The long-term effect of intentional weight loss on changes in bone mineral density in persons with type 2 diabetes: results from the Look AHEAD randomized trial.

Intentional weight loss has been shown to increase bone loss short term but the long-term effects are not known. Data from the Look AHEAD clinical trial shows that a long term intentional weight loss intervention was associated with greater bone loss at the hip in men. PURPOSE: Intentional weight loss has been shown to increase bone loss short term and increase frailty fracture risk, but the long-term effects on bone mineral density (BMD) are not known. METHODS: Data from a subgroup from the Look AHEAD (LA) multicenter, randomized clinical trial was used to evaluate whether a long term intentional weight loss intervention would increase bone loss. In a preplanned substudy, BMD was assessed at 5 of the 16 LA clinical centers using dual-energy X-ray absorptiometry at baseline, year 8, and the observational visit 12.6-16.3 years after randomization (year 12-16). RESULTS: At year 8, bone density loss (%) was greater in the Intensive Lifestyle Intervention (ILI) group compared with the control group (DSE) for the femoral neck (p = 0.0122) but this finding was not observed at the year 12-16 visit. In analyses stratified by gender, bone density loss (%) was greater at the total hip for men in the ILI group than the DSE group at both the year 8 and year 12-16 visits (year 8 p = 0.0263 and year 12-16 p = 0.0062). This finding was not observed among women. CONCLUSION: Long term intentional weight loss was associated with greater bone loss at the hip in men. These results taken with the previously published Look AHEAD data from the entire clinical trial showing increased frailty fracture risk with weight loss in the ILI group suggest that when intentional weight loss is planned, consideration of bone density preservation and fracture prevention strategies is warranted. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00017953. June 21, 2001.

Changes in mood and health-related quality of life in Look AHEAD 6 years after termination of the lifestyle intervention.

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.

Association of Intensive Lifestyle and Metformin Interventions With Frailty in the Diabetes Prevention Program Outcomes Study.

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).

Inpatient Culture and Satisfaction With Care: A Novel Perspective.

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.

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.

Impact of an 8-Year Intensive Lifestyle Intervention on an Index of Multimorbidity.

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.

Intensive Weight Loss Intervention and Cancer Risk in Adults with Type 2 Diabetes: Analysis of the Look AHEAD Randomized Clinical Trial.

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.

Weight Change 2 Years After Termination of the Intensive Lifestyle Intervention in the Look AHEAD Study.

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.

History of Cardiovascular Disease, Intensive Lifestyle Intervention, and Cardiovascular Outcomes in the Look AHEAD Trial.

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.

Provider-Related Linkages Between Primary Care Clinics and Community-Based Senior Centers Associated With Diabetes-Related Outcomes.

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.

Weight Loss Experiences of African American, Hispanic, and Non-Hispanic White Men and Women with Type 2 Diabetes: The Look AHEAD Trial.

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.

Patient-centered Involvement in Decision-Making: Ethnic Group and Sex as Indicators of Patients' Preferences and Perceptions.

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.

Long-term Association of Depression Symptoms and Antidepressant Medication Use With Incident Cardiovascular Events in the Look AHEAD (Action for Health in Diabetes) Clinical Trial of Weight Loss in Type 2 Diabetes.

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 <10 or ≥10). ADM use was coded from participants' prescription medications. Four composite CVD outcomes were defined in the study protocol. Sex-stratified Cox proportional hazards models were adjusted for a range of baseline covariates. 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.

Distinguishing Comorbidity, Disability, and Frailty.

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.

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

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

The Effect of Intentional Weight Loss on Fracture Risk in Persons With Diabetes: Results From the Look AHEAD Randomized Clinical Trial.

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/m2 . Weight loss over the intervention period (median 9.6 years) was 6.0% in ILI and 3.5% in DSE. A total of 731 participants had a confirmed incident fracture (358 in DSE versus 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 to 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. © 2017 American Society for Bone and Mineral Research.

Effect of a long-term intensive lifestyle intervention on prevalence of cognitive impairment.

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. CLINICALTRIALSGOV 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.

Effect of a Long-Term Intensive Lifestyle Intervention on Cognitive Function: Action for Health in Diabetes Study.

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.

Primary care-public health linkages: Older primary care patients with prediabetes & type 2 diabetes encouraged to attend community-based senior centers.

The Institute of Medicine (IOM) suggests that primary care-public health integration can improve health outcomes for vulnerable patients, but the extent to which formal linkages may enhance patients' use of community resources, or the factors that may influence providers to encourage their patients to use these resources, remain unclear. We conducted baseline assessments in 2014-2015 with 149 older adults with prediabetes or diabetes who had recently joined three senior centers linked to a network of primary care clinics in San Antonio, Texas. In addition to collecting sociodemographic and clinical characteristics, we asked members to identify their source of primary care and whether a health care provider had encouraged them to go to the senior center. We also asked members why they had joined the senior centers and which programs interested them the most. Members' source of primary care was not associated with being encouraged to attend the senior centers by a health care professional. Multivariable analysis indicated that participants with total annual household incomes of $20,000 or less [OR = 2.78; 95% CI = (1.05, 7.14)] and those reporting 12 years of education or less [OR = 3.57; 95% CI = (1.11, 11.11)] were significantly more likely to report being encouraged to attend the senior center by a health care provider. Providers who are aware of community-based resources to support patient self-management may be just as likely to encourage their socioeconomically vulnerable patients with prediabetes or diabetes to use them as providers who have a more formal partnership with the senior centers.

Association of Weight Loss Maintenance and Weight Regain on 4-Year Changes in CVD Risk Factors: the Action for Health in Diabetes (Look AHEAD) Clinical Trial.

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.