Partitioning the MAT-sf into four groups revealed that persons with scores <40, 40-49, 50-59, and 60+ had failure rates across 42 months of follow-up of 66%, 52%, 35%, and 22%, respectively. CONCLUSIONS: The MAT-sf is a quick and efficient way of identifying older adults at risk for MMD. It could be used to clinically identify older adults that are in need of intervention for MMD and provides a simple means for monitoring the status of patients' mobility, an important dimension of functional health.

Work safety climate, personal protection use, and injuries among Latino residential roofers.

BACKGROUND: This analysis describes work safety climate, personal protective equipment (PPE) use, and injuries among Latino residential roofers, and examines the associations of work safety climate with PPE use and injuries. METHODS: Eighty-nine North Carolina residential roofers completed a baseline interview and daily logs about perceptions and use of PPE, occurrence of injuries in last 12 months, and work safety climate. RESULTS: The mean work safety climate score was 26.5 (SD = 5.6). In the baseline interview, participants reported that the majority of employers provided PPE and that they used it most or all of the time; daily log data indicated that PPE was used for half or fewer of hours worked. 39.9% reported any injury in the last 12 months. Work safety climate was significantly correlated with the provision and use of most types of PPE, and was inversely associated with injury. CONCLUSIONS: Supervisors promoting safety may increase the PPE use and decrease injuries.

The LIFE Cognition Study: design and baseline characteristics.

Observational studies have shown beneficial relationships between exercise and cognitive function. Some clinical trials have also demonstrated improvements in cognitive function in response to moderate-high intensity aerobic exercise; however, these have been limited by relatively small sample sizes and short durations. The Lifestyle Interventions and Independence for Elders (LIFE) Study is the largest and longest randomized controlled clinical trial of physical activity with cognitive outcomes, in older sedentary adults at increased risk for incident mobility disability. One LIFE Study objective is to evaluate the effects of a structured physical activity program on changes in cognitive function and incident all-cause mild cognitive impairment or dementia. Here, we present the design and baseline cognitive data. At baseline, participants completed the modified Mini Mental Status Examination, Hopkins Verbal Learning Test, Digit Symbol Coding, Modified Rey-Osterrieth Complex Figure, and a computerized battery, selected to be sensitive to changes in speed of processing and executive functioning. During follow up, participants completed the same battery, along with the Category Fluency for Animals, Boston Naming, and Trail Making tests. The description of the mild cognitive impairment/dementia adjudication process is presented here. Participants with worse baseline Short Physical Performance Battery scores (prespecified at ≤ 7) had significantly lower median cognitive test scores compared with those having scores of 8 or 9 with modified Mini Mental Status Examination score of 91 versus (vs) 93, Hopkins Verbal Learning Test delayed recall score of 7.4 vs 7.9, and Digit Symbol Coding score of 45 vs 48, respectively (all P<0.001). The LIFE Study will contribute important information on the effects of a structured physical activity program on cognitive outcomes in sedentary older adults at particular risk for mobility impairment. In addition to its importance in the area of prevention of cognitive decline, the LIFE Study will also likely serve as a model for exercise and other behavioral intervention trials in older adults.

Fiber intake and plasminogen activator inhibitor-1 in type 2 diabetes: Look AHEAD (Action for Health in Diabetes) trial findings at baseline and year 1.

Plasminogen activator inhibitor 1 (PAI-1) is elevated in obese individuals with type 2 diabetes and may contribute, independently of traditional factors, to increased cardiovascular disease risk. Fiber intake may decrease PAI-1 levels. We examined the associations of fiber intake and its changes with PAI-1 before and during an intensive lifestyle intervention (ILI) for weight loss in 1,701 Look AHEAD (Action for Health in Diabetes) participants with dietary, fitness, and PAI-1 data at baseline and 1 year. Look AHEAD was a randomized cardiovascular disease trial in 5,145 overweight/obese patients with type 2 diabetes, comparing ILI (goal of ≥7% reduction in baseline weight) with a control arm of diabetes support and education. ILI participants were encouraged to consume vegetables, fruits, and grain products low in sugar and fat. At baseline, median fiber intake was 17.9 g/day. Each 8.3 g/day higher fiber intake was associated with a 9.2% lower PAI-1 level (P=0.008); this association persisted after weight and fitness adjustments (P=0.03). Higher baseline intake of fruit (P=0.019) and high-fiber grain and cereal (P=0.029) were related to lower PAI-1 levels. Although successful in improving weight and physical fitness at 1 year, the ILI in Look AHEAD resulted in small increases in fiber intake (4.1 g/day, compared with -2.35 g/day with diabetes support and education) that were not related to PAI-1 change (P=0.34). Only 31.3% of ILI participants (39.8% of women, 19.1% of men) met daily fiber intake recommendations. Increasing fiber intake in overweight/obese individuals with diabetes interested in weight loss is challenging. Future studies evaluating changes in fiber consumption during weight loss interventions are warranted.

Impact of an intensive lifestyle intervention on use and cost of medical services among overweight and obese adults with type 2 diabetes: the action for health in diabetes.

OBJECTIVE: To assess the relative impact of an intensive lifestyle intervention (ILI) on use and costs of health care within the Look AHEAD trial. RESEARCH DESIGN AND METHODS: A total of 5,121 overweight or obese adults with type 2 diabetes were randomly assigned to an ILI that promoted weight loss or to a comparison condition of diabetes support and education (DSE). Use and costs of health-care services were recorded across an average of 10 years. RESULTS: ILI led to reductions in annual hospitalizations (11%, P = 0.004), hospital days (15%, P = 0.01), and number of medications (6%, P < 0.001), resulting in cost savings for hospitalization (10%, P = 0.04) and medication (7%, P < 0.001). ILI produced a mean relative per-person 10-year cost savings of $5,280 (95% CI 3,385-7,175); however, these were not evident among individuals with a history of cardiovascular disease. CONCLUSIONS: Compared with DSE over 10 years, ILI participants had fewer hospitalizations, fewer medications, and lower health-care costs.

The MAT-sf: clinical relevance and validity.

BACKGROUND: The measurement of mobility is essential to both aging research and clinical practice. A newly developed self-report measure of mobility, the mobility assessment tool-short form (MAT-sf), uses video animations to improve measurement accuracy/precision. Using a large baseline data set, we recalibrated the items, evaluated the extent to which older patients' self-efficacy (i.e., confidence) for walking was related to MAT-sf scores beyond their actual 400-m walk time, and assessed the relationship of the MAT-sf with body mass index and other clinical variables. METHODS: The analyses employed baseline data from the Lifestyle Interventions and Independence for Elders Study. RESULTS: Item recalibration demonstrated that the MAT-sf scoring algorithm was robust. In an analysis with 400-m walk time and self-efficacy regressed on the MAT-sf, both variables shared unique variance with the MAT-sf (p < .001). The MAT-sf was inversely related to several comorbidities, most notably hypertension and arthritis (p < .001), and scores were lowest when body mass index ≥ 35 kg/m(2). Finally, MAT-sf scores were directly related to Short Physical Performance Battery scores, inversely related to difficulty with activities of daily living (p < .001) and higher for men than for women (p < .001). CONCLUSIONS: The findings extend the validity and clinical utility of this innovative tool for assessing self-reported mobility in older adults. Longitudinal data on the MAT-sf from the Lifestyle Interventions and Independence for Elders Study will enable us to evaluate the relative contributions of self-report and performance-based measures of mobility on important health outcomes.

Performance of a computer-based assessment of cognitive function measures in two cohorts of seniors.

BACKGROUND: Computer-administered assessment of cognitive function is being increasingly incorporated in clinical trials; however, its performance in these settings has not been systematically evaluated. DESIGN: The Seniors Health and Activity Research Program pilot trial (N = 73) developed a computer-based tool for assessing memory performance and executive functioning. The Lifestyle Interventions and Independence for Elders investigators incorporated this battery in a full-scale multicenter clinical trial (N = 1635). We describe relationships that test scores have with those from interviewer-administered cognitive function tests and risk factors for cognitive deficits and describe performance measures (completeness, intraclass correlations [ICC]). RESULTS: Computer-based assessments of cognitive function had consistent relationships across the pilot and full-scale trial cohorts with interviewer-administered assessments of cognitive function, age, and a measure of physical function. In the Lifestyle Interventions and Independence for Elders cohort, their external validity was further demonstrated by associations with other risk factors for cognitive dysfunction: education, hypertension, diabetes, and physical function. Acceptable levels of data completeness (>83%) were achieved on all computer-based measures; however, rates of missing data were higher among older participants (odds ratio = 1.06 for each additional year; p < 0.001) and those who reported no current computer use (odds ratio = 2.71; p < 0.001). ICCs among clinics were at least as low (ICC < 0.013) as for interviewer measures (ICC < 0.023), reflecting good standardization. All cognitive measures loaded onto the first principal component (global cognitive function), which accounted for 40% of the overall variance. CONCLUSION: Our results support the use of computer-based tools for assessing cognitive function in multicenter clinical trials of older individuals.

Lifestyle intervention and/or statins for the reduction of C-reactive protein in type 2 diabetes: from the look AHEAD study.

OBJECTIVE: Cardiovascular risk remains high despite statin use. Overweight/obese diabetic persons usually have normal/low LDL-cholesterol but high C-reactive protein (CRP) levels. We aimed to examine the effects of intensive lifestyle intervention for weight loss (ILI) on CRP levels in overweight/obese diabetic individuals by statin use. DESIGN AND METHODS: Look AHEAD was a randomized trial in overweight/obese type 2 diabetic individuals testing whether ILI would reduce cardiovascular mortality, when compared to usual care. CRP changes in 1,431 participants with biomarker levels, who remained on or off statin treatment for 1 year, were evaluated. RESULTS: The reduction in CRP levels with ILI at 1 year in men and women on statins was -44.9 and -42.3%, respectively, compared to -13.7 and -21.0% for those on statins and usual care (P < 0.0001). At 1 year, median CRP levels were: 1.8 mg L(-1) in participants randomized to ILI on statin therapy; 2.6 mg L(-1) for those on statins randomized to usual care and 2.9 mg L(-1) for participants not on statins but randomized to ILI. Weight loss was associated with 1-year CRP reduction (P < 0.0001) in statin and nonstatin users. CONCLUSIONS: Our findings suggest that in overweight/obese diabetic persons, ILI and statin therapy may have substantial additive anti-inflammatory benefits.

Feasibility of interactive voice response methods in health behavior research with immigrant Latinos.

OBJECTIVES: Determine the feasibility of using interactive voice response (IVR) for conducting daily diary research with immigrant Latinos. METHODS: Baseline data containing demographic, health, and job-related characteristics were obtained from immigrant Latino construction workers (N=119). Participants also completed an IVR-based daily diary for 21 consecutive days. RESULTS: Over one third (37%) of the sample adhered to the 21-day protocol; a comparable percent-age (38.7%) initiated but did not adhere to the protocol; and 24% never began the diary protocol. Adherence was generally not predicted by demographic, health, or job-related characteristics. CONCLUSIONS: IVR technology makes diary studies with Latino samples feasible.