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Objective The Action for Health in Diabetes (Look AHEAD) study previously reported that intensive lifestyle intervention (ILI) reduced incident depressive symptoms and improved health-related quality of life (HRQOL) over nearly 10 years of intervention compared with a control group (the diabetes support and education group [DSE]) in participants with type 2 diabetes and overweight or obesity. The present study compared incident depressive symptoms and changes in HRQOL in these groups for an additional 6 years following termination of the ILI in September 2012. Methods A total of 1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36) were measured. Results ILI participants and DSE participants lost 3.1 (0.3) and 3.8 (0.3) kg [represented as mean (SE); p = 0.10], respectively, during the 6-year postintervention follow-up. No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36. In both groups, mental component summary scores were higher than physical component summary scores. Conclusions Prior participation in the ILI, compared with the DSE group, did not appear to improve subsequent mood or HRQOL during 6 years of postintervention follow-up.

Background Frailty is a geriatric syndrome of decreased physiologic reserve and resistance to stressors that results in increased vulnerability to adverse health outcomes with aging. Diabetes and hyperglycemia are established risk factors for frailty. We sought to examine whether the odds of frailty among individuals at high risk of diabetes randomized to treatment with intensive lifestyle (ILS), metformin, or placebo differed after long-term follow-up. Method The sample comprised participants in the Diabetes Prevention Program (DPP) clinical trial, who continued follow-up in the DPP Outcomes Study (DPPOS) and completed frailty assessments in DPPOS Years 8 (n = 2385) and 10 (n = 2289), approximately 12 and 14 years after DPP randomization. Frailty was classified using Fried Frailty Phenotype criteria. GEE models adjusting for visit year with repeated measures pooled for Years 8 and 10 were used to estimate pairwise odds ratios (ORs) between ILS, metformin, and placebo for the outcomes of frail and prefrail versus nonfrail. Results Frailty prevalence by treatment group was ILS = 3.0%, metformin = 5.4%, placebo = 5.7% at Year 8, and ILS = 3.6%, metformin = 5.3%, placebo = 5.4% at Year 10. Odds ratios (95% CI) estimated with GEE models were ILS versus placebo, 0.62 (0.42–0.93), p = .022; metformin versus placebo, 0.99 (0.69–1.42), p = .976; and ILS versus metformin, 0.63 (0.42–0.94), p = .022. Odds of being frail versus nonfrail were 37% lower for ILS compared to metformin and placebo. Conclusions Early ILS intervention, at an average age of about 50 years, in persons at high risk of diabetes may reduce frailty prevalence in later life. Metformin may be ineffective in reducing frailty prevalence. Clinical Trials Registration Numbers NCT00004992 (DPP) and NCT00038727 (DPPOS).

Objective This study was designed to determine whether intensive lifestyle intervention (ILI) aimed at weight loss lowers cancer incidence and mortality. Methods Data from the Look AHEAD trial were examined to investigate whether participants randomized to ILI designed for weight loss would have reduced overall cancer incidence, obesity-related cancer incidence, and cancer mortality, as compared with the diabetes support and education (DSE) comparison group. This analysis included 4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer. Results After a median follow-up of 11 years, 684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer. The incidence rates of obesity-related cancers were 6.1 and 7.3 per 1,000 person-years in ILI and DSE, respectively, with a hazard ratio (HR) of 0.84 (95% CI: 0.68-1.04). There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). Conclusions An ILI aimed at weight loss lowered incidence of obesity-related cancers by 16% in adults with overweight or obesity and type 2 diabetes. The study sample size likely lacked power to determine effect sizes of this magnitude and smaller.

Objective: This study evaluated weight changes after cessation of the 10-year intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. It was hypothesized that ILI participants would be more likely to gain weight during the 2-year observational period following termination of weight-loss-maintenance counseling than would participants in the diabetes support and education (DSE) control group. Methods: Look AHEAD was a randomized controlled trial that compared the effects of ILI and DSE on cardiovascular morbidity and mortality in participants with overweight/obesity and type 2 diabetes. Look AHEAD was converted to an observational study in September 2012. Results: Two years after the end of the intervention (EOI), ILI and DSE participants lost a mean (SE) of 1.2 (0.2) kg and 1.8 (0.2) kg, respectively (P = 0.003). In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001). Two years after the EOI, ILI participants reported greater use of weight-control behaviors than DSE participants. Conclusions: Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.

OBJECTIVE Patients with type 2 diabetes are encouraged to lose weight, but excessive weight loss in older adults may be a marker of poor health and subsequent mortality. We examined weight change during the postintervention period of Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) with diabetes support and education (DSE) (control) in overweight/obese individuals with type 2 diabetes and sought to identify predictors of excessive postintervention weight loss and its association with mortality. RESEARCH DESIGN AND METHODS These secondary analyses compared postintervention weight change (year 8 to final visit; median 16 years) in ILI and DSE in 3,999 Look AHEAD participants. Using empirically derived trajectory categories, we compared four subgroups: weight gainers (n = 307), weight stable (n = 1,561), steady losers (n = 1,731), and steep losers (n = 380), on postintervention mortality, demographic variables, and health status at randomization and year 8. RESULTS Postintervention weight change averaged −3.7 ± 9.5%, with greater weight loss in the DSE than the ILI group. The steep weight loss trajectory subgroup lost on average 17.7 ± 6.6%; 30% of steep losers died during postintervention follow-up versus 10–18% in other trajectories (P < 0001). The following variables distinguished steep losers from weight stable: baseline, older, longer diabetes duration, higher BMI, and greater multimorbidity; intervention, randomization to control group and less weight loss in years 1–8; and year 8, higher prevalence of frailty, multimorbidity, and depressive symptoms and lower use of weight control strategies. CONCLUSIONS Steep weight loss postintervention was associated with increased risk of mortality. Older individuals with longer duration of diabetes and multimorbidity should be monitored for excessive unintentional weight loss.

Objective To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]). Methods This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes. Results Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group. Conclusions Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.

OBJECTIVE: Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) and diabetes support and education (DSE) (control) in 5,145 individuals with overweight/obesity and type 2 diabetes, found no significant differences in all-cause or cardiovascular mortality or morbidity during 9.6 (median) years of intervention. Participants in ILI who lost ≥10% at 1 year had lower risk of composite cardiovascular outcomes relative to DSE. Since effects of ILI may take many years to emerge, we conducted intent-to-treat analyses comparing mortality in ILI over 16.7 years (9.6 years of intervention and then observation) to DSE. In a secondary exploratory analysis, we compared mortality by magnitude of weight loss in ILI relative to DSE. RESEARCH DESIGN AND METHODS: Primary outcome was all-cause mortality from randomization to 16.7 years. Other outcomes included cause-specific mortality, interactions by subgroups (age, sex, race/ethnicity, and cardiovascular disease history), and an exploratory analysis by magnitude of weight loss in ILI versus DSE as reference. Analyses used proportional hazards regression and likelihood ratio. RESULTS: The incidence of all-cause mortality did not differ significantly in ILI and DSE (549 and 589 participants, respectively) (hazard ratio [HR] 0.91 [95% CI 0.81, 1.02]; P = 0.11). There were no significant differences between treatments in cause-specific mortality or within prespecified subgroups. ILI participants who lost ≥10% at 1 year had a 21% reduced risk of mortality (HR 0.79 [95% CI 0.67, 0.94]; P = 0.007) relative to DSE. CONCLUSIONS: ILI focused on weight loss did not significantly affect mortality risk. However, ILI participants who lost ≥10% had reduced mortality relative to DSE.

OBJECTIVETo conduct post hoc secondary analysis examining the association between change in physical activity. Measured with self-report and accelerometry, from baseline to 1 and 4 years and cardiovascular disease (CVD) outcomes in the Look AHEAD Trial.RESEARCH DESIGN AND METHODSParticipants were adults with overweight/obesity and type 2 diabetes with physical activity. Data at baseline and year 1 or 4 (n = 1,978). Participants were randomized to diabetes support and education or intensive lifestyle intervention. Measures included accelerometry-measured moderate-to-vigorous physical activity (MVPA), self-reported physical activity, and composite (morbidity and mortality) CVD outcomes.RESULTSIn pooled analyses of all participants, using Cox proportional hazards models, each 100 MET-min/week increase in accelerometry-measured MVPA from baseline to 4 years was associated with decreased risk of the subsequent primary composite outcome of CVD. Results were consistent for changes in total MVPA (hazard ratio 0.97 [95% CI 0.95, 0.99]) and MVPA accumulated in ≥10-min bouts (hazard ratio 0.95 [95% CI 0.91, 0.98]), with a similar pattern for secondary CVD outcomes. Change in accelerometry-measured MVPA at 1 year and self-reported change in physical activity at 1 and 4 years were not associated with CVD outcomes.CONCLUSIONSIncreased accelerometry-measured MVPA from baseline to year 4 is associated with decreased risk of CVD outcomes. This suggests the need for long-term engagement in MVPA to reduce the risk of CVD in adults with overweight/obesity and type 2 diabetes.

Introduction: The original Framingham Stroke Risk Profile (oFSRP) was designed to predict first-time, 10-year stroke risk and has been updated as the revised FSRP (rFSRP) to reflect current temporal trends in stroke. We assessed the performance of both profiles in a South Texas bi-ethnic cohort which includes European Americans (EA) and Mexican Americans (MA). Methods: Both profiles were calculated from a sample of the San Antonio Longitudinal Study of Aging (SALSA) cohort and included 439 subjects (69.4 +/-3.3 years), 265 (60%) women, and 225 (51%) MA. All subjects were aged 65 and older, stroke-free at baseline examination performed from 1992-1996, and followed for up to 12 years. Calibration of both profiles was assessed using the Hosmer-Lemeshow goodness-of-fit test and by comparing the expected with the observed 10-year stroke risks. C-statistics were calculated for the overall SALSA cohort and subgroups by sex and ethnicity with outcome of first-time stroke. Results: After a mean follow-up of 9.3 +/- 2.0 years, a total of 55 (12.6%) stroke events occurred. Predicted stroke risks using the oFSRP and rFSRP were 13.2% and 9.1%, respectively (Table). Overall, neither profile demonstrated good calibration (p Conclusions: Compared to the oFSRP, the rFSRP signaled better fit and discriminative ability for predicting 10-year stroke risk in our SALSA cohort sample. Although the rFSRP downgraded stroke risk, our sample spanned the 1990s and early 2000s and thus, may not represent current healthy lifestyle and stroke prevention trends. Our findings support the use of the rFSRP, rather than the oFSRP, for MA in South Texas and highlight the need for further studies with ongoing multi-ethnic cohorts.

Background Hospital professionals must attend to patients’ satisfaction with care. Along with technical quality of care, patients’ personal characteristics may affect that satisfaction, but standard demographics research often overlooks cultural links. Methods We, therefore, asked 58 San Antonio, Texas, inpatients their satisfaction with care and examined responses for attitudes related to ethnic—Mexican-American (MA), Euro-American (EA), or African-American (AA)—and gender cultures. Results Many attitudes occurred widely. Most respondents expected doctors to attend them faithfully, inform them honestly, and pursue their needs and wishes singularly. Most also trusted doctors, and expressed satisfaction with doctors’ generally exemplary character and service ethic. But most respondents also feared hospital treatments, and some expressed dissatisfaction that doctors had inadequately informed them or ignored their wishes. Only rare attitudes distinguished particular ethnic-gender groups. Unlike other groups few EA or AA men expressed dissatisfactions. But some MA and EA women said hospitals use too many caregivers or coordinate care poorly. Furthermore, most AA women expressed no explicit trust in doctors, and most EA women expressed actual distrust of doctors, often doubting their technical competence or altruism. Conclusions These findings suggest a novel perspective: a unique inpatient culture, largely unaffected by ethnic group or gender. Patients interpret their hospital experience through that culture. Hospital professionals might respond with both universal measures (addressing patients’ fears, dissatisfactions, and distrust) and targeted ones (explicitly asking EA and AA men about dissatisfactions, and AA and EA women about distrust). Such culturally grounded measures may help maintain or increase inpatients’ satisfaction.

PURPOSE OF REVIEW: Over half of the older adults in U.S. have multimorbidity, defined broadly as the presence of 2 or more chronic diseases in an individual. Multimorbidity has significant overlap with disability and frailty. In this review, we broadly review the concepts of multimorbidity, disability, and frailty, as well as their interrelationships, and ability to predict future adverse health outcomes in older adults. RECENT FINDINGS: Depending on the study, the prevalence of individuals with all three of multimorbidity, disability, and frailty ranges from 2–20%. Multimorbidity and patterns of multimorbidity are predictive of functional limitations, disability, health care usage, and mortality. The degree to which multimorbidity predicts these outcomes depends on many factors but partly upon the population examined and the presence of frailty and disability. SUMMARY: Multimorbidity is an emerging public health concern that is observed with and predictive of disability and frailty.

The Institute of Medicine (IOM) suggests that linkages between primary care practices and community-based resources can improve health in lower income and minority patients, but examples of these are rare. We conducted a prospective, mixed-methods observational study to identify indicators of primary care–community linkage associated with the frequency of visits to community-based senior centers and improvements in diabetes-related outcomes among 149 new senior center members (72% Hispanic). We used semistructured interviews at baseline and 9-month follow-up, obtaining visit frequency from member software and clinical assessments including hemoglobin A1c (HbA1c) from colocated primary care clinics. Members’ discussion of their activities with their primary care providers (PCPs) was associated with increased visits to the senior centers, as well as diabetes-related improvements. Direct feedback from the senior centers to their PCPs was desired by the majority of members and may help to reinforce use of community resources for self-management support.

Intentional weight loss is an important treatment option for overweight persons with type 2 diabetes mellitus (DM), but the effects on long term fracture risk are not known. The purpose of this Look AHEAD analysis was to evaluate whether long term intentional weight loss would increase fracture risk in overweight or obese persons with DM. Look AHEAD is a multicenter, randomized clinical trial. Recruitment began in August 2001 and follow-up continued for a median of 11.3 years at 16 academic centers. 5145 persons aged 45 – 76 with DM were randomized to either an intensive lifestyle intervention (ILI) with reduced calorie consumption and increased physical activity designed to achieve and maintain ≥7% weight loss or to diabetes support and education intervention (DSE). Incident fractures were ascertained every 6 months by self-report and confirmed with central adjudication of medical records. The baseline mean age of participants was 59 years, 60% were women, 63% were Caucasian, and the mean BMI was 36 kg/m2. Weight loss over the intervention period (median 9.6 years) was 6.0% in ILI and 3.5% in DSE. 731 participants had a confirmed incident fracture (358 in DSE v. 373 in ILI). There were no statistically significant differences in incident total or hip fracture rates between the ILI and DSE groups. However, compared to the DSE group, the ILI group had a statistically significant 39% increased risk of a frailty fracture (HR = 1.39, 95% CI 1.02, 1.89). An intensive lifestyle intervention resulting in long term weight loss in overweight/obese adults with DM was not associated with an overall increased risk of incident fracture but may be associated with an increased risk of frailty fracture. When intentional weight loss is planned, consideration of bone preservation and fracture prevention is warranted.

Type 2 diabetes mellitus (T2DM) is a major risk factor for falls and frailty in older adults. The purpose of this review was to survey, the current literature on risk factors and interventions for prevention of falls and frailty in older adults with T2DM. Screening for falls and frailty in the clinical setting is recommended. Exercise to improve balance, strength, and mobility; health education; and diabetes self-management are potential interventions for falls and frailty in older adults with T2DM. Pharmacologic agents are the focus of current studies which may lead to potential future interventions for both falls and frailty. Evidence-based guidelines and tools for prevention and management of falls and frailty have been developed for clinicians caring for older adults. Because of the reciprocal relationship between falls and frailty, interventions to prevent one may also improve the other geriatric syndrome.

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.

Background/objectives Type 2 diabetes mellitus and obesity are sometimes described as conditions that accelerate aging. Multidomain lifestyle interventions have shown promise to slow the accumulation of age-related diseases, a hallmark of aging. However, they have not been assessed among at-risk individuals with these two conditions. We examined the relative impact of 8 years of a multidomain lifestyle intervention on an index of multimorbidity. Design Randomized controlled clinical trial comparing an intensive lifestyle intervention (ILI) that targeted weight loss through caloric restriction and increased physical activity with a control condition of diabetes support and education (DSE). Setting Sixteen U.S. academic centers. Participants A total of 5,145 volunteers, aged 45 to 76, with established type 2 diabetes mellitus and overweight or obesity who met eligibility criteria for a randomized controlled clinical trial. Measurements A multimorbidity index that included nine age-related chronic diseases and death was tracked over 8 years of intervention delivery. Results Among individuals assigned to DSE, the multimorbidity index scores increased by an average of .98 (95% confidence interval [CI] = .94-1.02) over 8 years, compared with .89 (95% CI = .85-.93) among those in the multidomain ILI, which was a 9% difference (P = .003). Relative intervention effects were similar among individuals grouped by baseline body mass index, age, and sex, and they were greater for those with lower levels of multimorbidity index scores at baseline. Conclusions Increases in multimorbidity over time among adults with overweight or obesity and type 2 diabetes mellitus may be slowed by multidomain ILI. J Am Geriatr Soc 68:2249-2256, 2020.

OBJECTIVES Cognitive decline and gait speed slowing are independent predictors of disability and mortality. While both factors increase in prevalence with advancing age, little is known about their combined patterns of change. The study goal was to identify joint trajectories of cognition and gait speed within an aging bi-ethnic cohort of Mexican Americans and European Americans. METHODS/DESIGN Participants included 182 Mexican Americans and 188 European Americans, ages 65 to 74, who were followed over a mean of 9.5 years. Cognition was assessed with the mini-mental state examination and gait speed was examined with a timed 10-ft walk. Joint trajectory classes of cognition and gait speed were identified with latent growth mixture modeling. Odd-ratios assessed predictors for trajectory classes. RESULTS Three latent trajectory classes were identified: (a) relatively stable cognition and gait (termed stable cognition and gait class, 65.4%); (b) deteriorating cognition and gait (termed cognitive and physical vulnerability class, 22.2%); (c) stable cognition and deteriorating gait (termed physical vulnerability class, 12.4%). The odds of classification in the cognitive and physical vulnerability class vs stable cognition and gait class was associated with Mexican American ethnicity (OR = 3.771, P = .016), age (OR = 1.186, P = .017), income (OR = 0.828, P = .029), education (OR = 0.703, P

Background/objectives Ideally, doctors ask each patient's current views about involvement in decision-making, but inquiries prove inconclusive with some inpatients. Doctors may then need indirect indicators of those views. We, therefore, explored ethnic group and sex as cultural indicators of patients' current preferences and perceptions about such involvement. Methods In open-response interviews, we asked those preferences and perceptions of 26 Mexican American (MA), 18 Euro-American (EA), and 14 African American (AA) adult inpatients. We content-analyzed responses blindly to identify themes and linked those themes to ethnic group and sex. Results Only sex indicated patients' current preferences. Regardless of ethnic group, most men preferred decision-making by the doctor (with or without the patient); most women, decision-making by the patient (with or without the doctor). But both ethnic group and sex together indicated patients' current perceptions. Specifically, each ethnic group as a whole most often perceived decision-making by the doctor alone and the patient alone on separate occasions, but the sexes within ethnic groups differed. For MAs roughly equal numbers of men and women perceived such decision making, for EAs more men than women did so, and for AAs more women than men did so. In addition, no EA men but some EA women perceived decision-making by the doctor alone, and some MA men and women-but no EAs or AAs-perceived decision-making by the patient alone. Primarily ethnic group indicated matches between current preferences and perceptions: Most EAs had matches; most MAs and AAs did not. Conclusions Whenever direct inquiries fail, ethnic group and sex may indicate adult inpatients' current preferences and perceptions about involvement in decision-making. Yet matching those preferences and perceptions, especially for minority patients, remains difficult.

OBJECTIVE To examine whether depression symptoms or antidepressant medication (ADM) use predicts the probability of cardiovascular events in overweight/obese individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS Preplanned analyses of depression and incident cardiovascular disease (CVD) were performed in the Look AHEAD (Action for Health in Diabetes) weight loss trial after a median follow-up of 9.6 years. Depression symptoms, assessed with the Beck Depression Inventory (BDI), were analyzed both as a continuous and dichotomized variable (BDI score RESULTS Depression symptoms were only significantly associated with a composite secondary outcome comprising CVD death, nonfatal myocardial infarction, nonfatal stroke, hospitalized angina, congestive heart failure, peripheral vascular disease, coronary artery bypass graft, and carotid endarterectomy. Significant sex interactions were observed for BDI score and BDI score ≥10. BDI score was significantly associated with higher probability of this composite outcome in men but was not associated with the outcome in women. BDI score ≥10 was positively associated with this composite outcome in men but was negatively associated in women. Exploratory analysis identified a significant BDI ≥10 × ADM use interaction for this composite outcome that differed in men versus women. Men with both BDI score ≥10 and ADM use compared with those with neither had 60% higher probability of the outcome, whereas women with both compared with those with neither had 50% lower probability. CONCLUSIONS Sex differences in the association of depression symptoms and ADM use with incident CVD warrant further investigation.

Higher diabetes prevalence and lower socioeconomic status (SES) may explain the greater frailty prevalence observed among MAs compared to EAs (11.3 vs. 7.0%). In this study, subjects were 371 MA and 344 EA participants in the San Antonio Longitudinal Study of Aging baseline examination. Logistic regression was used to examine odds of frailty (Fried criteria) by ethnicity, adjusting for age, sex, diabetes, income, and comorbidity. Frailty odds remained significantly higher in MAs vs. EAs after adjustment for age and sex (OR =1.79, 95%CI: 1.05–3.05, p=0.03). However, the ethnic difference was not significant after adjustment for diabetes, which was associated with three-fold greater frailty odds (OR =3.05, 95%CI: 1.73–5.38, p

The Institute of Medicine has noted that there is great potential to leverage the infrastructure of community resources to improve health outcomes in lower income and minority patients through primary care-public health linkages, but examples of these are rare. We conducted a prospective, mixed methods observational study to identify indicators of primary care-community linkage associated with frequency of visits to community-based, multi-purpose senior centers and improvements in diabetes-related outcomes among 149 newly enrolled senior center members (72% Hispanic). We used semi-structured interviews at baseline and 9-months follow-up to ascertain patient characteristics and experiences, obtaining visit frequency from senior center software and measures of Hemoglobin A1c (HbA1c) and BMI from co-located primary care clinics. In multivariable linear regression, patients’ discussion of senior center activities with their primary care providers (PCPs) (t=2.15, p=0.03), but not source of primary care (t= -0.48, p=0.63) or referral status (t= -0.86, p=0.39), was significantly associated with frequency of visits after controlling for sociodemographic characteristics, travel distance from home to senior center, disease burden, diabetes status, and sedentary behavior. Members’ discussion of senior center activities with their PCPs was significantly associated with reductions of 0.57% in HbA1c (p=0.005) and 0.68 kg/m2 in BMI (p=0.046) at follow-up, controlling for baseline covariates and number of senior center visits. In addition, the majority of these patients wanted direct feedback from the senior centers to their PCPs, which may help reinforce use of community-based resources to support self-management among aging patients, including minorities, with diabetes or other chronic conditions.

Objective The aim of this study was to characterize weight loss, treatment engagement, and weight control strategies utilized by African American, Hispanic, and non-Hispanic white participants in the Action for Health in Diabetes (Look AHEAD) Intensive Lifestyle Intervention by racial/ethnic and sex subgroups. Methods Weight losses at 1, 4, and 8 years among 2,361 adults with obesity and type 2 diabetes randomized to intervention (31% minority; 42% men) are reported by subgroup. Multivariable models within subgroups examine relative contributions of treatment engagement variables and self-reported weight control behaviors. Results All subgroups averaged weight losses ≥ 5% in year 1 but experienced regain; losses ≥ 5% were sustained at year 8 by non-Hispanic white participants and minority women (but not men). Session attendance was high (≥ 86%) in year 1 and exceeded protocol-specified minimum levels into year 8. Individual session attendance had stronger associations with weight loss among Hispanic and African American participants than non-Hispanic white participants at 4 years (P = 0.04) and 8 years (P = 0.001). Daily self-weighing uptake was considerable in all subgroups and was a prominent factor associated with year 1 weight loss among African American men and women. Greater meal replacement use was strongly associated with poorer 1-year weight losses among African American women. Conclusions Experiences of minority men and women with diabetes in lifestyle interventions fill important gaps in the literature that can inform treatment delivery.

Objective: To examine whether odds of frailty differ by DPP intervention arms (intensive lifestyle intervention [ILS], metformin [MET], placebo [PLB] after long-term follow-up in the DPPOS. Methods: DPP, a randomized trial of individuals at high risk of diabetes, lasted 2.8 years, after which there was a 13-month bridge period in which 16 sessions of group ILS was offered to all participants. During DPPOS, ILS was offered lifestyle reinforcement semi-annually and MET received unmasked metformin. Frailty was measured initially in DPPOS Year 8 in 2385 participants and repeated in 2264 of these in Year 10 (12 and 14 years after randomization). Using Fried criteria, presence of 3 of 5 characteristics (slow walking speed, weak grip strength, unintentional weight loss, low physical activity, and exhaustion) was classified as frail, 1 or 2 pre-frail, and 0 non-frail.: GEE models adjusting for visit year were employed with repeated measures pooled from Years 8 and 10 to estimate pairwise odds ratios between ILS, MET and PLB for the outcomes of frail and pre-frail vs. non-frail. Results: Odds of frailty vs. non-frailty were 37% lower in ILS compared to PLB (Table) and MET (OR=0.629, CI= 0.420-0.942, p=0.024). There were no significant treatment group differences in odds of pre-frailty. Conclusion: ILS intervention in persons at high risk of diabetes may reduce frailty in later life.12 years Post-randomization14 years post-randomizationOdds of Frailty vs. Non-Frailty Pooled over both examsTreatment GroupPrevalencePrevalence OR (95% CI) compared with placeboP-valuePre-FrailtyFrailtyPre-FrailtyFrailtyPlacebo42.8%5.7%43.7%5.4%1 (referent)n/aMetformin45.8%5.4%42.5%5.3%0.994 (0.694-1.424)0.976Lifestyle46.8%3.0%46.3%3.6%0.625 (0.419-0.934)0.022 Disclosure H.P. Hazuda: None. Q. Pan: None. J.P. Crandall: None. H. Florez: Advisory Panel; Self; Sanofi. J.A. Luchsinger: None. E.M. Venditti: None. A. Kriska: None. S. Golden: None. G. Bray: Advisory Panel; Self; Herbalife International of America, Inc., Novo Nordisk A/S. D. Research Group: None.

Weight loss prevents progression to diabetes but long term effects on lean mass are unknown. We determined if intensive lifestyle modification (ILS), metformin (MET) or placebo (PLB) treatment in the Diabetes Prevention Program (DPP) had differential effects on appendicular lean mass (ALM) and sarcopenic-obesity (SO) ∼16 years after DPP randomization in the DPP Outcome Study (DPPOS). During DPP, 3234 participants at high risk for diabetes were randomized to ILS, MET or PLB; 2779 continued in DPPOS and were offered modified group ILS. During DPPOS, ILS was offered additional lifestyle reinforcement semi-annually and MET received unmasked metformin. This analysis includes 1374 DPPOS participants who had dual-energy X-ray absorptiometry scans at year 12 for ALM (sum of lean mass in arms and legs). Low ALM was defined as ALM/BMI 30. Prevalence of low ALM and SO was compared across the 3 groups using Pearson’s chi-squared test. Logistic regression models determined the associations between treatment and low ALM or SO and between weight loss and low ALM or SO. Mean age at Y12 was 66.5 (±9.5) years. Mean time since DPP baseline was 15.6 (±0.7) years. Weight loss (DPP baseline to DPPOS Y12) did not differ by group (-4.4 kg ILS; -3.5 kg MET; -3.1 kg PLB; p=0.114). Prevalence of low ALM differed by group in men (35.7% ILS, 28.3% MET, 22.5% PLB; p=0.049) but not women (20.9% ILS, 24.8% MET, 24.1% PLB; p=0.482). In men, low ALM prevalence was higher in ILS compared with PLB (P=0.024) but not in MET vs. PLB. Prevalence of SO did not differ across groups in men (23.1% ISL, 22.0% MET, 14.1% PLB; p=0.112) or women (17.3% ILS, 20.9% MET, 20.3% PLB; p=0.492). SO prevalence was not different in ILS vs. PLB or in MET vs. PLB in men or women. More weight loss was associated with higher risk of low ALM and SO in women and men (p Disclosure A.V. Schwartz: None. Q. Pan: None. H.P. Hazuda: None. E. Horton: Advisory Panel; Self; PTS Diagnostics, Merck & Co., Inc., Theracos, Inc.. M.A. Hoskin: None. R. Rastogi Kalyani: None. W.C. Knowler: None. A. Kriska: None. M. Schlögl: None. H. Florez: Advisory Panel; Self; Sanofi. D. Research Group: None.

Objective Little is known about the effects of social support on weight loss in Latinos. This study determined whether sex moderated and treatment adherence mediated the association between social support and weight loss. Methods Data from 278 Latino males and females with type 2 diabetes in the Intensive Lifestyle Intervention of the Look AHEAD trial were analyzed. Multivariable modeling tested for moderation and parallel multiple mediator modeling simultaneously tested the mediating effects of adherence to physical activity, diet, and session attendance on the relationship between baseline social support and percent weight loss at 1 year. Results Social support for physical activity (having family and friends join in physical activity) was related to weight loss. Adherence to physical activity was related to both social support for physical activity and weight loss. Sex did not moderate these relationships. Adherence to physical activity completely mediated the relationship between social support for physical activity and weight loss. Conclusions Increasing companionship for physical activity may be an effective intervention strategy to promote behaviors important for weight loss among Latinos.

Background Mexican Americans comprise the most rapidly growing segment of the older US population and are reported to have poorer functional health than European Americans, but few studies have examined factors contributing to ethnic differences in walking speed between Mexican Americans and European Americans. Objective The purpose of this study was to examine factors that contribute to walking speed and observed ethnic differences in walking speed in older Mexican Americans and European Americans using the disablement process model (DPM) as a guide. Design This was an observational, cross-sectional study. Methods Participants were 703 Mexican American and European American older adults (aged 65 years and older) who completed the baseline examination of the San Antonio Longitudinal Study of Aging (SALSA). Hierarchical regression models were performed to identify the contribution of contextual, lifestyle/anthropometric, disease, and impairment variables to walking speed and to ethnic differences in walking speed. Results The ethic difference in unadjusted mean walking speed (Mexican Americans=1.17 m/s, European Americans=1.29 m/s) was fully explained by adjustment for contextual (ie, age, sex, education, income) and lifestyle/anthropometric (ie, body mass index, height, physical activity) variables; adjusted mean walking speed in both ethnic groups was 1.23 m/s. Contextual variables explained 20.3% of the variance in walking speed, and lifestyle/anthropometric variables explained an additional 8.4%. Diseases (ie, diabetes, stroke, chronic obstructive pulmonary disease) explained an additional 1.9% of the variance in walking speed; impairments (ie, FEV1, upper leg pain, and lower extremity strength and range of motion) contributed an additional 5.5%. Thus, both nonmodifiable (ie, contextual, height) and modifiable (ie, impairments, body mass index, physical activity) factors contributed to walking speed in older Mexican Americans and European Americans. Limitations The study was conducted in a single geographic area and included only Mexican American Hispanic individuals. Conclusions Walking speed in older Mexican Americans and European Americans is influenced by modifiable and nonmodifiable factors, underscoring the importance of the DPM framework, which incorporates both factors into the physical therapist patient/client management process.

Objectives To examine the association between neighborhood residence and frailty prevalence in older Mexican Americans (MAs). Design Cross-sectional, observational study. Setting Socioeconomically and ethnically diverse neighborhoods in San Antonio, Texas. Participants Community-dwelling older MA adults (aged ≥65) who completed the baseline examination of the San Antonio Longitudinal Study of Aging (SALSA) (1992–1996) (N = 394). Measurements Subjects were randomly sampled from three types of neighborhoods that varied in ethnic composition and economic environment: barrio (low-income, exclusively MA), transitional (middle-income, equal proportion MAs and European Americans (EAs)) and suburban (upper-income, predominantly EA). Frailty was classified using the Fried criteria. Frailty odds were estimated according to neighborhood using logistic regression, with the suburban neighborhood as the reference category. Covariates included age, sex, diseases, depressive symptoms, and cognitive function. Results Frailty prevalence was 15.6% in the barrio, 9.4% in the transitional neighborhood, and 3.5% in the suburbs (P = .01). After adjusting for sociodemographic characteristics and disease covariates, odds of frailty were 4.15 times as high for MAs residing in the barrio as for those residing in the suburbs (P = .03). After adjustment for depression and cognition, this association was no longer significant. Diabetes mellitus and depression accounted for the higher odds of frailty in the barrio. Although odds of frailty in the transitional neighborhood were 1.95 times as high as those in the suburbs, the difference was not statistically significant. Conclusion The ethnic composition and economic environment of the neighborhoods in which MA older adults reside are strongly associated with their odds of being frail.

Objective:To assess whether an average of 10 years of lifestyle intervention designed to reduce weight and increase physical activity lowers the prevalence of cognitive impairment among adults at increased risk due to type 2 diabetes and obesity or overweight.Methods:Central adjudication of mild cognitive impairment and probable dementia was based on standardized cognitive test battery scores administered to 3,802 individuals who had been randomly assigned, with equal probability, to either the lifestyle intervention or the diabetes support and education control. When scores fell below a prespecified threshold, functional information was obtained through proxy interview.Results:Compared with control, the intensive lifestyle intervention induced and maintained marked differences in weight loss and self-reported physical activity throughout follow-up. At an average (range) of 11.4 (9.5–13.5) years after enrollment, when participants' mean age was 69.6 (54.9–87.2) years, the prevalence of mild cognitive impairment and probable dementia was 6.4% and 1.8%, respectively, in the intervention group, compared with 6.6% and 1.8%, respectively, in the control group (p = 0.93). The lack of an intervention effect on the prevalence of cognitive impairment was consistent among individuals grouped by cardiovascular disease history, diabetes duration, sex, and APOE ε4 allele status (all p ≥ 0.50). However, there was evidence (p = 0.03) that the intervention effect ranged from benefit to harm across participants ordered from lowest to highest baseline BMI.Conclusions:Ten years of behavioral weight loss intervention did not result in an overall difference in the prevalence of cognitive impairment among overweight or obese adults with type 2 diabetes.Clinicaltrials.gov identifier:NCT00017953 (Action for Health in Diabetes).Level of evidence:This study provides Class II evidence that for overweight adults with type 2 diabetes, a lifestyle intervention designed to reduce weight and increase physical activity does not lower the risk of cognitive impairment.

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/m(2)) 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, SPPB(exp)), 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 (

Intentional weight loss is an important treatment option for overweight persons with type 2 diabetes mellitus (DM), but the effects on long-term fracture risk are not known. The purpose of this Look AHEAD analysis was to evaluate whether long-term intentional weight loss would increase fracture risk in overweight or obese persons with DM. Look AHEAD is a multicenter, randomized clinical trial. Recruitment began in August 2001 and follow-up continued for a median of 11.3 years at 16 academic centers. A total of 5145 persons aged 45 to 76 years with DM were randomized to either an intensive lifestyle intervention (ILI) with reduced calorie consumption and increased physical activity designed to achieve and maintain ≥7% weight loss or to diabetes support and education intervention (DSE). Incident fractures were ascertained every 6 months by self-report and confirmed with central adjudication of medical records. The baseline mean age of participants was 59 years, 60% were women, 63% were white, and the mean BMI was 36 kg/m

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 metabolically healthy (MHO) and unhealthy obese (MUHO) differ in terms of cardiovascular risk. However, little is known about predicting the development of these phenotypes and the future stability of the MHO phenotype. Therefore, we examined these two issues in the San Antonio Heart Study. Longitudinal, population-based study of cardiometabolic risk factors among Mexican Americans and non-Hispanic whites in San Antonio. The study sample included 2368 participants with neither MUHO nor diabetes at baseline. Median follow-up was 7.8 years. MHO was defined as obesity with ⩽1 metabolic abnormality; MUHO, as obesity with ⩾2 abnormalities. At baseline, 1595 and 498 individuals were non-obese with ⩽1 and ⩾2 metabolic abnormalities, respectively, and 275 were MHO. Among non-obese individuals, independent predictors of incident MHO (odds ratio (OR) for 1 s.d. change (95% confidence interval)) included body mass index (8.12 (5.66–11.7)), triglycerides (0.52 (0.39–0.68)) and high-density lipoprotein cholesterol (HDL-C) (1.41 (1.11–1.81)), whereas independent predictors of incident MUHO included body mass index (5.97 (4.58–7.77)) and triglycerides (1.26 (1.05–1.51)). Among participants with ⩽1 metabolic abnormality, obesity was associated with greater odds of developing multiple metabolic abnormalities (OR 2.26 (1.74–2.95)). Triglycerides and HDL-C may be useful for predicting progression to MHO. MHO may not be a stable condition, because it confers an increased risk of developing multiple metabolic abnormalities.

Mexican Americans (MA) have higher morbidity compared to European Americans (EA); however, the mortality rate remains lower (Hispanic Paradox). The Healthy Aging Index (HAI) captures clinical and subclinical morbidity in older adults and is useful in examining ethnic differences in mortality for a given disease burden. We assessed the association between baseline HAI and all-cause mortality over 12 years of follow-up among older MAs (n=394) and EAs (n=355) in the San Antonio Longitudinal Study of Aging (SALSA) and examined differences between ethnic groups. HAI incorporates non-invasive measures (systolic blood pressure, forced vital capacity, creatinine, fasting plasma glucose (FPG), Mini-Mental State Exam). Missing baseline data for HAI components and covariates were imputed using multiple imputations. Proteinuria was used instead of creatinine due to non-availability. Scores of 0, 1, 2 were given from lowest to highest tertile HAI categories; diagnosis of diabetes, hypertension, and renal failure were included in the highest tertiles. Cox proportional hazards models estimated the association between HAI and mortality, adjusting for confounders. After adjusting for age, gender, education, income, BMI, smoking and ethnicity, HAI was independently associated with mortality (HR 1.25 (1.16-1.35), p-value

Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients.In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years.The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51).An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others; Look AHEAD ClinicalTrials.gov number, NCT00017953.).

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.

Objectives To assess whether randomization to 10 years of lifestyle intervention to induce and maintain weight loss improves cognitive function. Design Randomized controlled clinical trial. Setting Data obtained as part of the Action for Health in Diabetes (Look AHEAD) trial (NCT00017953) and Look AHEAD Continuation study (U01 DK057136-15). Participants Overweight and obese individuals with type 2 diabetes mellitus aged 45 to 76 (N = 3,751). Intervention Intensive lifestyle intervention (ILI) for weight loss through reduced caloric intake and increased physical activity compared with a control condition of diabetes support and education (DSE). Measurements Certified examiners who were masked to intervention assignment administered a standard battery of cognitive function tests (Modified Mini-Mental State Examination, Rey Auditory Verbal Learning Test, Digit Symbol Coding, Trail-Making Test, Modified Stroop Color-Word Test) to participants 10 to 13 years after enrollment. Results Assignment to lifestyle intervention was not associated with significantly different overall (P = .10) or domain-specific (all P > .10) cognitive function than assignment to diabetes support and education. Results were fairly consistent across prespecified groups, but there was some evidence of trends for differential intervention effects showing modest harm in ILI in participants with greater body mass index and in individuals with a history of cardiovascular disease. Cognitive function was not associated with changes in weight or fitness (all P > .05). Conclusion A long-term behavioral weight loss intervention for overweight and obese adults with diabetes mellitus was not associated with cognitive benefit. Trial Registration clinicaltrials.gov Identifier: NCT00017953.

Aims/hypothesis The aim of this study was to evaluate the effects on diabetic peripheral neuropathy (DPN) of a long-term intensive lifestyle intervention (ILI) programme designed to achieve and maintain weight loss. Methods Beginning in 2001, a total of 5145 overweight or obese people with type 2 diabetes, aged 45–76 years, participating in the multicentre Look AHEAD (Action for Health in Diabetes) study were randomised to ILI (n = 2570) or to a diabetes support and education (DSE) control group (n = 2575) using a web-based management system at the study coordinating centre at Wake Forest School of Medicine (Winston-Salem, NC, USA). Randomisation was stratified by clinical centre and was not revealed to the clinical staff responsible for obtaining data on study outcomes. Because of the nature of the study, patients and the local centre interventionists were not blinded to the study group assignments. In addition, the coordinating centre staff members responsible for data management and statistical analyses were not blinded to the study group assignments. The interventions were terminated in September 2012, 9–11 years after randomisation, but both groups continued to be followed for both primary and secondary outcomes. Neuropathy evaluations included the Michigan Neuropathy Screening Instrument (MNSI) questionnaire completed at baseline in 5145 participants (ILI n = 2570, DSE n = 2575) and repeated annually thereafter and the MNSI physical examination and light touch sensation testing conducted in 3775 participants (ILI n = 1905, DSE n = 1870) 1–2.3 years after discontinuation of the intervention. Results At baseline, the MNSI questionnaire scores were 1.9 ± 0.04 and 1.8 ± 0.04 in the ILI and DSE groups, respectively (difference not statistically significant). After 1 year, when weight loss was maximal in the ILI group (8.6 ± 6.9%) compared with DSE (0.7 ± 4.8%), the respective MNSI scores were 1.7 ± 0.04 and 2.0 ± 0.04 (p ≤ 0.001). Subsequently, the scores increased gradually in both groups, but remained significantly lower in the ILI group for the first 3 years and at the end of follow-up. In both groups, there was a significant association between changes in the MNSI scores and changes in body weight, HbA1c and serum lipids. There were no significant between-group differences in the proportions of participants with MNSI physical examination scores ≥2.5, considered to be indicative of diabetic neuropathy. The light touch sensation measured separately in either the right or left big toes (halluces) did not differ between ILI and DSE, but when the data were combined for both toes, light touch was better preserved in the ILI group. Conclusions/interpretation ILI resulted in a significant decrease in questionnaire-based DPN, which was associated with the magnitude of weight loss. In both the ILI and DSE groups, changes in the MNSI score were also related to changes in HbA1c and lipids. There were no significant effects of ILI on physical examination measures of DPN conducted 1–2.3 years after termination of the active intervention, except for light touch sensation, which was significantly better in the ILI group when measurements were combined for both toes. However, a potential limiting factor to the interpretation of the physical examination data is that no baseline studies are available for comparison. Trial registration: ClinicalTrials.gov NCT00017953. Funding: This work was funded by the National Institutes of Health through cooperative agreements with the National Institute of Diabetes and Digestive and Kidney Diseases. Electronic supplementary material The online version of this article (doi:10.1007/s00125-017-4253-z) contains peer-reviewed but unedited supplementary material, which is available to authorised users.

OBJECTIVE We examined the association of the Diabetes Prevention Program (DPP) intervention arms (lifestyle intervention, metformin, and placebo) with cognition in the Diabetes Prevention Program Outcomes Study (DPPOS). We also examined metformin use, incident type 2 diabetes, and glycemia as exposures. RESEARCH DESIGN AND METHODS The DPP lasted 2.8 years, followed by a 13-month bridge to DPPOS. Cognition was assessed in DPPOS years 8 and 10 (12 and 14 years after randomization) with the Spanish English Verbal Learning Test (SEVLT), letter fluency and animal fluency tests, Digit Symbol Substitution Test (DSST), and a composite cognitive score. RESULTS A total of 2,280 participants (749 lifestyle, 776 metformin, and 755 placebo) aged 63.1 ± 10.7 years underwent cognitive assessments; 67.7% women, 54.6% non-Hispanic white, 20.7% non-Hispanic black, 14.6% Hispanic, 5.5% American Indian, and 4.6% Asian; 26.6% were homozygous or heterozygous for APOE-ε4. At the time of cognitive assessment, type 2 diabetes was higher in the placebo group (57.9%; P < 0.001) compared with lifestyle (47.0%) and metformin (50.4%). Metformin exposure was higher in the metformin group (8.72 years; P < 0.001) compared with placebo (1.43 years) and lifestyle (0.96 years). There were no differences in cognition across intervention arms. Type 2 diabetes was not related to cognition, but higher glycated hemoglobin at year 8 was related to worse cognition after confounder adjustment. Cumulative metformin exposure was not related to cognition. CONCLUSIONS Exposure to intensive lifestyle intervention or metformin was not related to cognition among DPPOS participants. Higher glycemia was related to worse cognitive performance. Metformin seemed cognitively safe among DPPOS participants.

Background Findings from the Look AHEAD trial showed no significant reductions in the primary outcome of cardiovascular disease incidence in adults with type 2 diabetes randomly assigned to an intensive lifestyle intervention for weight loss compared with those randomly assigned to diabetes support and education (control). We examined whether the incidence of cardiovascular disease in Look AHEAD varied by changes in weight or fitness. Methods Look AHEAD was a randomised clinical trial done at 16 clinical sites in the USA, recruiting patients from Aug 22, 2001, to April 30, 2004. In the trial, 5145 overweight or obese adults aged 45-76 years with type 2 diabetes were assigned (1:1) to an intensive lifestyle intervention or diabetes support and education. In this observational, post-hoc analysis, we examined the association of magnitude of weight loss and fitness change over the first year with incidence of cardiovascular disease. The primary outcome of the trial and of this analysis was a composite of death from cardiovascular causes, non-fatal acute myocardial infarction, non-fatal stroke, or admission to hospital for angina. The secondary outcome included the same indices plus coronary artery bypass grafting, carotid endartectomy, percutaneous coronary intervention, hospitalisation for congestive heart failure, peripheral vascular disease, or total mortality. We adjusted analyses for baseline differences in weight or fitness, demographic characteristics, and risk factors for cardiovascular disease. The Look AHEAD trial is registered with ClinicalTrials.gov, number NCT00017953. Findings For the analyses related to weight change, we excluded 311 ineligible participants, leaving a population of 4834; for the analyses related to fitness change, we excluded 739 participants, leaving a population of 4406. In analyses of the full cohort (ie, combining both study groups), over a median 10·2 years of follow-up (IQR 9·5-10·7), individuals who lost at least 10% of their bodyweight in the first year of the study had a 21% lower risk of the primary outcome (adjusted hazard ratio [HR] 0·79, 95% CI 0·64-0·98; p=0·034) and a 24% reduced risk of the secondary outcome (adjusted HR 0·76, 95% CI 0·63-0·91; p=0·003) compared with individuals with stable weight or weight gain. Achieving an increase of at least 2 metabolic equivalents in fitness change was associated with a significant reduction in the secondary outcome (adjusted HR 0·77, 95% CI 0·61-0·96; p=0·023) but not the primary outcome (adjusted HR 0·78, 0·60-1·03; p=0·079). In analyses treating the control group as the reference group, participants in the intensive lifestyle intervention group who lost at least 10% of their bodyweight had a 20% lower risk of the primary outcome (adjusted HR 0·80, 95% CI 0·65-0·99; p=0·039), and a 21% lower risk of the secondary outcome (adjusted HR 0·79, 95% CI 0·66-0·95; p=0·011); however, change in fitness was not significantly associated with a change in the primary outcome. Interpretation The results of this post-hoc analysis of Look AHEAD suggest an association between the magnitude of weight loss and incidence of cardiovascular disease in people with type 2 diabetes. These findings suggest a need to continue to refine approaches to identify individuals who are most likely to benefit from lifestyle interventions and to develop strategies to improve the magnitude of sustained weight loss with lifestyle interventions. Funding US National Institute of Diabetes and Digestive and Kidney Diseases.

OBJECTIVE Short-term weight loss improves cardiovascular disease (CVD) risk factors. We sought to determine the longer-term effects of maintaining weight loss or, conversely, regaining weight. RESEARCH DESIGN AND METHODS We used data from Action for Health in Diabetes (Look AHEAD), a randomized trial of intensive lifestyle intervention (ILI) compared to a control condition in overweight/obese individuals with type 2 diabetes. ILI participants were grouped according to weight change patterns, as follows: 1) no weight loss (±3% at years 1 and 4); 2) moderate weight loss (3–8% at years 1 and 4); 3) large weight loss (8–20% at years 1 and 4); 4) moderate loss/full regain (3–8% at year 1/±3% at year 4); 5) large loss/full regain (8–20% at year 1/± 3% year 4); and 6) large loss/partial regain (8–20% at year 1/3–8% at year 4) and changes in CVD risk factors were compared. RESULTS Adjusting for baseline differences and medication use, larger weight losses produced greater improvements in HbA1c, systolic blood pressure, HDL cholesterol, and triglycerides at years 1 and 4 (all P ≤ 0.02). Despite maintenance of weight loss, HbA1c levels worsened between years 1 and 4, and remained below baseline only in those with large weight losses. We found no negative associations of losing and regaining weight relative to not having lost weight. Moreover, those who had large initial weight loss but full regain of weight had greater improvements in HbA1c levels at year 4 than those with smaller or no initial weight loss. CONCLUSIONS Larger initial weight loss should be encouraged in individuals with type 2 diabetes, despite the possibility of regain.

Background Because beliefs about the soul after death affect the dying experience, patients and survivors may want to discuss those beliefs with their healthcare provider; however, almost no medical research describes such beliefs, leaving healthcare professionals ill prepared to respond. This exploratory study begins the descriptive process. Methods Assuming that culture is key, we asked older adult Mexican American (MA), European American (EA), and African American (AA) inpatients their beliefs about whether the soul lives on after physical death; if so, where; and what the "afterlife" is like. Results Some beliefs varied little across the sample. For example, most participants said that the soul lives on after physical death, leaves the body immediately at death, and eventually reaches heaven. Many participants also said death ends physical suffering; however, other beliefs varied distinctly by ethnic group or sex. More AAs than MAs or EAs said that they believed that the soul after physical death exists in the world (57% vs 35% and 33%) or interacts with the living (43% vs 31% and 28%). Furthermore, in every ethnic group more women than men said they believed that the soul exists in the world (42% vs 29% for MAs, 45% vs 14% for EAs, and 71% vs 43% for AAs). Conclusions As death nears, patients or survivors may want to discuss beliefs about the soul after death with their healthcare provider. This preliminary study characterizes some of those beliefs. By suggesting questions to ask and responses to give, the study provides healthcare professionals a supportive, knowledgeable way to participate in such discussions.

Mexican-Americans have more diabetes than non-Hispanic whites, but the extent to which insulin resistance and insulin secretion explain the ethnic difference is unknown.We analyzed selected indices of insulin resistance and secretion for both the ethnic difference and predictive discrimination.The San Antonio Heart Study is a longitudinal population-based study with a follow-up period of 7.5 yr.A total of 1540 nondiabetic individuals aged 25-64 yr were enrolled from January 1984 to December 1988.Homeostasis model assessment (HOMA) of insulin resistance and secretion were estimated by available formulas (HOMA-IR and HOMA β-cell) and computer program (HOMA2S and HOMA2B). Matsuda index and insulinogenic index from 0 to 30 and 0 to 120 min (ΔI0-30/ΔG0-30 and ΔI0-120/ΔG0-120) were also calculated.Incident diabetes was defined by the 2003 American Diabetes Association criteria.Incident diabetes was in excess in Mexican-Americans [odds ratio 2.26 (95% confidence interval, 1.53-3.34)]. Matsuda index explained a larger proportion of the ethnic difference than did HOMA-IR (49.2 vs. 31.0%; P0.001). The ethnic difference was not explained by measures of insulin secretion. Matsuda index and ΔI0-30/ΔG0-30 had a better predictive discrimination than their HOMA equivalents and ΔI0-120/ΔG0-120. HOMA estimates by the computer program offered no advantage over simple formulas for HOMA.Insulin resistance accounts for a large and significant proportion of the excess risk of diabetes in Mexican-Americans. Matsuda index is better than HOMA-IR for both explaining the ethnic difference and predicting diabetes.

To examine frailty transitions in Mexican American (MA) and European American (EA) older adults.Longitudinal, observational cohort study.Socioeconomically diverse neighborhoods in San Antonio, Texas.Three hundred twelve MA and 285 EA community-dwelling older adults (≥ 65) with frailty information at baseline (1992-1996) and transition information at follow-up (2000/01) in the San Antonio Longitudinal Study of Aging.Five frailty characteristics (weight loss, exhaustion, weakness, slowness, and low physical activity), frailty score (0-5), and overall frailty state (nonfrail = 0 characteristics, prefrail = 1 or 2, frail = ≥ 3) were assessed at baseline. Transitions (progressed, regressed, or no change) were assessed for frailty score and state. Odds ratios (ORs) of progression and regression in individual characteristics were estimated using generalized estimating equations adjusted for age, sex, ethnic group, socioeconomic status, comorbidity, diabetes, and follow-up interval.Diabetes mellitus with macrovascular complications (OR = 1.84, 95% confidence interval (CI) = 1.02-3.33), fewer years of education (OR = 0.96, 95% CI = 0.93-1.0) and follow-up interval (OR = 1.3, 95% CI = 1.17-1.46) were significant predictors of progression in any frailty characteristic. Mortality increased with greater frailty state, and prefrail individuals were more likely than frail individuals to regress.Diabetes mellitus with macrovascular complications and fewer years of education are important predictors of progression in any frailty characteristic. Because of greater risk of death than for the nonfrail state and greater likelihood of regression than for the frail state, the prefrail state may be an optimal target for intervention.

BACKGROUND: Beliefs about what happens at the time of death surely affect a patient's whole dying experience and could help guide end-of-life care. Yet virtually no research describes those beliefs. This exploratory study begins the descriptive process. METHODS: Assuming culture is key, we interviewed 26 Mexican-American (MA), 18 Euro-American (EA), and 14 African-American (AA) inpatients about their beliefs concerning what happens at the time of death. RESULTS: One belief, that death separates the dead from the living, was widespread. Majorities of all 3 ethnic group samples and of 5 of the 6 gender subsamples expressed this belief, saying the dead “go” or “leave” from this life. Other beliefs differed by ethnic group or gender. For example, more EAs (50%) than others said death is a momentary event, and more MAs (35%) than others said death involves “being taken” by an external force (always God or Jesus). Furthermore, considerably more EA women (45%) than others said some senses persist after death. In contrast, the physiologic signs that participants cited as defining the exact time of death varied from individual to individual with no ethnic or gender pattern, and no one sign predominated. CONCLUSIONS: A few beliefs about what happens at the time of death may characterize Americans in general; many other beliefs may characterize only certain ethnic groups, genders, or individuals. To identify such beliefs and to use them to guide end-of-life care, hospitalists and other health professionals may have to elicit them directly from patients or survivors. Journal of Hospital Medicine 2012. © 2011 Society of Hospital Medicine