BACKGROUND Weight loss is recommended for overweight and obese individuals with type 2 diabetes based on short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether intensive lifestyle intervention for weight loss decreased cardiovascular morbidity and mortality in overweight or obese adults with type 2 diabetes. METHODS We randomly assigned 5,145 overweight or obese individuals with type 2 diabetes recruited at 16 US centers to intensive lifestyle intervention (the intervention group), which promoted weight loss through decreased calorie intake and increased physical activity, or diabetes support and education (the control group). The primary outcome was the first post-randomization occurrence of a composite cardiovascular outcome (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalized angina) over a planned maximum follow-up of 13.5 years. RESULTS The trial was stopped early based on a futility analysis when median follow-up was 9.6 years. Weight loss was greater in the intervention group than the control group throughout (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). Intensive lifestyle intervention also produced greater reductions in hemoglobin A1c and greater initial improvements in fitness and all cardiovascular risk factors, except LDL cholesterol. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83/100 person-years and 1.92/100 person-years, respectively; hazard ratio 0.95; 95% CI 0.83 to 1.09, p=0.505). CONCLUSION In our study, intensive lifestyle intervention focused on weight loss did not reduce cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the Department of Health and Human Services and others; ClinicalTrials.gov number, NCT00017953.)

Cost-effective strategies to maintain healthy active lifestyle in aging populations are required to address the global burden of age-related diseases. ASPREE will examine whether the potential primary prevention benefits of low dose aspirin outweigh the risks in older healthy individuals. Our primary hypothesis is that daily oral 100 mg enteric-coated aspirin will extend a composite primary endpoint termed ‘disability-free life’ including onset of dementia, total mortality, or persistent disability in at least one of the Katz Activities of Daily Living in 19,000 healthy participants aged 65 years and above (‘US minorities’) and 70 years and above (non ‘US minorities’). ASPREE is a double-blind, randomized, placebo-controlled trial of oral 100 mg enteric-coated acetyl salicylic acid (ASA) or matching placebo being conducted in Australian and US community settings on individuals free of dementia, disability and cardiovascular disease (CVD) events. Secondary endpoints are all-cause and cause specific mortality, fatal and non-fatal cardiovascular events, fatal and non-fatal cancer (excluding non-melanoma skin cancer), dementia, mild cognitive impairment, depression, physical disability, and clinically significant bleeding. To 20 September 2013 14383 participants have been recruited. Recruitment and study completion is anticipated in July 2014 and December 2018 respectively. In contrast to other aspirin trials that have largely focused on cardiovascular endpoints, ASPREE has a unique composite primary endpoint to better capture the overall risk and benefit of aspirin to extend healthy independent lifespan in older adults in the US and Australia.

Background Little is known about diet quality with a reduced-energy, low-fat, partial meal replacement (PMR) plan, especially in individuals with type 2 diabetes. The Action for Health in Diabetes (Look AHEAD) trial implemented a PMR plan in the intensive lifestyle intervention (ILI). Objective Compare dietary intake and percent meeting fat-related and food group dietary recommendations in ILI and diabetes support and education (DSE) groups at 12 months. Design Randomized controlled trial, comparing ILI to DSE, at 0- and 12-months. Participants/setting From 16 United States sites, the first 50% of participants (aged 45 to 76 years, overweight or obese, with type 2 diabetes) were invited to complete dietary assessments. Complete 0- and 12-month dietary assessments (collected between 2001 and 2004) were available on 2,397 participants (46.6% of total participants), with 1,186 randomized to DSE and 1,211 randomized to ILI. Main outcome measures A food frequency questionnaire assessed intake: energy; percent energy from protein, fat, carbohydrate, polyunsaturated fatty acids (PUFA), and saturated fats; trans fatty acids; cholesterol; fiber; weekly meal replacements (MRs); and daily servings from food groups from the Food Guide Pyramid. Statistical analyses performed Mixed-factor analyses of covariance (ANCOVA), using Proc MIXED with a repeated statement, with age, sex, race/ethnicity, education, and income controlled. Unadjusted chi-square tests compared percent meeting fat-related and food group recommendations at 12 months. Results At 12 months, ILI had a significantly lower fat and cholesterol intake and greater fiber intake than DSE. ILI consumed more servings/day of fruits; vegetables; and milk, yogurt & cheese; and fewer servings/day of fats, oils & sweets than DSE. A greater percentage of ILI than DSE participants met fat-related and most food group recommendations. Within ILI, a greater percentage of participants consuming ≥ 2 MRs/day than < 1 MR/day met most fat-related and food group recommendations. Conclusions The PMR plan consumed by ILI was related to superior diet quality.

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 changes during the post-intervention period of Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) and diabetes support and education (DSE; control) in individuals with overweight/obesity and type 2 diabetes and sought to identify predictors of excessive post-intervention weight loss and its association with mortality. <p>Research Design and Methods. These secondary analyses compared post-intervention weight change (year-8 to final visit [median 16 years]) in ILI and DSE in 3999 Look AHEAD participants. Using empirically derived trajectory categories, we compared four subgroups: Weight Gainers (N= 307), Weight Stable (N=1561), Steady Losers (N=1731) and Steep Losers (N=380) on post-intervention mortality, demographic variables and health status at randomization and year-8.</p> <p>Results. Post-intervention weight change averaged -3.7 ±9.5%, with greater weight loss in DSE than ILI. The steep weight loss trajectory subgroup lost on average 17.7 + 6.6%.; 30% of Steep Losers died during post-intervention follow-up vs 10-18% in other trajectories (p<. 0001). The following variables distinguished Steep Losers from Weight Stable: <i>Baseline </i>- older; longer diabetes duration; higher BMI; greater multimorbidity; <i>Intervention </i>– randomization to control group; less weight loss in years 1-8; <i>Year 8 </i>- higher prevalence of frailty, multimorbidity and depressive symptoms; lower use of weight control strategies. </p> <p>Conclusion. Steep weight losses post-intervention were associated with increased risk of mortality. Older individuals with longer duration diabetes and multi-morbidity should be monitored for excessive, unintentional weight loss. </p>

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.Obesity (2020) 28, 893-901.